Can Brief, Daily Training Using a Mobile App Help Change Maladaptive Beliefs? Crossover Randomized Controlled Trial

Background Obsessive-compulsive disorder (OCD) is a disabling condition with a wide variety of clinical presentations including contamination fears, fear of harm, and relationship-related obsessions. Cognitive behavioral models of OCD suggest that OC symptoms result from catastrophic misinterpretations of commonly occurring intrusive experiences and associated dysfunctional strategies used to manage them. OCD-related maladaptive beliefs including inflated responsibility, importance and control of thoughts, perfectionism, and intolerance for uncertainty increase the likelihood of such misinterpretations. Objective Considering accumulating evidence suggesting that mobile health (mHealth) apps based on cognitive-behavioral principles may lead to significant reductions in psychopathological symptoms, we assessed the effectiveness of a novel cognitive training app (GGRO) designed to challenge OCD-related beliefs. Methods A total of 97 students were randomized to groups undertaking immediate-use (iApp) or delayed use (dApp) of GGRO. All participants were requested to complete Web-based assessments, with questionnaires relating to maladaptive beliefs, mood, and OC symptoms at baseline (T1), 15 days from baseline (T2), and 30 days from baseline (T3). Participants in iApp group started using the app at baseline and continued using the app for 15 consecutive days. They were then requested to stop using the app until T3. Participants in the dApp group were requested to wait for 15 days and only then start using the app (crossover) for 15 consecutive days. Results All participants used the app for a mean of 14.07 (SD 1.41) days with 2.94 levels per day. Consistent with previous findings, app use was associated with medium-large effect size reductions in both iApp (n=51) and dApp (n=46) groups. In the iApp group, all effects remained significant during the 15 days of follow-up. Analyses focusing on the first two assessment occasions revealed significant treatment × repeated measures interactions on maladaptive beliefs, several OC symptom measures, and self-esteem. Conclusions This study provides further evidence for the efficacy of GGRO as a mobile-delivered training exercise that is useful for reducing OCD-related beliefs and symptoms. Trial Registration ClinicalTrials.gov NCT03571464; https://clinicaltrials.gov/ct2/show/NCT03571464 (Archived by WebCite at http://www.webcitation.org/7675sYPsH)

yes: all primary outcomes were signiUcantly better in intervention group vs control partly: SOME primary outcomes were signiUcantly better in intervention group vs control no statistically signiUcant difference between control and intervention potentially harmful: control was signiUcantly better than intervention in one or more outcomes inconclusive: more research is needed Otro: Approx. Percentage of Users (starters) still using the app as recommended after 3 months * Overall, was the app/intervention effective? * Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if osine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the title specify the mode of delivery with the following words: "daily training using a mobile applications 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support").
Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the title does not include non-web-based components or important cointerventions because the app platform does not include any of them.
subitem not at all important 1 2 3 4 5 essential 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.
subitem not at all important 1 2 3 4 5 essential 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the title does not mention the primary condition group, but mention the target symptom "obsessive-compulsive symptoms" 1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, in the Method it speciUes: "Ninety-seven students were randomized to immediate use (iApp) or delayed use (dApp) groups of GGRO." "Participants in iApp group started using the app at baseline and continued using the app for 15 consecutive days. They were then requested to stop using the app until T3.
Participants in the dApp group were requested to wait for 15 days and only then start using the app (cross-over) for 15 consecutive days." 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study The abstract specify the assessment was web-based.
1b-iv) RESULTS section in abstract must contain use data Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes. Does your paper address subitem 1b-v?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the abstract does not include discussion for negative trial because it is not considered as a negative trial. Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the paper speciUes objectives and hypotheses: "The aim of the present study was to further evaluate the ejcacy of GGRO reducing OCD related maladaptive beliefs and OCD symptoms. (…). Our main hypothesis was that students using GGRO immediately following baseline assessment (iApp) would exhibit greater declines in obsessive compulsive related beliefs than would students that did not use GGRO at this phase of the study (…)". METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the Method includes the description of the trial design and the allocation in the procedure section, namely "The study was a randomized controlled trial with crossover design (see Figure 1). The intervention was a mobile delivered cognitive training using GGRO." Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the manuscript does not include important changes to methods after trial commencement because there were not changes in our study after commencement.

3b-i) Bug Uxes, Downtimes, Content Changes
Bug Uxes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug Uxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have intuenced study design such as staff changes, system failures/downtimes, etc.
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the manuscript does not include bug Uxes, downtimes, of content changes because they were not necessary as they were done in a previous study.
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the paper includes inclusion criteria: "Inclusion criteria were being a Spanish at native level, having had at least experienced one stable romantic relationship and having a mobile device capable of installing the application GGRO." 4a-i) Computer / Internet literacy Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariUed.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it has been speciUed that the person should have "the possibility to use a mobile device (mobile phone or tablet) with the possibility of installing the App GGRO" Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. osine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conUrmation, phone calls) were used to detect/prevent these.
Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it was speciUed that "Participants were recruited from the University of Valencia during the Urst semester of the 2016/2017 course from nine classes at the Psychology Faculty" "Ninety-eight students attended a recruitment seminar and completed the pre-treatment evaluation (Time 0) during the seminar but through online platform. During the seminar, participants received a link for having free access to the GGRO platform. For the assessments at Time 1 and Time 2, participants received an email with a link to access to the questionnaires via the online platform.

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it was speciUed that " The students were invited to voluntarily participate in a study about beliefs, self-talk, mood and relationships. Participants interested in participating were informed of their rights and provided online informed consent in accordance with university IRB standards".
Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it was speciUed that "Participants were recruited from the University of Valencia during the Urst semester of the 2016/2017 course from nine Psychology classes at the Psychology Faculty".
4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise. 5) The interventions for each group with sujcient details to allow replication, including how and when they were actually administered Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it was speciUed that participants completed the questionnaires "completed the pre-treatment evaluation (Time 0) during the seminar through online platform. During the seminar, participants received a link for having free access to the GGRO platform. For the assessments at Time 1 and Time 2, participants received an email with a link to access to the questionnaires via the online platform".
4b-ii) Report how institutional ajliations are displayed Report how institutional ajliations are displayed to potential participants [on ehealth media], as ajliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the manuscript does not address the ajliations.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-i) Mention names, credential, ajliations of the developers, sponsors, and owners Mention names, credential, ajliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Contict of interest" section or mentioned elsewhere in the manuscript).
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study The paper speciUes that "The cognitive training exercise was developed by GD an expert in OCD and related disorders in collaboration with GI a mobile platform developer". It is also speciUed in the contict of interests that "One of the authors (GD) is a co-developer of GGRO. GD is also a co-founder of GGapps.net. GGRO is the subject of this evaluation and therefore has Unancial interest to GGapps.net" 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the history/development process is not speciUed in the present manuscript, since it is explained in a previous paper.

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the manuscript does not specify revisions and updating because they were not relevant at this stage.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the paper does not specify quality assurance methods. -v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing towcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing towcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiUc reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the manuscript does not specify source code, screenshots/screen capture video, or towcharts of the algorism. In order to replicate the study researchers could acces to the App GGRO asking one of the authors (GD) for the link.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the manuscript does not include the digital preservation.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speciUc group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it is speciUed in the manuscript that "During the seminar, participants received a link for having free access to the GGRO platform". subitem not at all important 1 2 3 4 5 essential Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it is speciUed the Mode of delivery, features/functionalities/components of the intervention, as well as the theoretical background with explanations as the following: "It consists of training exercises intended to help people increase accessibility to functional self-statements encouraging alternative, more adaptive interpretations for thoughts, emotions and events associated with OCD. Users are presented with 'blocks' featuring statements such as "I take things as they come" or "Everything can end in a catastrophe". Users then have to respond to these statements by either pulling 'blocks' towards themselves (i.e., downwards) or throwing the blocks away from themselves (i.e., rejecting them upwards)."

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, in the manuscript it is speciUed that "Following the completion of 3-levels at a given day, a screen prompting users to stop using the app for that day appears.
Users are also advised to train once a day at a preset time rather than in response to distressing thoughts or events." 29/6/18 13:23 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the paper do not specify the level of human involvement since it is an app platform that they use everyday at the time they choose without any technical or professional assisstance.

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it is speciUed that "Push notiUcations remind users to use the app each day." 29/6/18 13:23 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, it is not speciUed in the manuscript any co-intervention since it is a nonclinical sample and they do not receive any co-intervention.
Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, in the manuscript it is speciUed that "Ninety-eight students attended a recruitment seminar and completed the pre-treatment evaluation (Time 0) during the seminar through online platform". "For the assessments at Time 1 and Time 2, participants received an email with a link to access to the questionnaires via the online platform." 29/6/18 13:23 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text No, it is not speciUed that the questionnaires were validated for online use because it has not been tested. However, the internal consistency is speciUed for each questionnaire for our speciUc data.

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was deUned/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was deUned/measured/monitored (logins, logUle analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial.
Does your paper address subitem 6a-ii?
Copy and paste relevant sections from manuscript text Yes, it is speciUed in the manuscript that "Participants used the app for a mean 14.07 (SD = 1.41) days with a mean of 2.94 (SD = 0.37) levels per day. Additionally, the highest level completed by participants was mean 40.93 (SD = 10.20)". Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the manuscript do not specify any change to trial outcomes after the trial commenced because it was not pertinent. Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the paper do not specify how the sample size was calculated.
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the paper do not specify any interim analyses and stopping guidelines as it was not applicable.
8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the method used to generate the random allocation sequence was speciUed as follows: "Randomization was carried out on a 1:1 ratio and based on a prespeciUed computer-generated randomization list (randomizer.org). Group assignment was performed onsite using the next available number on the randomization list. It was not possible to blind participants to their treatment allocation." Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it was speciUed that "Group assignment was performed onsite using the next available number on the randomization list. It was not possible to blind participants to their treatment allocation.", but it was not speciUed details of any restriction because they were not applied any restriction.
10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the method used to generate the random allocation sequence was speciUed as follows: "Randomization was carried out on a 1:1 ratio and based on a prespeciUed computer-generated randomization list (randomizer.org). Group assignment was performed onsite using the next available number on the randomization list. It was not possible to blind participants to their treatment allocation." Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it is speciUed that it was generated based on a prespeciUed computer generated randomization list (randomizer.org). It is not speciUed who enrolled participants. 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, there was not speciUed the who was blinded because every participant and researcher knowed the allocation group. It was speciUed that "It was not possible to blind participants to their treatment allocation".
11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study It was speciUed that "It was not possible to blind participants to their treatment allocation". 29/6/18 13:23 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form Página 33 de 50 https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS6…m?hl=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 11b) If relevant, description of the similarity of interventions (this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study It is not described the similarity of interventions because the study used a wainting list control group with the same intervention after a period of 15 days Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the manuscript describes the statistical methods used to compare groups for primary and secondary outcomes as follows: "t tests and χ2 were calculated to analyse differences in age, duration of the relationship in months, gender, and socioeconomic level between groups, and for all the measures: OCI-r, OBQ-20, PROCSI, ROCI, DASS, and SISE. A series of repeated measures ANOVA with Bonferroni adjustment were calculated in order to analyse the effect of the App in both groups." 29/6/18 13:23 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it is speciUed in the manuscript "In order to avoid overoptimistic estimates of the ejcacy of the training (Gupta, 2011), an intention-to-treat analysis using the Last-Observation-Carried-Forward method was used (Overall, Tonidandel, & Starbuck, 2009)".
Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, in the manuscript it is speciUed "A series of repeated measures ANOVA with Bonferroni adjustment were calculated in order to analyse the effect of the App in both groups". Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it is speciUed in the manuscript "Participants were informed of their rights and provided online informed consent in accordance with university IRB standards. The study received the approval of the University of Valencia ethic's committee (H-1488382719361)."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained osine or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it is speciUed in the manuscript "Participants were informed of their rights and provided online informed consent in accordance with university IRB standards." 29/6/18 13:23 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons X26-iii) Safety and security procedures Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the paper does not address the safety and security procedures. This information was provided to the ethical commitees.
Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the manuscript speciUes the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome. Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT tow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the manuscript includes a CONSORT tow diagram with information about losses and exclusions for each group.

13b-i) Attrition diagram
Strongly recommended: An attrition diagram (e.g., proportion of participants still logging in or using the intervention/comparator in each group plotted over time, similar to a survival curve) or other Ugures or tables demonstrating usage/dose/engagement.

Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the Ugure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the manuscript includes a tow diagram with the proportion of participants in each over time.
Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it is speciUed that "Participants were recruited from the University of Valencia during the Urst semester of the 2016/2017 course".
subitem not at all important 1 2 3 4 5 essential 14b) Why the trial ended or was stopped (early)

15) A table showing baseline demographic and clinical characteristics for each group
NPT: When applicable, a description of care providers (case volume, qualiUcation, expertise, etc.) and centers (volume) in each group 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., signiUcant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the paper does not address critical "secular events" because it is not relevant.
Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study The manuscript specify age, gender, and socio-economic status. The education is known because all of them were university students.

16-i) Report multiple "denominators" and provide deUnitions
Report multiple "denominators" and provide deUnitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speciUc pre-deUned time points of interest (in absolute and relative numbers per group). Always clearly deUne "use" of the intervention.
subitem not at all important 1 2 3 4 5 essential 17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% conUdence interval) Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the manuscript speciUes the number of participants in each analysis.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it is speciUed in the manuscript "In order to avoid overoptimistic estimates of the ejcacy of the training (Gupta, 2011), an intention-to-treat analysis using the Last-Observation-Carried-Forward method was used (Overall, Tonidandel, & Starbuck, 2009)".
Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the paper includes information about the primary and secondary outcome.
subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-speciUed from exploratory 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational deUnitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is deUned (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it is included in the manuscript that "Participants used the app for a mean 14.07 (SD = 1.41) days with a mean of 2.94 (SD = 0.37) levels per day.
Additionally, the highest level completed by participants was mean 40.93 (SD = 10.20)." Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the manuscript includes other analyses performed.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the manuscript do not include analysis comparing only users Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study No, the manuscript does not specify harms or unintended effects because it is not applicable. Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the discussion restates the study questions and summarize the answers suggested by the data.

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the paper address limitations of the study: "Although recent reviews support the utility of nonclinical participants in OCD related research and taxometric Undings suggest a dimensional view of OC-related beliefs and symptoms, future studies may assess the usefulness of GGRO in individuals with OCD." "Previous research using similar methodologies showed comparable dropout rates [50,51].
We also performed intention-to-treat analysis with the Last-Observation-Carried-Forward method [42] to prevent overestimation of treatment effects. Nevertheless, care should be taken in the interpretation of our results and future studies may beneUt from the use of additional dropout reduction strategies (e.g., monitory or course credit compensation)." 29/6/18 13:23 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the paper indicates the generalisability to anothers populations: at OCD risk populations, as relapse prevention for OCD patients.
21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study It is speciUed that"clinical studies may consider using this platform as an accessible, alternative method for relapse prevention". Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Reg. Number: ClinicalTrials.gov ID: NCT03571464 Study of the Ejcacy of GGRO: a Novel Cognitive Training Does your paper address CONSORT subitem 24? * Cite a Multimedia Appendix, other reference, or copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study The full trial protocol can be accessed in ClinicalTrials.gov 29/6/18 13:23 CONSORT-EHEALTH (V 1.6.1) -Submission/Publication Form About the CONSORT EHEALTH checklist Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, it is speciUed that "This study was supported by the Spanish MINECO-Grant PSI2013-44733-R and Acciones Especiales, University of Valencia -Grant UV-INV-AE17-70620" X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests (Unancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briety explain why the item is not applicable/relevant for your study Yes, the paper states that "The third author (GD) is a co-developer of GGRO. GD is also a co-founder of GGapps.net. GGRO is the subject of this evaluation and therefore has Unancial interest to GGapps.net." As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?
Adding more information to specify the Method section.
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * We spent approximately 6 hours As a result of using this checklist, do you think your manuscript has improved? * Would you like to become involved in the CONSORT EHEALTH group?
This would involve for example becoming involved in participating in a workshop and writing an "Explanation and Elaboration" document