Study of the Efficacy of GGRO: a Novel Cognitive Training App

Study Overview
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Brief Summary
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The aim of the present study was to evaluate the efficacy of GGRO reducing OCD related maladaptive beliefs and OCD symptoms. Specifically, a randomized controlled trial with crossover design was carried out in non-clinical population to assess pre-post changes in levels of OCD-related maladaptive beliefs and OCD symptoms, including relationship OCD (ROCD) symptoms, self-esteem, and depressive symptoms following 15 days of using GGRO.

Detailed Description
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The implementation of Information and Communication Technologies in the treatment or prevention of OCD symptoms has been significantly lower compared to with its application in other anxiety disorders. Recently, an exploratory study evaluated a brief, game-like, training exercise for challenging OCD-beliefs delivered via a mobile application platform named GGRO. However, more studies are needed to test the efficacy.

Official Title
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Can Brief, Daily Training Using a Mobile Applications Help Change Maladaptive Beliefs? A Cross-over Randomized-control Study Evaluating the Efficacy of GGRO in Reducing Maladaptive Beliefs and Obsessive-compulsive Symptoms

Conditions
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Obsessive Thoughts

Intervention / Treatment
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* Device: GGRO Mobile App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being a Spanish at native level, and having a mobile device capable of installing the application GGRO Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants were requested to complete web-based assessment, with questionnaires relating to maladaptive beliefs, mood and OC symptoms at baseline (T1), 15 days following baseline (T2) and 30 days following baseline (T3). Participants in Immediate use GGRO 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 Delayed use GGRO group were requested to wait for 15 days and only then start using the app (cross-over) for 15 consecutive days.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate use GGRO Mobile App<br>The group starts using the GGRO Mobile App immediately after the first assessment (T1) for 15 days. | Device: GGRO Mobile App<br>* GGRO was designed to challenge maladaptive beliefs that underlie common OCD symptoms (e.g., contamination, repugnant thoughts) as well as relationships obsessions. 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).<br>|
| Active Comparator: Delayed use GGRO Mobile App<br>Delayed use GGRO Mobile App group started using the App 15 days after the first assessment (T2). | Device: GGRO Mobile App<br>* GGRO was designed to challenge maladaptive beliefs that underlie common OCD symptoms (e.g., contamination, repugnant thoughts) as well as relationships obsessions. 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in obsessive beliefs | Score change in obsessive compulsive maladaptive beliefs measured by the short form of the Obsessive Beliefs Questionnaire (OBQ-20). Total score is computed as a mean of the 20 items, ranging from 1 disagree very much to 7 agree very much. Higher scores indicate the person has more obsessive beliefs. | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in obsessive compulsive symptoms | Score change in obsessive-compulsive symptoms measured by the Obsessive Compulsive Inventory- Revised version (OCI-R). Total score is computed as a mean of the 18 items, ranging from 0 not at all to 4 Extremely. Higher scores indicate a greater presence of obsessive-compulsive symptoms. | 15 days | 
| Change in depression symptoms | Score change in depression symptoms measured by Depression, Anxiety and Stres Scale (DASS). The depression scale is composed by the mean of 7 items, ranging from 0 did not apply to me at all to 3 applied to me very much, or most of the time. Higher scores indicate a greater presence of obsessive -compulsive symptoms. | 15 days | 
| Change in Self-Esteem | Change in score of Single Ítem Self Esteem Scale (SISE). Self-Esteem is measured with this single item ranging from 1 not very true for me to 9 very true for me. Higher scores indicates a higher Self-Esteem. | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obsessive compulsive disorder, cognitive therapy, maladaptive beliefs, mobile app