Mobile App for Obsessive-compulsive Disorder in Adolescents

Study Overview
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Brief Summary
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The aim of the present study is to assess the efficacy of the module GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents) in reducing obsessive-compulsive disorder (OCD) related maladaptive beliefs and OCD symptoms in adolescents from 15 to 18 years old. Specifically, a randomized controlled trial with two conditions (experimental and control) will be carried out in a non-clinical adolescent population to assess pre-post-intervention changes. After 14 days of using GGOC-AD, it is expected, primarily, to find a decrease in OCD-related maladaptive beliefs and OCD symptoms. As secondary results, we do not expect changes in emotional symptomatology, but we do expect an increase in self-esteem. Additionally, these changes are expected to be found in a one-month follow-up.

Detailed Description
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Pediatric OCD is a serious problem and, if not treated early on, is associated with significant impairment. The app GGOC, aimed at working on OCD-related dysfunctional beliefs in adults, has proven in previous studies in adult clinical and non-clinical samples, to significantly decrease maladaptive beliefs associated with OCD and obsessive-compulsive symptomatology. Also, it can significantly increase self-esteem. Therefore, it is relevant to adapt the GGOC application to the adolescent population (GGOC-AD) and evaluate its effectiveness.

Official Title
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Promoting Mental Health in Adolescents Through Mobile Apps: the Case of Obsessive-compulsive Disorder

Conditions
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Obsessive-Compulsive Disorder in Adolescence

Intervention / Treatment
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* Device: GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)
* Device: GGN-AD (GG Neutral - Adolescents)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To have signed the informed consent, both the adolescents and their parents or legal guardians. For the children to be within the established age range. To have a mobile phone (indistinctly Android or iOS mobile system) with Internet access.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants that meet the inclusion criteria will complete the web-based baseline assessment (pre), with questionnaires relating to maladaptive beliefs, mood (anxiety and depressions), self-esteem and OCD symptoms. After, experimental group will use the GGOC-AD, and control group will use the GGN-AD for 14 days. Then, both groups will complete again the above-mentioned assessment instruments (post use of the app). Finally, all participants will complete the follow-up measures at one month.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)<br>The experimental group will use the GGOC-AD module for 14 days after the first assessment. | Device: GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)<br>* GGOC was originally designed to challenge maladaptive beliefs that underline OCD symptoms in adult population. It was adapted to adolescent population. It consists of statements that are presented to the user, and that can portray either negative (I can't trust myself) or positive beliefs (I have a lot of good characteristics). Users have to respond by either pulling these towards Accept or Reject.<br>|
| Active Comparator: GGN-AD (GG Neutral - Adolescents)<br>The control group will use the GGN-AD module for 14 days after the first assessment. | Device: GGN-AD (GG Neutral - Adolescents)<br>* it was designed to have a comparison group. It consists of neutral statements such as Madrid is a Spanish city, that ought not to produce changes in the direction of our hypothesis. These have to be Accepted or Rejected based on their veracity.<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 Obsessive Beliefs Questionnaire-Child Version (OBQ-CV). Total score is computed as a mean of the 44 items, ranging from 0 strongly disagree to 4 strongly agree. Higher scores indicate the person has more obsessive beliefs. | Through app completion (14 days) and 1 month follow-up | 
| Change in obsessive-compulsive symptomatology | Score change in obsessive-compulsive symptoms measured by the Obsessive Compulsive Inventory- Child Version (OCI-R-CV). Total score is computed as a mean of the 21 items, ranging from 0 never to 2 always. Higher scores indicate a greater presence of obsessive-compulsive symptoms. | Through app completion (14 days) and 1 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in emotional symptoms | Change in depression and anxiety symptoms measured by The Patient Health Questionnaire for Depression and Anxiety (PH-4). It consists of 4 items, two for Anxiety and two for Depression, with a 4-point Likert scale (from 0 = never to 3 = almost every day). Higher scores indicate a greater presence of depression or anxiety symptoms. | Through app completion (14 days) and 1 month follow-up | 
| Change in self-esteem | Change in score of Single Item Self Esteem Scale (SISE). Self-Esteem is measured with this single item ranging from 1 It is not very true for me to 7 It is very true for me. Higher scores indicate a higher self-esteem. | Through app completion (14 days) and 1 month follow-up | 

 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, adolescence