Mobile App for Obsessive-compulsive Disorder in Adolescents

Obsessive-Compulsive Disorder in Adolescence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06033391
• Other study ID #: 2557724
• Status: Completed
• Phase: N/A
• Start date: April 9, 2024
• Est. completion date: May 24, 2024

Study information

• Verified date: June 2024
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 24, 2024
• Est. primary completion date: May 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 17 Years

Eligibility

Inclusion Criteria:

1. To have signed the informed consent, both the adolescents and their parents or legal guardians.

2. Being enrolled in 4th level of Obligatory Secondary Education of the Spanish Education System (ISCED levels 2 and 3 in the International Standard Classification of Education)

3. To have a mobile phone (indistinctly Android or iOS mobile system) with Internet access.

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder
• Obsessive-Compulsive Disorder in Adolescence

Intervention

Device:
• GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)
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".
• GGN-AD (GG Neutral - Adolescents)
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.

Locations

Country	Name	City	State
Spain	University of Valencia/ Universitat de València	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Ministry of Science and Innovation

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Roncero M, Belloch A, Doron G. Can Brief, Daily Training Using a Mobile App Help Change Maladaptive Beliefs? Crossover Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Feb 13;7(2):e11443. doi: 10.2196/11443. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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

External Links

•   Link to download the app from Google Play