Mobile App for Obsessive-compulsive Disorder in Adolescents

NCT06033391 | Completed

• 1 other identifier: 2557724
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obsessive-Compulsive Disorder in Adolescence

Keywords

obsessive-compulsive disorder; cognitive therapy; maladaptive beliefs; mobile app; adolescence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in emotional symptoms

  Through app completion (14 days) and 1 month follow-up

• Change in self-esteem

  Through app completion (14 days) and 1 month follow-up

Study Arms (2)

GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)

EXPERIMENTAL

The experimental group will use the GGOC-AD module for 14 days after the first assessment.

Device: GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)

GGN-AD (GG Neutral - Adolescents)

ACTIVE COMPARATOR

The control group will use the GGN-AD module for 14 days after the first assessment.

Device: GGN-AD (GG Neutral - Adolescents)

Interventions

GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents) DEVICE

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".

GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)

GGN-AD (GG Neutral - Adolescents) DEVICE

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.

GGN-AD (GG Neutral - Adolescents)

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• To have signed the informed consent, both the adolescents and their parents or legal guardians.
• 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)
• To have a mobile phone (indistinctly Android or iOS mobile system) with Internet access.

Sponsors & Collaborators

• University of Valencia: lead
• Ministry of Science and Innovation, Spain: collaborator

Study Sites (1)

University of Valencia/ Universitat de València

Valencia, 46010, Spain

Location

Related Publications (2)

• 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.

  PMID: 30758294 BACKGROUND

• Saman Y, Pascual-Vera B, Corberan M, Arnaez S, Roncero M, Garcia-Soriano G. A mobile app to challenge obsessional beliefs in adolescents: a protocol of a two-armed, parallel randomized controlled trial. BMC Psychiatry. 2024 Apr 9;24(1):265. doi: 10.1186/s12888-024-05735-x.

  PMID: 38594680 DERIVED

Related Links

• Link to download the app from Google Play

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Gemma García-Soriano

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, associate professor

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 13, 2023
• Study Start: April 9, 2024
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: It will be available after the publication of the study.
• Access Criteria: Data will be available in a repository website: Zenodo.

Locations

ES (1)