Mobile App for Obsessive-compulsive Disorder in Adolescents
Promoting Mental Health in Adolescents Through Mobile Apps: the Case of Obsessive-compulsive Disorder
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Gemma García-Soriano
- Phone Number: +34 963983389
- Email: gemma.garcia@uv.es
Study Locations
-
-
-
Valencia, Spain, 46010
- University of Valencia/ Universitat de València
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)
The experimental group will use the GGOC-AD module for 14 days after the first assessment.
|
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".
|
|
Active Comparator: GGN-AD (GG Neutral - Adolescents)
The control group will use the GGN-AD module for 14 days after the first assessment.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in obsessive beliefs
Time Frame: Through app completion (14 days) and 1 month follow-up
|
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
Time Frame: Through app completion (14 days) and 1 month follow-up
|
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
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in self-esteem
Time Frame: Through app completion (14 days) and 1 month follow-up
|
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
|
|
Change in emotional symptoms
Time Frame: Through app completion (14 days) and 1 month follow-up
|
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
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Gemma García-Soriano, University of Valencia
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2557724
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.