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Mobile App for Obsessive-compulsive Disorder in Adolescents

Primary Purpose

Obsessive-Compulsive Disorder in Adolescence

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)
GGN-AD (GG Neutral - Adolescents)
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obsessive-Compulsive Disorder in Adolescence focused on measuring obsessive-compulsive disorder, cognitive therapy, maladaptive beliefs, mobile app, adolescence

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Valencia/ Universitat de València

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

GGN-AD (GG Neutral - Adolescents)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 4, 2023
Last Updated
October 2, 2023
Sponsor
University of Valencia
Collaborators
Ministry of Science and Innovation
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1. Study Identification

Unique Protocol Identification Number
NCT06033391
Brief Title
Mobile App for Obsessive-compulsive Disorder in Adolescents
Official Title
Promoting Mental Health in Adolescents Through Mobile Apps: the Case of Obsessive-compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Ministry of Science and Innovation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder in Adolescence
Keywords
obsessive-compulsive disorder, cognitive therapy, maladaptive beliefs, mobile app, adolescence

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)
Arm Type
Experimental
Arm Description
The experimental group will use the GGOC-AD module for 14 days after the first assessment.
Arm Title
GGN-AD (GG Neutral - Adolescents)
Arm Type
Active Comparator
Arm Description
The control group will use the GGN-AD module for 14 days after the first assessment.
Intervention Type
Device
Intervention Name(s)
GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)
Intervention Description
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".
Intervention Type
Device
Intervention Name(s)
GGN-AD (GG Neutral - Adolescents)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in obsessive beliefs
Description
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.
Time Frame
Through app completion (14 days) and 1 month follow-up
Title
Change in obsessive-compulsive symptomatology
Description
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.
Time Frame
Through app completion (14 days) and 1 month follow-up
Secondary Outcome Measure Information:
Title
Change in emotional symptoms
Description
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.
Time Frame
Through app completion (14 days) and 1 month follow-up
Title
Change in self-esteem
Description
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.
Time Frame
Through app completion (14 days) and 1 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gemma García-Soriano
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Valencia/ Universitat de València
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Share all IPD that underlie results in a publication.
IPD Sharing Time Frame
It will be available for 3 months after the publication of the study.
IPD Sharing Access Criteria
Data will be available in the repository website of the University of Valencia.
IPD Sharing URL
http://roderic.uv.es/
Citations:
PubMed Identifier
30758294
Citation
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.
Results Reference
background
Links:
URL
https://play.google.com/store/apps/details?id=air.com.samuramu.gg.oc
Description
Link to download the app from Google Play

Learn more about this trial

Mobile App for Obsessive-compulsive Disorder in Adolescents

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