Mobile App for Obsessive-compulsive Disorder in Adolescents

Sponsor

University of Valencia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06033391

Collaborator

Ministry of Science and Innovation (Other)

100

Enrollment

Arms

2.4

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder in Adolescence	Device: GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents) Device: GGN-AD (GG Neutral - Adolescents)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 18, 2023

Anticipated Primary Completion Date :

Nov 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/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.	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".
Active Comparator: GGN-AD (GG Neutral - Adolescents) The control group will use the GGN-AD module for 14 days after the first assessment.	Device: 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.

Arm

Intervention/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.

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".

Active Comparator: GGN-AD (GG Neutral - Adolescents)

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

Device: 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.

Outcome Measures

Primary Outcome Measures

Change in obsessive beliefs [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.
Change in obsessive-compulsive symptomatology [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.

Secondary Outcome Measures

No change in emotional symptoms [Through app completion (14 days) and 1 month follow-up]
No changes 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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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.