Clinical trial NCT06033391: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder in Adolescence
Keywords: obsessive-compulsive disorder
cognitive therapy
maladaptive beliefs
mobile app
adolescence
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Innovation, Spain
First posted: 2023-09-13
Enrollment: 94
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in obsessive beliefs
timeFrame: Through app completion (14 days) and 1 month follow-up
measure: Change in obsessive-compulsive symptomatology
timeFrame: Through app completion (14 days) and 1 month follow-up
Secondary outcomes:
measure: Change in emotional symptoms
timeFrame: Through app completion (14 days) and 1 month follow-up
measure: Change in self-esteem
timeFrame: Through app completion (14 days) and 1 month follow-up
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia/ Universitat de València
Study officials:
affiliation: University of Valencia
name: Gemma García-Soriano
role: PRINCIPAL_INVESTIGATOR
References:
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.