Clinical trial NCT04777292: ESTOCMA: Mental Health Application for Enhancing Mental Health Literacy About Obsessive-compulsive Disorder
Official title: A Randomized Controlled Trial of a Mobile Health Application for Enhancing Mental Health Literacy About Obsessive-compulsive Disorder and Reduce Stigmatizing Attitudes in Community (ESTOCMA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: mental health literacy
randomized controlled trial
obsessive-compulsive disorder
stigma
seeking help
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of the study is to analyze the efficacy of a mobile health application (app) designed to increase mental health literacy, help seeking attitudes and reduce stigma associated with obsessive-compulsive disorder. A randomized controlled trial with crossover design will be carried out in non-clinical population to assess pre-post changes in levels mental health literacy, help seeking attitudes and stigma through app completion (an estimation of 10 days). Moreover, the stability of the changes will be tested at 3 months. Participants from community will be randomly assigned to one of two conditions: undertaking immediate-use or delayed use. We hypothesized that after using the app, participants will have a greater knowledge about obsessive-compulsive disorder, will be more prone to ask for help in case of showing OCD symptoms, and will show lower stigma attitudes and social distance.

Detailed description: Stigmatizing attitudes are a problem associated to mental disorders. In obsessive-compulsive disorder (OCD) stigma has been associated to shame, guilty and delay asking for help. The aim of the study is to analyze the efficacy of a mobile health application (app) designed to increase mental health literacy, help seeking attitudes and reduce stigma associated with obsessive-compulsive disorder. The app has been named esTOCma. It consists in a game in which participants are asked to fight against the OCD stigma monster through ten missions. Participants have to liberate 10 characters who are prisoners of EsTOCma monster. A randomized controlled trial with crossover design will be carried out in non-clinical population to assess pre-post changes in levels mental health literacy, help seeking attitudes and stigma through app completion. Participants from community will be randomly assigned to one of two conditions: undertaking immediate-use (experimental group) or delayed-use (wait list control group) of the intervention through the esTOCma mobile app. Participants will be randomized through the app either to the experimental or control group. Then, within each group, participants will be randomized to one of six vignettes describing different obsessive-compulsive contents, and will be asked to complete baseline questionnaires (T0). Participants in the experimental group will be allowed to start using the app immediately after completing T0 and until completing the game (approximately 10 days). Immediately after finishing the app they will be asked to complete the post intervention assessment (T1), and then, 10 days after they will be asked to complete a follow up (T2). Participants in the control group will work as a waiting list comparison, in this sense, after completing the baseline assessment (T0), they will not be allowed to use the app. Then, days after completing the baseline questionnaires will be asked to complete again the baseline assessment (T1), and then, they will be allowed to begin the game until completing it. After, they will be asked to complete the post intervention assessment (T2). All participants will be asked to complete again the questionnaires 3 months after the post intervention assessment.

Eligibility criteria: Inclusion Criteria:

* having 18 years old or more
* mobile phone

Exclusion Criteria:

- having an obsessive-compulsive disorder diagnosis or suspictious of having OCD

Primary outcomes:
measure: Change in mental health literacy about obsessive-compulsive disorder
timeFrame: Through app completion, an average 10 days, and at 3 months follow-up
measure: Change in stigmatizing attitudes associated with obsessive-compulsive disorder
timeFrame: Through app completion, an average 10 days, and at 3 months follow-up.
measure: Change in social distance associated with obsessive-compulsive disorder
timeFrame: Through app completion, an average 10 days, and at 3 months follow-up.
measure: Change in help-seeking attitudes associated with obsessive-compulsive symptoms
timeFrame: Through app completion, an average 10 days, and at 3 months follow-up.
measure: Change in Obsessive-Compulsive symptoms
timeFrame: Through app completion, an average 10 days, and at 3 months follow-up
Secondary outcomes:
measure: Change in Self-esteem
timeFrame: Through app completion, an average 10 days, and at 3 months follow-up
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia/ Universitat de València
Study officials:
References:
citation: Chaves A, Arnaez S, Castilla D, Roncero M, Garcia-Soriano G. Enhancing mental health literacy in obsessive-compulsive disorder and reducing stigma via smartphone: A randomized controlled trial protocol. Internet Interv. 2022 Jul 13;29:100560. doi: 10.1016/j.invent.2022.100560. eCollection 2022 Sep.