ESTOCMA: Mental Health Application for Enhancing Mental Health Literacy About Obsessive-compulsive Disorder

NCT04777292 | Completed

• 2 other identifiers: 29401RTI2018-098349-B-I00
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

mental health literacy; randomized controlled trial; obsessive-compulsive disorder; stigma; seeking help

Outcome Measures

Primary Outcomes (5)

• Change in mental health literacy about obsessive-compulsive disorder

  Score change in mental health literacy (MHL) from baseline to app completion. MHL will be assessed through a self-report questionnaire developed ad hoc to assess general OCD knowledge and OCD identification. It is composed by 8 items with different alternatives. Correct answers will be computed. Higher score indicates higher number of correct answers, that is, higher OCD knowledge and identification.

  Through app completion, an average 10 days, and at 3 months follow-up

• Change in stigmatizing attitudes associated with obsessive-compulsive disorder

  Score change in stigma from baseline to app completion. Stigma will be assessed by the Spanish Mental Illness Stigma Attribution Questionnaire. It is composed by 27 items and a Likert scale from 1 to 9. Higher scores indicate higher stigmatizing attitudes.

  Through app completion, an average 10 days, and at 3 months follow-up.

• Change in social distance associated with obsessive-compulsive disorder

  Score change in social distance from baseline to app completion. Social distance will be measured through a self-report questionnaire: Social Distance Scale, 7 items, Likert scale from 0 to 3. Higher scores, higher social distance.

  Through app completion, an average 10 days, and at 3 months follow-up.

• Change in help-seeking attitudes associated with obsessive-compulsive symptoms

  Score change in attitudes toward seeking help from baseline to app completion. It will be assessed with a self-report questionnaire assessing intention of seeking from formal/ informal sources of help: the General Help Seeking Questionnaire. It is composed by 7 items with a Likert scale from 1 to 7. Higher scores indicate higher intentions of asking for help except in item 7 (reversed score).

  Through app completion, an average 10 days, and at 3 months follow-up.

• Change in Obsessive-Compulsive symptoms

  Score change on distress caused by obsessive-compulsive symptoms from baseline to app completion.. It will be assessed with the Obsessive-Compulsive Inventory-Revised. It is an 18-item self-report questionnaire, rated on a 4-point scale ranging from 1 ("not at all") to 4 ("extremely") that provides a total score (ranging from 0 to 72) and scores on six subscales: washing, checking, ordering, obsessing, hoarding and neutralizing. The total score will be used.

  Through app completion, an average 10 days, and at 3 months follow-up

Secondary Outcomes (1)

• Change in Self-esteem

  Through app completion, an average 10 days, and at 3 months follow-up

Study Arms (2)

Immediate-use

EXPERIMENTAL

Immediate use of esTOCma mobile app. Participants will use the mobile application immediately after the baseline assessment (T0) during approximately 10 days or until app completion.

Device: Use of a mobile health application until app completion

Delayed use

ACTIVE COMPARATOR

Delayed use of esTOCma mobile app. Participants will start using the app 10 days after the first assessment (T0), and immediately after the T1 assessment.

Device: Use of a mobile health application until app completion

Interventions

Use of a mobile health application until app completion DEVICE

Participants are asked to use esTOCma app approximately during 10 days, until app completion. This app has been designed to increase knowledge about obsessive-compulsive disorder (OCD), help seeking attitudes, and reduce stigmatizing attitudes. 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.

Also known as: Use of esTOCma app

Delayed use; Immediate-use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having 18 years old or more
• mobile phone

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

University of Valencia/ Universitat de València

Valencia, 46010, Spain

Location

Related Publications (2)

• 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.

  PMID: 35874968 BACKGROUND

• Garcia-Soriano G, Arnaez S, Chaves A, Del Valle G, Roncero M, Moritz S. Can an app increase health literacy and reduce the stigma associated with obsessive-compulsive disorder? A crossover randomized controlled trial. J Affect Disord. 2024 Apr 1;350:636-647. doi: 10.1016/j.jad.2024.01.168. Epub 2024 Jan 20.

  PMID: 38253133 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Social Stigma

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 2, 2021
• Study Start: December 21, 2021
• Primary Completion: April 30, 2022
• Study Completion: July 30, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)