ESTOCMA: Mental Health Application for Enhancing Mental Health Literacy About Obsessive-compulsive Disorder (ESTOCMA)
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Use of a mobile health application until app completion
Sponsored by

About this trial
This is an interventional prevention trial for Obsessive-Compulsive Disorder focused on measuring mental health literacy, randomized controlled trial, obsessive-compulsive disorder, stigma, seeking help
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
Sites / Locations
- University of Valencia/ Universitat de València
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate-use
Delayed use
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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).
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.
Secondary Outcome Measures
Change in Self-esteem
Score change in self-esteem from baseline to app completion. It will be assessed with the Single-Item Self-esteem Scale, a single item to measure self-esteem (i.e., I have high self-esteem) on a 5-point Likert Scale ranging from 1 ("not very true of me") to 5 ("very true of me"). The scale has strong convergent validity with the Rosenberg Self-Esteem Scale and showed similar predictive validity.
Full Information
NCT ID
NCT04777292
First Posted
February 23, 2021
Last Updated
November 1, 2022
Sponsor
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT04777292
Brief Title
ESTOCMA: Mental Health Application for Enhancing Mental Health Literacy About Obsessive-compulsive Disorder
Acronym
ESTOCMA
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
mental health literacy, randomized controlled trial, obsessive-compulsive disorder, stigma, seeking help
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate-use
Arm Type
Experimental
Arm Description
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.
Arm Title
Delayed use
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Use of a mobile health application until app completion
Other Intervention Name(s)
Use of esTOCma app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mental health literacy about obsessive-compulsive disorder
Description
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.
Time Frame
Through app completion, an average 10 days, and at 3 months follow-up
Title
Change in stigmatizing attitudes associated with obsessive-compulsive disorder
Description
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.
Time Frame
Through app completion, an average 10 days, and at 3 months follow-up.
Title
Change in social distance associated with obsessive-compulsive disorder
Description
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.
Time Frame
Through app completion, an average 10 days, and at 3 months follow-up.
Title
Change in help-seeking attitudes associated with obsessive-compulsive symptoms
Description
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).
Time Frame
Through app completion, an average 10 days, and at 3 months follow-up.
Title
Change in Obsessive-Compulsive symptoms
Description
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.
Time Frame
Through app completion, an average 10 days, and at 3 months follow-up
Secondary Outcome Measure Information:
Title
Change in Self-esteem
Description
Score change in self-esteem from baseline to app completion. It will be assessed with the Single-Item Self-esteem Scale, a single item to measure self-esteem (i.e., I have high self-esteem) on a 5-point Likert Scale ranging from 1 ("not very true of me") to 5 ("very true of me"). The scale has strong convergent validity with the Rosenberg Self-Esteem Scale and showed similar predictive validity.
Time Frame
Through app completion, an average 10 days, and at 3 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
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
No
Citations:
PubMed Identifier
35874968
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.
Results Reference
background
Learn more about this trial
ESTOCMA: Mental Health Application for Enhancing Mental Health Literacy About Obsessive-compulsive Disorder
We'll reach out to this number within 24 hrs