- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04777292
ESTOCMA: Mental Health Application for Enhancing Mental Health Literacy About Obsessive-compulsive Disorder (ESTOCMA)
November 1, 2022 updated by: Gemma García-Soriano, University of Valencia
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
228
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Valencia, Spain, 46010
- University of Valencia/ Universitat de València
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- having 18 years old or more
- mobile phone
Exclusion Criteria:
- having an obsessive-compulsive disorder diagnosis or suspictious of having OCD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate-use
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.
|
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.
Other Names:
|
Active Comparator: Delayed use
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mental health literacy about obsessive-compulsive disorder
Time Frame: Through app completion, an average 10 days, and at 3 months follow-up
|
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
Time Frame: Through app completion, an average 10 days, and at 3 months follow-up.
|
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
Time Frame: Through app completion, an average 10 days, and at 3 months follow-up.
|
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
Time Frame: Through app completion, an average 10 days, and at 3 months follow-up.
|
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
Time Frame: Through app completion, an average 10 days, and at 3 months follow-up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Self-esteem
Time Frame: Through app completion, an average 10 days, and at 3 months follow-up
|
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.
|
Through app completion, an average 10 days, and at 3 months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 21, 2021
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
July 30, 2022
Study Registration Dates
First Submitted
February 23, 2021
First Submitted That Met QC Criteria
February 25, 2021
First Posted (Actual)
March 2, 2021
Study Record Updates
Last Update Posted (Actual)
November 4, 2022
Last Update Submitted That Met QC Criteria
November 1, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29401
- RTI2018-098349-B-I00 (Other Grant/Funding Number: ERDF/Ministry Science&Innovation,State Research Agency-Spain)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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