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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
228

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Spain
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Use of a mobile health application 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:
  • Use of esTOCma app
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.
Device: Use of a mobile health application 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:
  • Use of esTOCma app

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valencia

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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