Impact of EsTOCma on OCD Family Members (esTOCma family)
September 23, 2024 updated by: Gemma García-Soriano, University of Valencia
The goal of this clinical trial is to test the acceptability, feasibility, and effectiveness of esTOCma in families and relatives of individuals with obsessive-compulsive disorder (OCD).
Specifically, a randomized controlled trial with two conditions (experimental and control) has been carried out in a sample of families and relatives of individuals with obsessive-compulsive disorder to assess pre-post-intervention changes. Researchers will compare experimental and control group to see if after using the app there is: lower stigma, higher knowledge and understanding about OCD, higher intention to seek help, and higher self-esteem and lower obsessive-compulsive symptoms. and there are no changes in the control group.
The experimental group received the intervention through the esTOCma app.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
211
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
- 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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- having signed the informed consent
- being over 18 years of age;
- having an Android or iOS mobile device with Internet access
- being a family member of a person diagnosed with OCD.
Exclusion Criteria:
- not completing one or more of the evaluation time points (pre- or post-intervention)
- not finishing the intervention (experimental group only)
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Participants used the app esTOCma
|
The intervention consists of playing a serious game, called esTOCma, on a mobile phone.
In the game, players must use their knowledge to battle the stigma monster of OCD, complete 10 missions, and release 10 individuals who have been afflicted by the esTOCma monster, a creature that feeds on false beliefs and misinformation in society.
|
|
No Intervention: Control group
Participants did nothing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change on mental health literacy about OCD
Time Frame: through study completion, an average of 10 days
|
Score change on mental health literacy about OCD from baseline to after app completion in the experimental group, and no changes after 10 days in the control group.
It will be assessed with the Mental Health Literacy Questionnaire (MHL) that was designed to assess level of knowledge about OCD, specifically the understanding of OCD and its treatment.
Higher scores indicate higher knowledge.
|
through study completion, an average of 10 days
|
|
Change in social distance
Time Frame: through study completion, an average of 10 days
|
Score change in social distance from baseline to after app completion (experimental group), or no changes on the control group after 10 days.
It will be assessed with the Social Distance Scale (SDS) that employs a four-point Likert scale, ranging from 0 to 3, to assess an individual's willingness to interact with a person who has a mental disorder as depicted in the assigned OC vignette across seven different settings.
Higher scores indicate a stronger desire for social distance.
|
through study completion, an average of 10 days
|
|
Change in stigma associated with OCD
Time Frame: through study completion, an average of 10 days
|
Score change in stigma from baseline to app completion (estimation of 10 days) in the experimental group, and after 10 days in the control group.
Stigma will be assessed by the Spanish version of the Attribution Questionnaire (AQ-27) that assesses public stigma related to a vignette.
Respondents rate 27 items on a Likert-type scale from 1 to 9. Elevated scores indicate greater public stigma.
|
through study completion, an average of 10 days
|
|
Change in help-seeking intention
Time Frame: through study completion, an average of 10 days
|
Score change in help-seeking intention General after the intervention in the experimental group, and after 10 days in the control group.
It will be assessed with the Help-Seeking Questionnaire (GHSQ) that comprises 10 items assessing the intention to seek help from various sources in the event of experiencing symptoms similar to those described in the assigned OC vignette.
Higher scores indicate a greater tendency to seek help.
|
through study completion, an average of 10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in obsessive-compulsive symptoms
Time Frame: through study completion, an average of 10 days
|
Score change in obsessive-compulsive symptoms after the intervention (experimental group) or after 10 days (control group).
It will be assessed with the Obsessive-Compulsive Inventory-Revised (OCI-R), an 18-item self-report questionnaire designed to assess the severity of OC symptoms.
Higher scores indicate a greater degree of distress associated with OC symptoms.
|
through study completion, an average of 10 days
|
|
Change on self-esteem
Time Frame: through study completion, an average of 10 days
|
Change on self-esteem is measured with the Single-Item Self-Esteem Scale, a single item that measures self-esteem, with higher scores reflecting greater self-esteem
|
through study completion, an average of 10 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of acceptability
Time Frame: through study completion, an average of 10 days
|
After using the app, the acceptability level will be measured with three multiple choice questiones developed ad-hoc.
Higher scores indicated a higher level of acceptability of the application.
|
through study completion, an average of 10 days
|
|
System usability level
Time Frame: through study completion, an average of 10 days
|
The usability of the app will be assessed after using it.
We sill use the System Usability Scale to assess the usability and user satisfaction of the technology application.
Scores above 70 are indicative of good usability, with higher scores denoting superior usability.
|
through study completion, an average of 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gemma García-Soriano, PhD, Universitat de València
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)
April 4, 2022
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
September 30, 2022
Study Registration Dates
First Submitted
September 19, 2024
First Submitted That Met QC Criteria
September 23, 2024
First Posted (Actual)
September 27, 2024
Study Record Updates
Last Update Posted (Actual)
September 27, 2024
Last Update Submitted That Met QC Criteria
September 23, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1276901_FAMILY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
It will be available for 3 months after the publication of the study.
IPD Sharing Access Criteria
Data will be available in the repository ZENODO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.