Impact of EsTOCma on OCD Family Members

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder (OCD)

• Registration Number: NCT06616350
• Lead Sponsor: University of Valencia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-04
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2024-09
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-27
• Last Update Posted: 2024-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change on mental health literacy about OCD	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.
Change in social distance	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.
Change in stigma associated with OCD	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.
Change in help-seeking intention	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.

Secondary Outcome Measures

Name	Time	Method
Change in obsessive-compulsive symptoms	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.
Change on self-esteem	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

Trial Locations

Locations (1)

Universitat de València; 🇪🇸 Valencia, Spain