Impact of EsTOCma on OCD Family Members

NCT06616350 | Completed

• 1 other identifier: 1276901_FAMILY
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder (OCD)

Keywords

stigma; obsessive-compulsive disorder; family; mental health literacy; esTOCma; app

Outcome Measures

Primary Outcomes (4)

• Change on mental health literacy about OCD

  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

  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

  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

  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 Outcomes (2)

• Change in obsessive-compulsive symptoms

  through study completion, an average of 10 days

• Change on self-esteem

  through study completion, an average of 10 days

Other Outcomes (2)

• Level of acceptability

  through study completion, an average of 10 days

• System usability level

  through study completion, an average of 10 days

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants used the app esTOCma

Device: esTOCma: an app to fight stigma associated with OCD

Control group

NO INTERVENTION

Participants did nothing

Interventions

esTOCma: an app to fight stigma associated with OCD DEVICE

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• not completing one or more of the evaluation time points (pre- or post-intervention)
• not finishing the intervention (experimental group only)

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Universitat de València

Valencia, 46010, Spain

Location

Related Publications (1)

• Garcia-Soriano G, Arnaez S, Chaves A, Del Valle G, Roncero M, Moritz S. Can an app increase health literacy and reduce the stigma associated with obsessive-compulsive disorder? A crossover randomized controlled trial. J Affect Disord. 2024 Apr 1;350:636-647. doi: 10.1016/j.jad.2024.01.168. Epub 2024 Jan 20.

  PMID: 38253133 BACKGROUND

Related Links

• Link to download the app from Google Play
• Link to download the app for iOs

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Social Stigma; Alzheimer Disease

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Social Behavior; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Gemma García-Soriano, PhD

  Universitat de València

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Model Details: This study is a two-arm randomized controlled trial with measurements taken at two time points: pre-intervention and post-intervention. Participants who met the inclusion criteria were automatically randomized within the app into either the experimental or control group using a 1:1 allocation ratio. The experimental group received the intervention through the esTOCma app, and completed the assessment questionnaires before and after the intervention. Participants in the control group did not receive the intervention and completed the assessment questionnaires again 10 days after the pre-assessment (post-intervention).

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 27, 2024
• Study Start: April 4, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: It will be available for 3 months after the publication of the study.
• Access Criteria: Data will be available in the repository ZENODO

Locations

ES (1)