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Completed

NCT Number: NCT06616350

Impact of EsTOCma on OCD Family Members

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.

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Key information

Conditions

Obsessive-Compulsive Disorder (OCD) Alzheimer Disease Anxiety Disorders Behavior Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Obsessive-Compulsive Disorder Social Behavior Social Stigma Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat de València

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Acronym: esTOCma family

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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