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Impact of EsTOCma on OCD Family Members

Impact of EsTOCma on OCD Family Members

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06616350
Acronym
esTOCma family
Enrollment
211
Registered
2024-09-27
Start date
2022-04-04
Completion date
2022-09-30
Last updated
2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-Compulsive Disorder (OCD)

Keywords

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

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.

Interventions

DEVICEesTOCma: an app to fight stigma associated with OCD

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.

Sponsors

University of Valencia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in help-seeking intentionthrough study completion, an average of 10 daysScore 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.
Change on mental health literacy about OCDthrough study completion, an average of 10 daysScore 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 distancethrough study completion, an average of 10 daysScore 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 OCDthrough study completion, an average of 10 daysScore 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.

Secondary

MeasureTime frameDescription
Change in obsessive-compulsive symptomsthrough study completion, an average of 10 daysScore 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-esteemthrough study completion, an average of 10 daysChange 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

MeasureTime frameDescription
Level of acceptabilitythrough study completion, an average of 10 daysAfter 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.
System usability levelthrough study completion, an average of 10 daysThe 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026