Impact of EsTOCma on OCD Family Members

NCT ID: NCT06616350

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-04

Study Completion Date

2022-09-30

Brief Summary

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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

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Conditions

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Obsessive-Compulsive Disorder (OCD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group

Participants used the app esTOCma

Group Type EXPERIMENTAL

esTOCma: an app to fight stigma associated with OCD

Intervention Type 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.

Control group

Participants did nothing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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esTOCma: 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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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Gemma García-Soriano

Assistant Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gemma García-Soriano, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat de València

Locations

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Universitat de València

Valencia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 38253133 (View on PubMed)

Related Links

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Other Identifiers

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1276901_FAMILY

Identifier Type: -

Identifier Source: org_study_id

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