Clinical trial NCT06616350: Impact of EsTOCma on OCD Family Members
Official title: Impact of EsTOCma on OCD Family Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder (OCD)
Keywords: stigma
obsessive-compulsive disorder
family
mental health literacy
esTOCma
app
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change on mental health literacy about OCD
timeFrame: through study completion, an average of 10 days
measure: Change in social distance
timeFrame: through study completion, an average of 10 days
measure: Change in stigma associated with OCD
timeFrame: through study completion, an average of 10 days
measure: Change in help-seeking intention
timeFrame: through study completion, an average of 10 days
Secondary outcomes:
measure: Change in obsessive-compulsive symptoms
timeFrame: through study completion, an average of 10 days
measure: Change on self-esteem
timeFrame: through study completion, an average of 10 days
Other outcomes:
measure: Level of acceptability
timeFrame: through study completion, an average of 10 days
measure: System usability level
timeFrame: through study completion, an average of 10 days
Locations:
city: Valencia
country: Spain
facility: Universitat de València
Study officials:
affiliation: Universitat de València
name: Gemma García-Soriano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.