Impact of EsTOCma on OCD Family Members
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 2
- 主要终点
- Change on mental health literacy about OCD
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •not completing one or more of the evaluation time points (pre- or post-intervention)
- •not finishing the intervention (experimental group only)
结局指标
主要结局
Change on mental health literacy about OCD
时间窗: 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.
Change in social distance
时间窗: 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.
Change in stigma associated with OCD
时间窗: 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.
Change in help-seeking intention
时间窗: 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.
次要结局
- 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)
研究者
Gemma García-Soriano
Assistant Professor of Psychology
University of Valencia