The Efficacy of an OCD Prevention Programme for at Risk Adults: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline in depressive symptoms on the PHQ-9 after the intervention
研究概览
简要总结
The main purpose of this randomised clinical trial is to test the efficacy of a prevention program for adult who are at risk of developing OCD, thus constituting a form of tertiary prevention.
详细描述
After being informed about the study and giving written informed consent, all eligible participants will be randomised into the experimental group or the control group (TAU). Participants will be blind to the group allocation.
The experimental group will undergo a two weeks OCD prevention program, consisting of three group sessions per week.
The control group will not receive any intervention.
Researchers will compare the experimental group to the control group to test wether the prevention programme is efficient in reducing OCD symptomatology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- age over 18
排除标准
- •clinically diagnosed OCD
- •current psychiatric/psychotherapeutic treatment
- •personality disorder diagnosis
- •suicidal ideation
研究组 & 干预措施
Control
Treatment as Usual
Prevention
6 group, online sessions over two weeks. A prevention program using cognitive and behavioral strategies to reduce OCD risk factors and related symptoms.
干预措施: Prevention (Behavioral)
结局指标
主要结局
Change from baseline in depressive symptoms on the PHQ-9 after the intervention
时间窗: Baseline and Week 2
The PHQ-9 is a validated self-report instrument assessing depressive symptoms. Possible scores range from 0 to 27. Change = end of intervention score - baseline score
Change from baseline in anxiety symptoms on the GAD-7 after the intervention
时间窗: Baseline and Week 2
The GAD-7 is a validated self-report instrument assessing anxiety symptoms. Possible scores range from 0 to 21. Change = end of intervention score - baseline score
Change from baseline in OCD symptoms on the OCI-R after the intervention
时间窗: Baseline and Week 2
The OCI-R is a validated self-report instrument assessing OCD symptoms. Possible scores range from 0 to 72. Change = end of intervention score - baseline score
次要结局
- Change from baseline in resilience on the RSA after the intervention(Baseline and Week 2)
- Change from baseline in experiential avoidance on the EAQ after the intervention(Baseline and Week 2)
- Change from baseline in cognitive distortions on the OBQ-44 after the intervention(Baseline and Week 2)
- Change from baseline in uncertainty intolerance on the IUS after the intervention(Baseline and Week 2)
研究者
Roxana Cardos
Principal Investigator
Babes-Bolyai University