Targeting Taboo Thoughts In Obsessive-Compulsive Disorder Using Internet- Delivered Cognitive Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- The clinician rated Yale Brown Obsessive Compulsive Scale (Y-BOCS)
研究概览
简要总结
The purpose of this pilot study is to investigate if a cognitive treatment targeting obsessive beliefs in patients with aggressive obsessions is feasible and effective as an online treatment.
详细描述
Patients with obsessive-compulsive disorder who presents with aggressive obsessions (also known as taboo thoughts e.g. fear of being a pedophile) and mental rituals have shown to respond less well to treatment. Thus, there is room for further innovation. The primary objective of this pilot study is to investigate if an internet-based cognitive therapy (I-CT) is feasible and effective in reducing the frequency and distress of aggressive obsessions. The study will also investigate if I-CT is associated with any significant side effects. Another objective of this study is to get a power estimate of the treatment effects for a subsequent randomized controlled study (RCT). This will be done by using an open pilot study with repeated measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of OCD taboo thoughts as specified in the DSM-5
- •≥ 18 years
- •Situated in Sweden
- •Informed consent
排除标准
- •No signed consent
- •Not fluent speaking in Swedish or cognitive abilities to read written material in the study
- •Adjusted pharmacological treatment the last month symptoms that may affect OCD symptoms
- •Substance dependence during the last six months
- •Psychosis
- •Ongoing mania or hypomania
- •Suicidal risk that may affect study participation
- •Personality disorder that may significantly affect the treatment participation
- •Other ongoing psychological treatments that may affect OCD-symptoms
- •Other primary psychiatric diagnosis
结局指标
主要结局
The clinician rated Yale Brown Obsessive Compulsive Scale (Y-BOCS)
时间窗: Week 0, week 10, and 6 months follow up
Change in obsessions and compulsions from baseline to week 10 and 6 months after treatment has ended. Minimum value is 0. Maximum value is 40. Higher score means more symptoms.
次要结局
- Clinical Global Impression (CGI)(Week 0, week 10 and 6 months follow-up)
- The self-rated Yale Brown Obsessive Compulsive Scale (Y-BOCS)(Weeks 0 to 10 through treatment and 6 months follow-up)
- Penn State Worry Questionnaire (PSWQ)(Week 0, week 10 and 6 months follow-up)
- Patient Satisfaction Questionnaire (PSQ)(Week 10)
- Personal Significance Scale (PSS)(Weeks 0 to 10 through treatment and 6 months follow-up)
- Work and social adjustment scale (WSAS)(Week 0, week 10 and 6 months follow-up)
- Montgomery Åsberg Depression Rating Scale - Self report (MADRS-S)(Week 0, week 10 and 6 months follow-up)
- Thought Action Fusion Scale (TAFS)(Week 0, week 10 and 6 months follow-up)
- Meta-Cognitive Questionnaire (Negative metacognitions subscale; MCQ-NC)(Week 0, week 10 and 6 months follow-up)
- Adverse events (AE)(Weeks 0 to 10 through treatment and 6 months follow-up)
研究者
Erik Andersson
Principal investigator
Karolinska Institutet