Cognitive Behavioral Therapy for Health Anxiety: a Randomized Controlled Non-inferiority Trial of Internet-delivered and Face-to-Face Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Health Anxiety Inventory (HAI)
研究概览
简要总结
Background
Severe health anxiety is a highly distressing, often debilitating, psychological problem. Since the release of the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) its clinical manifestations are increasingly often referred to as Somatic Symptom Disorder (SSD) or Illness Anxiety Disorder (IAD). Despite often being overlooked in routine care, several treatments for severe health anxiety have shown great promise, the most well-established being Cognitive Behavioral Therapy (CBT). Traditionally, CBT - like most other psychotherapies - has typically been delivered face-to-face. That is, the patient physically meeting with the therapist once a week for the whole of the treatment. Internet-delivered CBT does not rest on this requirement, but has nevertheless been shown to be efficacious for severe health anxiety (see for example NCT01673035).
Aim of the study
The present study aims to compare the effects of Internet-delivered CBT and CBT face-to-face for severe health anxiety in a randomized controlled trial. A non-inferiority criterion is applied to determine if Internet-delivered CBT is at least as efficacious as its well-established predecessor.
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
- 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
- •A primary diagnosis of severe health anxiety (somatic symptom disorder or illness anxiety disorder) according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)
- •Registered citizen of Stockholm county
- •At least 18 years old
排除标准
- •Other primary axis-I disorder
- •Substance abuse or addiction during the last 6 months
- •Current or previous episode of psychosis or bipolar disorder
- •Severe major depressive disorder
- •Suicide risk
- •Personality disorder making the treatment procedure very difficult
- •Non-stable psychiatric pharmacotherapy (dosage changed during the last 2 months) and the drug is likely to affect outcome measures
- •Ongoing concurrent psychological treatment for severe health anxiety
- •Having received previous high quality Cognitive Therapy or Cognitive Behavioural Therapy during the recent year
- •Ongoing serious somatic disorder, precluding CBT
结局指标
主要结局
Health Anxiety Inventory (HAI)
时间窗: baseline, post-treatment (12 weeks), weekly during treatment, 6 month follow-up, 12 month follow-up
Change in HAI at post-treatment and follow-ups compared to baseline. Analyses will be conducted both within an intention-to-treat (ITT) framework and on a complete case basis. A non-inferiority limit of 0.3 d (effect size) will be used.
次要结局
- Illness Attitude Scale (IAS)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Anxiety Sensitivity Index (ASI)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Sheehan Disability Scale (SDS)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Self-rated health 5 (SRH-5)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Quality of Life Inventory (QOLI)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Alcohol Use Disorders Identification Test (AUDIT)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Euroqol-5D (EQ-5D)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Insomnia Severity Index (ISI)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Sickness Questionnaire (SQ)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- WHO Disability Assessment Schedule (WHODAS) 2.0, 12-item version(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Whiteley Index (WI)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Disgust Scale-Rev (DS-R)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Client Satisfaction Questionnaire (CSQ-8)(Post-treatment (12 weeks))
- Beck Anxiety Inventory (BAI)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Perceived Vulnerability for Disease (PVD)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)