Self-help Based Cognitive Behavior Therapy for Health Anxiety Delivered Via the Internet or in Book Form - the Effect of Administration Strategy and Therapist Contact: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 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, Somatic symptom disorder or Illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5), is associated with considerable personal distress, functional disability and societal costs. Several studies have demonstrated the efficacy of Cognitive Behavior Therapy (CBT) for severe health anxiety, both on anxiety itself and on secondary symptom measures (for example of depression). One published randomized controlled trial (RCT) has examined the feasibility of delivering CBT for severe health anxiety via the Internet as a form of guided self help. Participants had contact with a therapist via an e-mail-like system throughout the treatment. This approach yielded results superior to a waiting-list condition, thus potentially greatly increasing the availability of psychological treatment. However, more studies on the effects of Internet-delivered CBT are warranted (NCT01673035 being one). Additionally, little is known about the active ingredients and mechanisms of change involved in Internet-delivered CBT. For example, the significance of therapist support in relation to treatment outcomes remains to be determined. CBT-based self-help literature, so called bibliotherapy, has shown great promise in the treatment of several anxiety disorders, including panic disorder and social anxiety disorder. Two small pilot studies have indicated that bibliotherapy with no or minimal therapist contact could be suitable for treating health anxiety.
Aim of the study
The aim of the present RCT is to compare therapist-guided Internet-delivered CBT (n=33), Internet-delivered CBT without therapist guidance (n=33), CBT-based bibliotherapy without therapist guidance (n=33) and a waiting-list control condition (n=33) for adult participants with severe health anxiety.
Participants in all treatment programs are expected to be significantly improved on measures of health anxiety, compared to participants allocated to the waiting-list condition.
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
- •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)
- •At least 18 years old
- •Able to read and write in Swedish
排除标准
- •Other primary axis-I disorder
- •Ongoing substance abuse or addiction
- •Current or previous episode of psychosis or bipolar disorder
- •Severe major depressive disorder
- •Higher than 5 on the suicidality scale of the Mini International diagnostic Interview
- •Non-stable antidepressant medication (changed during the last 2 months) or not agreeing to keep dosage constant throughout the study
- •Ongoing concurrent psychological treatment for severe health anxiety
- •Having received previous high quality Cognitive Therapy or Cognitive Behavior Therapy during the recent year
- •Ongoing serious somatic disorder
结局指标
主要结局
Health Anxiety Inventory (HAI)
时间窗: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Change in HAI at post-treatment and follow-ups compared to baseline
次要结局
- Illness Attitude Scale (IAS)(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)
- Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Beck Anxiety Inventory (BAI)(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)
- Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)(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)
- Obsessive Compulsive Inventory Revised (OCI-R)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS)(baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up)
- The Swedish Scales of Personalities(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)
- Insomnia Severity Index (ISI)(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)