Transdiagnostic Versus Diagnosis-specific Cognitive-behavioral Therapy for Anxiety Disorders: a Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Feasibility measure 3
研究概览
简要总结
The primary aim of the pilot study is to investigate the feasibility of conducting a randomized controlled trial (RCT) comparing the effects of transdiagnostic and diagnosis-specific cognitive-behavioral therapy (CBT) for patients with anxiety disorders in routine psychiatric outpatient care in Stockholm, Sweden. It is hypothesized that an RCT is feasible in terms of recruitment, retention, therapist competence and adherence to treatments, and that the treatments are well received by participants.
详细描述
Aim
The primary aim of the pilot study is to investigate the feasibility of conducting an RCT comparing the the effects of two types of protocol-based individual CBT for patients with anxiety disorders: transdiagnostic CBT using the unified protocol (UP) and diagnosis-specific CBT using single disorder protocols (SDP). The aim of a future RCT is to replicate the only equivalence RCT of the UP and SDPs for patients with anxiety disorders (Barlow et al., 2017). Feasibility is investigated in terms of a) recruitment of participants across diagnoses, b) retention of participants and data loss at post treatment, c) therapist competence in and adherence to the UP and SDPs, d) treatment credibility and expectancy of improvement and treatment satisfaction, and e) adverse effects. A secondary aim is to explore the effects of the treatments in terms of a) clinical severity of diagnosis, b) anxiety and depressive symptoms, and c) functional impairment and quality of life.
Design
Randomized controlled design by which the UP is compared to SDPs. Randomization of participants is conduced using a 1:1 ratio. A sequence of random numbers are generated per therapist by an independent assistant using an online random number service. The study is conducted in routine psychiatric outpatient care at clinics in Stockholm, Sweden.
Participants
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators are blinded to treatment condition in the analysis phase. Outcome assessors conducting diagnostic interviews and clinical severity ratings are blinded to treatment condition at post assessment.
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
- 否
入选标准
- •18-65 years of age,
- •Being able to speak Swedish without interpreter support,
- •A principal diagnosis of panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, or posttraumatic stress disorder, and
- •Pharmacological treatment (if any) that is stable six weeks prior to treatment start
排除标准
- •Current diagnosis of psychotic disorder, bipolar disorder, or moderate to severe substance use disorder,
- •Moderate to severe risk of suicide,
- •Psychiatric, somatic, or social problems which require other management or intervention than cognitive-behavioral therapy, and
- •Other simultaneous psychological treatment
结局指标
主要结局
Feasibility measure 3
时间窗: Prior to pre assessment, up to 6 months
Therapist competence in and adherence to the unified protocol according to the UP Adherence and Competence Scale, and diagnosis-specific cognitive-behavioral therapy according to the Cognitive Therapy Scale-Revised
Feasibility measure 4
时间窗: During treatment Week 2
Treatment credibility and expectancy of improvement according to the Credibility/Expectancy Questionnaire
Feasibility measure 5
时间窗: At post assessment, up to 18 weeks
Treatment satisfaction according to the Client Satisfaction Questionnaire
Feasibility measure 6
时间窗: At post assessment, up to 18 weeks
Adverse effects according to the Negative Effects Questionnaire
Feasibility measure 1
时间窗: Prior to pre assessment, up to 1 month
Recruitment of participants: the number of participants per diagnosis included in the study
Feasibility measure 2
时间窗: During treatment, up to 18 weeks
Attrition: the number of participants dropping out of treatment
次要结局
- Change in Overall Depression Severity and Impairment Scale(Change from baseline at up to 18 weeks)
- Change in Overall Anxiety Severity and Impairment Scale(Change from baseline at up to 18 weeks)
- Change in Clinical Severity Rating - primary outcome measure for preliminary exploration of treatment effects(Change from baseline at up to 18 weeks)
- Change in EuroQol Five Dimensional Questionnaire(Change from baseline at up to 18 weeks)
- Change in Eysenck Personality Questionnaire - Revised(Change from baseline at up to 18 weeks)
- Change in Diagnosis-specific symptoms measures(Change from baseline at up to 18 weeks)
- Change in World Health Organization Disability Assessment Schedule(Change from baseline at up to 18 weeks)
研究者
Benjamin Bohman
Study Principal Investigator
Karolinska Institutet