Blended Cognitive Behavioural Therapy Versus Face-to-face Cognitive Behavioural Therapy: A Randomised Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire 9-item change
研究概览
简要总结
Depression is a prevalent and disabling disorder with great cost to the individual and the society. Lately, the use of internet interventions as guided self-help has demonstrated remarkable results. However, certain shortcomings such as lack of personal adaptation has been identified.
The presents study aims to investigate the potential of blending Internet based interventions with face-to-face consultations using cognitive behavioural therapy (B-CBT). The main hypotheses are, that that B-CBT will be as clinically effective as TAU, and that it will be acceptable to patients and clinicians.
The study is designed as a two arm randomised non-inferiority trial comparing internet based B-CBT for depression to treatment as usual (TAU) defined as 12 sessions of face-to-face CBT.
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 (Investigator)
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
- •Being 18 years of age or older.
- •Meet Diagnostic and Statistic Manual of Mental Disorders 4th. edition (DSM-IV) diagnostic criteria for major depressive disorder as confirmed by the telephone administered Mini International Neuropsychiatric Interview version 5.0 (MINI)and a score of 5 or higher on the Patient Health Questionnaire nine items (PHQ-9).
排除标准
- •Current high risk of suicide according to the MINI Interview section C.
- •Co-morbid substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview.
- •Currently receiving psychological treatment for depression in primary or specialised mental health care
- •Being unable to comprehend the spoken and written language of Danish.
- •Not having access to a computer and fast Internet connection (i.e. broadband or comparable)
结局指标
主要结局
Patient Health Questionnaire 9-item change
时间窗: Change from Baseline, 3 months, 6 months, 12 months
次要结局
未报告次要终点
研究者
Kim Mathiasen
Ph.D. fellow
University of Southern Denmark