An Assessor-blinded, Randomized, 20-week, Parallel-group, Superiority Study to Compare the Efficacy of Transdiagnostic Cognitive Behavioral Therapy Versus Waiting-list in Depressive and Anxiety Symptoms of Depressive and Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)
研究概览
简要总结
This study is to examine the superiority of the combined treatments of transdiagnostic cognitive-behavior therapy (Unified Protocol; UP) and Treatment-As-Usual in comparison with the waiting-list with Treatment-As-Usual in the reduction of depressive and anxiety symptoms among depressive and anxiety disorders.
详细描述
Participants with depressive or anxiety disorders will be randomized to either Unified Protocol with Treatment-As-Usual or Wail-list with Treatment-As-Usual. Intervention period will be 20-week and the follow-up period will be 43 week from registration.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of Major Depressive Disorder, Dysthymia, Depressive Disorder Not Otherwise Specified, Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia, Agoraphobia Without History of Panic Disorder, Social Phobia(Social Anxiety Disorder), Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder Not Otherwise Specified assessed by SCID.
- •Depressive and anxiety symptoms is mild or more severe (GRID-HAMD >= 8).
- •Ages 20 years or older, and 65 years or younger at screening.
- •Subjects who give full consent in the participation of the study.
排除标准
- •No alcohol or substance use disorder in 6 months prior to the screening assessed by SCID
- •No current manic episode or current schizophrenia and other psychotic disorders at baseline assessed by SCID
- •No serious suicidal ideation at baseline (GRID-HAMD Item3 severity is 3 or higher.)
- •No life-threatening, severe or unstable physical disorders or major cognitive deficits at baseline.
- •Evidence of unable to participate half or more of the intervention phase.
- •No structured psychotherapy during at baseline.
- •Other relevant reason decided by the investigators.
研究组 & 干预措施
Unified Protocol with Treatment As Usual
Unified Protocol is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more adaptive ways. Individual treatment sessions will be conducted by experienced clinicians who will be trained in the administration of this protocol. A workbook will be provided to each patient as part of this manualized treatment. During this treatment period, the participants continue the Treatment As Usual.
干预措施: Unified Protocol with Treatment As Usual (Behavioral)
Unified Protocol with Treatment As Usual
Unified Protocol is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more adaptive ways. Individual treatment sessions will be conducted by experienced clinicians who will be trained in the administration of this protocol. A workbook will be provided to each patient as part of this manualized treatment. During this treatment period, the participants continue the Treatment As Usual.
干预措施: Treatment As Usual (Other)
Waitlist Control with Treatment As Usual
Waitlist participants will not receive treatment during a 20-week waitlist period, but will receive the unified protocol immediately following the 20 week waiting period. During the waitlist period, the waitlist participants continue the treatment as usual.
干预措施: Treatment As Usual (Other)
结局指标
主要结局
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)
时间窗: 21 weeks
次要结局
- Hamilton Anxiety Rating Scale 14 item(HAM-A)(21 weeks)
- Clinical Global Impression-Improvement(CGI-I)(21 weeks)
- Clinical Global Impression- Severity(CGI-S)(21 weeks)
- Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID)(21 weeks)
- Responder Status assessed by GRID-HAMD(21 weeks)
- Remission of symptoms assessed by GRID-HAMD(21 weeks)
研究者
Masaya ITO
Chief of dissemination and training at National Center of Cognitive-Behavior Therapy and Research
National Center of Neurology and Psychiatry, Japan