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临床试验/NCT00426426
NCT00426426已完成不适用

A Randomised Controlled Trial Comparing the Effectiveness of Cognitive Behaviour Therapy (CBT) With Metacognitive Therapy (MCT) in the Treatment of Patients With Generalised Anxiety Disorder (GAD)

Norwegian University of Science and Technology2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2007年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
STAI-T

研究概览

简要总结

Meta Cognitive Therapy (MCT) has been introduced as a new specific treatment for generalised anxiety disorder. So far, no studies have examined CBT and MCT in comparison with each other in a randomised controlled trial. Sixty patients with a diagnosis of generalised anxiety disorder will be selected and randomised into three treatment conditions. The first group (N=20) will be treated with CBT, the second group (N=20) with MCT, and the third condition is a waiting list control (N=20). The patients in both groups will have full treatment, in accordance to treatment manuals developed by the originators. Patients in the waiting list control will be randomly allocated to either CBT or MCT after 12 weeks of waiting period.

The patients will be assessed with the primary measures at pre-treatment, at the end of treatment, and at follow-up after one and two years. In addition they will be assessed weekly on symptom measures and worry outcome diary. The therapist will be treating equally amount of patients in both conditions to control for any biased distribution connected to the therapist's characteristics.

Measures will be used on at least three main sources; self-report inventories (including symptom diaries), clinical assessments by independent raters and psycho-physiological assessments.

We aim to (1) evaluate and compare the effectiveness of CBT and MCT, (2) investigate the patterns of change and the mechanisms of action involved during treatment in each of the conditions and, (3) evaluate pre and post-treatment somatic change by psycho-physiological assessments as a response to CBT and MCT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

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

入选标准

  • Signed written informed consent obtained prior to entry in the study.
  • Diagnosed with generalised anxiety disorder (DSM-IV, APA, 1994).
  • 18 years or older.

排除标准

  • Known somatic diseases
  • Past suicidal attempts and/or current intent
  • Cluster A or cluster B personality disorder
  • Substance dependence
  • Not willing to accept random allocation.
  • Patients not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial

研究组 & 干预措施

Meta-Cognitive Therapy

Active Comparator

first Meta-cognitive therapy then Cognitive Behaviour Therapy

干预措施: Cognitive-Behavioural Therapy (Behavioral)

Meta-Cognitive Therapy

Active Comparator

first Meta-cognitive therapy then Cognitive Behaviour Therapy

干预措施: Meta-Cognitive Therapy (Behavioral)

Meta-Cognitive Therapy

Active Comparator

first Meta-cognitive therapy then Cognitive Behaviour Therapy

干预措施: Waiting list (Behavioral)

Cognitive Behaviour Therapy

Active Comparator

first Cognitive Behaviour Therapy then Meta-cognitive therapy

干预措施: Cognitive-Behavioural Therapy (Behavioral)

Cognitive Behaviour Therapy

Active Comparator

first Cognitive Behaviour Therapy then Meta-cognitive therapy

干预措施: Meta-Cognitive Therapy (Behavioral)

Cognitive Behaviour Therapy

Active Comparator

first Cognitive Behaviour Therapy then Meta-cognitive therapy

干预措施: Waiting list (Behavioral)

Waiting List

Other

Waiting List

干预措施: Waiting list (Behavioral)

结局指标

主要结局

STAI-T

时间窗: March 2011

PSWQ by post treatment and by two year follow up.

时间窗: March 2011

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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