A Randomized Controlled Trial of the Effectiveness of Group Metacognitive Therapy vs Clinical Management for Patients With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in diagnosis
研究概览
简要总结
The main aims of the study are to (1) compare the effectiveness of Group metacognitive therapy (GMCT) treatment to that of clinical management and (2) explore patterns of change and investigate factors associated with treatment outcome
详细描述
Major depressive disorder (MDD) is a disabling condition which adversely affects a person's family, work or school life, sleeping and eating habits, and general health.
Cognitive-behavioral therapy (CBT) is a well established effective recommended treatment for MDD. However, only 40-58 % of patients receiving CBT may be classified as recovered using clinical significant change assessed by the Beck Depression Inventory and only between one-third and one quarter of patients receiving CBT remain recovered 18 months after treatment.
A new treatment approach to MDD is Metacognitive Therapy (MCT). In this treatment approach, MDD is conceptualized as being maintained by rumination and meta-cognitions. Treatment seeks to challenge and change specific meta-cognitions and rumination, through behavioural experiments and verbal reattribution. There is accumulating evidence that MCT is effective in the treatment of depression, both individualized and in Groups. A recent pilot study indicated effectiveness above that of CBT. However, the results need to be tested in a randomized controlled trial with a larger sample of patients and a comparison group of active treatment.
The purpose of this trial is to evaluate the effectiveness of Group MCT treatment compared to clinical management included guided self-help and to explore which factors that are associated with depressive symptom outcome in terms of psychological factors, biomarker in terms of heart rate variabilities and polygenic risk score.
The study will be a randomized controlled, trial comprising 64 patients with a primary diagnosis of major depressive disorder (DSM-IV; American Psychiatric Association (APA), 1994). Experienced diagnosticians will assess all patients by using structural interviews such as Structured Clinical Interview for DSM-IV, axis I(SCID I), and axis II disorders (SCID II) and the Hamilton Rating Scale for Depression (HDRS).
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
- 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
- 否
入选标准
- •MDD is primary problem
- •18-65 years
- •stable on medication for at least 8 weeks or medication free
- •able to understand and write the Norwegian Language
- •signed written informed consent prior to participation
排除标准
- •Medical or physical condition underlying depression
- •psychosis or organic mental illness
- •current suicide intent
- •not willing to Accept no changes in medication during treatment
- •not willing to Accept random allocation
- •cluster A or cluster B personality disorder
- •alcohol/substance dependence/abuse
- •concurrent psychological treatment or evidence based psychotherapy for depression past year
- •bipolar disorder
研究组 & 干预措施
Group metacognitive therapy (GMCT)
10 weekly sessions of GMCT With 90 minutes duration
干预措施: Group metacognitive therapy (Behavioral)
Clinical Management
10 weekly individual sessions with up to 60 minutes duration
干预措施: Clinical management (Behavioral)
结局指标
主要结局
Change in diagnosis
时间窗: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
SCID-I
Change in depression
时间窗: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up
Beck Depression Inventory
次要结局
- Change in metacognitions(baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up)
- Change in dysfunctional attitudes and beliefs(baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up)
- change in report of executive function(baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up)
- Change in positive beliefs(baseline to 10 weeks, 6 months, 12 months and 24 months follow up)
- Change in Negative beliefs(baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up)
- Change in anxiety(baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up)
- Change in personality(baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up)
- Change in resilience(baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up)
- change in personality diagnoses(baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up)
- Change in sleep(baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up)
- Change in rumination(baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up)
研究者
Toril Dammen
Professor
University of Oslo