A Randomized Controlled Trial of the Effectiveness of Metacognitive Therapy (MCT) in the Treatment of Patients With Major Depressive Disorder (MDD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in depression
Study Overview
Brief Summary
The main aim of this study is to (1) evaluate the effectiveness of metacognitive therapy for major depressive disorder. Additional aims are to (2) investigate patterns of change and the mechanisms of action involved during treatment, and to (3) examine the impact of meta-cognitions in the treatment and relapse prevention of depression.
Detailed Description
Major depressive disorder 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 recommended treatment for depression, with a large number of clinical trials supporting its efficacy. However, despite the success of CBT relative to other treatments, only 40-58 % of patients receiving CBT may be classified as recovered using clinical significant change assessed by the Beck Depression Inventory. Moreover, research demonstrates that only between one-third and one quarter of patients receiving CBT remain recovered at 18 months follow-up.
A new treatment approach to MDD is Meta-Cognitive Therapy. 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. No randomized controlled studies have compared the effectiveness of MCT to a waiting-list condition for MDD. Related to this, no study has examined the specific elements of therapy that are hypothesized to be of most importance for changing rumination, leading to positive treatment outcomes.
The purpose of this trial is to investigate the efficacy of Wells' MCT for Major Depressive Disorder (MDD). Another aim will be to examine the in-treatment processes associated with positive treatment outcomes.
The study will be a randomized controlled, trial comprising 50 patients with a primary diagnosis of major depressive disorder (DSM-IV; APA, 1994). Experienced diagnosticians will assess all patients by using structural interviews such as SCID-I, SCID II and the Hamilton Rating Scale for Depression.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Major depressive disorder
- •18 years or older
- •Signed written informed consent prior to entry in the study
Exclusion Criteria
- •Known somatic disease
- •Psychosis
- •Current suicide intent
- •Cluster A or cluster B personality disorder
- •Substance dependence
- •Not willing to accept random allocation
- •Not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial
Arms & Interventions
Metacognitive therapy
Intervention: Metacognitive therapy (Behavioral)
Waiting list control
Outcomes
Primary Outcomes
Change in depression
Time Frame: baseline (before treatment), week 1-11, 12 months follow-up
Hamilton Depression Rating Scale (HDRS-17; Hamilton, 1967)
Change in diagnosis
Time Frame: baseline (before treatment), week 11, 12 months follow-up
SCID I and II (First et al., 1995, 1997)
Secondary Outcomes
- Change in rumination(baseline (before treatment), week 11, 6 and 12 months follow-up)
- Change in negative beliefs(baseline (before treatment), week 11, 6 and 12 months follow-up)
- Change in metacognitions(baseline (before treatment), week 11, 6 and 12 months follow-up)
- Change in interpersonal problems(baseline (before treatment), week 11, 6 and 12 months follow-up)
- Change in worry(baseline (before treatment), week 11, 6 and 12 months follow-up)
- Change in depression(baseline (before treatment), week 1-11, 6 and 12 months follow-up)
- Change in automatic thought(baseline (before treatment), week 11, 6 and 12 months follow-up)
- Change in resilience(baseline (before treatment), week 11, 6 and 12 months follow-up)
- Change in anxiety(baseline (before treatment), week 1-11, 6 and 12 months follow-up)
- Quality of working alliance(week 3)
- Change in positive beliefs(baseline (before treatment), week 11, 6 and 12 months follow-up)
