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Clinical Trials/NCT01608399
NCT01608399CompletedNot Applicable

A Randomized Controlled Trial of the Effectiveness of Metacognitive Therapy (MCT) in the Treatment of Patients With Major Depressive Disorder (MDD)

Norwegian University of Science and Technology1 site in 1 country40 target enrollmentStarted: March 1, 2012Last updated:
Conditions
Interventions

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

Experimental

Intervention: Metacognitive therapy (Behavioral)

Waiting list control

No Intervention

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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