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Clinical Trials/NCT02771535
NCT02771535
Completed
Not Applicable

Long-term Efficacy of Metacognitive Training for Depression (D-MCT): a 3-year Follow up

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country84 target enrollmentMarch 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Unipolar Depression
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
84
Locations
1
Primary Endpoint
Hamilton Depression Rating Scale
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Aim of the current study is to investigate the long-term efficacy of Metacognitive Training for Depression (D-MCT) and to explore whether previously observed effects at the 6-month follow-up of a randomized, controlled, assessor-blind, parallel group trial are maintained at the 3-year follow-up.

Detailed Description

Dissemination of treatment for depression is still unsatisfying: every second patient does not receive, refuses, or is waiting for treatment. Moreover, with a drop-out rate of almost 25% in routine clinical practice, and a 54% relapse rate for treatment responders within the two years after treatment termination, improving treatment is necessary. Metacognitive Training for depression (D-MCT), a low threshold, easy to administer group intervention was designed to fill this gap. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research. It was positively evaluated with regard to feasibility and acceptance in a non-randomized pilot study. Moreover, efficacy of D-MCT was suggested in a randomized controlled trail (RCT) in comparison to an active control intervention (Jelinek et al., in press). In this trial patients with depressive disorder were completing a psychosomatic outpatient treatment program and were randomly assigned to either D-MCT or general health training. Severity of depression and cognitive biases were assessed at baseline (t0), post treatment (t1) and 6 months (t2) later by raters blind to diagnostic status. Intention-to-treat analyses demonstrated that at the end of treatment, as well as 6 months later, improvement in depression was significantly greater in the D-MCT relative to the health training group at medium effect sizes. A significantly greater number of patients in the D-MCT group were in remission at 6-month follow-up. Moreover, the decrease in cognitive biases and increase in psychological well-being/quality of life was larger in the D-MCT than the health training group over time. Aim of the current study is to investigate the long-term efficacy of D-MCT. For this purpose, an additional 3 year follow-up assessment (t3) is conducted. The Hamilton Depression Rating Scale (HDRS, 17-item version) total score serves as the primary outcome. Self-assessed depression, dysfunctional beliefs, self-esteem, quality of life, and ability to work serve as secondary outcomes.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
May 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Hamilton Depression Rating Scale

Time Frame: 3 years from baseline (t0) to 3-year follow up (t3)

Primary outcome is change on the Hamilton Depression Rating Scale (HDRS, 17-item version) from baseline to follow-up (t0 - t3)

Secondary Outcomes

  • Quality of life(3 years from baseline (t0) to 3-year follow up (t3))
  • Work status(at 3-year follow-up (t3))
  • Dysfunctional metacognitive beliefs(3 years from baseline (t0) to 3-year follow up (t3))
  • Self-assessed depression(3 years from baseline (t0) to 3-year follow up (t3))
  • Dysfunctional beliefs(3 years from baseline (t0) to 3-year follow up (t3))
  • Self-esteem(3 years from baseline (t0) to 3-year follow up (t3))
  • Remission rate(at 3-year follow up (t3))

Study Sites (1)

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