A Trial on Metacognitive Training for Depression (D-MCT)

Not Applicable

Completed

• Conditions: Depression

• Registration Number: NCT02437357
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

The purpose of the present randomized-controlled trial is to investigate the efficacy of Metacognitive Training for Depression (D-MCT), a new low-threshold, modular group intervention.

Detailed Description

Despite the existence of evidence-based treatment methods, a significant treatment gap remains for major depression. While in acute psychiatric treatment of severely depressed patients a pharmacological treatment is usually applied, depression-specific psychotherapeutic (group) concepts are rarely part of the treatment, though recommended in clinical guidelines. A main reason is that present group concepts were designed primarily for outpatient settings and do not meet the structural requirements of inpatient care (i.e., short residence time, continuous admissions and dismissals).

Metacognitive Training for Depression (D-MCT) is a new low-threshold, modular group intervention which was designed to fill this treatment gap by addressing contextual and structural shortcomings of existing concepts for the use in inpatient treatment. The training targets depressive symptoms by changing (meta-) cognitive biases identified in both cognitive models of depression and basic research. D-MCT was positively evaluated with regard to feasibility and acceptance in a non-randomized pilot study.

Aim of the present randomized-controlled trial is to investigate the efficacy of D-MCT as an add-on intervention in inpatient treatment of depressed patients compared with a standard add-on group therapy (Positivity Training, PT). Based on a power analysis, the investigators target a sample size of 60 depressed patients, who will be randomized either to D-MCT or PT. Blind to diagnostic status, symptom level as well as cognitive biases will be assessed pre- and post-treatment (8 group sessions) as well as 3 months later (follow-up). Primary outcome parameter is severity of depressive symptoms measured with the HDRS total score (17-item version). Secondary outcome measures are self-assessed depression (BDI), dysfunctional beliefs (DAS), metacognitions (MCQ), self-esteem (RSE), and quality of life (WHOQOL-BREF).

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-23
• Study First Submitted QC: 2015-05-04
• Study First Posted: 2015-05-07
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosis of Major Depression according to DSM-IV (MINI Interview)

• Diagnosis of Dysthymia according to DSM-IV (MINI Interview)

  • DSM-IV = The Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition, Text Revision (American Psychiatric Association, 2000)

Exclusion Criteria

• Lifetime psychotic symptoms (i.e., hallucinations, delusions, or bipolar disorder) according to DSM-IV (MINI Interview)
• Current substance dependency according to DSM-IV (MINI Interview)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Hamilton Depression Rating Scale (HDRS), total score from pre to post treatment (4 weeks) and follow-up (3months)	4 months	Clinician-rated severity of depressive symptoms, 17-item version, most commonly used interview-based measure of depression

Secondary Outcome Measures

Name	Time	Method
Change in Rosenberg Self-Esteem-Scale (RSE) from pre to post treatment (4 weeks) and follow-up (3months)	4 months	questionnaire
Change in Metacognitions Questionnaire (MCQ-30) from pre to post treatment (4 weeks) and follow-up (3months)	4 months	questionnaire
Change in Ruminative Responses Scale (RRS) from pre to post treatment (4 weeks) and follow-up (3months)	4 months	questionnaire
Change in coping (Brief-Cope) from pre to post treatment (4 weeks) and follow-up (3months)	4 months	questionnaire
Change in Beck Depression Inventory (BDI), total score from pre to post treatment (4 weeks) and follow-up (3months)	4 months	Self-assessed severity of depressive symptoms (questionnaire)
Change in Dysfunctional Attitudes Scale (DAS) from pre to post treatment (4 weeks) and follow-up (3months)	4 months	questionnaire
Change in quality of life (WHOQOL-BREF) from pre to post treatment (4 weeks) and follow-up (3months)	4 months	questionnaire

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany