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Completed

NCT Number: NCT02437357

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Metacognitive Training

Other

8 group sessions á 60 min

Positivity Training

Other

8 group sessions á 60 min

Primary outcomes

  1. Change in Hamilton Depression Rating Scale (HDRS), total score from pre to post treatment (4 weeks) and follow-up (3months)

    Time frame: 4 months

    Clinician-rated severity of depressive symptoms, 17-item version, most commonly used interview-based measure of depression

Secondary outcomes

  1. Change in Beck Depression Inventory (BDI), total score from pre to post treatment (4 weeks) and follow-up (3months)

    Time frame: 4 months

    Self-assessed severity of depressive symptoms (questionnaire)

  2. Change in Dysfunctional Attitudes Scale (DAS) from pre to post treatment (4 weeks) and follow-up (3months)

    Time frame: 4 months

    questionnaire

  3. Change in Metacognitions Questionnaire (MCQ-30) from pre to post treatment (4 weeks) and follow-up (3months)

    Time frame: 4 months

    questionnaire

  4. Change in Ruminative Responses Scale (RRS) from pre to post treatment (4 weeks) and follow-up (3months)

    Time frame: 4 months

    questionnaire

  5. Change in Rosenberg Self-Esteem-Scale (RSE) from pre to post treatment (4 weeks) and follow-up (3months)

    Time frame: 4 months

    questionnaire

  6. Change in quality of life (WHOQOL-BREF) from pre to post treatment (4 weeks) and follow-up (3months)

    Time frame: 4 months

    questionnaire

  7. Change in coping (Brief-Cope) from pre to post treatment (4 weeks) and follow-up (3months)

    Time frame: 4 months

    questionnaire

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

A Randomized-Controlled Trial on Metacognitive Training for Depression (D-MCT) - an New Group Intervention for Depressed Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 7, 2015
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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