Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02437357
Recruitment Status : Completed
First Posted : May 7, 2015
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Depression Other: Metacognitive Training Other: Positivity Training Not Applicable

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).


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized-Controlled Trial on Metacognitive Training for Depression (D-MCT) - an New Group Intervention for Depressed Patients
Study Start Date : March 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metacognitive Training
D-MCT is conceptualized as a variant of cognitive behavioral therapy (CBT) that uses a metacognitive perspective to focus on the modification of cognitive biases by using creative and engaging strategies (e.g., multimedial presentation). The training seeks to enable group members to recognize and correct the often automatic and unconscious depressive thought patterns, in part by viewing this depressive thought process at a distance (i.e., depersonalizing). Besides dysfunctional assumptions about one's thought processes, more general cognitive biases, which have been identified by basic research are at the core of the D-MCT. Finally, dysfunctional coping-strategies (i.e., thought suppression, rumination as problem-solving) are discussed and modified.
Other: Metacognitive Training
8 group sessions á 60 min

Active Comparator: Positivity Training
Positivity Training (PT) is a "euthymic therapy" group based on cognitive behavioral therapy (CBT) with a focus on the education and training of sensual enjoyment and pleasure. Aim of the training is to reduce depressive symptomatology by increasing the ability to enjoy and to (re-)install positive sensory experiences. Therefore, group members are informed about the impact of positive experiences on well-being and the awareness of the five senses is trained in different practical exercises (hearing, sight, smell, taste, and touch).
Other: Positivity Training
8 group sessions á 60 min




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437357


Locations
Layout table for location information
Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Layout table for investigator information
Principal Investigator: Marit Hauschildt, Ph.D. Universitätsklinikum Hamburg-Eppendorf

Publications:
Jelinek L, Otte C, Arlt, S, Hauschildt M. Denkverzerrungen erkennen und korrigieren: Eine Machbarkeitsstudie zum Metakognitiven Training bei Depressionen (D-MKT). Zeitschrift für Psychiatrie und Psychotherapie, 61(4): 1-8, 2014.

Layout table for additonal information
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02437357     History of Changes
Other Study ID Numbers: NWF-15/03
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Psychotherapy, Group
Metacognition
Cognitive Bias

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders