Long-term Efficacy of Metacognitive Training for Depression (D-MCT)
Primary Purpose
Unipolar Depression
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
D-MCT
Health Training
Sponsored by

About this trial
This is an interventional treatment trial for Unipolar Depression
Eligibility Criteria
Inclusion Criteria for the current study are:
- informed consent
- intention-to-treat-sample of the study Evaluation of Metacognitive Training for Depression (D-MKT) in psychosomatic rehabilitation, DRKS-ID: DRKS00007907 (see Jelinek et al., in press, Psychotherapy and Psychosomatics)
- age between 18 and 65 years
- diagnosis of a single episode or recurrent major depressive disorder (MDD) or dysthymia (verified by the MINI).
The exclusion criteria were:
- lifetime psychotic symptoms (i.e., hallucinations, delusions, or mania), suicidality (Suicidal Behaviors Questionnaire-Revised ≥ 7), intellectual disability (estimated IQ < 70).
Sites / Locations
- University Medical Center Hamburg Eppendorf
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
D-MCT Group
Health Training Group
Arm Description
Metacognitive Training for Depression (D-MCT), 8 sessions (60min); twice a week over a period of 4 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. 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.
Health Training Group (Walking/ Psychoeducation on health); 8 sessions (60min), twice a week over a period of 4 weeks
Outcomes
Primary Outcome Measures
Hamilton Depression Rating Scale
Primary outcome is change on the Hamilton Depression Rating Scale (HDRS, 17-item version) from baseline to follow-up (t0 - t3)
Secondary Outcome Measures
Self-assessed depression
Change in self-assessed depression as measured by the Beck-Depression Inventory (BDI) from baseline to follow-up (t0 to t3)
Dysfunctional beliefs
Change in dysfunctional beliefs as measured by the Dysfunctional Attitude Scale (DAS) from baseline to follow-up (t0 to t3)
Dysfunctional metacognitive beliefs
Change in metacognitive beliefs as measured by the Metacognitions Questionnaire (MCQ-30) from baseline to follow-up (t0 to t3)
Quality of life
Change in quality of life as measured by the World Health Organization Quality of Life Assessment (WHOQOL-BREF) from baseline to follow-up (t0 to t3)
Work status
Work status (full or part-time employment, unemployed, house wife/husband, student, on sick leave, retired) at T3 assessment
Self-esteem
Change in self-esteem as measured by the Rosenberg Self-Esteem Scale (RSE) from from baseline to follow-up (t0 to t3)
Remission rate
Remission rate at T3 as measured by the Hamilton Depression Rating Scale (HDRS score ≤ 8)
Full Information
NCT ID
NCT02771535
First Posted
April 5, 2016
Last Updated
August 2, 2017
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT02771535
Brief Title
Long-term Efficacy of Metacognitive Training for Depression (D-MCT)
Official Title
Long-term Efficacy of Metacognitive Training for Depression (D-MCT): a 3-year Follow up
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
D-MCT Group
Arm Type
Experimental
Arm Description
Metacognitive Training for Depression (D-MCT), 8 sessions (60min); twice a week over a period of 4 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. 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.
Arm Title
Health Training Group
Arm Type
Active Comparator
Arm Description
Health Training Group (Walking/ Psychoeducation on health); 8 sessions (60min), twice a week over a period of 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
D-MCT
Other Intervention Name(s)
Metacognitive Training for Depression
Intervention Description
Metacognitive Training for Depression (D-MCT), 8 sessions (60min); twice a week over a period of 4 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. 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.
Intervention Type
Behavioral
Intervention Name(s)
Health Training
Intervention Description
Health Training Group (Walking/ Psychoeducation on health); 8 sessions (60min), twice a week over a period of 4 weeks
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale
Description
Primary outcome is change on the Hamilton Depression Rating Scale (HDRS, 17-item version) from baseline to follow-up (t0 - t3)
Time Frame
3 years from baseline (t0) to 3-year follow up (t3)
Secondary Outcome Measure Information:
Title
Self-assessed depression
Description
Change in self-assessed depression as measured by the Beck-Depression Inventory (BDI) from baseline to follow-up (t0 to t3)
Time Frame
3 years from baseline (t0) to 3-year follow up (t3)
Title
Dysfunctional beliefs
Description
Change in dysfunctional beliefs as measured by the Dysfunctional Attitude Scale (DAS) from baseline to follow-up (t0 to t3)
Time Frame
3 years from baseline (t0) to 3-year follow up (t3)
Title
Dysfunctional metacognitive beliefs
Description
Change in metacognitive beliefs as measured by the Metacognitions Questionnaire (MCQ-30) from baseline to follow-up (t0 to t3)
Time Frame
3 years from baseline (t0) to 3-year follow up (t3)
Title
Quality of life
Description
Change in quality of life as measured by the World Health Organization Quality of Life Assessment (WHOQOL-BREF) from baseline to follow-up (t0 to t3)
Time Frame
3 years from baseline (t0) to 3-year follow up (t3)
Title
Work status
Description
Work status (full or part-time employment, unemployed, house wife/husband, student, on sick leave, retired) at T3 assessment
Time Frame
at 3-year follow-up (t3)
Title
Self-esteem
Description
Change in self-esteem as measured by the Rosenberg Self-Esteem Scale (RSE) from from baseline to follow-up (t0 to t3)
Time Frame
3 years from baseline (t0) to 3-year follow up (t3)
Title
Remission rate
Description
Remission rate at T3 as measured by the Hamilton Depression Rating Scale (HDRS score ≤ 8)
Time Frame
at 3-year follow up (t3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for the current study are:
informed consent
intention-to-treat-sample of the study Evaluation of Metacognitive Training for Depression (D-MKT) in psychosomatic rehabilitation, DRKS-ID: DRKS00007907 (see Jelinek et al., in press, Psychotherapy and Psychosomatics)
age between 18 and 65 years
diagnosis of a single episode or recurrent major depressive disorder (MDD) or dysthymia (verified by the MINI).
The exclusion criteria were:
lifetime psychotic symptoms (i.e., hallucinations, delusions, or mania), suicidality (Suicidal Behaviors Questionnaire-Revised ≥ 7), intellectual disability (estimated IQ < 70).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena Jelinek, PD Dr.
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25103718
Citation
Moritz S, Veckenstedt R, Andreou C, Bohn F, Hottenrott B, Leighton L, Kother U, Woodward TS, Treszl A, Menon M, Schneider BC, Pfueller U, Roesch-Ely D. Sustained and "sleeper" effects of group metacognitive training for schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2014 Oct;71(10):1103-11. doi: 10.1001/jamapsychiatry.2014.1038.
Results Reference
background
PubMed Identifier
27230865
Citation
Jelinek L, Hauschildt M, Wittekind CE, Schneider BC, Kriston L, Moritz S. Efficacy of Metacognitive Training for Depression: A Randomized Controlled Trial. Psychother Psychosom. 2016;85(4):231-4. doi: 10.1159/000443699. Epub 2016 May 27. No abstract available.
Results Reference
background
Citation
Jelinek L, Otte C, Arlt S, Hauschildt M: Denkverzerrungen erkennen und korrigieren: Eine Machbarkeitsstudie zum Metakognitiven Training bei Depression (D-MKT). [Identifying and correcting cognitive biases: A pilot study on the Metacognitive Training for Depression (D-MCT)]. Zeitschrift Für Psychiatr Psychol Und Psychother 61:1-8, 2013.
Results Reference
background
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Long-term Efficacy of Metacognitive Training for Depression (D-MCT)
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