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Unipolar DepressionNCT02771535

Long-term Efficacy of Metacognitive Training for Depression (D-MCT)

A study testing D-MCT and Health Training in people with Unipolar Depression, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Unipolar Depression
What is being tested?
D-MCT and Health Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteGermany
Study dates
Mar 2016to May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medical Center Hamburg Eppendorf

    Hamburg, 20246

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
D-MCT, Health Training
Medical subject headings
Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • D-MCTBehavioural

    Also called Metacognitive Training for Depression

    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 TrainingBehavioural

    Health Training Group (Walking/ Psychoeducation on health); 8 sessions (60min), twice a week over a period of 4 weeks

Study groups in NCT02771535
Study groupRoleWhat they receive
D-MCT GroupExperimentalMetacognitive 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.
Receives: Behavioral: D-MCT
Health Training GroupActive comparatorHealth Training Group (Walking/ Psychoeducation on health); 8 sessions (60min), twice a week over a period of 4 weeks
Receives: Behavioral: Health Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

Secondary outcomes (7)

  1. Self-assessed depression

    Change in self-assessed depression as measured by the Beck-Depression Inventory (BDI) from baseline to follow-up (t0 to t3)

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

  2. Dysfunctional beliefs

    Change in dysfunctional beliefs as measured by the Dysfunctional Attitude Scale (DAS) from baseline to follow-up (t0 to t3)

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

  3. Dysfunctional metacognitive beliefs

    Change in metacognitive beliefs as measured by the Metacognitions Questionnaire (MCQ-30) from baseline to follow-up (t0 to t3)

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

  4. 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)

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

  5. Work status

    Work status (full or part-time employment, unemployed, house wife/husband, student, on sick leave, retired) at T3 assessment

    Measured: at 3-year follow-up (t3)

  6. Self-esteem

    Change in self-esteem as measured by the Rosenberg Self-Esteem Scale (RSE) from from baseline to follow-up (t0 to t3)

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

  7. Remission rate

    Remission rate at T3 as measured by the Hamilton Depression Rating Scale (HDRS score ≤ 8)

    Measured: at 3-year follow up (t3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02771535
Sponsor's protocol ID
1027/106
Status last verified
Aug 2017
First submitted
5 Apr 2016
Last updated
3 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25103718

  • 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.

    PubMed 27230865

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing D-MCT and Health Training in people with Unipolar Depression, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Rating Scale (time frame: 3 years from baseline (t0) to 3-year follow up (t3)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02771535, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.

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