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Evaluation of Metacognitive Training for Depression (D-MCT) in Outpatient Care

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ClinicalTrials.gov Identifier: NCT03268434
Recruitment Status : Completed
First Posted : August 31, 2017
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
Asklepios Kliniken Hamburg GmbH
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
Aim of the current study is to investigate the acceptance and efficacy of Metacognitive Training for Depression (D-MCT) compared to cognitive remediation in outpatients with major depressive disorders in a randomized, controlled, assessor-blind, group trial.

Condition or disease Intervention/treatment Phase
Unipolar Depression Behavioral: D-MCT Behavioral: Cognitive remediation Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Double Blind (Investigator, Outcome Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Metacognitive Training for Depression (D-MCT) in Outpatient Psychiatric-psychotherapeutic Care: Randomized Controlled Trial
Actual Study Start Date : October 10, 2017
Actual Primary Completion Date : August 22, 2019
Actual Study Completion Date : September 24, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: D-MCT Group
Metacognitive Training for Depression (D-MCT), 8 sessions (60min); once a week over a period of 8 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.
Behavioral: D-MCT
Metacognitive Training for Depression (D-MCT), 8 sessions (60min); once a week over a period of 8 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.
Other Name: Metacognitive Training for Depression

Active Comparator: Cognitive remediation
A computerized cognitive remediation program that covers several cognitive domains, such as attention, visuomotor skills, and Memory.The difficulty level adapts automatically to the performance level of each patient. At the end of each session, the patient receives individual feedback on his or her performance.; 8 sessions (60min), once a week over a period of 8 weeks
Behavioral: Cognitive remediation
A computerized cognitive remediation program that covers several cognitive domains, such as attention, visuomotor skills, and Memory. The difficulty level adapts automatically to the performance level of each patient. At the end of each session, the patient receives individual feedback on his or her performance; 8 sessions (60min), once a week over a period of 8 weeks




Primary Outcome Measures :
  1. Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: eight months from baseline (t0) to 6-months follow up (t2) ]
    Primary outcome is change on the Quick Inventory of Depressive Symptomatology (QIDS) from baseline to follow-up (t0 - t2)


Secondary Outcome Measures :
  1. Hamilton Depression Rating Scale [ Time Frame: [Time Frame: eight months from baseline (t0) to 6-months follow up (t2)] ]
    Change on the Hamilton Depression Rating Scale (HDRS, 17-item version) from baseline to follow-up (t0 - t2)

  2. Self-assessed depression [ Time Frame: [Time Frame: eight months from baseline (t0) to 6-months follow up (t2)] ]
    Change in self-assessed depression as measured by the Patient Health Questionnaire (PHQ-9) from baseline to follow-up (t0 to t2)

  3. Quick Inventory of Depressive Symptomatology (QIDS) [ Time Frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks] ]
    Change on the Quick Inventory of Depressive Symptomatology (QIDS) from baseline to post intervention assessment (t0 - t1)

  4. Hamilton Depression Rating Scale [ Time Frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks] ]
    Change on the Hamilton Depression Rating Scale from baseline to post intervention assessment (t0 - t1)

  5. Patient Health Questionnaire (PHQ-9) [ Time Frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks] ]
    Change on the Patient Health Questionnaire (PHQ-9) from baseline to post intervention assessment (t0 - t1)

  6. Dysfunctional beliefs [ Time Frame: eight months from baseline (t0) to 6-months follow up (t2 ]
    Change in dysfunctional beliefs as measured by the Dysfunctional Attitude Scale (DAS) from baseline to follow-up (t0 to t2)

  7. Quality of life [ Time Frame: eight months from baseline (t0) to 6-months follow up (t2) ]
    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 t2)

  8. Dysfunctional metacognitive beliefs [ Time Frame: eight months from baseline (t0) to 6-months follow up (t2) ]
    Change in metacognitive beliefs as measured by the Metacognitions Questionnaire (MCQ-30) from baseline to follow-up (t0 to t2)

  9. Rumination [ Time Frame: eight months from baseline (t0) to 6-months follow up (t2) ]
    Rumination measured by the Ruminative Response Scale (RRS) from baseline to follow-up (t0 to t2)

  10. Self-esteem [ Time Frame: eight months from baseline (t0) to 6-months follow up (t2) ]
    Change in self-esteem as measured by the Rosenberg Self-Esteem Scale (RSE) from from baseline to follow-up (t0 to t2)

  11. Remission rate [ Time Frame: eight months from baseline (t0) to 6-months follow up (t2) ]
    Remission rate at T2 as measured by the Hamilton Depression Rating Scale (HDRS score ≤ 8)

  12. Information processing [ Time Frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks] ]
    Information processing as measured by the Trail-Making Test A (TMT-A) from baseline to post treatment assessment (t0 to t1)

  13. Subjective appraisal of the training [ Time Frame: each week (session data) [time frame: 8 weeks] and six months from post treatment assessment (t1) to 6 months follow up (t1 to t2) [time frame: 6 months] ]
    Subjective appraisal of the training after each session as well as at post treatment and follow up assessment (for questionnaire see Jelinek et al., 2017)

  14. Executive functioning [ Time Frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks] ]
    Executive functions as measured by the Trail-Making Test B (TMT-B) from baseline to post treatment assessment (t0 to t1)

  15. Verbal memory [ Time Frame: from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks] ]
    Memory functioning as measured by Rivermead Behavioral Memory Test from baseline to post treatment assessment (t0 to t1)



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

Inclusion Criteria:

  • informed consent
  • age between 18 and 70 years
  • diagnosis of a single Episode or recurrent Major depressive disorder (MDD) or dysthymia (verified by the MINI)

Exclusion Criteria:

  • lifetime psychotic symptoms (i.e., hallucinations, delusions, or mania), suicidality (Suicidal Behaviors Questionnaire-Revised ≥ 7), intellectual disability (estimated IQ < 70) or dementia.

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): NCT03268434


Locations
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Germany
Asklepios Klinik Nord-Ochsenzoll
Hamburg, Germany, 22419
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Asklepios Kliniken Hamburg GmbH
Investigators
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Principal Investigator: Marion Hagemann-Goebel, Dr. Asklepios Klinik Nord-Ochsenzoll

Publications:
Jelinek L, Otte C, Arlt S, & Hauschildt M. Denkverzerrungen erkennen und korrigieren: Eine Machbarkeitsstudie zum Metakognitiven Training bei Depressionen (D-MKT). [Identifying and correcting cognitive biases: A Pilot study on the Metacognitive Training for Depression (D-MCT)] Zeitschrift für Psychiatrie, Psychologie und Psychotherapie, 61, 247-254, 2013.
Wells, A., 2011. Metacognitive Therapy for anxiety and depression. The Guilford Press, New York.

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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03268434     History of Changes
Other Study ID Numbers: LJ05207
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Depression
Metacognition
CBT
D-MCT
cognitive bias
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Demeclocycline
Anti-Bacterial Agents
Anti-Infective Agents