NCT03268434

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 10, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

1.9 years

First QC Date

August 3, 2017

Last Update Submit

September 26, 2019

Conditions

Unipolar Depression

Keywords

DepressionMetacognitionCBTD-MCTcognitive bias

Outcome Measures

Primary Outcomes (1)

  • Quick Inventory of Depressive Symptomatology (QIDS)

    Primary outcome is change on the Quick Inventory of Depressive Symptomatology (QIDS) from baseline to follow-up (t0 - t2)

    eight months from baseline (t0) to 6-months follow up (t2)

Secondary Outcomes (15)

  • Hamilton Depression Rating Scale

    [Time Frame: eight months from baseline (t0) to 6-months follow up (t2)]

  • Self-assessed depression

    [Time Frame: eight months from baseline (t0) to 6-months follow up (t2)]

  • Quick Inventory of Depressive Symptomatology (QIDS)

    from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]

  • Hamilton Depression Rating Scale

    from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]

  • Patient Health Questionnaire (PHQ-9)

    from baseline (t0) to post intervention assessment at 8 weeks (t1) [time frame: 8 weeks]

  • +10 more secondary outcomes

Study Arms (2)

D-MCT Group

EXPERIMENTAL

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

Cognitive remediation

ACTIVE COMPARATOR

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

Interventions

D-MCTBEHAVIORAL

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.

Also known as: Metacognitive Training for Depression
D-MCT Group
Cognitive remediationBEHAVIORAL

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

Cognitive remediation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asklepios Klinik Nord-Ochsenzoll

Hamburg, 22419, Germany

Location

Related Publications (10)

  • 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.

    PMID: 25103718BACKGROUND

  • 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.

    PMID: 27230865BACKGROUND

  • 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.

    BACKGROUND

  • Jelinek L, Moritz S, Hauschildt M. Patients' perspectives on treatment with Metacognitive Training for Depression (D-MCT): Results on acceptability. J Affect Disord. 2017 Oct 15;221:17-24. doi: 10.1016/j.jad.2017.06.003. Epub 2017 Jun 7.

    PMID: 28628763BACKGROUND

  • Andrews G, Issakidis C, Sanderson K, Corry J, Lapsley H. Utilising survey data to inform public policy: comparison of the cost-effectiveness of treatment of ten mental disorders. Br J Psychiatry. 2004 Jun;184:526-33. doi: 10.1192/bjp.184.6.526.

    PMID: 15172947BACKGROUND

  • Cuijpers P. Psychotherapies for adult depression: recent developments. Curr Opin Psychiatry. 2015 Jan;28(1):24-9. doi: 10.1097/YCO.0000000000000121.

    PMID: 25415495BACKGROUND

  • Fernandez E, Salem D, Swift JK, Ramtahal N. Meta-analysis of dropout from cognitive behavioral therapy: Magnitude, timing, and moderators. J Consult Clin Psychol. 2015 Dec;83(6):1108-22. doi: 10.1037/ccp0000044. Epub 2015 Aug 24.

    PMID: 26302248BACKGROUND

  • Mathews A, MacLeod C. Cognitive vulnerability to emotional disorders. Annu Rev Clin Psychol. 2005;1:167-95. doi: 10.1146/annurev.clinpsy.1.102803.143916.

    PMID: 17716086BACKGROUND

  • Vittengl JR, Clark LA, Dunn TW, Jarrett RB. Reducing relapse and recurrence in unipolar depression: a comparative meta-analysis of cognitive-behavioral therapy's effects. J Consult Clin Psychol. 2007 Jun;75(3):475-88. doi: 10.1037/0022-006X.75.3.475.

    PMID: 17563164BACKGROUND

  • Wells, A., 2011. Metacognitive Therapy for anxiety and depression. The Guilford Press, New York.

    BACKGROUND

MeSH Terms

Conditions

Depressive DisorderDepression

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marion Hagemann-Goebel, Dr.

    Asklepios Klinik Nord-Ochsenzoll

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double Blind (Investigator, Outcome Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 31, 2017

Study Start

October 10, 2017

Primary Completion

August 22, 2019

Study Completion

September 24, 2019

Last Updated

September 27, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)