NCT02437357

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Mar 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 7, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

March 23, 2015

Last Update Submit

September 26, 2016

Conditions

Depression

Keywords

Psychotherapy, GroupMetacognitionCognitive Bias

Outcome Measures

Primary Outcomes (1)

  • Change in Hamilton Depression Rating Scale (HDRS), total score from pre to post treatment (4 weeks) and follow-up (3months)

    Clinician-rated severity of depressive symptoms, 17-item version, most commonly used interview-based measure of depression

    4 months

Secondary Outcomes (7)

  • Change in Beck Depression Inventory (BDI), total score from pre to post treatment (4 weeks) and follow-up (3months)

    4 months

  • Change in Dysfunctional Attitudes Scale (DAS) from pre to post treatment (4 weeks) and follow-up (3months)

    4 months

  • Change in Metacognitions Questionnaire (MCQ-30) from pre to post treatment (4 weeks) and follow-up (3months)

    4 months

  • Change in Ruminative Responses Scale (RRS) from pre to post treatment (4 weeks) and follow-up (3months)

    4 months

  • Change in Rosenberg Self-Esteem-Scale (RSE) from pre to post treatment (4 weeks) and follow-up (3months)

    4 months

  • +2 more secondary outcomes

Study Arms (2)

Metacognitive Training

EXPERIMENTAL

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

Positivity Training

ACTIVE COMPARATOR

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

Interventions

Metacognitive TrainingOTHER

8 group sessions á 60 min

Metacognitive Training
Positivity TrainingOTHER

8 group sessions á 60 min

Positivity Training

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Marit Hauschildt, Ph.D.

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

May 7, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations

DE(1)