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Group Metacognitive Therapy vs Clinical Management for Depression

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ClinicalTrials.gov Identifier: NCT03711123
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Toril Dammen, University of Oslo

Brief Summary:
The main aims of the study are to (1) compare the effectiveness of Group metacognitive therapy (GMCT) treatment to that of clinical management and (2) explore patterns of change and investigate factors associated with treatment outcome

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Behavioral: Group metacognitive therapy Behavioral: Clinical management Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of the Effectiveness of Group Metacognitive Therapy vs Clinical Management for Patients With Major Depressive Disorder
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group metacognitive therapy (GMCT)
10 weekly sessions of GMCT With 90 minutes duration
Behavioral: Group metacognitive therapy
10 weekly Group session of 90 minutes duration

Active Comparator: Clinical Management
10 weekly individual sessions with up to 60 minutes duration
Behavioral: Clinical management
10 weekly individual sessions With clinical management including guided self-help




Primary Outcome Measures :
  1. Change in depression [ Time Frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up ]
    Beck Depression Inventory

  2. Change in diagnosis [ Time Frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up ]
    SCID-I

  3. Change in depression [ Time Frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up ]
    Hamilton Depression Rating Scale 17-item version (HDRS-17) yielding total scores from 0 (least severe) to 52 (most severe)


Secondary Outcome Measures :
  1. Change in rumination [ Time Frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up ]
    Ruminative Responses Scale (RRS)

  2. Change in positive beliefs [ Time Frame: baseline to 10 weeks, 6 months, 12 months and 24 months follow up ]
    Positive Beliefs about rumination scale (PBRS)

  3. Change in Negative beliefs [ Time Frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up ]
    Negative beliefs about rumination scale (NBRS)

  4. Change in metacognitions [ Time Frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up ]
    Metacognitions questionnaire-30 (MCQ-30)

  5. Change in personality [ Time Frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up ]
    Distressed type personality (DS-14)

  6. Change in dysfunctional attitudes and beliefs [ Time Frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up ]
    Dysfunctional attitude scales (DAS)

  7. Change in resilience [ Time Frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up ]
    Resilience Scale for adults (RSA)

  8. Change in anxiety [ Time Frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up ]
    Beck Anxiety Inventory (BAI)

  9. Change in sleep [ Time Frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up ]
    Pittsburgh sleep quality inventory (PSQI)

  10. change in report of executive function [ Time Frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up ]
    Behaviour Rating of Executive Function (BRIEF-A)

  11. change in personality diagnoses [ Time Frame: baseline to 10 weeks (post treatment), 6 months, 12 months and 24 months follow up ]
    SCID-II



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MDD is primary problem
  • 18-65 years
  • stable on medication for at least 8 weeks or medication free
  • able to understand and write the Norwegian Language
  • signed written informed consent prior to participation

Exclusion Criteria:

  • Medical or physical condition underlying depression
  • psychosis or organic mental illness
  • current suicide intent
  • not willing to Accept no changes in medication during treatment
  • not willing to Accept random allocation
  • cluster A or cluster B personality disorder
  • alcohol/substance dependence/abuse
  • concurrent psychological treatment or evidence based psychotherapy for depression past year
  • bipolar disorder

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): NCT03711123


Contacts
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Contact: Toril Dammen, PhD 4790163433 toril.dammen@medisin.uio.no

Locations
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Norway
Specialist practice Dr Toril Dammen Recruiting
Drammen, Buskerud, Norway, 3014
Contact: Toril Dammen, PhD    4790163433    toril.dammen@medisin.uio.no   
Sponsors and Collaborators
University of Oslo

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Responsible Party: Toril Dammen, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT03711123     History of Changes
Other Study ID Numbers: 2015/673-1
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

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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 Toril Dammen, University of Oslo:
metacognitive therapy, psychotherapy

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms