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The Effect of Group Treatment for Depression: A Study of Metacognitive Therapy, Mindfulness and Support Groups

This study is not yet open for participant recruitment.
Verified November 2016 by Tonny Elmose Andersen, phd., University of Southern Denmark
Sponsor:
ClinicalTrials.gov Identifier:
NCT02538835
First Posted: September 2, 2015
Last Update Posted: November 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Center for Kognitive Terapier og Supervision
Information provided by (Responsible Party):
Tonny Elmose Andersen, phd., University of Southern Denmark
  Purpose
This study evaluates the effect of metacognitive group therapy on depression compared to mindfulness groups and supportive groups. The participants, all with a history of depression and with current symptoms of depression, will be randomized to one of the three group interventions.

Condition Intervention
Depression Behavioral: Metacognitive therapy Behavioral: Mindfulness based cognitive therapy, group Behavioral: Support groups

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Group Treatment for Depression: A Randomised Controlled Study of Metacognitive Therapy, Mindfulness and Support Groups

Further study details as provided by Tonny Elmose Andersen, phd., University of Southern Denmark:

Primary Outcome Measures:
  • Change from baseline on Hamilton depression scale [ Time Frame: 8 weeks ]
  • Change from baseline on Hamilton depression scale [ Time Frame: 32 weeks ]

Secondary Outcome Measures:
  • Change from baseline on Becks depression inventory [ Time Frame: 8 weeks ]
  • Change from baseline on Becks depression inventory [ Time Frame: 32 weeks ]
  • Change from baseline on Becks Anxiety Inventory [ Time Frame: 8 weeks ]
  • Change from baseline on Becks Anxiety Inventory [ Time Frame: 32 weeks ]
  • Change from baseline on Ruminative Response Scale [ Time Frame: 8 weeks ]
  • Change from baseline on Ruminative Response Scale [ Time Frame: 32 weeks ]
  • Change from baseline on Metacognitive questionnaire [ Time Frame: 8 weeks ]
  • Change from baseline on Metacognitive questionnaire [ Time Frame: 32 weeks ]

Estimated Enrollment: 165
Study Start Date: August 2018
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metacognitive Therapy Behavioral: Metacognitive therapy
Group format, 10-12 participants in each group. 8 weekly sessions of two hours each.
Active Comparator: Mindfulness based cognitive therapy Behavioral: Mindfulness based cognitive therapy, group
Group format, 10-12 participants in each group. 8 weekly sessions of two hours each following the manual described by Williams, Zindel & Segal.
Placebo Comparator: Support groups Behavioral: Support groups
Group format, 10-12 participants in each group. The sessions will only be of supportive character and will not focus on changing or restructuring thoughts, scripts or thought patterns. The format will follow a manual but compared to the other intervention groups the format allow participants to suggests themes for discussions.

Detailed Description:
Metacognitive therapy (MCT) show promising results in alleviating depressive symptoms and reducing relapse of depression. However studies of MCT as a group intervention is limited and higher quality studies of the effectiveness of MCT is warranted. The present study aim to produce more conclusive evidence on the effect of MCT comparing MCT in groups with both and active control group and mindfulness based cognitive therapy (MBCT), which together with pharmacotherapy is currently one of the preferred treatment choices. Currently pharmacotherapy, cognitive therapy and MBCT seem to help 40-58% of the patients efficiently. The current studies of MCT indicate that this intervention may help a higher proportion of the patients.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Consent to participate
  • History of clinical depression
  • Current depressive symptoms
  • Verbal and cognitive abilities to complete the questionnaires during the study
  • Stable medication - if any medication is ordinated
  • Speaks fluently danish

Exclusion Criteria:

  • If criteria for psychosis, bipolar disorder or personality disorder is matched
  • known brain damage or mental retardation
  • substance abuse
  • women who are pregnant or breast feeding
  Contacts and Locations
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): NCT02538835


Contacts
Contact: Mette E Andersen, PhD 65504625 ext +45 melandersen@health.sdu.dk
Contact: Tonny Andersen, PhD 65502778 ext +45 tandersen@health.sdu.dk

Locations
Denmark
University of Southern Denmark Not yet recruiting
Odense, Southern Denmark, Denmark, 5230
Contact: Mette E Andersen, PhD    65504625 ext +45    melandersen@health.sdu.dk   
Contact: Tonny Andersen, PhD    65502778 ext +45    tandersen@health.sdu.dk   
Sponsors and Collaborators
University of Southern Denmark
Center for Kognitive Terapier og Supervision
  More Information

Responsible Party: Tonny Elmose Andersen, phd., Associate Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02538835     History of Changes
Other Study ID Numbers: 46332
First Submitted: August 31, 2015
First Posted: September 2, 2015
Last Update Posted: November 15, 2016
Last Verified: November 2016

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