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

November 14, 2016 updated by: Tonny Elmose Andersen, phd., University of Southern Denmark

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Southern Denmark
      • Odense, Southern Denmark, Denmark, 5230
        • University of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline on Hamilton depression scale
Time Frame: 8 weeks
8 weeks
Change from baseline on Hamilton depression scale
Time Frame: 32 weeks
32 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline on Becks depression inventory
Time Frame: 8 weeks
8 weeks
Change from baseline on Becks depression inventory
Time Frame: 32 weeks
32 weeks
Change from baseline on Becks Anxiety Inventory
Time Frame: 8 weeks
8 weeks
Change from baseline on Becks Anxiety Inventory
Time Frame: 32 weeks
32 weeks
Change from baseline on Ruminative Response Scale
Time Frame: 8 weeks
8 weeks
Change from baseline on Ruminative Response Scale
Time Frame: 32 weeks
32 weeks
Change from baseline on Metacognitive questionnaire
Time Frame: 8 weeks
8 weeks
Change from baseline on Metacognitive questionnaire
Time Frame: 32 weeks
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Center for Kognitive Terapier og Supervision

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2018

Primary Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Estimate)

November 15, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 46332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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