The Effect of Group Treatment for Depression: A Study of Metacognitive Therapy, Mindfulness and Support Groups
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Metacognitive therapy
Mindfulness based cognitive therapy, group
Support groups
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility 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
Sites / Locations
- University of Southern Denmark
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Metacognitive Therapy
Mindfulness based cognitive therapy
Support groups
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline on Hamilton depression scale
Change from baseline on Hamilton depression scale
Secondary Outcome Measures
Change from baseline on Becks depression inventory
Change from baseline on Becks depression inventory
Change from baseline on Becks Anxiety Inventory
Change from baseline on Becks Anxiety Inventory
Change from baseline on Ruminative Response Scale
Change from baseline on Ruminative Response Scale
Change from baseline on Metacognitive questionnaire
Change from baseline on Metacognitive questionnaire
Full Information
NCT ID
NCT02538835
First Posted
August 31, 2015
Last Updated
November 14, 2016
Sponsor
University of Southern Denmark
Collaborators
Center for Kognitive Terapier og Supervision
1. Study Identification
Unique Protocol Identification Number
NCT02538835
Brief Title
The Effect of Group Treatment for Depression: A Study of Metacognitive Therapy, Mindfulness and Support Groups
Official Title
The Effect of Group Treatment for Depression: A Randomised Controlled Study of Metacognitive Therapy, Mindfulness and Support Groups
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2018 (undefined)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Center for Kognitive Terapier og Supervision
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
165 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metacognitive Therapy
Arm Type
Experimental
Arm Title
Mindfulness based cognitive therapy
Arm Type
Active Comparator
Arm Title
Support groups
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Metacognitive therapy
Intervention Description
Group format, 10-12 participants in each group. 8 weekly sessions of two hours each.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based cognitive therapy, group
Intervention Description
Group format, 10-12 participants in each group. 8 weekly sessions of two hours each following the manual described by Williams, Zindel & Segal.
Intervention Type
Behavioral
Intervention Name(s)
Support groups
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline on Hamilton depression scale
Time Frame
8 weeks
Title
Change from baseline on Hamilton depression scale
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Change from baseline on Becks depression inventory
Time Frame
8 weeks
Title
Change from baseline on Becks depression inventory
Time Frame
32 weeks
Title
Change from baseline on Becks Anxiety Inventory
Time Frame
8 weeks
Title
Change from baseline on Becks Anxiety Inventory
Time Frame
32 weeks
Title
Change from baseline on Ruminative Response Scale
Time Frame
8 weeks
Title
Change from baseline on Ruminative Response Scale
Time Frame
32 weeks
Title
Change from baseline on Metacognitive questionnaire
Time Frame
8 weeks
Title
Change from baseline on Metacognitive questionnaire
Time Frame
32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mette E Andersen, PhD
Phone
65504625
Ext
+45
Email
melandersen@health.sdu.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Tonny Andersen, PhD
Phone
65502778
Ext
+45
Email
tandersen@health.sdu.dk
Facility Information:
Facility Name
University of Southern Denmark
City
Odense
State/Province
Southern Denmark
ZIP/Postal Code
5230
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette E Andersen, PhD
Phone
65504625
Ext
+45
Email
melandersen@health.sdu.dk
First Name & Middle Initial & Last Name & Degree
Tonny Andersen, PhD
Phone
65502778
Ext
+45
Email
tandersen@health.sdu.dk
12. IPD Sharing Statement
Learn more about this trial
The Effect of Group Treatment for Depression: A Study of Metacognitive Therapy, Mindfulness and Support Groups
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