The Effect of Group Treatment for Depression: A Study of Metacognitive Therapy, Mindfulness and Support Groups
1 other identifier
interventional
165
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
1 active site
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
First Submitted
Initial submission to the registry
August 31, 2015
CompletedFirst Posted
Study publicly available on registry
September 2, 2015
CompletedStudy Start
First participant enrolled
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedNovember 15, 2016
November 1, 2016
1.9 years
August 31, 2015
November 14, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline on Hamilton depression scale
8 weeks
Change from baseline on Hamilton depression scale
32 weeks
Secondary Outcomes (8)
Change from baseline on Becks depression inventory
8 weeks
Change from baseline on Becks depression inventory
32 weeks
Change from baseline on Becks Anxiety Inventory
8 weeks
Change from baseline on Becks Anxiety Inventory
32 weeks
Change from baseline on Ruminative Response Scale
8 weeks
- +3 more secondary outcomes
Study Arms (3)
Metacognitive Therapy
EXPERIMENTALMindfulness based cognitive therapy
ACTIVE COMPARATORSupport groups
PLACEBO COMPARATORInterventions
Group format, 10-12 participants in each group. 8 weekly sessions of two hours each.
Group format, 10-12 participants in each group. 8 weekly sessions of two hours each following the manual described by Williams, Zindel \& Segal.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Southern Denmark
Odense, Southern Denmark, 5230, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 31, 2015
First Posted
September 2, 2015
Study Start
August 1, 2018
Primary Completion
July 1, 2020
Last Updated
November 15, 2016
Record last verified: 2016-11