The Effect of Group Treatment for Depression: A Randomised Controlled Study of Metacognitive Therapy, Mindfulness and Support Groups
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 165
- Locations
- 1
- Primary Endpoint
- Change from baseline on Hamilton depression scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Metacognitive Therapy
Intervention: Metacognitive therapy (Behavioral)
Mindfulness based cognitive therapy
Intervention: Mindfulness based cognitive therapy, group (Behavioral)
Support groups
Intervention: Support groups (Behavioral)
Outcomes
Primary Outcomes
Change from baseline on Hamilton depression scale
Time Frame: 32 weeks
Change from baseline on Hamilton depression scale
Time Frame: 8 weeks
Secondary Outcomes
- Change from baseline on Ruminative Response Scale(32 weeks)
- Change from baseline on Becks depression inventory(32 weeks)
- Change from baseline on Becks Anxiety Inventory(32 weeks)
- Change from baseline on Metacognitive questionnaire(32 weeks)
- Change from baseline on Becks Anxiety Inventory(8 weeks)
- Change from baseline on Becks depression inventory(8 weeks)
- Change from baseline on Ruminative Response Scale(8 weeks)
- Change from baseline on Metacognitive questionnaire(8 weeks)
Investigators
Tonny Elmose Andersen, phd.
Associate Professor
University of Southern Denmark