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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Metacognitive therapy
* Behavioral: Mindfulness based cognitive therapy, group
* Behavioral: Support groups


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metacognitive Therapy<br> | Behavioral: Metacognitive therapy<br>* Group format, 10-12 participants in each group. 8 weekly sessions of two hours each.<br>|
| Active Comparator: Mindfulness based cognitive therapy<br> | Behavioral: Mindfulness based cognitive therapy, group<br>* Group format, 10-12 participants in each group. 8 weekly sessions of two hours each following the manual described by Williams, Zindel & Segal.<br>|
| Placebo Comparator: Support groups<br> | Behavioral: Support groups<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline on Hamilton depression scale |  | 8 weeks | 
| Change from baseline on Hamilton depression scale |  | 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Change from baseline on Ruminative Response Scale |  | 32 weeks | 
| Change from baseline on Metacognitive questionnaire |  | 8 weeks | 
| Change from baseline on Metacognitive questionnaire |  | 32 weeks |