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

Not Applicable

• Conditions: Depression
• Interventions: Behavioral: Metacognitive therapy; Behavioral: Mindfulness based cognitive therapy, group; Behavioral: Support groups

• Registration Number: NCT02538835
• Lead Sponsor: University of Southern Denmark

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 Timeline

• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15
• Study Start: 2018-08
• Primary Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 165

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metacognitive Therapy	Metacognitive therapy	-
Mindfulness based cognitive therapy	Mindfulness based cognitive therapy, group	-
Support groups	Support groups	-

Primary Outcome Measures

Name	Time	Method
Change from baseline on Hamilton depression scale	32 weeks

Secondary Outcome Measures

Name	Time	Method
Change from baseline on Becks depression inventory	32 weeks
Change from baseline on Becks Anxiety Inventory	32 weeks
Change from baseline on Ruminative Response Scale	32 weeks
Change from baseline on Metacognitive questionnaire	32 weeks

Trial Locations

Locations (1)

University of Southern Denmark; 🇩🇰 Odense, Southern Denmark, Denmark