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Clinical Trials/NCT02538835
NCT02538835
Unknown
Not Applicable

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

University of Southern Denmark1 site in 1 country165 target enrollmentAugust 2018
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Southern Denmark
Enrollment
165
Locations
1
Primary Endpoint
Change from baseline on Hamilton depression scale
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2018
End Date
July 2020
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tonny Elmose Andersen, phd.

Associate Professor

University of Southern Denmark

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

Outcomes

Primary Outcomes

Change from baseline on Hamilton depression scale

Time Frame: 32 weeks

Secondary Outcomes

  • Change from baseline on Metacognitive questionnaire(32 weeks)
  • 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)

Study Sites (1)

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