Clinical trial NCT02538835: The Effect of Group Treatment for Depression: A Study of Metacognitive Therapy, Mindfulness and Support Groups
Official title: The Effect of Group Treatment for Depression: A Randomised Controlled Study of Metacognitive Therapy, Mindfulness and Support Groups
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Center for Kognitive Terapier og Supervision
First posted: 2015-09-02
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline on Hamilton depression scale
timeFrame: 8 weeks
measure: Change from baseline on Hamilton depression scale
timeFrame: 32 weeks
Secondary outcomes:
measure: Change from baseline on Becks depression inventory
timeFrame: 8 weeks
measure: Change from baseline on Becks depression inventory
timeFrame: 32 weeks
measure: Change from baseline on Becks Anxiety Inventory
timeFrame: 8 weeks
measure: Change from baseline on Becks Anxiety Inventory
timeFrame: 32 weeks
measure: Change from baseline on Ruminative Response Scale
timeFrame: 8 weeks
measure: Change from baseline on Ruminative Response Scale
timeFrame: 32 weeks
measure: Change from baseline on Metacognitive questionnaire
timeFrame: 8 weeks
measure: Change from baseline on Metacognitive questionnaire
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
state: Southern Denmark
Study officials:
References: