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

NCT ID: NCT02538835

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

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.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Metacognitive Therapy

Group Type EXPERIMENTAL

Metacognitive therapy

Intervention Type BEHAVIORAL

Group format, 10-12 participants in each group. 8 weekly sessions of two hours each.

Mindfulness based cognitive therapy

Group Type ACTIVE_COMPARATOR

Mindfulness based cognitive therapy, group

Intervention Type BEHAVIORAL

Group format, 10-12 participants in each group. 8 weekly sessions of two hours each following the manual described by Williams, Zindel \& Segal.

Support groups

Group Type PLACEBO_COMPARATOR

Support groups

Intervention Type BEHAVIORAL

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.

Interventions

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Metacognitive therapy

Group format, 10-12 participants in each group. 8 weekly sessions of two hours each.

Intervention Type BEHAVIORAL

Mindfulness based cognitive therapy, group

Group format, 10-12 participants in each group. 8 weekly sessions of two hours each following the manual described by Williams, Zindel \& Segal.

Intervention Type BEHAVIORAL

Support groups

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center for Kognitive Terapier og Supervision

UNKNOWN

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Tonny Elmose Andersen, phd.

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Southern Denmark

Odense, Southern Denmark, Denmark

Site Status

Countries

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Denmark

Central Contacts

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Mette E Andersen, PhD

Role: CONTACT

Phone: 65504625

Email: [email protected]

Tonny Andersen, PhD

Role: CONTACT

Phone: 65502778

Email: [email protected]

Facility Contacts

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Mette E Andersen, PhD

Role: primary

Tonny Andersen, PhD

Role: backup

Other Identifiers

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46332

Identifier Type: -

Identifier Source: org_study_id