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

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ClinicalTrials.gov Identifier: NCT02538835
Recruitment Status : Not yet recruiting
First Posted : September 2, 2015
Last Update Posted : November 15, 2016
Sponsor:
Collaborator:
Center for Kognitive Terapier og Supervision
Information provided by (Responsible Party):
Tonny Elmose Andersen, phd., University of Southern Denmark

Tracking Information
First Submitted Date  ICMJE August 31, 2015
First Posted Date  ICMJE September 2, 2015
Last Update Posted Date November 15, 2016
Study Start Date  ICMJE August 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
  • Change from baseline on Hamilton depression scale [ Time Frame: 8 weeks ]
  • Change from baseline on Hamilton depression scale [ Time Frame: 32 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02538835 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
  • Change from baseline on Becks depression inventory [ Time Frame: 8 weeks ]
  • Change from baseline on Becks depression inventory [ Time Frame: 32 weeks ]
  • Change from baseline on Becks Anxiety Inventory [ Time Frame: 8 weeks ]
  • Change from baseline on Becks Anxiety Inventory [ Time Frame: 32 weeks ]
  • Change from baseline on Ruminative Response Scale [ Time Frame: 8 weeks ]
  • Change from baseline on Ruminative Response Scale [ Time Frame: 32 weeks ]
  • Change from baseline on Metacognitive questionnaire [ Time Frame: 8 weeks ]
  • Change from baseline on Metacognitive questionnaire [ Time Frame: 32 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Group Treatment for Depression: A Study of Metacognitive Therapy, Mindfulness and Support Groups
Official Title  ICMJE The Effect of Group Treatment for Depression: A Randomised Controlled Study of Metacognitive Therapy, Mindfulness and Support Groups
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Behavioral: Metacognitive therapy
    Group format, 10-12 participants in each group. 8 weekly sessions of two hours each.
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Metacognitive Therapy
    Intervention: Behavioral: Metacognitive therapy
  • Active Comparator: Mindfulness based cognitive therapy
    Intervention: Behavioral: Mindfulness based cognitive therapy, group
  • Placebo Comparator: Support groups
    Intervention: Behavioral: Support groups
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 1, 2015)
165
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mette E Andersen, PhD 65504625 ext +45 melandersen@health.sdu.dk
Contact: Tonny Andersen, PhD 65502778 ext +45 tandersen@health.sdu.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02538835
Other Study ID Numbers  ICMJE 46332
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tonny Elmose Andersen, phd., University of Southern Denmark
Study Sponsor  ICMJE University of Southern Denmark
Collaborators  ICMJE Center for Kognitive Terapier og Supervision
Investigators  ICMJE Not Provided
PRS Account University of Southern Denmark
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP