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Trial record 45 of 1065 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

Rumination Focused Cognitive Behavioral Therapy for Major Depression and Recurrent Depression (RuCoD)

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ClinicalTrials.gov Identifier: NCT02278224
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : February 25, 2016
Sponsor:
Collaborators:
University of Exeter
The University of Western Australia
Information provided by (Responsible Party):
Morten Hvenegaard, University of Copenhagen

Brief Summary:

Group based cognitive behavioural therapy (CBT) is an effective treatment of depression, however, one third of patients do not respond satisfactorily (McDermut, Miller, & Brown, 2001), and relapse rates around 30% have been reported from several studies (Butler, Chapman, Forman, & Beck, 2006).

The present study compares group based CBT with rumination focused CBT for depression with respect to outcome and relapse.

Rumination has been evidenced as a crucial vulnerability to depression (Smith & Alloy, 2009), predicting the onset, severity and duration of future depression (Nolen-Hoeksema, 2000). Depressed individuals show a negative bias in the perception of facial emotion, in the acute phase as well as in remission (Bouhuys, Geerts, & Gordijn, 1999), and display difficulties in disengaging from negative stimuli (Koster, De Raedt, Goeleven, Franck, & Crombez, 2005). In addition the present study investigate rumination and perceptual attention bias as potential key mechanisms underlying depression.

128 depressed patients will be recruited and randomised for group based CBT or group based rumination focused CBT. Patients are assessed subsequently during treatment and at 6 month follow-up regarding depression, rumination, worry, negative perceptual bias, attention control. Results are expected at spring 2016.


Condition or disease Intervention/treatment Phase
Depression Recurrent Depression Behavioral: Group based rumination focused CBT Behavioral: Group based CBT Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rumination Focused Cognitive Behavioral Therapy for Major Depression and Recurrent Depression and Relapse Prevention -a Pragmatic RCT Study in a Danish Psychiatric Outpatient Service
Study Start Date : November 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rumination Focused CBT
11 sessions of manualised group based Rumination Focused CBT for depression. 3 hours sessions are administered once during 11 weeks in groups of approximately 8 patients and two therapist.
Behavioral: Group based rumination focused CBT
The RFCBT is a group trans-diagnostic manual based psychotherapy for depression and anxiety. RFCBT focuses on increasing effective behaviour - i.e., not stopping rumination but making it functional. It's grounded within the core principles and techniques of CBT for depression with two adaptations: (1) a functional-analytical perspective using Behavioural Activation (BA) approaches, (2) an explicit focus on shifting processing style via imagery and experiential approaches.

Active Comparator: Cognitive Behavioral Therapy
11 sessions of manualised group based CBT for depression. 3 hours sessions are administered once during 11 weeks in groups of approximately 8 patients and two therapist.
Behavioral: Group based CBT
The control group is gold standard group based CBT based on Becks manual for CBT for depression.




Primary Outcome Measures :
  1. Hamilton Depression Rating Scale 17 [ Time Frame: up to 6 months follow up ]
    The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), abbreviated HAM-D, is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Depression or recurrent depression with Hamilton score of 13 or above.

Exclusion Criteria:

  • Bipolar disorder
  • Psychotic disorder
  • Substance abuse
  • Eating disorder
  • Functional illiterate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278224


Locations
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Denmark
Psychiatric Outpatient Service
Hilleroed, Denmark, 3400
Sponsors and Collaborators
University of Copenhagen
University of Exeter
The University of Western Australia
Investigators
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Study Chair: Stig B Poulsen, Ph.d. University of Copenhagen

Publications:
McDermut W, Miller IW, Brown RA: The Efficacy of Group Psychotherapy for Depression: A Meta-analysis and Review of the Empirical Research. Clinical Psychology: Science and Practice 2006, 8:98-116.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Morten Hvenegaard, Cand.psych. Ph.d. student, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02278224     History of Changes
Other Study ID Numbers: RuCoD-CPH
RuCoD-UoC ( Other Identifier: University of Copenhagen )
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders