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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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.
- 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
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
|Psychiatric Outpatient Service|
|Hilleroed, Denmark, 3400|
|Study Chair:||Stig B Poulsen, Ph.d.||University of Copenhagen|