Rumination Focused Cognitive Behavioral Therapy for Major Depression and Recurrent Depression and Relapse Prevention -a Pragmatic RCT Study in a Danish Psychiatric Outpatient Service
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 131
- Locations
- 2
- Primary Endpoint
- Hamilton Depression Rating Scale 17
Study Overview
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.
Detailed Description
Background and rationale
The aim of the present study is to compare the effectiveness of rumination-focused cognitive behavior therapy vs. cognitive behavior therapy for treatment of depression.
Understanding the mechanisms involved in effective cognitive behavioural therapy is a key focus of clinical research (Watkins, 2009). The study will investigate possible underlying mechanisms of rumination and thereby provide insights about the information processing and symptoms of depression.
Rumination, a process of recurrent negative thinking and dwelling on negative affect, is a common residual symptom (Kim, Yu, Lee, & Kim, 2012; Riso et al., 2003). 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).
Such knowledge indicates that rumination is a key factor involved in the initiation and maintenance of depressive symptoms. Individuals that display high levels of rumination even if not currently presenting depressive symptoms may therefore have an increased risk for developing future depression. Consequently, if involved in the pathogenesis of depression, rumination may constitute an active ingredient of psychological intervention. Hence, interventions explicitly targeting rumination may improve the efficiency of CBT for recurrent and chronic depression (Watkins, 2009). However, few studies have tested interventions targeting rumination, with the exception of Watkins (2007; 2011).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Morten Hvenegaard
Cand.psych. Ph.d. student
University of Copenhagen
