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Clinical Trials/NCT02278224
NCT02278224CompletedNot Applicable

Rumination Focused Cognitive Behavioral Therapy for Major Depression and Recurrent Depression and Relapse Prevention -a Pragmatic RCT Study in a Danish Psychiatric Outpatient Service

University of Copenhagen2 sites in 1 country131 target enrollmentStarted: November 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Morten Hvenegaard

Cand.psych. Ph.d. student

University of Copenhagen

Study Sites (2)

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