Rumination Focused Cognitive Behavioral Therapy for Major Depression and Recurrent Depression

NCT02278224 | Completed DMC

• 2 other identifiers: RuCoD-CPHRuCoD-UoC
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Recurrent Depression

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale 17

  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

  up to 6 months follow up

Study Arms (2)

Rumination Focused CBT

EXPERIMENTAL

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

Cognitive Behavioral Therapy

ACTIVE COMPARATOR

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

Interventions

Group based rumination focused CBT BEHAVIORAL

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.

Rumination Focused CBT

Group based CBT BEHAVIORAL

The control group is gold standard group based CBT based on Becks manual for CBT for depression.

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Copenhagen: lead
• University of Exeter: collaborator
• The University of Western Australia: collaborator

Study Sites (1)

Psychiatric Outpatient Service

Hilleroed, 3400, Denmark

Location

Related Publications (20)

• Cuijpers P, Karyotaki E, Weitz E, Andersson G, Hollon SD, van Straten A. The effects of psychotherapies for major depression in adults on remission, recovery and improvement: a meta-analysis. J Affect Disord. 2014 Apr;159:118-26. doi: 10.1016/j.jad.2014.02.026. Epub 2014 Feb 24.

  PMID: 24679399 BACKGROUND

• 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.

  BACKGROUND

• Butler AC, Chapman JE, Forman EM, Beck AT. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006 Jan;26(1):17-31. doi: 10.1016/j.cpr.2005.07.003. Epub 2005 Sep 30.

  PMID: 16199119 BACKGROUND

• Dimidjian S, Hollon SD, Dobson KS, Schmaling KB, Kohlenberg RJ, Addis ME, Gallop R, McGlinchey JB, Markley DK, Gollan JK, Atkins DC, Dunner DL, Jacobson NS. Randomized trial of behavioral activation, cognitive therapy, and antidepressant medication in the acute treatment of adults with major depression. J Consult Clin Psychol. 2006 Aug;74(4):658-70. doi: 10.1037/0022-006X.74.4.658.

  PMID: 16881773 BACKGROUND

• Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.

  PMID: 23459093 BACKGROUND

• Kennedy N, Paykel ES. Residual symptoms at remission from depression: impact on long-term outcome. J Affect Disord. 2004 Jun;80(2-3):135-44. doi: 10.1016/S0165-0327(03)00054-5.

  PMID: 15207926 BACKGROUND

• Riso LP, du Toit PL, Blandino JA, Penna S, Dacey S, Duin JS, Pacoe EM, Grant MM, Ulmer CS. Cognitive aspects of chronic depression. J Abnorm Psychol. 2003 Feb;112(1):72-80.

  PMID: 12653415 BACKGROUND

• van Rijsbergen GD, Kok GD, Elgersma HJ, Hollon SD, Bockting CL. Personality and cognitive vulnerability in remitted recurrently depressed patients. J Affect Disord. 2015 Mar 1;173:97-104. doi: 10.1016/j.jad.2014.10.042. Epub 2014 Nov 4.

  PMID: 25462402 BACKGROUND

• Vittengl JR, Clark LA, Dunn TW, Jarrett RB. Reducing relapse and recurrence in unipolar depression: a comparative meta-analysis of cognitive-behavioral therapy's effects. J Consult Clin Psychol. 2007 Jun;75(3):475-88. doi: 10.1037/0022-006X.75.3.475.

  PMID: 17563164 BACKGROUND

• Paykel ES, Scott J, Teasdale JD, Johnson AL, Garland A, Moore R, Jenaway A, Cornwall PL, Hayhurst H, Abbott R, Pope M. Prevention of relapse in residual depression by cognitive therapy: a controlled trial. Arch Gen Psychiatry. 1999 Sep;56(9):829-35. doi: 10.1001/archpsyc.56.9.829.

  PMID: 12884889 BACKGROUND

• Jarrett RB, Vittengl JR, Clark LA. How much cognitive therapy, for which patients, will prevent depressive relapse? J Affect Disord. 2008 Dec;111(2-3):185-92. doi: 10.1016/j.jad.2008.02.011. Epub 2008 Mar 21.

  PMID: 18358541 BACKGROUND

• Watkins ER. Depressive rumination: investigating mechanisms to improve cognitive behavioural treatments. Cogn Behav Ther. 2009;38 Suppl 1(S1):8-14. doi: 10.1080/16506070902980695.

  PMID: 19697180 BACKGROUND

• Watkins E, Scott J, Wingrove J, Rimes K, Bathurst N, Steiner H, Kennell-Webb S, Moulds M, Malliaris Y. Rumination-focused cognitive behaviour therapy for residual depression: a case series. Behav Res Ther. 2007 Sep;45(9):2144-54. doi: 10.1016/j.brat.2006.09.018. Epub 2007 Mar 26.

  PMID: 17367751 BACKGROUND

• Smith JM, Alloy LB. A roadmap to rumination: a review of the definition, assessment, and conceptualization of this multifaceted construct. Clin Psychol Rev. 2009 Mar;29(2):116-28. doi: 10.1016/j.cpr.2008.10.003. Epub 2008 Nov 5.

  PMID: 19128864 BACKGROUND

• Nolen-Hoeksema S, Wisco BE, Lyubomirsky S. Rethinking Rumination. Perspect Psychol Sci. 2008 Sep;3(5):400-24. doi: 10.1111/j.1745-6924.2008.00088.x.

  PMID: 26158958 BACKGROUND

• Nolen-Hoeksema S. The role of rumination in depressive disorders and mixed anxiety/depressive symptoms. J Abnorm Psychol. 2000 Aug;109(3):504-11.

  PMID: 11016119 BACKGROUND

• Watkins ER, Mullan E, Wingrove J, Rimes K, Steiner H, Bathurst N, Eastman R, Scott J. Rumination-focused cognitive-behavioural therapy for residual depression: phase II randomised controlled trial. Br J Psychiatry. 2011 Oct;199(4):317-22. doi: 10.1192/bjp.bp.110.090282. Epub 2011 Jul 21.

  PMID: 21778171 BACKGROUND

• Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967 Dec;6(4):278-96. doi: 10.1111/j.2044-8260.1967.tb00530.x. No abstract available.

  PMID: 6080235 BACKGROUND

• Hvenegaard M, Moeller SB, Poulsen S, Gondan M, Grafton B, Austin SF, Kistrup M, Rosenberg NGK, Howard H, Watkins ER. Group rumination-focused cognitive-behavioural therapy (CBT) v. group CBT for depression: phase II trial. Psychol Med. 2020 Jan;50(1):11-19. doi: 10.1017/S0033291718003835. Epub 2019 Jan 11.

  PMID: 30630555 DERIVED

• Hvenegaard M, Watkins ER, Poulsen S, Rosenberg NK, Gondan M, Grafton B, Austin SF, Howard H, Moeller SB. Rumination-focused cognitive behaviour therapy vs. cognitive behaviour therapy for depression: study protocol for a randomised controlled superiority trial. Trials. 2015 Aug 11;16:344. doi: 10.1186/s13063-015-0875-y.

  PMID: 26260780 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Stig B Poulsen, Ph.d.

  University of Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cand.psych. Ph.d. student

Study Record Dates

• First Submitted: August 31, 2014
• First Posted: October 29, 2014
• Study Start: November 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 25, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)