Condition category
Mental and Behavioural Disorders
Date applied
11/03/2011
Date assigned
15/04/2011
Last edited
15/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Edward Watkins

ORCID ID

Contact details

Mood Disorders Centre
College of Life and Environmental Sciences
University of Exeter
Exeter
EX4 4QG
United Kingdom
+44 (0)13 9272 4692
e.r.watkins@exeter.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Rumination-Focused Cognitive Behavioural Therapy for residual depression: a pilot randomised controlled trial

Acronym

RFCBT

Study hypothesis

The addition of rumination-focused CBT to standard clinical management and antidepressant medication (CM + ADM) for residual depression will produce significantly greater reduction in rumination and symptoms of depression than CM + ADM alone.

Ethics approval

North and East Devon REC approved on 18th November 2003 (REC ref no : 2003/11/222)

Study design

Multi-site randomised controlled adjunctive trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in the web format, please use the contact details below to request a patient information sheet

Condition

Residual treatment-resistant depression

Intervention

Intervention: Rumination-focused cognitive-behavioural therapy (RFCBT) as ajdunct to treatment-as-usual. RFCBT is a manualised CBT treatment, consisting of up to 12 individual 60 minute sessions scheduled weekly or fortnightly. RFCBT is theoretically informed by experimental research indicating that there are distinct constructive and unconstructive forms of rumination.It is designed to coach patients to shift from unconstructive rumination to constructive rumination, through the use of functional analysis, experiential/imagery exercises and behavioural experiments. As such, RFCBT incorporates the functional-analytic and contextual principles and techniques of Behavioural Activation (BA), but focused on rumination

Control: treatment-as-usual (TAU). TAU consisted of ongoing maintenance antidepressant medication and outpatient clinical management across the same 5 months time period of the combined treatment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Hamilton Rating Scale for Depression (HRSD)
2. Beck Depression Inventory (BDI-II)

Secondary outcome measures

1. The Structured Clinical Interview for DSM-IV (SCID) to assess diagnostic status for major depression
2. Ruminative Response Scale of the Response Styles Questionnaire (RRS) to assess rumination

Overall trial start date

01/09/2004

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged >18
2. Meeting criteria for medication-refractory residual depression defined as:
2.1. Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for major depression within the last 18 months but not in the last 2 months
2.2. Residual symptoms reaching at least 8 on the 17-item Hamilton Depression Rating Scale (HRSD) and 9 on the Beck Depression Inventory (BDI-II)
2.3. Taking antidepressant medication at a therapeutic dose as recommended by the British National Formulary and/or equivalent to 125mg of amitriptyline for at least 8 weeks continuously during the current episode and within the last 2 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant exclusion criteria

1. A history of bipolar disorder, psychosis
2. Current drug or alcohol dependence
3. Learning disability
4. Organic brain damage
5. Concurrent psychotherapy at point of entry to the study

There were no exclusion criteria with respect to co-morbid anxiety disorders or Axis II diagnosis

Recruitment start date

01/09/2004

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Mood Disorders Centre
Exeter
EX4 4QG
United Kingdom

Sponsor information

Organisation

University of Exeter (UK)

Sponsor details

Research & Knowledge Transfer
University of Exeter (Streatham Campus)
Innovation Centre Phase 2
Rennes Drive
Devon
Exeter
EX4 4RN
United Kingdom

Sponsor type

University/education

Website

http://www.exeter.ac.uk

Funders

Funder type

Charity

Funder name

NARSAD (National Alliance for Research into Schizophrenia and Depression) (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17367751

Publication citations

  1. Results

    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, 45, 9, 2144-2154, doi: 10.1016/j.brat.2006.09.018.

Additional files

Editorial Notes