Rumination-Focused Cognitive Behavioural Therapy for residual depression
| ISRCTN | ISRCTN22782150 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22782150 |
| Protocol serial number | N/A |
| Sponsor | University of Exeter (UK) |
| Funder | NARSAD (National Alliance for Research into Schizophrenia and Depression) (USA) |
- Submission date
- 11/03/2011
- Registration date
- 15/04/2011
- Last edited
- 15/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Edward Watkins
Scientific
Scientific
Mood Disorders Centre
College of Life and Environmental Sciences
University of Exeter
Exeter
EX4 4QG
United Kingdom
| Phone | +44 (0)13 9272 4692 |
|---|---|
| e.r.watkins@exeter.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-site randomised controlled adjunctive trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Rumination-Focused Cognitive Behavioural Therapy for residual depression: a pilot randomised controlled trial |
| Study acronym | RFCBT |
| Study objectives | 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(s) | North and East Devon REC approved on 18th November 2003 (REC ref no : 2003/11/222) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Hamilton Rating Scale for Depression (HRSD) |
| Key secondary outcome measure(s) |
1. The Structured Clinical Interview for DSM-IV (SCID) to assess diagnostic status for major depression |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 42 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Mood Disorders Centre
Exeter
EX4 4QG
United Kingdom
EX4 4QG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2007 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
