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| Behavioural therapy of depression: a randomised controlled trial of behavioural therapy of depression delivered by specifically trained generic mental health staff |
| Source of record | UK Trials |
| ISRCTN | ISRCTN27045243 |
| Date ISRCTN assigned | 30/11/2007 |
| Local reference number(s) | N/A |
| Public title | Behavioural therapy of depression: a randomised controlled trial of behavioural therapy of depression delivered by specifically trained generic mental health staff |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Depression |
| Study hypothesis | 1. After 12 weeks of treatment, depressed patients in the Behavioural Therapy (BT) group will have superior clinical outcomes (measured by Beck Depression Inventory) compared to those in the monitoring control arm 2. Patient satisfaction will be superior in BT than in monitoring control arm 3. BT will be a cost effective intervention |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics approval to be submitted to the North East Research Ethics Committee (REC) in November 2007. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients aged 18+ 2. A General Practitioner (GP) diagnosis of depression 3. On no antidepressant medication or have been on a stable dose for at least 6 weeks 4. Consent to take part in the study Eligibility will be assessed by trained research interviewer using the Clinical Interview Schedule Revised (CSIR) prior to randomisation. |
| Participants - exclusion criteria | 1. Currently actively suicidal 2. Have psychosis, diagnosis of bi-polar disorder or organic brain disease 3. Use alcohol or non prescription drugs requiring a primary clinical intervention |
| Patient information material | |
| Anticipated start date | 01/04/2008 |
| Anticipated end date | 01/04/2009 |
| Status of trial | Ongoing |
| Target number of participants | 60 |
| Interventions | BT: Patients will receive a 45 minute assessment and up to twelve 30 - 45 minute BT therapy sessions from a mental health worker using structured materials following a BT protocol. BT consists of a structured programme of reducing the frequency of negatively reinforced avoidant behaviours in parallel with increasing the frequency of positively reinforcing behaviours to improve functioning and raise mood. The control group is a monitoring control arm. Participants will be placed on a 12 week monitoring control group. They will be contacted fortnightly by phone for approximately 10 minutes. Depression severity will be assesed via the Patient Health Questionaire. Should clinical indications suggest further intervention is required, patients will be asked to contact their GP. At 12 weeks participants in this arm will be offered intervention as per BT treatment arm. |
| Primary outcome measure(s) | Assessments will be conducted by a research worker blind to treatment allocation at pre-treatment and 12 weeks follow up. The primary clinical outcome will be depression symptom level as measured by the Beck Depression inventory. |
| Secondary outcome measure(s) | Secondary outcome measures include: 1. The Social Adjustment Scale 2. Measures of treatment satisfaction, assessed using the 8-item Client Satisfaction Questionnaire (CSQ8) 3. Service utilisation data collected on frequency of primary, secondary and tertiary service use via patient diaries and questionnaires 4. Health utility data, measured by the Euroqol All measurements will be collected pre treatment and at 12 weeks. |
| Sources of funding | Tees Esk & Wear Valleys NHS Trust (UK) |
| Sponsor name | Tees Esk & Wear Valleys NHS Trust (UK) |
| Sponsor details | Research and Development Office TAD Centre Ormesby Road Middlesbrough United Kingdom TS3 7SF |
| Sponsor telephone | +44 (0)1642 516981 |
| Sponsor email | j.g.reilly@dur.ac.uk |
| Sponsor website | http://www.tewv.nhs.uk/ |
| Contact name | Mr David Ekers |
| Contact details | Health Centre Newcastle Road Chester Le Street Co Durham United Kingdom DH3 3UR |
| Contact telephone | +44 (0)191 333 6000 |
| Contact email | david.ekers@dur.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN27045243 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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