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ISRCTN
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ISRCTN27045243
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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
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Ethics approval
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Ethics approval received from the Northumberland Research Ethics Committee on the 4th April 2008 (ref: 08/H0902/26).
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Depression
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2008
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Anticipated end date
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01/04/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60 (70 as of 29/04/2008)
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Interventions
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Please note that the interventions section of this trial has been updated as of 29/04/2008 to the following:
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.
Usual GP care (Delayed BT): Treatment in this arm of the study will be delivered by participant's GP as per usual practise. In addition participants will be contacted for 15-20 minutes via phone monthly by research staff. During this call depression symptom level will be assessed using the PHQ9 (Koneke et al 2001) and participants will be
advised to contact their GP should information be elicited that requires further clinical intervention (such as increased risk, significant deterioration in depression symptom level).
Previous 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.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Tees Esk & Wear Valleys NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Mr
David
Ekers
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Address
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Health Centre
Newcastle Road
Chester Le Street
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City/town
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Co Durham
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Zip/Postcode
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DH3 3UR
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Country
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United Kingdom
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Tel
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+44 (0)191 333 6000
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Email
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david.ekers@dur.ac.uk
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Sponsor
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Tees Esk & Wear Valleys NHS Trust (UK)
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Address
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Research and Development Office
TAD Centre
Ormesby Road
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City/town
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Middlesbrough
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Zip/Postcode
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TS3 7SF
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Country
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United Kingdom
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Tel
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+44 (0)1642 516981
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Email
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j.g.reilly@dur.ac.uk
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Sponsor website:
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http://www.tewv.nhs.uk/
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Date applied
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02/11/2007
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Last edited
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29/04/2008
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Date ISRCTN assigned
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30/11/2007
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