Condition category
Mental and Behavioural Disorders
Date applied
02/11/2007
Date assigned
30/11/2007
Last edited
01/02/2012
Prospective/Retrospective
Prospectively 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

Mr David Ekers

ORCID ID

Contact details

Health Centre
Newcastle Road
Chester Le Street
County Durham
DH3 3UR
United Kingdom
+44 (0)191 333 6000
david.ekers@dur.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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

Ethics approval

Ethics approval received from the Northumberland Research Ethics Committee on the 4th April 2008 (ref: 08/H0902/26).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Depression

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/04/2008

Overall trial end date

01/04/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60 (70 as of 29/04/2008)

Participant 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

Recruitment start date

01/04/2008

Recruitment end date

01/04/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Centre
County Durham
DH3 3UR
United Kingdom

Sponsor information

Organisation

Tees Esk & Wear Valleys NHS Trust (UK)

Sponsor details

Research and Development Office
TAD Centre
Ormesby Road
Middlesbrough
TS3 7SF
United Kingdom
+44 (0)1642 516981
j.g.reilly@dur.ac.uk

Sponsor type

Government

Website

http://www.tewv.nhs.uk/

Funders

Funder type

Government

Funder name

Tees Esk & Wear Valleys NHS Trust (UK)

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21200079
2. 2011 cost-effectiveness results in http://www.ncbi.nlm.nih.gov/pubmed/21947655

Publication citations

  1. Results

    Ekers D, Richards D, McMillan D, Bland JM, Gilbody S, Behavioural activation delivered by the non-specialist: phase II randomised controlled trial., Br J Psychiatry, 2011, 198, 1, 66-72, doi: 10.1192/bjp.bp.110.079111.

  2. Ekers D, Godfrey C, Gilbody S, Parrott S, Richards DA, Hammond D, Hayes A, Cost utility of behavioural activation delivered by the non-specialist., Br J Psychiatry, 2011, 199, 6, 510-511, doi: 10.1192/bjp.bp.110.090266.

Additional files

Editorial Notes