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| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
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Back On Track: Groups for Women
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Evaluation of a group based intervention for women with depression
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Topic
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Mental Health (co-adopted by PCRN)
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Portfolio Eligibility
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Funded by UKCRC partner
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ISRCTN
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EudraCT
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MREC N° |
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UKCRN ID |
4103
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WHO ID
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Research Summary
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Depression and anxiety disorders are common in primary care, especially among women. GPs are rewarded for recognizing depression but they often find themselves with little to offer their patients with depression of moderate or minor severity. Various types of psychological therapy have been shown to be effective in the treatment of depression. However, there is little availability of such interventions in primary care, and limited evidence on the cost-effectiveness or feasibility of group based interventions.
Our project is a pilot study for a group-based intervention amongst women with mild to moderate depression or anxiety in primary care. The intervention will be based on principles derived from cognitive behaviour therapy and problem-solving approaches. The proposed intervention aims to empower patients through improving their self-management skills. We expect to show that this intervention is feasible, affordable, efficacious, and widely accepted by participants, group leaders and staff. If this pilot study demonstrates encouraging results, we will submit a proposal for a large-scale, multi-centre effectiveness trial in due course.
This randomised controlled trial pilot will compare the intervention with usual care in socially deprived areas in Bristol, incorporating qualitative methods to assess acceptability
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Study Type |
Interventional
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Design Type |
Treatment
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Disease(s) |
Depression
Anxiety
All Diseases
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Phase |
N/A
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Current Status
| Closed - follow-up complete |
| Closure Date | 30/09/2008 |
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Sample Size
| 55 |
| Accrual to Date |
 | 132% |
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Geographical Scope
| UK Multi-Centre |
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Lead Country
| England |
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Main Inclusion Criteria
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a) Age between 30-55
b) Mild to moderately severe depression according to the PHQ-9 (Score between 10-20 on two occasions, at initial eligibility assessment and at baseline assessment)
c) Female
NB Current or past use of antidepressants or benzodiazepines would not be a contraindication to participation in the study
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Main Exclusion Criteria
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a) Severe current drug or alcohol abuse. Individuals with mild problems according to GPs will be accepted provided there are no signs of use when coming to the sessions
b) Severe depression (PHQ>20 at baseline) with or without suicidal ideation
c) Currently attending specialist psychiatric services (including psychotherapy but not including practice-based counselling) for mental health problems
d) Unable to speak English
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Chief Investigator(s)
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| Prof Ricardo Araya | Prof Chris Salisbury |
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Further details, please contact
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Dr Helen Cramer
University of Bristol
Academic Unit of Primary Health Care
25-27 Belgrave Road
Bristol
Somerset
BS8 2AA
UNITED KINGDOM
Tel: 0117 331 3820
Helen.Cramer@bristol.ac.uk
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Funder(s) |
NIHR - National School for Primary Health Care
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Sponsor(s) |
University of Bristol
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