title: Group cognitive behavioural therapy for women with depression: pilot and feasibility study for a randomised controlled trial using mixed methods.
abstract: BACKGROUND
  Group Cognitive Behavioural Therapy (CBT) may provide a means of improving mental health among people with depression but few studies have explored its effectiveness. Our aim was to examine the feasibility and acceptability of a randomised controlled trial of a group intervention based on CBT principles for women with depression in primary care.
  
  
  METHODS
  Women aged 30 to 55 years were recruited and randomly assigned to either 12 weeks of the group intervention or usual care (control). The group intervention was based on a manual and used CBT and problem solving principles with weekly topics including raising activity levels, spotting and catching negative thoughts, problem solving and relaxation. Women were recruited from deprived areas of Bristol. The groups were run by facilitators with some experience and background in group work and one weeks training in use of the course manual. Assessments of mental health were made using measures including the PHQ-9. Follow-up was at 3 and 6 months after the intervention. Qualitative methods were used to support the design of the intervention and to help understand issues of acceptability and feasibility. Interviews were conducted with all participants at baseline and at 3 and 6 months although detailed qualitative analysis was based on a purposive sample of 20 participants at the 3 time points.
  
  
  RESULTS
  Of the 86 participants assessed for eligibility, 52 were allocated to the intervention arm and 21 to the control group. The intervention was delivered according to the manual despite the limited training of the facilitators. The intervention was received favourably by participants and facilitators, with good attendance at sessions for those who engaged with the intervention. Follow up rates at 3 and 6 months for women in both the intervention and control arms were also good. The trial methodology used was appropriate and feasible.
  
  
  CONCLUSIONS
  This study showed that a randomised controlled trial of group CBT for women with depression is feasible and the intervention is acceptable, and may possibly prove to be effective in a larger trial. The cost effectiveness of group CBT for depression should be explored further in a full trial.
  
  
  BACKGROUND
  NCT00663078.
authors.affiliation: Academic Unit of Primary Health Care, School of Social and Community Medicine, University of Bristol, Canynge Hall, Bristol, BS8 2PS, UK. helen.cramer@bristol.ac.uk
authors.forename: Helen
authors.initials: H
authors.lastname: Cramer
authors.forename: Chris
authors.initials: C
authors.lastname: Salisbury
authors.forename: Joel
authors.initials: J
authors.lastname: Conrad
authors.forename: James
authors.initials: J
authors.lastname: Eldred
authors.forename: Ricardo
authors.initials: R
authors.lastname: Araya
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000379:methods / Q000706:statistics & numerical data*; D003863:Depression / Q000628:therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010342:Patient Acceptance of Health Care / Q000523:psychology; D010865:Pilot Projects; D011320:Primary Health Care / Q000379:methods; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D011615:Psychotherapy, Group / Q000379:methods / Q000706:statistics & numerical data*; D016387:Women's Health