title: A written self-help intervention for depressed adults comparing behavioural activation combined with physical activity promotion with a self-help intervention based upon behavioural activation alone: study protocol for a parallel group pilot randomised controlled trial (BAcPAc).
abstract: BACKGROUND
  Challenges remain to find ways to support patients with depression who have low levels of physical activity (PA) to overcome perceived barriers and enhance the perceived value of PA for preventing future relapse. There is an evidence-base for behavioural activation (BA) for depression, which focuses on supporting patients to restore activities that have been avoided, but practitioners have no specific training in promoting PA. We aimed to design and evaluate an integrated BA and PA (BAcPAc) practitioner-led, written, self-help intervention to enhance both physical and mental health.
  
  
  METHODS
  This study is informed by the Medical Research Council Complex Intervention Framework and describes a protocol for a pilot phase II randomised controlled trial (RCT) to test the feasibility and acceptability of the trial methods to inform a definitive phase III RCT. Following development of the augmented written self-help intervention (BAcPAc) incorporating behavioural activation with physical activity promotion, depressed adults are randomised to receive up to 12 sessions over a maximum of 4 months of either BAcPAc or behavioural activation alone within a written self-help format, which represents treatment as usual. The study is located within two 'Improving Access to Psychological Therapies' services in South West England, with both written self-help interventions supported by mental health paraprofessionals. Measures assessed at 4, 9, and 12 month follow-up include the following: CIS-R, PHQ-9, accelerometer recorded (4 months only) and self-reported PA, body mass index, blood pressure, Insomnia Severity Index, quality of life, and health and social care service use. Process evaluation will include analysis of recorded support sessions and patient and practitioner interviews. At the time of writing the study has recruited 60 patients.
  
  
  CONCLUSIONS
  The feasibility outcomes will inform a definitive RCT to assess the clinical and cost-effectiveness of the augmented BAcPAc written self-help intervention to reduce depression and depressive relapse, and bring about improvements across a range of physical health outcomes.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN74390532, 26.03.2013.
authors.affiliation: Mood Disorders Centre, School of Psychology, Washington Singer Laboratories, University of Exeter, Perry Road, Exeter EX4 4QG, UK. p.a.farrand@exeter.ac.uk.
authors.forename: Paul
authors.initials: P
authors.lastname: Farrand
authors.forename: Claire
authors.initials: C
authors.lastname: Pentecost
authors.forename: Colin
authors.initials: C
authors.lastname: Greaves
authors.forename: Rod S
authors.initials: RS
authors.lastname: Taylor
authors.forename: Fiona
authors.initials: F
authors.lastname: Warren
authors.forename: Colin
authors.initials: C
authors.lastname: Green
authors.forename: Melvyn
authors.initials: M
authors.lastname: Hillsdon
authors.forename: Phil
authors.initials: P
authors.lastname: Evans
authors.forename: Jo
authors.initials: J
authors.lastname: Welsman
authors.forename: Adrian H
authors.initials: AH
authors.lastname: Taylor
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D003866:Depressive Disorder / Q000523:psychology* / Q000628:therapy*; D015438:Health Behavior; D006801:Humans; D009043:Motor Activity; D010865:Pilot Projects; D012107:Research Design; D012648:Self Care / Q000191:economics / Q000379:methods*; D016037:Single-Blind Method; D014956:Writing