title: Acupuncture, Counseling, and Usual care for Depression (ACUDep): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  The evidence on the effect of acupuncture or counseling for depression is not conclusive yet is sufficient to warrant further research. Our aim is to conduct a full-scale RCT to determine the clinical and cost effectiveness of acupuncture and counseling compared to usual care alone. We will explore the experiences and perspectives of patients and practitioners.
  
  
  METHODS
  Randomized controlled trial with three parallel arms: acupuncture plus usual care, counseling plus usual care, and usual care alone, in conjunction with a nested qualitative study using in-depth interviews with purposive samples of trial participants.
  
  
  METHODS
  Patients aged over 18 years diagnosed with depression or mood disorder by their GP and with a score of 20 or above on the Beck Depression Inventory (BDI-II).Randomization: Computer randomization by York Trials Unit to acupuncture, counseling, and usual care alone in proportions of 2:2:1, respectively, with secure allocation concealment.
  
  
  METHODS
  Patients allocated to acupuncture and counseling groups receive the offer of up to 12 weekly sessions. Both interventions allow flexibility to address patient variation, yet are constrained within defined protocols. Acupuncture is based on traditional Chinese medicine and counseling is non-directive within the humanistic tradition.
  
  
  RESULTS
  The PHQ-9 is the primary outcome measure, collected at baseline, 3, 6, 9, and 12 months. Also measured is BDI-II, SF-36 Bodily pain subscale, and EQ-5D. Texted mood scores are collected weekly over the first 15 weeks. Health-related resource use is collected over 12 months.
  
  
  METHODS
  The sample size target was for 640 participants, calculated for an effect size of 0.32 on the PHQ-9 when comparing acupuncture with counseling given 90% power, 5% significance, and 20% loss to follow-up. ANALYSIS of covariance will be used on an intention-to-treat basis. Thematic analysis will be used for qualitative data. We will compare incremental cost-effectiveness of the three treatment options at 12 months.
  
  
  CONCLUSIONS
  Ethical approval was obtained in October 2009. There were six subsequent protocol amendments, the last of which was approved in January 2012. Recruitment of 755 participants took place over 18 months. Data collection will be completed by June 2012. No interim analyses have been conducted.
  
  
  BACKGROUND
  ISRCTN63787732.
authors.affiliation: Department of Health Sciences, University of York, York YO10 5DD, United Kingdom. hugh.macpherson@york.ac.uk
authors.forename: Hugh
authors.initials: H
authors.lastname: MacPherson
authors.forename: Stewart
authors.initials: S
authors.lastname: Richmond
authors.forename: J Martin
authors.initials: JM
authors.lastname: Bland
authors.forename: Harriet
authors.initials: H
authors.lastname: Lansdown
authors.forename: Ann
authors.initials: A
authors.lastname: Hopton
authors.forename: Arthur
authors.initials: A
authors.lastname: Kang'ombe
authors.forename: Stephen
authors.initials: S
authors.lastname: Morley
authors.forename: Sara
authors.initials: S
authors.lastname: Perren
authors.forename: Eldon
authors.initials: E
authors.lastname: Spackman
authors.forename: Karen
authors.initials: K
authors.lastname: Spilsbury
authors.forename: David
authors.initials: D
authors.lastname: Torgerson
authors.forename: Ian
authors.initials: I
authors.lastname: Watt
mesh_terms: D015670:Acupuncture Therapy; D002985:Clinical Protocols; D003376:Counseling; D003863:Depression / Q000628:therapy*; D006801:Humans; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D018401:Sample Size