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Open Access Study protocol

Acupuncture, Counseling, and Usual care for Depression (ACUDep): study protocol for a randomized controlled trial

Hugh MacPherson1*, Stewart Richmond1, J Martin Bland1, Harriet Lansdown1, Ann Hopton1, Arthur Kang’ombe1, Stephen Morley2, Sara Perren1, Eldon Spackman3, Karen Spilsbury1, David Torgerson1 and Ian Watt1

Author Affiliations

1 Department of Health Sciences, University of York, York YO10 5DD, United Kingdom

2 University of Leeds, Leeds, LS2 9LJ, UK

3 Centre for Health Economics, University of York, York, YO10 5DD, United Kingdom

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Trials 2012, 13:209  doi:10.1186/1745-6215-13-209

Published: 14 November 2012

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/Design

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.

Participants: 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.

Interventions: 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.

Outcome: 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.

Analysis: 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.

Discussion

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.

Trial registration

ISRCTN63787732

Keywords:
Depression; Acupuncture; Counseling; Primary care; Randomized controlled trial; Effectiveness; Cost-effectiveness