Abstract
Depression is one of the most common reasons for consulting in primary
care. Acupuncture is a popular complementary therapy choice for depression
but its evidence base is poor with more robust high quality trials
being required. More than half of depressed patients experience painful
symptoms, with severe pain being associated with poor response to
antidepressants. Acupuncture may have much to offer as an intervention
for depression that also helps alleviate pain. Non-directive counselling
is the most widely used psychological approach for depression in
NHS settings, and provides a useful pragmatic comparison for acupuncture
that would, according to our pre-trial qualitative research, be of
high interest to doctors and patients.The pilot study uses five arms
and involves a pragmatic design. All patients will continue to receive
usual care. Four groups of patients will be allocated to acupuncture,
or non-directive counselling, in addition to usual GP care. The acupuncture
and counselling arms will be further split into two groups to explore
different treatment regimens. The primary outcome measure is the
BDI II. Potentially eligible patients will be screened for depression
using the PHQ-9, which is also a secondary outcome measure. Other
secondary measures include the SF 36 bodily pain subscale, the CORE
OM, the WBQ-12 and the EQ5D. Health economic data will be collected
and measures of therapeutic engagement will be used to compare patient's
views of therapists and GPs. The study will employ a fully randomised
preference design with collection of data on patient preferences
and prior expectations.This study has been implemented, and data
are currently being analysed to inform the design of a full scale
trial. Two practical operational issues that impacted on study implementation
are discussed. Firstly, the challenge of recruiting depressed patients
via GP consultation. Secondly, the problem of poor uptake and high
attrition for counselling and acupuncture, which appeared to be associated
with poor questionnaire return, and resulted in missing data. These
problems may be relevant to other researchers working in the area
of depression, or similar illnesses, where patients may lack motivation
and energy to engage in research, or attend for treatment.Current
Controlled Trials (ISRCTN 59267538).
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