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ALASTAIR DOBBIN ET AL.
given an information pack. Patients were also issued a prescription for
antidepressants by their GP but asked not to have this filled until they
had spoken to the research nurse. The research nurse telephoned the
patient the next day and, if the patient consented to participate,
enrolled them in the trial. Each patient was given a unique identifier
(number) and after initial assessment those who did not express a pref-
erence were then randomized using a sealed envelope allocation pro-
cess. Envelopes were filled by an administrative assistant independent
of the research team.
The self-hypnosis group then gave their prescriptions to be held
by the nurse, watched a short film (10 minutes) of a doctor explain-
ing self-hypnosis, listened to the first recording in the series
(18 minutes) and were given the first CD (out of three) containing
the first four tracks and an instruction sheet. The antidepressant
group was told to fill their prescriptions and to start taking the
medication. Both groups continued nurse-supervised treatment for
12 weeks, which involved regular phone calls checking for prob-
lems and monitoring for suicidal thoughts but were specifically
under the care of their GP.
The trial protocol for self-hypnosis is illustrated in Figure 2.
Time of Study
Patients were recruited between June and December 2004, and data
collection finished in March 2005.
Instruments
Outcome measures were the Beck Depression Inventory (BDI-II;
Beck, Steer, Ball, & Ranieri, 1996; Beck, Ward, Mendelson, Mock, &
Erbaugh, 1961), the Brief Symptom Inventory (BSI 18; Derogatis, 1993),
and the Short-Form Quality of Life Questionnaire (SF-36; McHorney,
Ware, & Raczek, 1993; Ware & Sherbourne, 1992) given at intake and at
12 weeks. A target sample size was not calculated as this study was
designed as a feasibility study.
Statistical Tests
We compared depression scores at the end of the study period
between groups by analysis of covariance, adjusting for age, sex, and
the corresponding baseline measurement. Analysis of covariance was
also used for the SF-36 scores, except in the case of the very short scales
role emotional and role physical, which were analyzed using ordinal
logistic rather than linear regression. Between-groups comparisons of
outcome, using two-sample
t
tests, were carried out.
The outcome assessors and the data analyst had no contact with the
patients; all data collection was done by post. The statistician, indepen-
dent of the clinical research team, analyzed the data using SPSS.
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