Randomisation
Participants were randomised using simple randomisation with a
10:7 ratio of standard care to music therapy (details in Fig. 1). This
unequal ratio was chosen to maximise feasibility and power within
the given budget and time constraints. An independent person at
Uni Health, Bergen, Norway, generated the randomisation list
using a spreadsheet software program and kept each participant’s
allocation concealed from the investigators until a decision about
inclusion was made. Once all baseline data had been collected
and informed consent obtained, the investigators used email to
receive the allocation for the respective participant. After
randomisation the participants were considered part of the study
regardless of whether they decided to leave the study prematurely
(intention-to-treat principle).
Assessment procedure
Psychiatric assessments were conducted at baseline and at 3- and
6-month follow-up, where 3-month follow-up took place
immediately after the intervention in the music therapy group,
and the 6-month follow-up 3 months after the treatment had been
completed.
One masked clinical expert (I.P.), with training in psychiatric
nursing and long experience in psychiatry, conducted all the
psychiatric assessments. The expert had in addition specific
training in the treatment and assessment of depression based on
collaborative care for depression (psychiatric nurses working at
healthcare centres with special training in depression treatment),23
which is applied in some healthcare districts in Finland, including
Jyva¨skyla¨. The assessor was masked to the participants’ group
assignment, and the evaluations were conducted in another
physical setting outside the clinic in order to avoid accidental
meetings with the members of the music therapy group. The
assessor was excluded from meetings at which the masking could
have been endangered. Any instances of broken masking were
reported.
RandomisationParticipants were randomised using simple randomisation with a10:7 ratio of standard care to music therapy (details in Fig. 1). Thisunequal ratio was chosen to maximise feasibility and power withinthe given budget and time constraints. An independent person atUni Health, Bergen, Norway, generated the randomisation listusing a spreadsheet software program and kept each participant’sallocation concealed from the investigators until a decision aboutinclusion was made. Once all baseline data had been collectedand informed consent obtained, the investigators used email toreceive the allocation for the respective participant. Afterrandomisation the participants were considered part of the studyregardless of whether they decided to leave the study prematurely(intention-to-treat principle).Assessment procedurePsychiatric assessments were conducted at baseline and at 3- and6-month follow-up, where 3-month follow-up took placeimmediately after the intervention in the music therapy group,and the 6-month follow-up 3 months after the treatment had beencompleted.One masked clinical expert (I.P.), with training in psychiatricnursing and long experience in psychiatry, conducted all thepsychiatric assessments. The expert had in addition specifictraining in the treatment and assessment of depression based oncollaborative care for depression (psychiatric nurses working athealthcare centres with special training in depression treatment),23which is applied in some healthcare districts in Finland, includingJyva¨skyla¨. The assessor was masked to the participants’ groupassignment, and the evaluations were conducted in anotherphysical setting outside the clinic in order to avoid accidentalmeetings with the members of the music therapy group. Theassessor was excluded from meetings at which the masking couldhave been endangered. Any instances of broken masking werereported.
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