The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavioral therapy (CBT) for insomnia delivered by ordinary primary care personnel (primary care nurses and social workers) in general medical practice with unselected patients, in line with a stepped care approach. The study design was a randomised controlled parallel group design, with allocation to CBT and waiting list control group (WL). Following an active treatment-control period, the control group were re-assigned to CBT. The study hypothesis was that the CBT group would experience less symptoms of insomnia after treatment compared with the WL group. Primary outcome measure was a brief self-report screening form, Insomnia severity index.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.
Uppsala University
Uppsala, Sweden
Change from baseline in the Insomnia severity index (ISI)
A brief self-report screening form
Time frame: After 9 weeks
Change from baseline in sleep-onset latency (SOL)
Time to fall asleep, measured with sleep diary
Time frame: 9 weeks
Change from baseline in wake time after sleep onset (WASO)
Time awake during the night, measured with sleep diary
Time frame: After 9 weeks
Change from baseline in number of awakenings during the night (NWAK)
Measured with sleep diary
Time frame: After 9 weeks
Change from baseline in Sleep efficiency (SE)
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
Time frame: After 9 weeks
Change from baseline in time in bed (TIB)
Measured with sleep diary
Time frame: After 9 weeks
Change from baseline in total sleep time (TST)
Measured with sleep diary
Time frame: After 9 weeks
Change from baseline in sleep quality (SQ)
Subjective sleep quality (likert scale)
Time frame: After 9 weeks
Change from baseline in the fatigue severity scale (FSS)
Self-report questionnaire
Time frame: After 9 weeks
Change from baseline in the MOS 36-item short-form health survey, SF-36
Questionnaire assessing physical and mental health
Time frame: After 9 weeks
Change from baseline in the Hospital anxiety and depression scale, HADS
Self-report questionnaire measuring depression and anxiety
Time frame: After 9 weeks
Change from baseline in the Epworth sleepiness scale, ESS
Self-report questionnaire assessing daytime sleepiness
Time frame: After 9 weeks
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Self-report form assessing sleep quality
Time frame: After 9 weeks
Change from baseline in the Minimal insomnia severity scale, MISS
Ultra short screening questionnaire for insomnia
Time frame: After 9 weeks
Change from baseline in the Insomnia acceptance questionnaire, IQA
A questionnaire intended to assess acceptance of insomnia
Time frame: After 9 weeks
Change from baseline in Body mass index
Time frame: After 9 weeks
Change from baseline in sagittal abdominal diameter
Abdominal height (cm)
Time frame: After 9 weeks
Change from baseline in waist-hip ratio
A ratio of the circumference of the waist to the hips
Time frame: After 9 weeks
Change from baseline in blood pressure
Time frame: After 9 weeks
Change from baseline in heart rate
Time frame: After 9 weeks
Change from baseline in ALAT
Liver function
Time frame: After 9 weeks
Change from baseline in HbA 1c
Glycated hemoglobin
Time frame: After 9 weeks
Change from baseline in blood glucose
Time frame: After 9 weeks
Change from baseline in triglycerides
A type of fat found in the blood
Time frame: After 9 weeks
Change from baseline in cholesterol (LDL/HDL)
Time frame: After 9 weeks
Change from baseline in sleep-onset latency (SOL)
Time to fall asleep, measured with sleep diary
Time frame: After 18 months
Change from baseline in wake time after sleep onset (WASO)
Time awake during the night, measured with sleep diary
Time frame: After 18 months
Change from baseline in number of awakenings during the night (NWAK)
Measured with sleep diary
Time frame: After 18 months
Change from baseline in Sleep efficiency (SE)
Time actually spent sleeping out of the total time in bed (%), measured with sleep diary
Time frame: After 18 months
Change from baseline in time in bed (TIB)
Measured with sleep diary
Time frame: After 18 months
Change from baseline in total sleep time (TST)
Measured with sleep diary
Time frame: After 18 months
Change from baseline in sleep quality (SQ)
Subjective sleep quality (likert scale)
Time frame: After 18 months
Change from baseline in the fatigue severity scale (FSS)
Self-report questionnaire
Time frame: After 18 months
Change from baseline in the MOS 36-item short-form health survey, SF-36
Questionnaire assessing physical and mental health
Time frame: After 18 months
Change from baseline in the Hospital anxiety and depression scale, HADS
Self-report questionnaire measuring depression and anxiety
Time frame: After 18 months
Change from baseline in the Epworth sleepiness scale, ESS
Self-report questionnaire assessing daytime sleepiness
Time frame: After 18 moths
Change form baseline in the Pittsburgh sleep quality index (PSQI)
Self-report form assessing sleep quality
Time frame: After 18 months
Change from baseline in the Minimal insomnia severity scale, MISS
Ultra short screening questionnaire for insomnia
Time frame: After 18 months
Change from baseline in the Insomnia acceptance questionnaire, IQA
A questionnaire intended to assess acceptance of insomnia
Time frame: After 18 months
Change from baseline in Body mass index
Time frame: After 18 months
Change from baseline in sagittal abdominal diameter
Abdominal height (cm)
Time frame: After 18 months
Change from baseline in waist-hip ratio
A ratio of the circumference of the waist to the hips
Time frame: After 18 months
Change from baseline in blood pressure
Time frame: After 18 months
Change from baseline in heart rate
Time frame: After 18 months
Change from baseline in ALAT
Liver function
Time frame: After 18 months
Change from baseline in HbA 1c
Glycated hemoglobin
Time frame: After 18 months
Change from baseline in blood glucose
Time frame: After 18 months
Change from baseline in triglycerides
A type of fat found in the blood
Time frame: After 18 months
Change from baseline in cholesterol (LDL/HDL)
Time frame: After 18 months
Change from baseline in the Insomnia severity index (ISI)
A brief self-report screening form
Time frame: After 18 months
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