Insomnia
Conditions
Keywords
insomnia, cognitive behavior therapy, primary care
Brief summary
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.
Interventions
BEHAVIORALCognitive behavior therapy for insomnia
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.
Sponsors
Uppsala-Örebro Regional Research Council
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fulfilled research criteria for chronic insomnia
Exclusion criteria
* other untreated sleep disturbance * pregnancy * shift work * concurrent medical or psychiatric condition that could be negatively affected by the treatment * drug abuse * severe depression * dementia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the Insomnia severity index (ISI) | After 9 weeks | A brief self-report screening form |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in sleep quality (SQ) | After 9 weeks | Subjective sleep quality (likert scale) |
| Change from baseline in the fatigue severity scale (FSS) | After 9 weeks | Self-report questionnaire |
| Change from baseline in the MOS 36-item short-form health survey, SF-36 | After 9 weeks | Questionnaire assessing physical and mental health |
| Change from baseline in wake time after sleep onset (WASO) | After 9 weeks | Time awake during the night, measured with sleep diary |
| Change from baseline in number of awakenings during the night (NWAK) | After 9 weeks | Measured with sleep diary |
| Change from baseline in Sleep efficiency (SE) | After 9 weeks | Time actually spent sleeping out of the total time in bed (%), measured with sleep diary |
| Change from baseline in time in bed (TIB) | After 9 weeks | Measured with sleep diary |
| Change from baseline in sleep-onset latency (SOL) | 9 weeks | Time to fall asleep, measured with sleep diary |
| Change from baseline in the Hospital anxiety and depression scale, HADS | After 9 weeks | Self-report questionnaire measuring depression and anxiety |
| Change from baseline in the Epworth sleepiness scale, ESS | After 9 weeks | Self-report questionnaire assessing daytime sleepiness |
| Change form baseline in the Pittsburgh sleep quality index (PSQI) | After 9 weeks | Self-report form assessing sleep quality |
| Change from baseline in the Minimal insomnia severity scale, MISS | After 9 weeks | Ultra short screening questionnaire for insomnia |
| Change from baseline in total sleep time (TST) | After 9 weeks | Measured with sleep diary |
| Change from baseline in Body mass index | After 9 weeks | — |
| Change from baseline in sagittal abdominal diameter | After 9 weeks | Abdominal height (cm) |
| Change from baseline in waist-hip ratio | After 9 weeks | A ratio of the circumference of the waist to the hips |
| Change from baseline in blood pressure | After 9 weeks | — |
| Change from baseline in heart rate | After 9 weeks | — |
| Change from baseline in ALAT | After 9 weeks | Liver function |
| Change from baseline in HbA 1c | After 9 weeks | Glycated hemoglobin |
| Change from baseline in blood glucose | After 9 weeks | — |
| Change from baseline in triglycerides | After 9 weeks | A type of fat found in the blood |
| Change from baseline in cholesterol (LDL/HDL) | After 9 weeks | — |
| Change from baseline in the Insomnia severity index (ISI) | After 18 months | A brief self-report screening form |
| Change from baseline in the Insomnia acceptance questionnaire, IQA | After 9 weeks | A questionnaire intended to assess acceptance of insomnia |
Countries
Sweden
Outcome results
None listed