Cognitive Behavior Therapy for Insomnia in Primary Care

Study Overview
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Brief Summary
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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.

Official Title
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Treating Insomnia in Primary Care: A Study of Effectiveness and Dissemination

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Cognitive behavior therapy for insomnia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT<br>The treatment group received manualized CBT-I using a adapted version of a manual designed for use by primary care personnel. 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. | Behavioral: Cognitive behavior therapy for insomnia<br>* 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.<br>|
| No Intervention: Wait-list<br>A deferred treatment wait-list condition, with no restrictions placed on the usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Insomnia severity index (ISI) | A brief self-report screening form | After 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sleep-onset latency (SOL) | Time to fall asleep, measured with sleep diary | 9 weeks | 
| Change from baseline in wake time after sleep onset (WASO) | Time awake during the night, measured with sleep diary | After 9 weeks | 
| Change from baseline in number of awakenings during the night (NWAK) | Measured with sleep diary | 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 | After 9 weeks | 
| Change from baseline in time in bed (TIB) | Measured with sleep diary | After 9 weeks | 
| Change from baseline in total sleep time (TST) | Measured with sleep diary | After 9 weeks | 
| Change from baseline in sleep quality (SQ) | Subjective sleep quality (likert scale) | After 9 weeks | 
| Change from baseline in the fatigue severity scale (FSS) | Self-report questionnaire | After 9 weeks | 
| Change from baseline in the MOS 36-item short-form health survey, SF-36 | Questionnaire assessing physical and mental health | After 9 weeks | 
| Change from baseline in the Hospital anxiety and depression scale, HADS | Self-report questionnaire measuring depression and anxiety | After 9 weeks | 
| Change from baseline in the Epworth sleepiness scale, ESS | Self-report questionnaire assessing daytime sleepiness | After 9 weeks | 
| Change form baseline in the Pittsburgh sleep quality index (PSQI) | Self-report form assessing sleep quality | After 9 weeks | 
| Change from baseline in the Minimal insomnia severity scale, MISS | Ultra short screening questionnaire for insomnia | After 9 weeks | 
| Change from baseline in the Insomnia acceptance questionnaire, IQA | A questionnaire intended to assess acceptance of insomnia | After 9 weeks | 
| Change from baseline in Body mass index |  | After 9 weeks | 
| Change from baseline in sagittal abdominal diameter | Abdominal height (cm) | After 9 weeks | 
| Change from baseline in waist-hip ratio | A ratio of the circumference of the waist to the hips | After 9 weeks | 
| Change from baseline in blood pressure |  | After 9 weeks | 
| Change from baseline in heart rate |  | After 9 weeks | 
| Change from baseline in ALAT | Liver function | After 9 weeks | 
| Change from baseline in HbA 1c | Glycated hemoglobin | After 9 weeks | 
| Change from baseline in blood glucose |  | After 9 weeks | 
| Change from baseline in triglycerides | A type of fat found in the blood | After 9 weeks | 
| Change from baseline in cholesterol (LDL/HDL) |  | After 9 weeks | 
| Change from baseline in sleep-onset latency (SOL) | Time to fall asleep, measured with sleep diary | After 18 months | 
| Change from baseline in wake time after sleep onset (WASO) | Time awake during the night, measured with sleep diary | After 18 months | 
| Change from baseline in number of awakenings during the night (NWAK) | Measured with sleep diary | 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 | After 18 months | 
| Change from baseline in time in bed (TIB) | Measured with sleep diary | After 18 months | 
| Change from baseline in total sleep time (TST) | Measured with sleep diary | After 18 months | 
| Change from baseline in sleep quality (SQ) | Subjective sleep quality (likert scale) | After 18 months | 
| Change from baseline in the fatigue severity scale (FSS) | Self-report questionnaire | After 18 months | 
| Change from baseline in the MOS 36-item short-form health survey, SF-36 | Questionnaire assessing physical and mental health | After 18 months | 
| Change from baseline in the Hospital anxiety and depression scale, HADS | Self-report questionnaire measuring depression and anxiety | After 18 months | 
| Change from baseline in the Epworth sleepiness scale, ESS | Self-report questionnaire assessing daytime sleepiness | After 18 moths | 
| Change form baseline in the Pittsburgh sleep quality index (PSQI) | Self-report form assessing sleep quality | After 18 months | 
| Change from baseline in the Minimal insomnia severity scale, MISS | Ultra short screening questionnaire for insomnia | After 18 months | 
| Change from baseline in the Insomnia acceptance questionnaire, IQA | A questionnaire intended to assess acceptance of insomnia | After 18 months | 
| Change from baseline in Body mass index |  | After 18 months | 
| Change from baseline in sagittal abdominal diameter | Abdominal height (cm) | After 18 months | 
| Change from baseline in waist-hip ratio | A ratio of the circumference of the waist to the hips | After 18 months | 
| Change from baseline in blood pressure |  | After 18 months | 
| Change from baseline in heart rate |  | After 18 months | 
| Change from baseline in ALAT | Liver function | After 18 months | 
| Change from baseline in HbA 1c | Glycated hemoglobin | After 18 months | 
| Change from baseline in blood glucose |  | After 18 months | 
| Change from baseline in triglycerides | A type of fat found in the blood | After 18 months | 
| Change from baseline in cholesterol (LDL/HDL) |  | After 18 months | 
| Change from baseline in the Insomnia severity index (ISI) | A brief self-report screening form | After 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia, cognitive behavior therapy, primary care