Cognitive Behavior Therapy for Insomnia in Primary Care

Not Applicable

Completed

• Conditions: Insomnia

• Registration Number: NCT01655797
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-07
• Study First Submitted: 2012-07-04
• Study First Submitted QC: 2012-07-30
• Last Update Submitted: 2012-07-30
• Study First Posted: 2012-08-02
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Insomnia severity index (ISI)	After 9 weeks	A brief self-report screening form

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Uppsala University; 🇸🇪 Uppsala, Sweden