Cognitive Behavior Therapy for Insomnia in Primary Care (TIRED)

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

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 Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Cognitive behavior therapy for insomnia

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75105
    • Uppsala University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT; 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; 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.
No Intervention: Wait-list; A deferred treatment wait-list condition, with no restrictions placed on the usual care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Uppsala-Örebro Regional Research Council
• Investigators: Principal Investigator: Jan-Erik Broman, PhD, Uppsala University

Publications and helpful links

General Publications

• Espie CA, MacMahon KM, Kelly HL, Broomfield NM, Douglas NJ, Engleman HM, McKinstry B, Morin CM, Walker A, Wilson P. Randomized clinical effectiveness trial of nurse-administered small-group cognitive behavior therapy for persistent insomnia in general practice. Sleep. 2007 May;30(5):574-84. doi: 10.1093/sleep/30.5.574.
• Bothelius K, Kyhle K, Espie CA, Broman JE. Manual-guided cognitive-behavioural therapy for insomnia delivered by ordinary primary care personnel in general medical practice: a randomized controlled effectiveness trial. J Sleep Res. 2013 Dec;22(6):688-96. doi: 10.1111/jsr.12067. Epub 2013 Jul 16.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: July 4, 2012
• First Submitted That Met QC Criteria: July 30, 2012
• First Posted (Estimate): August 2, 2012

Study Record Updates

• Last Update Posted (Estimate): August 2, 2012
• Last Update Submitted That Met QC Criteria: July 30, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: primary care; insomnia; cognitive behavior therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: RFR-10276