Cognitive Behavior Therapy for Insomnia in Primary Care

Insomnia Clinical Trial

— TIRED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655797
• Other study ID #: RFR-10276
• Status: Completed
• Phase: N/A
• First received: July 4, 2012
• Last updated: July 30, 2012
• Start date: May 2008
• Est. completion date: September 2011

Study information

• Verified date: July 2012
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

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.

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Uppsala-Örebro Regional Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Insomnia severity index (ISI)	A brief self-report screening form	After 9 weeks	No
Secondary	Change from baseline in sleep-onset latency (SOL)	Time to fall asleep, measured with sleep diary	9 weeks	No
Secondary	Change from baseline in wake time after sleep onset (WASO)	Time awake during the night, measured with sleep diary	After 9 weeks	No
Secondary	Change from baseline in number of awakenings during the night (NWAK)	Measured with sleep diary	After 9 weeks	No
Secondary	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	No
Secondary	Change from baseline in time in bed (TIB)	Measured with sleep diary	After 9 weeks	No
Secondary	Change from baseline in total sleep time (TST)	Measured with sleep diary	After 9 weeks	No
Secondary	Change from baseline in sleep quality (SQ)	Subjective sleep quality (likert scale)	After 9 weeks	No
Secondary	Change from baseline in the fatigue severity scale (FSS)	Self-report questionnaire	After 9 weeks	No
Secondary	Change from baseline in the MOS 36-item short-form health survey, SF-36	Questionnaire assessing physical and mental health	After 9 weeks	No
Secondary	Change from baseline in the Hospital anxiety and depression scale, HADS	Self-report questionnaire measuring depression and anxiety	After 9 weeks	No
Secondary	Change from baseline in the Epworth sleepiness scale, ESS	Self-report questionnaire assessing daytime sleepiness	After 9 weeks	No
Secondary	Change form baseline in the Pittsburgh sleep quality index (PSQI)	Self-report form assessing sleep quality	After 9 weeks	No
Secondary	Change from baseline in the Minimal insomnia severity scale, MISS	Ultra short screening questionnaire for insomnia	After 9 weeks	No
Secondary	Change from baseline in the Insomnia acceptance questionnaire, IQA	A questionnaire intended to assess acceptance of insomnia	After 9 weeks	No
Secondary	Change from baseline in Body mass index		After 9 weeks	No
Secondary	Change from baseline in sagittal abdominal diameter	Abdominal height (cm)	After 9 weeks	No
Secondary	Change from baseline in waist-hip ratio	A ratio of the circumference of the waist to the hips	After 9 weeks	No
Secondary	Change from baseline in blood pressure		After 9 weeks	No
Secondary	Change from baseline in heart rate		After 9 weeks	No
Secondary	Change from baseline in ALAT	Liver function	After 9 weeks	No
Secondary	Change from baseline in HbA 1c	Glycated hemoglobin	After 9 weeks	No
Secondary	Change from baseline in blood glucose		After 9 weeks	No
Secondary	Change from baseline in triglycerides	A type of fat found in the blood	After 9 weeks	No
Secondary	Change from baseline in cholesterol (LDL/HDL)		After 9 weeks	No
Secondary	Change from baseline in sleep-onset latency (SOL)	Time to fall asleep, measured with sleep diary	After 18 months	No
Secondary	Change from baseline in wake time after sleep onset (WASO)	Time awake during the night, measured with sleep diary	After 18 months	No
Secondary	Change from baseline in number of awakenings during the night (NWAK)	Measured with sleep diary	After 18 months	No
Secondary	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	No
Secondary	Change from baseline in time in bed (TIB)	Measured with sleep diary	After 18 months	No
Secondary	Change from baseline in total sleep time (TST)	Measured with sleep diary	After 18 months	No
Secondary	Change from baseline in sleep quality (SQ)	Subjective sleep quality (likert scale)	After 18 months	No
Secondary	Change from baseline in the fatigue severity scale (FSS)	Self-report questionnaire	After 18 months	No
Secondary	Change from baseline in the MOS 36-item short-form health survey, SF-36	Questionnaire assessing physical and mental health	After 18 months	No
Secondary	Change from baseline in the Hospital anxiety and depression scale, HADS	Self-report questionnaire measuring depression and anxiety	After 18 months	No
Secondary	Change from baseline in the Epworth sleepiness scale, ESS	Self-report questionnaire assessing daytime sleepiness	After 18 moths	No
Secondary	Change form baseline in the Pittsburgh sleep quality index (PSQI)	Self-report form assessing sleep quality	After 18 months	No
Secondary	Change from baseline in the Minimal insomnia severity scale, MISS	Ultra short screening questionnaire for insomnia	After 18 months	No
Secondary	Change from baseline in the Insomnia acceptance questionnaire, IQA	A questionnaire intended to assess acceptance of insomnia	After 18 months	No
Secondary	Change from baseline in Body mass index		After 18 months	No
Secondary	Change from baseline in sagittal abdominal diameter	Abdominal height (cm)	After 18 months	No
Secondary	Change from baseline in waist-hip ratio	A ratio of the circumference of the waist to the hips	After 18 months	No
Secondary	Change from baseline in blood pressure		After 18 months	No
Secondary	Change from baseline in heart rate		After 18 months	No
Secondary	Change from baseline in ALAT	Liver function	After 18 months	No
Secondary	Change from baseline in HbA 1c	Glycated hemoglobin	After 18 months	No
Secondary	Change from baseline in blood glucose		After 18 months	No
Secondary	Change from baseline in triglycerides	A type of fat found in the blood	After 18 months	No
Secondary	Change from baseline in cholesterol (LDL/HDL)		After 18 months	No
Secondary	Change from baseline in the Insomnia severity index (ISI)	A brief self-report screening form	After 18 months	No