Clinical trial NCT01655797: Cognitive Behavior Therapy for Insomnia in Primary Care
Official title: Treating Insomnia in Primary Care: A Study of Effectiveness and Dissemination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: insomnia
cognitive behavior therapy
primary care
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala-Örebro Regional Research Council
First posted: 2012-08-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in the Insomnia severity index (ISI)
timeFrame: After 9 weeks
Secondary outcomes:
measure: Change from baseline in sleep-onset latency (SOL)
timeFrame: 9 weeks
measure: Change from baseline in wake time after sleep onset (WASO)
timeFrame: After 9 weeks
measure: Change from baseline in number of awakenings during the night (NWAK)
timeFrame: After 9 weeks
measure: Change from baseline in Sleep efficiency (SE)
timeFrame: After 9 weeks
measure: Change from baseline in time in bed (TIB)
timeFrame: After 9 weeks
measure: Change from baseline in total sleep time (TST)
timeFrame: After 9 weeks
measure: Change from baseline in sleep quality (SQ)
timeFrame: After 9 weeks
measure: Change from baseline in the fatigue severity scale (FSS)
timeFrame: After 9 weeks
measure: Change from baseline in the MOS 36-item short-form health survey, SF-36
timeFrame: After 9 weeks
measure: Change from baseline in the Hospital anxiety and depression scale, HADS
timeFrame: After 9 weeks
measure: Change from baseline in the Epworth sleepiness scale, ESS
timeFrame: After 9 weeks
measure: Change form baseline in the Pittsburgh sleep quality index (PSQI)
timeFrame: After 9 weeks
measure: Change from baseline in the Minimal insomnia severity scale, MISS
timeFrame: After 9 weeks
measure: Change from baseline in the Insomnia acceptance questionnaire, IQA
timeFrame: After 9 weeks
measure: Change from baseline in Body mass index
timeFrame: After 9 weeks
measure: Change from baseline in sagittal abdominal diameter
timeFrame: After 9 weeks
measure: Change from baseline in waist-hip ratio
timeFrame: After 9 weeks
measure: Change from baseline in blood pressure
timeFrame: After 9 weeks
measure: Change from baseline in heart rate
timeFrame: After 9 weeks
measure: Change from baseline in ALAT
timeFrame: After 9 weeks
measure: Change from baseline in HbA 1c
timeFrame: After 9 weeks
measure: Change from baseline in blood glucose
timeFrame: After 9 weeks
measure: Change from baseline in triglycerides
timeFrame: After 9 weeks
measure: Change from baseline in cholesterol (LDL/HDL)
timeFrame: After 9 weeks
measure: Change from baseline in sleep-onset latency (SOL)
timeFrame: After 18 months
measure: Change from baseline in wake time after sleep onset (WASO)
timeFrame: After 18 months
measure: Change from baseline in number of awakenings during the night (NWAK)
timeFrame: After 18 months
measure: Change from baseline in Sleep efficiency (SE)
timeFrame: After 18 months
measure: Change from baseline in time in bed (TIB)
timeFrame: After 18 months
measure: Change from baseline in total sleep time (TST)
timeFrame: After 18 months
measure: Change from baseline in sleep quality (SQ)
timeFrame: After 18 months
measure: Change from baseline in the fatigue severity scale (FSS)
timeFrame: After 18 months
measure: Change from baseline in the MOS 36-item short-form health survey, SF-36
timeFrame: After 18 months
measure: Change from baseline in the Hospital anxiety and depression scale, HADS
timeFrame: After 18 months
measure: Change from baseline in the Epworth sleepiness scale, ESS
timeFrame: After 18 moths
measure: Change form baseline in the Pittsburgh sleep quality index (PSQI)
timeFrame: After 18 months
measure: Change from baseline in the Minimal insomnia severity scale, MISS
timeFrame: After 18 months
measure: Change from baseline in the Insomnia acceptance questionnaire, IQA
timeFrame: After 18 months
measure: Change from baseline in Body mass index
timeFrame: After 18 months
measure: Change from baseline in sagittal abdominal diameter
timeFrame: After 18 months
measure: Change from baseline in waist-hip ratio
timeFrame: After 18 months
measure: Change from baseline in blood pressure
timeFrame: After 18 months
measure: Change from baseline in heart rate
timeFrame: After 18 months
measure: Change from baseline in ALAT
timeFrame: After 18 months
measure: Change from baseline in HbA 1c
timeFrame: After 18 months
measure: Change from baseline in blood glucose
timeFrame: After 18 months
measure: Change from baseline in triglycerides
timeFrame: After 18 months
measure: Change from baseline in cholesterol (LDL/HDL)
timeFrame: After 18 months
measure: Change from baseline in the Insomnia severity index (ISI)
timeFrame: After 18 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Jan-Erik Broman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.