Implementing Sleep Interventions for Older Veterans

Not Applicable

Completed

Conditions: Insomnia

Interventions: Behavioral: Manual-based cognitive behavioral therapy for insomnia
Behavioral: Non-directive sleep education

Registration Number: NCT00781963

Lead Sponsor: VA Office of Research and Development

Brief Summary: Sleep problems are common among older people, and research suggests that insomnia has negative effects on health and quality of life in older adults. Prior research suggests that insomnia symptoms are even more common among veterans compared to the general population. In addition, people with sleep problems also often have depression and other problems that seem to decrease their quality of life. In this study, we tested two methods of providing behavioral sleep interventions for treating insomnia in older veterans. The long-term objective of this work was to identify ways to improve access to these types of behavioral sleep interventions for older veterans, in order to improve their well-being and quality of life. This project was conducted in outpatient clinics of the VA Greater Los Angeles Healthcare System. Community-dwelling older veterans (aged 60 years and older) with insomnia were identified by a postal survey. Enrolled veterans with insomnia (N=150 total, 50 per group) were randomized to one of three groups: Individual-Cognitive Behavioral Therapy for Insomnia (Individual-CBTI), Group-CBTI or a group-based Sleep Education Control Condition (Control). Measures of sleep, depression and quality of life were performed at baseline (enrollment in the study), after the treatment was completed, and at 6-months and 12-months follow-up after randomization. Main outcome measures included sleep/wake patterns (sleep questionnaires, sleep diary and wrist actigraphy, which is an objective estimate of sleep and wakefulness). We hypothesized that the intervention would improve sleep at six months follow-up. We also expected that these improvements would be maintained at 12-months follow-up.

Detailed Description: Sleep disturbance is common among older people due to age-related changes in sleep, in addition to health conditions, psychosocial issues, medication effects and a variety of other factors that impact sleep. The evidence that insomnia has negative effects on health and quality of life in older adults is convincing. Prior research has demonstrated that insomnia symptoms are even more common among veterans compared to the general population. Our own work has demonstrated that sleep problems are associated with depressive symptoms and other impairments in quality of life in older people, and that nonpharmacological and behavioral interventions can improve sleep in a variety of settings.

Objectives: We tested two methods of providing behavioral sleep interventions for treating insomnia in older veterans. The long-term objective of this work was to identify ways to improve access to behavioral sleep interventions for older veterans, in order to improve their well-being and quality of life.

Methods: This project was conducted in outpatient clinics of the VA Greater Los Angeles Healthcare System. Community-dwelling older veterans (aged 60 years and older) with insomnia were identified by a postal survey. Enrolled veterans with insomnia (N=150, 50 per group) were randomized to one of three groups:Individual Cognitive Behavioral Therapy for Insomnia (Individual-CBTI), Group-CBTI, or group-based Sleep Education Control Condition (Control). The intervention involved a manual-based behavioral sleep intervention provided by a non-clinician sleep coach. Baseline data included subjective and objective measures of sleep, and structured assessments of depression and quality of life. Post-treatment assessments was performed after completion of the 6-week intervention, and follow-up assessments were performed at 6-months and 12-months after randomization. Main outcome measures were: sleep measures obtained from sleep diaries (i.e., sleep onset latency, wake after sleep onset, total wake time, sleep efficiency). Sleep efficiency was also obtained from wrist actigraphy. Subjective sleep quality was measured by the Pittsburgh Sleep Quality Index. Insomnia severity, depression and self-reported quality of life were measured as secondary outcomes. Data were analyzed for all randomized participants (n=159) in an intention to treat analysis. The study was not designed to compare differences in primary outcomes between individual and group CBT-I. Subjects who received individual and group CBT-I were pooled to form the intervention group. We hypothesized that the intervention would improve sleep (both objectively and subjectively) at six-month follow-up and improvements would be maintained at 12-month follow-up.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 519

Inclusion Criteria

Report symptoms that meet diagnostic criteria for insomnia and are:

age >=60,
community-dwelling,
live within a 30-mile radius of VA Greater Los Angeles Healthcare System (GLAHS), and
have transportation to VA GLAHS to attend the intervention/control programs.

Exclusion Criteria

Significant cognitive impairment (MMSE score <24) and have evidence of sleep apnea (by questionnaire and/or sleep monitoring).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT-I	Manual-based cognitive behavioral therapy for insomnia	Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach.
Control	Non-directive sleep education	Non-directive sleep education provided in 5 group sessions by a health educator.

Primary Outcome Measures

Name	Time	Method
Sleep Efficiency From Wrist Actigraphy	Six months from randomization	Sleep efficiency (mean percent time asleep while in bed) based on 7 days of wrist actigraphy.
Sleep Onset Latency	Six months after randomization	Mean time to fall asleep based on 7-day sleep diary.
Sleep Efficiency From Sleep Diary	Six months after randomization	Sleep efficiency (mean percent time asleep while in bed) based on 7-day sleep diary.
Pittsburgh Sleep Quality Index (PSQI)	Six months after randomization	The Pittsburgh Sleep Quality Index assesses subjective sleep quality and sleep disturbances The PSQI ia an 18-item questionnaire with a total score range from 0 - 21. A total score \> 8 indicates poor sleep quality.
Wake After Sleep Onset	Six months after randomization	Mean total minutes awake during nighttime awakenings based on 7-day sleep diary.
Total Wake Time	Six months after randomization	Mean total minutes awake from bedtime to rise time based on 7-day sleep diary.