N/A
N=159
Implementing Sleep Interventions for Older Veterans
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT00781963 ↗Enrolled (actual)
159
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Sleep Onset Latency — 21.3; 31.3 Minutes — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Manual-based cognitive behavioral therapy for insomnia (Behavioral); Non-directive sleep education (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Onset Latency |
21.3; 31.3 | <.001 sig |
| PRIMARY Wake After Sleep Onset |
30.3; 42.8 | 0.21 |
| PRIMARY Total Wake Time |
73.4; 108 | 0.004 sig |
| PRIMARY Sleep Efficiency From Sleep Diary |
82.7; 83.1 | .005 sig |
| PRIMARY Sleep Efficiency From Wrist Actigraphy |
82.7; 83.1 | 0.15 |
| PRIMARY Pittsburgh Sleep Quality Index (PSQI) |
6.0; 7.2 | <.001 sig |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT00781963). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.