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N/A N=159 Randomized Double-blind Treatment

Implementing Sleep Interventions for Older Veterans

Insomnia

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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