CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 519 enrolled
Drug / intervention
Manual-based cognitive behavioral therapy for insomnia +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00781963
NCT00781963N/ACompleted

Implementing Sleep Interventions for Older Veterans

VA Office of Research and Development·interventional·Posted Oct 29, 2008·Updated Apr 17, 2019

In Brief

A clinical study evaluating Manual-based cognitive behavioral therapy for insomnia and Non-directive sleep education for Insomnia. Completed, enrolled 519 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInsomnia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2008
Enrollment StartMay 1, 2010
Primary CompletionFeb 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.7 years ago

Interventions

Manual-based cognitive behavioral therapy for insomniabehavioral

Manual-based CBT-I provided in 5 individual or group sessions by a non-clinician sleep coach.

Non-directive sleep educationbehavioral

Manual-based non-directive sleep education provided in 5 group sessions by a health educator.