Implementing Sleep Interventions for Older Veterans

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ClinicalTrials.gov Identifier: NCT00781963

Recruitment Status : Completed

First Posted : October 29, 2008

Results First Posted : October 2, 2014

Last Update Posted : April 17, 2019

Sponsor:

Information provided by (Responsible Party):

VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Insomnia	Behavioral: Manual-based cognitive behavioral therapy for insomnia Behavioral: Non-directive sleep education	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	519 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Implementing Sleep Interventions for Older Veterans
Study Start Date :	May 2010
Actual Primary Completion Date :	February 2013
Actual Study Completion Date :	December 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: CBT-I Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach.	Behavioral: Manual-based cognitive behavioral therapy for insomnia Manual-based CBT-I provided in 5 individual or group sessions by a non-clinician sleep coach.
Active Comparator: Control Non-directive sleep education provided in 5 group sessions by a health educator.	Behavioral: Non-directive sleep education Manual-based non-directive sleep education provided in 5 group sessions by a health educator.

Outcome Measures

Primary Outcome Measures :

Sleep Onset Latency [ Time Frame: Six months after randomization ]
Mean time to fall asleep based on 7-day sleep diary.
Wake After Sleep Onset [ Time Frame: Six months after randomization ]
Mean total minutes awake during nighttime awakenings based on 7-day sleep diary.
Total Wake Time [ Time Frame: Six months after randomization ]
Mean total minutes awake from bedtime to rise time based on 7-day sleep diary.
Sleep Efficiency From Sleep Diary [ Time Frame: Six months after randomization ]
Sleep efficiency (mean percent time asleep while in bed) based on 7-day sleep diary.
Sleep Efficiency From Wrist Actigraphy [ Time Frame: Six months from randomization ]
Sleep efficiency (mean percent time asleep while in bed) based on 7 days of wrist actigraphy.
Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	60 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781963

Locations

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United States, California
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Sepulveda, California, United States, 91343

Sponsors and Collaborators

VA Office of Research and Development

Investigators

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Principal Investigator:	Cathy A. Alessi, MD	VA Greater Los Angeles Healthcare System, Sepulveda, CA

More Information

Publications of Results:

Fung CH, Martin JL, Igodan U, Jouldjian S, Alessi C. The association between difficulty using positive airway pressure equipment and adherence to therapy: a pilot study. Sleep Breath. 2013 May;17(2):853-9. doi: 10.1007/s11325-012-0779-y. Epub 2012 Nov 13.

Alessi C, Martin JL, Fiorentino L, Fung CH, Dzierzewski JM, Rodriguez Tapia JC, Song Y, Josephson K, Jouldjian S, Mitchell MN. Cognitive Behavioral Therapy for Insomnia in Older Veterans Using Nonclinician Sleep Coaches: Randomized Controlled Trial. J Am Geriatr Soc. 2016 Sep;64(9):1830-8. doi: 10.1111/jgs.14304. Epub 2016 Aug 22.

Fung CH, Martin JL, Josephson K, Fiorentino L, Dzierzewski JM, Jouldjian S, Song Y, Rodriguez Tapia JC, Mitchell MN, Alessi CA. Cognitive Expectancies for Hypnotic Use among Older Adult Veterans with Chronic Insomnia. Clin Gerontol. 2018 Mar-Apr;41(2):130-135. doi: 10.1080/07317115.2017.1356895. Epub 2017 Sep 29.

Hughes JM, Song Y, Fung CH, Dzierzewski JM, Mitchell MN, Jouldjian S, Josephson KR, Alessi CA, Martin JL. Measuring Sleep in Vulnerable Older Adults: A Comparison of Subjective and Objective Sleep Measures. Clin Gerontol. 2018 Mar-Apr;41(2):145-157. doi: 10.1080/07317115.2017.1408734. Epub 2017 Dec 28.

Yeung T, Martin JL, Fung CH, Fiorentino L, Dzierzewski JM, Rodriguez Tapia JC, Song Y, Josephson K, Jouldjian S, Mitchell MN, Alessi C. Sleep Outcomes With Cognitive Behavioral Therapy for Insomnia Are Similar Between Older Adults With Low vs. High Self-Reported Physical Activity. Front Aging Neurosci. 2018 Sep 13;10:274. doi: 10.3389/fnagi.2018.00274. eCollection 2018.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Song Y, Kelly MR, Fung CH, Dzierzewski JM, Grinberg AM, Mitchell MN, Josephson K, Martin JL, Alessi CA. Change in Dysfunctional Sleep-Related Beliefs is Associated with Changes in Sleep and Other Health Outcomes Among Older Veterans With Insomnia: Findings From a Randomized Controlled Trial. Ann Behav Med. 2022 Jan 1;56(1):35-49. doi: 10.1093/abm/kaab030.

Dzierzewski JM, Martin JL, Fung CH, Song Y, Fiorentino L, Jouldjian S, Rodriguez JC, Mitchell M, Josephson K, Alessi CA. CBT for late-life insomnia and the accuracy of sleep and wake perceptions: Results from a randomized-controlled trial. J Sleep Res. 2019 Aug;28(4):e12809. doi: 10.1111/jsr.12809. Epub 2019 Jan 4.

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Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT00781963
Other Study ID Numbers:	IIR 08-295
First Posted:	October 29, 2008 Key Record Dates
Results First Posted:	October 2, 2014
Last Update Posted:	April 17, 2019
Last Verified:	April 2019

Keywords provided by VA Office of Research and Development:


cognitive behavior therapy insomnia

Additional relevant MeSH terms:

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Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias	Sleep Wake Disorders Nervous System Diseases Mental Disorders

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