Implementing Sleep Interventions for Older Veterans

Insomnia Clinical Trial

Official title:

Implementing Sleep Interventions for Older Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781963
• Other study ID #: IIR 08-295
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: April 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 519
• Est. completion date: December 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, Sepulveda, CA	Sepulveda	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 — View Citation

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. — View Citation

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 — View Citation

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: — View Citation

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-R — View Citation

Outcome

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