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Implementing Sleep Interventions for Older Veterans

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual-based cognitive behavioral therapy for insomnia
Non-directive sleep education
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring cognitive behavior therapy, insomnia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • VA Greater Los Angeles Healthcare System, Sepulveda, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT-I

Control

Arm Description

Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach.

Non-directive sleep education provided in 5 group sessions by a health educator.

Outcomes

Primary Outcome Measures

Sleep Onset Latency
Mean time to fall asleep based on 7-day sleep diary.
Wake After Sleep Onset
Mean total minutes awake during nighttime awakenings based on 7-day sleep diary.
Total Wake Time
Mean total minutes awake from bedtime to rise time based on 7-day sleep diary.
Sleep Efficiency From Sleep Diary
Sleep efficiency (mean percent time asleep while in bed) based on 7-day sleep diary.
Sleep Efficiency From Wrist Actigraphy
Sleep efficiency (mean percent time asleep while in bed) based on 7 days of wrist actigraphy.
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.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2008
Last Updated
April 8, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00781963
Brief Title
Implementing Sleep Interventions for Older Veterans
Official Title
Implementing Sleep Interventions for Older Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
cognitive behavior therapy, insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
519 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-I
Arm Type
Experimental
Arm Description
Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a non-clinician sleep coach.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Non-directive sleep education provided in 5 group sessions by a health educator.
Intervention Type
Behavioral
Intervention Name(s)
Manual-based cognitive behavioral therapy for insomnia
Intervention Description
Manual-based CBT-I provided in 5 individual or group sessions by a non-clinician sleep coach.
Intervention Type
Behavioral
Intervention Name(s)
Non-directive sleep education
Intervention Description
Manual-based non-directive sleep education provided in 5 group sessions by a health educator.
Primary Outcome Measure Information:
Title
Sleep Onset Latency
Description
Mean time to fall asleep based on 7-day sleep diary.
Time Frame
Six months after randomization
Title
Wake After Sleep Onset
Description
Mean total minutes awake during nighttime awakenings based on 7-day sleep diary.
Time Frame
Six months after randomization
Title
Total Wake Time
Description
Mean total minutes awake from bedtime to rise time based on 7-day sleep diary.
Time Frame
Six months after randomization
Title
Sleep Efficiency From Sleep Diary
Description
Sleep efficiency (mean percent time asleep while in bed) based on 7-day sleep diary.
Time Frame
Six months after randomization
Title
Sleep Efficiency From Wrist Actigraphy
Description
Sleep efficiency (mean percent time asleep while in bed) based on 7 days of wrist actigraphy.
Time Frame
Six months from randomization
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
Six months after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy A. Alessi, MD
Organizational Affiliation
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System, Sepulveda, CA
City
Sepulveda
State/Province
California
ZIP/Postal Code
91343
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23149875
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.
Results Reference
result
PubMed Identifier
27550552
Citation
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.
Results Reference
result
PubMed Identifier
28960164
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):130-135. doi: 10.1080/07317115.2017.1356895. Epub 2017 Sep 29.
Results Reference
result
PubMed Identifier
29283797
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: 10.1080/07317115.2017.1408734. Epub 2017 Dec 28.
Results Reference
result
PubMed Identifier
30271340
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-Reported Physical Activity. Front Aging Neurosci. 2018 Sep 13;10:274. doi: 10.3389/fnagi.2018.00274. eCollection 2018.
Results Reference
result
PubMed Identifier
33944909
Citation
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.
Results Reference
derived
PubMed Identifier
30609099
Citation
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.
Results Reference
derived

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Implementing Sleep Interventions for Older Veterans

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