NCT00781963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
519

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2008

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
10 months until next milestone

Results Posted

Study results publicly available

October 2, 2014

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

2.8 years

First QC Date

October 28, 2008

Results QC Date

September 17, 2014

Last Update Submit

April 8, 2019

Conditions

Insomnia

Keywords

cognitive behavior therapyinsomnia

Outcome Measures

Primary Outcomes (6)

  • Sleep Onset Latency

    Mean time to fall asleep based on 7-day sleep diary.

    Six months after randomization

  • Wake After Sleep Onset

    Mean total minutes awake during nighttime awakenings based on 7-day sleep diary.

    Six months after randomization

  • Total Wake Time

    Mean total minutes awake from bedtime to rise time based on 7-day sleep diary.

    Six months after randomization

  • Sleep Efficiency From Sleep Diary

    Sleep efficiency (mean percent time asleep while in bed) based on 7-day sleep diary.

    Six months after randomization

  • 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

  • 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

Study Arms (2)

CBT-I

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Behavioral: Non-directive sleep education

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.

CBT-I
Non-directive sleep educationBEHAVIORAL

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

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Significant cognitive impairment (MMSE score \<24) and have evidence of sleep apnea (by questionnaire and/or sleep monitoring).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System, Sepulveda, CA

Sepulveda, California, 91343, United States

Location

Related Publications (7)

  • 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.

    PMID: 23149875RESULT

  • 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.

    PMID: 27550552RESULT

  • 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.

    PMID: 28960164RESULT

  • 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.

    PMID: 29283797RESULT

  • 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.

    PMID: 30271340RESULT

  • 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.

    PMID: 33944909DERIVED

  • 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.

    PMID: 30609099DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Limitations and Caveats

The study sample was predominantly older male veterans, so results may not be generalizable to older women.

Results Point of Contact

Title
Dr. Cathy Alessi
Organization
VA Greater Los Angeles Healthcare System
Cathy.Alessi@va.gov
818 895-9311

Study Officials

  • Cathy A. Alessi, MD

    VA Greater Los Angeles Healthcare System, Sepulveda, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2008

First Posted

October 29, 2008

Study Start

May 1, 2010

Primary Completion

February 1, 2013

Study Completion

December 1, 2013

Last Updated

April 17, 2019

Results First Posted

October 2, 2014

Record last verified: 2019-04

Locations

US(1)