NCT02967185

Brief Summary

The proposed study will examine changes in older insomniacs' cognitive functioning following behavioral treatment for insomnia using a combination of two methods. A traditional repeated measures design will be used to look at group level differences based on performance on a neuropsychological battery administered prior to, immediately after, and 3 months after completing a 4 week behavioral treatment program for insomnia. This data will be analyzed using standard repeated measures analytic techniques. A time-series design will also be used to look at within-subject differences based on a brief cognitive battery that will be self-administered on a daily basis. Data from this daily battery will be examined using intraindividual variability modeling.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2005

Typical duration for phase_2

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

Study Start

First participant enrolled

May 1, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 18, 2016

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

November 8, 2016

Last Update Submit

November 15, 2016

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (1)

  • Change in diary-assessed total sleep and wake time during sleep from baseline to follow-up

    Participants will complete a daily sleep dairies throughout the study period. They will report their bedtime, waketime, sleep onset latency, and wake time after sleep onset. Total sleep time and total wake time will be calculated from the diaries.

    from baseline to follow-up, approximately 1 year

Secondary Outcomes (9)

  • Change in actigraphy-assessed sleep variability from baseline to follow-up

    from baseline to follow-up, approximately 1 year

  • Change in performance on the Mini-Mental Status Exam

    from baseline to follow-up, approximately 1 year

  • Change in performance on Wechsler Adult Intelligence Scale-3, Vocabulary & Digit Symbol

    from baseline to follow-up, approximately 1 year

  • Change in performance on the Trails A & B (Reitan, 1958)

    from baseline to follow-up, approximately 1 year

  • Change in performance on the Controlled Oral Word Association

    from baseline to follow-up, approximately 1 year

  • +4 more secondary outcomes

Study Arms (2)

Brief Behavioral Therapy for Insomnia

EXPERIMENTAL

Treatment will consist of 4 weekly, 1 hour sessions and will be conducted by a trained graduate assistant on an individual basis.

Behavioral: Brief Behavioral Therapy for Insomnia

Waitlist Control

NO INTERVENTION

Participants in this group will receive no intervention, but will complete the same set of assessments as those in the Experimental Group. They will be given the option of receiving the behavioral treatment program at no charge.

Interventions

Brief Behavioral Therapy for InsomniaBEHAVIORAL

Treatment will consist of 4 weekly, 1 hour sessions and will be conducted by a trained graduate assistant on an individual basis. Treatment components will include education about aging and sleep. It will also include instruction in techniques designed to: (a) promote good sleep habits, (b) restrict the use of the bed and bedroom to sleep and sleep-conducive activities, (c) modify bed and wake times to better match the participants sleep needs, and (d) promote relaxation. Daily home practice of these techniques will be encouraged. Participants will maintain logs of their home practice sessions and will continue to record their daily sleep habits throughout treatment.

Brief Behavioral Therapy for Insomnia

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age \>65 years
  • Community dwelling
  • Available for duration of study
  • Insomnia according to American Sleep Disorders Association (1990) criteria: (a) \>30 minutes of unwanted awake time, 3 nights per week for at least 6 months and (b) Daytime dysfunction (reported mood, cognitive, social, or occupational impairment)

You may not qualify if:

  • Age less than 65
  • history of primary sleep disorder (e.g., sleep apnea, narcolepsy)
  • history of stroke
  • major medical illness known to contribute to sleep problems in last 12 months
  • cognitive impairment that interferes with ability to understand treatment (score \<23 on Mini-Mental State Examination)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • McCrae CS, McGovern R, Lukefahr R, Stripling AM. Research Evaluating Brief Behavioral Sleep Treatments for Rural Elderly (RESTORE): a preliminary examination of effectiveness. Am J Geriatr Psychiatry. 2007 Nov;15(11):979-82. doi: 10.1097/JGP.0b013e31813547e6.

    PMID: 17974868RESULT

  • McCrae CS, Curtis AF, Williams JM, Dautovich ND, McNamara JPH, Stripling A, Dzierzewski JM, Berry RB, McCoy KM, Marsiske M. Effects of Brief Behavioral Treatment for Insomnia on Daily Associations between Self-Reported Sleep and Objective Cognitive Performance in Older Adults. Behav Sleep Med. 2020 Sep-Oct;18(5):577-588. doi: 10.1080/15402002.2019.1632201. Epub 2019 Jun 15.

    PMID: 31203649DERIVED

  • Curtis AF, Williams JM, McCoy KJM, McCrae CS. Chronic Pain, Sleep, and Cognition in Older Adults With Insomnia: A Daily Multilevel Analysis. J Clin Sleep Med. 2018 Oct 15;14(10):1765-1772. doi: 10.5664/jcsm.7392.

    PMID: 30353817DERIVED

  • McCrae CS, Curtis AF, Williams JM, Dautovich ND, McNamara JPH, Stripling A, Dzierzewski JM, Chan WS, Berry RB, McCoy KJM, Marsiske M. Efficacy of brief behavioral treatment for insomnia in older adults: examination of sleep, mood, and cognitive outcomes. Sleep Med. 2018 Nov;51:153-166. doi: 10.1016/j.sleep.2018.05.018. Epub 2018 Jun 2.

    PMID: 30195661DERIVED

  • Chan WS, Williams J, Dautovich ND, McNamara JPH, Stripling A, Dzierzewski JM, Berry RB, McCoy KJM, McCrae CS. Night-to-Night Sleep Variability in Older Adults With Chronic Insomnia: Mediators and Moderators in a Randomized Controlled Trial of Brief Behavioral Therapy (BBT-I). J Clin Sleep Med. 2017 Nov 15;13(11):1243-1254. doi: 10.5664/jcsm.6790.

    PMID: 28992829DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Christina McCrae, PhD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 18, 2016

Study Start

May 1, 2005

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

November 18, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share