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CompletedNCT02967185RESTUpdated Jun 3, 2026

Intraindividual Variability in Sleep and Cognitive Performance in Older Adults

An interventional study of Brief Behavioral Therapy for Insomnia in Insomnia Chronic, sponsored by University of Missouri-Columbia. Completed. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Insomnia Chronic
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In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 62 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Brief Behavioral Therapy for Insomnia

    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

  • No intervention
    Waitlist Control

    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

  • BehavioralBrief Behavioral Therapy for Insomnia

    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.

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What researchers measure

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.

    Time frame: from baseline to follow-up, approximately 1 year

Secondary outcomes

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

    Participants wore an Actiwatch-L (ACTL) (Mini Mitter Co., Inc.) on their non-dominant wrists continuously throughout the study. The sensor of the ACTL is sampled 32 times per second and records peak values for each second. These peak values are then summed into 30-second "activity" counts. These activity counts are downloaded to a personal computer and analyzed using Actiware-Sleep v. 3.3, which uses a validated algorithm to identify periods of as sleep or wake. Total sleep time and total wake time will be computed.

    Time frame: from baseline to follow-up, approximately 1 year

  2. Change in performance on the Mini-Mental Status Exam

    Mini-Mental Status Exam (MMSE) (Folstein, Folstein, \& McHugh, 1975)

    Time frame: from baseline to follow-up, approximately 1 year

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

    Wechsler Adult Intelligence Scale-3, Vocabulary \& Digit Symbol (subtests) \[WAIS-3\]

    Time frame: from baseline to follow-up, approximately 1 year

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

    Trails A \& B (Reitan, 1958) was administered

    Time frame: from baseline to follow-up, approximately 1 year

  5. Change in performance on the Controlled Oral Word Association

    Controlled Oral Word Association (COWA) (Benton \& Hamsher, 1983)

    Time frame: from baseline to follow-up, approximately 1 year

  6. Change in performance on the Boston Naming Test (BNT)

    Boston Naming Test (BNT)

    Time frame: from baseline to follow-up, approximately 1 year

  7. Change in performance on the California Verbal Learning Test (CVLT, CVLT-II)

    California Verbal Learning Test (CVLT, CVLT-II) (Delis, Kramer, Kaplan, \& Ober, 1987)

    Time frame: from baseline to follow-up, approximately 1 year

  8. Change in performance on the Rey-Osterreith Complex Figure Test (Rey-O) (Hubley & Tremblay, 2002)

    Time frame: from baseline to follow-up, approximately 1 year

  9. Change in performance on the Wechsler Memory Scale-3, Logical Memory & Visual Reproduction subtests (WMS-3) Tremblay, 2002)

    Time frame: from baseline to follow-up, approximately 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 17974868 ↗
  • 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. PubMed 31203649 ↗
  • 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. PubMed 30353817 ↗
  • 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. PubMed 30195661 ↗
  • 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. PubMed 28992829 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02967185
Lead sponsor
University of Missouri-Columbia
Collaborators
University of Florida
Responsible party
Christina McCrae (Professor, University of Missouri-Columbia) — Principal investigator
First posted
Nov 18, 2016
Start date
May 2005
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Jun 3, 2026

Study contacts

Christina McCrae, PhD
principal investigator · University of Missouri-Columbia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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