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Insomnia ChronicRESTNCT02967185

Intraindividual Variability in Sleep and Cognitive Performance in Older Adults

A study testing Brief Behavioral Therapy for Insomnia in people with Insomnia Chronic, run by University of Missouri-Columbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Insomnia Chronic
What is being tested?
Brief Behavioral Therapy for Insomnia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
No sites listed yet
Study dates
May 2005to Apr 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

About this study

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.

Being tested
Brief Behavioral Therapy for Insomnia
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief Behavioral Therapy for InsomniaBehavioural

    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.

Study groups in NCT02967185
Study groupRoleWhat they receive
Brief Behavioral Therapy for InsomniaExperimentalTreatment will consist of 4 weekly, 1 hour sessions and will be conducted by a trained graduate assistant on an individual basis.
Receives: Behavioral: Brief Behavioral Therapy for Insomnia
Waitlist ControlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: from baseline to follow-up, approximately 1 year

Secondary outcomes (9)

  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.

    Measured: 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)

    Measured: 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]

    Measured: 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

    Measured: 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)

    Measured: from baseline to follow-up, approximately 1 year

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

    Boston Naming Test (BNT)

    Measured: 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)

    Measured: from baseline to follow-up, approximately 1 year

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

    Measured: 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)

    Measured: from baseline to follow-up, approximately 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2016 (estimated)
  2. Study startMay 2005
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02967185
Sponsor's protocol ID
221286
Acronym
REST
Status last verified
Jun 2026
First submitted
8 Nov 2016
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Brief Behavioral Therapy for Insomnia in people with Insomnia Chronic, run by University of Missouri-Columbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in diary-assessed total sleep and wake time during sleep from baseline to follow-up (time frame: from baseline to follow-up, approximately 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02967185, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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