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SleepSMART versus usual insomnia therapy for older Veterans with memory problems

Compares SleepSMART and usual insomnia therapy in Veterans with memory problems.

Key facts

Who runs it
VA Office of Research and Development
Where
San Diego, United StatesSee the site
Trial code
Registry title
SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment
Status
Not yet recruiting
People taking part
150 people, planned
Starts
5 Jan 2027
Expected to end
31 Mar 2030
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cognitive BehavioralTherapy for Insomnia (CBT-I)
  • SleepSMART
Record updated
9 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for Veterans aged 60 or older who have insomnia and mild cognitive impairment (mild memory and thinking problems). It compares SleepSMART with standard CBT-I, a talk-based sleep therapy.

Age
60 Years and older
Sex
All sexes
Disease stage
Mild cognitive impairment recorded in the medical chart, plus insomnia diagnosed by DSM-5 criteria.
Earlier treatment
Medicines must have been stable for at least 4 weeks before joining. People who had therapist-led CBT-I (one-on-one or group) in the past year cannot join.
Biomarker or test result
Insomnia Severity Index (ISI) score >7 at the start.

Main reasons for not taking part

  • Dementia, Parkinson's disease, seizures or other brain disorders
  • Moderate to severe brain injury in the past (>30 minutes loss of consciousness)
  • Schizophrenia, psychotic disorder or bipolar disorder
  • Untreated sleep apnea, other sleep disorders, or poorly controlled illnesses that affect sleep
  • Substance use disorder with <30 days without use, or more than mild suicide risk

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Veterans
  • chart diagnosis mild cognitive impairment (MCI)
  • DSM-5 diagnosis of insomnia and an Insomnia Severity Index (ISI) score >7 at baseline
  • ability to understand, speak, and read English with acceptable visual and auditory acuity
  • stable on medications for at least 4 weeks prior to enrollment

Who cannot take part

  • presence of neurological disorders such as Parkinson's disease or seizures, dementia (based on chart diagnosis or clear evidence of dementia at the baseline neuropsychological testing using DSM5 criteria for Major Neurocognitive Disorder)
  • and/or history of moderate to severe traumatic brain injury (determined by medical record or self-report of >30 minutes loss of consciousness)
  • schizophrenia, psychotic disorder, and/or bipolar disorder
  • untreated or poorly managed medical conditions that may impact sleep, including thyroid disease, nocturia, chronic respiratory or heart disease, or diabetes
  • current substance use disorder with <30 days abstinence
  • untreated obstructive sleep apnea and/or sleep disturbances other than insomnia
  • suicidality greater than mild risk as measured by the Columbia-Suicide Severity Rating Scale
  • exposure to therapist directed (individual or group) CBT-I within the past year

Where in United States

  • VA San Diego Healthcare System, San Diego, CASan Diego, United StatesContact: Erin Almklov, PhDNot yet recruiting

About the trial

What the trial wants to find out

Insomnia is a transdiagnostic health problem affecting the physical, cognitive, emotional, and social functioning of Veterans. Importantly, chronic insomnia may be a modifiable risk factor for progression to serious health conditions, such as mild cognitive impairment (MCI) and dementia. Sleep Symptom Management and Rehabilitation Therapy (SleepSMART) was developed as an adapted form of Cognitive Behavioral Therapy for Insomnia (CBT-I) specifically designed for older Veterans with cognitive impairments. SleepSMART focuses on enhancing CBT-I by providing supportive cognitive strategies to boost treatment learning and adherence. In a recent pilot investigation, SleepSMART was found to be feasible, acceptable, and demonstrated preliminary efficacy among a sample of Veterans with co-morbid insomnia and MCI. This proposed investigation aims to conduct a randomized controlled trial investigating the effectiveness of SleepSMART, compared to standard CBT-I in older Veterans with insomnia and MCI.

The 2 groups in the trial

  • SleepSMARTTreatment being tested

    SleepSMART was developed as an adapted form of CBT-I specifically designed for older Veterans with insomnia and cognitive impairments. SleepSMART focuses on enhancing CBT-I by providing supportive cognitive strategies to boost treatment learning and adherence.

  • CBT-IExisting treatment, for comparison

    Cognitive Behavioral Therapy for Insomnia (CBT-I) is a structured, evidence-based treatment designed to help individuals overcome chronic insomnia by addressing the underlying cognitive and behavioral factors contributing to sleep difficulties.

    Treatment: Cognitive BehavioralTherapy for Insomnia (CBT-I)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment: A Randomized Clinical Trial
Plain-language title
SleepSMART versus usual insomnia therapy for older Veterans with memory problemsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
9 November 2026