What this study is
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.
What's being tested
- Cognitive BehavioralTherapy for Insomnia (CBT-I)
Intervention · BEHAVIORAL
This manualized approach to treatment involves 6 weekly sessions and addresses the underlying causes of insomnia utilizing sleep restriction and stimulus control techniques, relaxation training, and relapse prevention. In Session 1 sleep education, goal setting, and Sleep Restriction Therapy (SRT) guidelines will be introduced. In Session 2 the Veteran's sleep diary will be reviewed, time in bed (TIB) will be modified based on SRT, and Stimulus Control (SC) instructions will be provided. Session 3 will commence with a review of the sleep diary and adjustments to TIB will be made. In this session a discussion of cognitive factors that may impact insomnia and therapy adherence will be discussed. Additionally, stress management and/or relaxation training will be introduced. In Sessions 4 and 5 sleep diaries will be reviewed, adherence to the treatment discussed, and TIB will be modified based on SRT rules. In Session 6 continued care and relapse prevention plans will be developed.
- SleepSMART
Intervention · BEHAVIORAL
This treatment involves six 50-minute sessions and addresses key CBT-I components including sleep education, sleep restriction/sleep compression therapy, stimulus control techniques, cognitive therapy, relaxation training, and relapse prevention. Each session includes CogSMART cognitive strategies designed to support treatment learning and adherence.
Study details
- Official title
- SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment: A Randomized Clinical Trial
- Sponsor
- VA Office of Research and Development
- Conditions
- Insomnia · Mild Cognitive Impairment
- Enrolling
- 150 people
- Starts
- 2026-11-02
- Est. completion
- 2030-03-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 60 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Veterans
- Chart diagnosis 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
You can't join if
- 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 TBI (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
- Untreated obstructive sleep apnea and/or sleep disturbances other than insomnia
- Current substance use disorder with <30 days abstinence
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openVA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
- Erin Almklov, PhD · Contact(858) 855-8585 ext. 2345erin.almklov@va.gov
- Erin Almklov, PhD · Principal investigator
Study team
Sponsor
VA Office of Research and Development
Study ID RRD4-013-25M
Principal investigator
Erin Almklov, PhD
VA San Diego Healthcare System, San Diego, CA
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.