InsomniaSleepSMARTNCT07397182
SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment
A study testing Cognitive BehavioralTherapy for Insomnia (CBT-I) and SleepSMART in people with Insomnia and Mild Cognitive Impairment, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Insomnia, Mild Cognitive Impairment
- What is being tested?
- Cognitive BehavioralTherapy for Insomnia (CBT-I) and SleepSMART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2026to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002
Erin Almklov, PhD, (858) 855-8585 ext. 2345, erin.almklov@va.gov
Erin Almklov, PhD
About this study
Official title: SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment: A Randomized Clinical Trial
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.
Read the detailed description
With increasing age, adults report greater frequency of insomnia symptoms, including difficulty falling and staying asleep, waking too early, and associated impairments in daytime functioning and quality of life. Veterans are particularly vulnerable to insomnia, with rates double and even triple those of civilian populations. When left untreated, chronic insomnia may contribute to increased risk for cognitive decline (e.g., Alzheimer's disease) and can lead to poorer physical health, disruption in major social and occupational responsibilities, and decreased quality of life. CBT-I is the first-line treatment for insomnia, but factors like poor adherence and poor recall for CBT-I content can diminish its impact for certain populations. Specifically, the cognitive impairments experienced by individuals with Mild Cognitive Impairment (MCI) may limit the adherence and rate of progress in CBT-I. Therefore, it is critical to ensure that vulnerable populations, such as older Veterans with MCI, can fully benefit from sleep treatment. The study team developed SleepSMART (Sleep Symptom Management and Rehabilitation Therapy) to help cognitively impaired Veterans learn and adhere to the CBT-I regimen, thereby leading to faster and more complete sleep treatment benefits. Based on the results of a recent pilot investigation, SleepSMART demonstrated preliminary efficacy as a modified form of CBT-I treatment that is uniquely tailored to aging Veterans with MCI. This investigation will build on previous research by conducting a randomized controlled trial investigating the effectiveness of SleepSMART, compared to standard CBT-I, in 150 Veterans age 60+ with insomnia and MCI.
- Conditions
- Insomnia, Mild Cognitive Impairment
- Being tested
- Cognitive BehavioralTherapy for Insomnia (CBT-I), SleepSMART
- Keywords
- Veterans, Insomnia, Mild Cognitive Impairment, Sleep treatment, Cognitive functioning
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive BehavioralTherapy for Insomnia (CBT-I)Behavioural
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.
SleepSMARTBehavioural
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 group | Role | What they receive |
|---|---|---|
| SleepSMART | Experimental | 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. Receives: Behavioral: SleepSMART |
| CBT-I | Active comparator | 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. Receives: Behavioral: Cognitive BehavioralTherapy for Insomnia (CBT-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
Pre-treatment (week 1), post-treatment (week 8), and 3-month follow up (week 20) scores on the ISI will be compared.
Measured: Pre-treatment (week 1), post-treatment (week 8), and 3-month follow up (week 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start2 Nov 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Participants will be randomized to one of two treatment conditions (SleepSMART or CBT-I).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Erin Almklov, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397182
- Sponsor's protocol ID
- RRD4-013-25M
- Other IDs
- 1I01RD000596-01A2
- Acronym
- SleepSMART
- Status last verified
- Jul 2026
- First submitted
- 2 Feb 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07397182
- Acronym / sponsor ID
- SleepSMART / RRD4-013-25M
- Conditions
- Insomnia, Mild Cognitive Impairment
- Keywords
- Veterans, Insomnia, Mild Cognitive Impairment, Sleep treatment, Cognitive functioning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
With increasing age, adults report greater frequency of insomnia symptoms, including difficulty falling and staying asleep, waking too early, and associated impairments in daytime functioning and quality of life. Veterans are particularly vulnerable to insomnia, with rates double and even triple those of civilian populations. When left untreated, chronic insomnia may contribute to increased risk for cognitive decline (e.g., Alzheimer's disease) and can lead to poorer physical health, disruption in major social and occupational responsibilities, and decreased quality of life. CBT-I is the first-line treatment for insomnia, but factors like poor adherence and poor recall for CBT-I content can diminish its impact for certain populations. Specifically, the cognitive impairments experienced by individuals with Mild Cognitive Impairment (MCI) may limit the adherence and rate of progress in CBT-I. Therefore, it is critical to ensure that vulnerable populations, such as older Veterans with MCI, can fully benefit from sleep treatment. The study team developed SleepSMART (Sleep Symptom Management and Rehabilitation Therapy) to help cognitively impaired Veterans learn and adhere to the CBT-I regimen, thereby leading to faster and more complete sleep treatment benefits. Based on the results of a recent pilot investigation, SleepSMART demonstrated preliminary efficacy as a modified form of CBT-I treatment that is uniquely tailored to aging Veterans with MCI. This investigation will build on previous research by conducting a randomized controlled trial investigating the effectiveness of SleepSMART, compared to standard CBT-I, in 150 Veterans age 60+ with insomnia and MCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two treatment conditions (SleepSMART or CBT-I).
| Arm | Type | Receives |
|---|---|---|
| SleepSMART | Experimental | Behavioral: SleepSMARTSleepSMART 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-I | Active comparator | Behavioral: Cognitive BehavioralTherapy for Insomnia (CBT-I)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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive BehavioralTherapy for Insomnia (CBT-I)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. | Behavioural | CBT-I |
| SleepSMARTThis 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. | Behavioural | SleepSMART |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Pre-treatment (week 1), post-treatment (week 8), and 3-month follow up (week 20)
Pre-treatment (week 1), post-treatment (week 8), and 3-month follow up (week 20) scores on the ISI will be compared.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin Almklov, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive BehavioralTherapy for Insomnia (CBT-I) and SleepSMART in people with Insomnia and Mild Cognitive Impairment, run by VA Office of Research and Development at 1 site in United States.
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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Almklov, PhD ((858) 855-8585 ext. 2345, erin.almklov@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Pre-treatment (week 1), post-treatment (week 8), and 3-month follow up (week 20)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2026.