InsomniaSleepSMARTNCT05016960

SleepSMART for Veterans With MCI and Insomnia

A study testing Sleep-SMART in people with Insomnia and Mild Cognitive Impairment, run by VA Office of Research and Development at 1 site in United States.

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

Who is it for?: Ages 60 years and older
Conditions the study is for: Insomnia, Mild Cognitive Impairment
What is being tested?: Sleep-SMART
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 4 Jan 2022to 31 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 ages 60 or older who are competent to provide informed consent
Chart diagnosis of MCI based on previously published criteria
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

Who cannot join

Sleep disorders other than insomnia as determined by medical chart review and clinical interview
History of a neurological disorder, dementia, or moderate to severe TBI
Auditory, visual, or other impairments that would prevent ability to use video teleconferencing or participate in assessments
Schizophrenia, psychotic disorder, bipolar disorder, and/or current substance use disorder
Suicidality more than "low risk" as assessed by the Columbia Suicide Severity Rating Scale

Trial locations and contacts

1 site in 1 country.

United States1 site

VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161-0002

Other trials in United States

About this study

Official title: Sleep-SMART for Veterans With MCI and Insomnia: A Pilot Study

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the first-line treatment for chronic insomnia. However, cognitive impairments may limit progress in CBT-I for older Veterans with Mild Cognitive Impairment (MCI). This study will develop and pilot test Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), an adapted CBT-I treatment that incorporates Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) principles with a goal of improving sleep treatment and rehabilitation outcomes for Veterans with co-occurring MCI and insomnia. The innovation of this study centers on enhancing CBT-I by providing supportive cognitive strategies designed to improve treatment adherence, learning, and acceptability. The investigators anticipate that by improving sleep it can concurrently improve daily functioning, increase quality of life, prevent or reduce late-life disability, and mitigate long-term cognitive decline in this Veteran population.

Read the detailed description

Mild cognitive impairment (MCI) is an important public health concern for aging Veterans due to the increased risk for progression to dementia and increased mortality. Insomnia is common in MCI (occurring in up to 60% of patients) and increases risk for dementia, disability, and poor quality of life. Rates of MCI and insomnia are higher among Veterans than civilians, thus aging Veterans with MCI and comorbid insomnia represent a particularly high-risk population. The gold standard treatment for insomnia, Cognitive Behavioral Therapy for Insomnia (CBT-I), is a multi-component behavioral intervention. However, cognitive impairments experienced by individuals with MCI may limit the rate of progress in CBT-I. The use of memory support strategies can improve patient recall of therapeutic information, enhance treatment adherence, and improve treatment outcomes. Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) provides compensatory strategies to improve learning, memory, attention, and executive functioning. CogSMART has been shown to improve cognition, functional capacity, neurobehavioral symptoms, and quality of life in diverse Veteran populations with cognitive impairment. Incorporating supportive CogSMART cognitive strategies into CBT-I has the potential to improve treatment learning, adherence, and outcomes for this Veteran population. This RR\&D SPiRE research project will assist us in developing and evaluating Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), an innovative user-informed approach for treatment of insomnia in Veterans with MCI. Sleep-SMART is intended to provide the core components of CBT-I along with training in compensatory cognitive strategies from CogSMART to enhance intervention adherence and learning. Provision of this supportive cognitive training will assist Veterans with cognitive impairments in maintaining compliance with the CBT-I regimen, thereby leading to faster and more complete treatment benefits. The principle aims for the investigation include: 1) developing the Sleep-SMART intervention and treatment manual; 2) assessing the feasibility and acceptability of Sleep-SMART in Veterans with MCI and insomnia; and 3) exploring the effects of Sleep-SMART on rehabilitation outcomes, quality of life, sleep, and cognitive functioning.

Conditions: Insomnia, Mild Cognitive Impairment
Being tested: Sleep-SMART
Keywords: Insomnia, Mild Cognitive Impairment, Veterans, Behavioral Sleep treatment, CBT for Insomnia, CogSMART, Feasibility, Acceptability
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.

Sleep-SMARTBehavioural
Sleep-SMART is a telehealth delivered treatment for insomnia that follows the standard 6 session 50-minute Cognitive Behavioral Therapy for Insomnia (CBT-I) format. Sleep-SMART delivers CBT-I treatment along with training in select cognitive strategies from CogSMART to enhance intervention learning and adherence.

Study groups in NCT05016960
Study group	Role	What they receive
Sleep-SMART	Experimental	Sleep-SMART intervention Receives: Behavioral: Sleep-SMART

What is being measured

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

Client Satisfaction Questionnaire (CSQ-8)
Self-report scale to assess level of client satisfaction for the intervention. Scores range from 8-32, higher score indicates higher satisfaction. Mean scores were calculated at post-treatment. No statistical analyses were performed.
Measured: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Telehealth Usability Questionnaire (TUQ)
Scale to assess the usability of telehealth to deliver the intervention. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree To determine the usability of the telehealth system, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the telehealth system.
Measured: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Acceptability of Intervention Measure (AIM)
Rating scale assessing intervention acceptability; scores range from 1-5 with higher scores indicating higher levels of acceptability. Ratings were collected at post-treatment. Mean scores were calculated. No statistical analyses were performed.
Measured: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Intervention Appropriateness Measure (IAM)
Rating scale assessing intervention appropriateness; scores range from 1-5 with higher scores indicating higher levels of appropriateness. Mean scores were calculated. No statistical analyses were performed.
Measured: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.

Timeline

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

4 Jan 202231 Dec 2023

First posted23 Aug 2021
Study start4 Jan 2022
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Other
Allocation: Not applicable
Intervention model: Single group
Model description: The investigators will develop and pilot test a modified CBT-I treatment that incorporates technology, user-centered design principles, and CogSMART strategies to improve sleep and rehabilitation outcomes for Veterans with co-occurring insomnia and MCI. The investigators will assess the feasibility and acceptability of Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), which will seamlessly incorporate select CogSMART cognitive strategies within a standard 6-session 50-minute CBT-I treatment protocol. Sleep-SMART will focus on enhancing CBT-I by providing supportive cognitive strategies designed to boost treatment learning and adherence.
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05016960
Sponsor's protocol ID: D3721-P
Acronym: SleepSMART
Status last verified: Dec 2025
First submitted: 13 Aug 2021
Last updated: 21 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sleep-SMART for Veterans With MCI and Insomnia: A Pilot Study
ClinicalTrials.gov ID: NCT05016960
Acronym / sponsor ID: SleepSMART / D3721-P
Conditions: Insomnia, Mild Cognitive Impairment
Keywords: Insomnia, Mild Cognitive Impairment, Veterans, Behavioral Sleep treatment, CBT for Insomnia, CogSMART, Feasibility, Acceptability
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 4 Jan 2022 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 23 Aug 2021 (actual)
Results: Posted 23 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The investigators will develop and pilot test a modified CBT-I treatment that incorporates technology, user-centered design principles, and CogSMART strategies to improve sleep and rehabilitation outcomes for Veterans with co-occurring insomnia and MCI. The investigators will assess the feasibility and acceptability of Sleep-SMART (Sleep Symptom Management and Rehabilitation Therapy), which will seamlessly incorporate select CogSMART cognitive strategies within a standard 6-session 50-minute CBT-I treatment protocol. Sleep-SMART will focus on enhancing CBT-I by providing supportive cognitive strategies designed to boost treatment learning and adherence.

Arm	Type	Receives
Sleep-SMART	Experimental	Behavioral: Sleep-SMARTSleep-SMART intervention

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Veterans ages 60 or older who are competent to provide informed consent
Chart diagnosis of MCI based on previously published criteria
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

Key exclusion criteria (5 listed)

Sleep disorders other than insomnia as determined by medical chart review and clinical interview
History of a neurological disorder, dementia, or moderate to severe TBI
Auditory, visual, or other impairments that would prevent ability to use video teleconferencing or participate in assessments
Schizophrenia, psychotic disorder, bipolar disorder, and/or current substance use disorder
Suicidality more than "low risk" as assessed by the Columbia Suicide Severity Rating Scale

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
Sleep-SMARTSleep-SMART is a telehealth delivered treatment for insomnia that follows the standard 6 session 50-minute Cognitive Behavioral Therapy for Insomnia (CBT-I) format. Sleep-SMART delivers CBT-I treatment along with training in select cognitive strategies from CogSMART to enhance intervention learning and adherence.	Behavioural	Sleep-SMART

Primary outcome

Client Satisfaction Questionnaire (CSQ-8)
Time frame: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Self-report scale to assess level of client satisfaction for the intervention. Scores range from 8-32, higher score indicates higher satisfaction. Mean scores were calculated at post-treatment. No statistical analyses were performed.
Telehealth Usability Questionnaire (TUQ)
Time frame: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Scale to assess the usability of telehealth to deliver the intervention. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree To determine the usability of the telehealth system, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the telehealth system.
Acceptability of Intervention Measure (AIM)
Time frame: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Rating scale assessing intervention acceptability; scores range from 1-5 with higher scores indicating higher levels of acceptability. Ratings were collected at post-treatment. Mean scores were calculated. No statistical analyses were performed.
Intervention Appropriateness Measure (IAM)
Time frame: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.
Rating scale assessing intervention appropriateness; scores range from 1-5 with higher scores indicating higher levels of appropriateness. Mean scores were calculated. No statistical analyses were performed.

Results and safety

Results posted to the registry on 23 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1 - Sleep-SMART Development	5	4
Phase 2 - Sleep-SMART Treatment	25	16

Primary outcome: Client Satisfaction Questionnaire (CSQ-8)

Time frame: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.. Mean (Standard Deviation). Unit: score on a scale

Measure	Phase 2 - Sleep-SMART Treatment n = 14
Value	29.43 (2.95)

Population analysed: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Primary outcome: Telehealth Usability Questionnaire (TUQ)

Measure	Phase 2 - Sleep-SMART Treatment n = 13
Value	5.92 (1.15)

Population analysed: Note: Data was analyzed for 13 participants as 3 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Primary outcome: Acceptability of Intervention Measure (AIM)

Measure	Phase 2 - Sleep-SMART Treatment n = 14
Value	4.39 (0.59)

Population analysed: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Primary outcome: Intervention Appropriateness Measure (IAM)

Measure	Phase 2 - Sleep-SMART Treatment n = 14
Value	4.41 (.66)

Population analysed: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.

Adverse events

Time frame: Deaths, serious adverse events, and non-serious adverse events were not assessed for this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sleep-SMART	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

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 Sleep-SMART 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 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 21 Jan 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?

Yes. Results are posted in the registry (first posted 23 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Client Satisfaction Questionnaire (CSQ-8) (time frame: At post-treatment (approximately 8 weeks from study enrollment). Note: study consenting and pre-treatment assessment occurred in week 1, followed by the 6-session SleepSMART treatment in weeks 2-7 and the post-treatment assessment in week 8.). The study lists 4 primary outcomes in all. 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 NCT05016960.

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 21 Jan 2026.