SleepSMART for Insomnia and Mild Cognitive Impairment

(SleepSMART Trial)

Overseen By Erin Almklov, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Dementia, TBI, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this 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.

Who Is on the Research Team?

Erin Almklov, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for older veterans who have trouble sleeping (insomnia) and are also experiencing mild cognitive impairment. Participants should be able to engage in therapy sessions and adhere to treatment guidelines.

Inclusion Criteria

Veterans

Ability to understand, speak, and read English with acceptable visual and auditory acuity

Stable on medications for at least 4 weeks prior to enrollment

Exclusion Criteria

I have a neurological disorder like Parkinson's or seizures.

History of moderate to severe TBI (determined by medical record or self-report of >30 minutes loss of consciousness)

I have been diagnosed with schizophrenia, a psychotic disorder, or bipolar disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SleepSMART or standard CBT-I for insomnia and MCI

8 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• SleepSMART

Trial Overview

The study tests SleepSMART, an adapted Cognitive Behavioral Therapy for Insomnia (CBT-I), against standard CBT-I. It aims to see if SleepSMART can better help those with insomnia and mild cognitive issues by adding supportive strategies.

How Is the Trial Designed?

Group I: SleepSMART Experimental Treatment 1 Intervention

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.

Group II: CBT-I Active Control 1 Intervention

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 Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+