SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment

Official title

SleepSMART for Veterans With Insomnia and Mild Cognitive Impairment: A Randomized Clinical Trial

Overview

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.

Interventions

• Behavioral 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
• Behavioral SleepSMART
  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.

Primary outcome measures

• Insomnia Severity Index (ISI) [Time frame: Pre-treatment (week 1), post-treatment (week 8), and 3-month follow up (week 20)]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• VA San Diego Healthcare System, San Diego, CA — San Diego

Identifiers

NCT: NCT07397182 · RRD4-013-25M · 1I01RD000596-01A2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗