Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at San Diego, California
Dates
study started
estimated completion
Principal Investigator
by Erin Almklov

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Insomnia Mild Cognitive Impairment Veterans Behavioral Sleep treatment CBT for Insomnia CogSMART Feasibility Acceptability Sleep Initiation and Maintenance Disorders Cognitive Dysfunction Sleep-SMART

Eligibility

You can join if…

Open to people ages 60 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • VA San Diego Healthcare System, San Diego, CA
    San Diego California 92161 United States

Lead Scientist at UCSD

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT05016960
Study Type
Interventional
Last Updated