Clinical trial NCT05016960: Sleep-SMART for Veterans With MCI and Insomnia
Official title: Sleep-SMART for Veterans With MCI and Insomnia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Mild Cognitive Impairment
Keywords: Insomnia
Mild Cognitive Impairment
Veterans
Behavioral Sleep treatment
CBT for Insomnia
CogSMART
Feasibility
Acceptability
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 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.
measure: Telehealth Usability Questionnaire (TUQ)
timeFrame: 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.
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 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.
measure: Intervention Appropriateness Measure (IAM)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
measure: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: At pre-treatment and post-treatment. 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.
measure: Quality of Life in Neurological Disorders (Neuro-QOL) Cognition Scale
timeFrame: At pre-treatment and post-treatment. 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.
measure: Everyday Cognition Scale (ECoG)
timeFrame: At pre-treatment and post-treatment. 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.
measure: Insomnia Severity Index (ISI)
timeFrame: At pre-treatment and post-treatment. 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.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: At pre-treatment and post-treatment. 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.
measure: Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span (Total Raw Score)
timeFrame: At pre-treatment and post-treatment. 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.
measure: Brief Visuospatial Memory Test-Revised (Total Recall Raw Score)
timeFrame: At pre-treatment and post-treatment. 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.
measure: Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number-letter Switching) Raw Score
timeFrame: At pre-treatment and post-treatment. 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.
measure: Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (Category Switching)
timeFrame: At pre-treatment and post-treatment. 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.
measure: Hopkins Verbal Learning Test-Revised (Delayed Recall Raw Score)
timeFrame: At pre-treatment and post-treatment. 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.
measure: Brief Visuospatial Memory Test-Revised (Delayed Recall Raw Score)
timeFrame: At pre-treatment and post-treatment. 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.
measure: Hopkins Verbal Learning Test-Revised (Total Immediate Recall Raw Score)
timeFrame: At pre-treatment and post-treatment. 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.
measure: Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number Sequencing)
timeFrame: At pre-treatment and post-treatment. 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.
measure: Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Letter Sequencing)
timeFrame: At pre-treatment and post-treatment. 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.
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Erin Almklov, PhD
role: PRINCIPAL_INVESTIGATOR
References: