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Sleep-SMART for Veterans (Sleep-SMART)

Primary Purpose

Insomnia, Mild Cognitive Impairment

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep-SMART
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insomnia focused on measuring Insomnia, Mild Cognitive Impairment, Veterans, Behavioral Sleep treatment, CBT for Insomnia, CogSMART, Feasibility, Acceptability

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sleep-SMART

Arm Description

Sleep-SMART intervention

Outcomes

Primary Outcome Measures

Feasibility of Intervention Measure (FIM)
Rating scale assessing intervention feasibility; minimum score is 4, maximum score is 20; higher scores indicating better/higher levels of feasibility.
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.
Telehealth Usability Questionnaire (TUQ)
Scale to assess the usability of telehealth to deliver the intervention. Responses are interpreted qualitatively.
Acceptability of Intervention Measure (AIM)
Rating scale assessing intervention acceptability; scores range from 4-20 with higher scores indicating higher levels of acceptability.
Intervention Appropriateness Measure (IAM)
Rating scale assessing intervention appropriateness; scores range from 4-20 with higher scores indicating higher levels of appropriateness.

Secondary Outcome Measures

WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Self-report scale assessing Subjective level of disability. Scores range from 0-100, where 0 = no disability; 100 = full disability.
Independent Living Skills Survey (ILSS)
Self-report scale assessing independent living skills; standardized scores ranging from 20 to 39 suggest maximum (full-time) supervision for daily living, scores from 40 to 49 suggest moderate supervision, and scores from 50 to 63 suggest minimum supervision, or independent living.
Quality of Life Inventory (QOLI)
Self-report scale assessing quality of life. Higher scores indicating better quality of life/satisfaction.
Quality of Life in Neurological Disorders (Neuro-QOL) cognition scale
Self-report scales assessing subjective cognitive complaints and subjective everyday functioning. Each response option is assigned a value (e.g., 1=Not at all). To find the total raw score, sum the values of the response to each question. For example, for an 8-item form that includes items with 5 response options ranging from 1 to 5, the lowest possible raw score is 8 (8 x 1) ; the highest possible raw score is 40 (8 x 5). Conversion tables are used to translate the total raw score into an IRT-based T score for each participant. A higher Neuro-QoL T-score represents more of the concept being measured - higher scores indicate worse functioning for the cognition scale.
Everyday Cognition Scale (ECoG)
Collateral measure of cognitive and everyday functioning. Is a 39 item questionnaire used to measure a patient's cognitive function and aid in the detection and diagnosis of dementia and other neurodegenerative diseases that are associated with aging. The final score is an average of the individual scores for each item answered out of the 39 items in the questionnaire and ranges from 1 to 4.
Insomnia Severity Index (ISI)
Self-report scale assessing perceived insomnia severity; scores range from 0-28 with higher scores indicating more severe insomnia.
Pittsburgh Sleep Quality Index (PSQI)
Self-report scale assessing sleep quality over a 1-month interval. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper
Hopkins Verbal Learning Test-Revised
Performance based measure of verbal list learning and memory. Higher scores indicate better performance.
Brief Visuospatial Memory Test-Revised
Performance based measure of Visual design learning and memory. Scores are based on individual performance. Higher scores indicate better performance/memory.
Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span
Performance based measure of auditory attention; raw scores range from 0-48 with higher scores indicating better performance.
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test
Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test. Raw scores are converted to age-based scaled scores with higher scaled scores indicating better performance.
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test
Performance based measures of executive function. Scores are based on the number of words generated for the verbal fluency task. Raw scores are converted to age-based scaled scores with higher scaled scores indicating better performance.

Full Information

First Posted
August 13, 2021
Last Updated
September 6, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05016960
Brief Title
Sleep-SMART for Veterans
Acronym
Sleep-SMART
Official Title
Sleep-SMART for Veterans With MCI and Insomnia: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Mild Cognitive Impairment
Keywords
Insomnia, Mild Cognitive Impairment, Veterans, Behavioral Sleep treatment, CBT for Insomnia, CogSMART, Feasibility, Acceptability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep-SMART
Arm Type
Experimental
Arm Description
Sleep-SMART intervention
Intervention Type
Behavioral
Intervention Name(s)
Sleep-SMART
Intervention Description
Sleep-SMART will be a treatment for insomnia that will follow the standard 6 session 50-minute CBT-I format and will deliver CBT-I treatment along with training in select CogSMART strategies to enhance intervention learning and adherence. It will be delivered via video-based telehealth.
Primary Outcome Measure Information:
Title
Feasibility of Intervention Measure (FIM)
Description
Rating scale assessing intervention feasibility; minimum score is 4, maximum score is 20; higher scores indicating better/higher levels of feasibility.
Time Frame
Immediately after the intervention
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
Self-report scale to assess level of client satisfaction for the intervention. Scores range from 8-32, higher score indicates higher satisfaction.
Time Frame
Immediately after the intervention
Title
Telehealth Usability Questionnaire (TUQ)
Description
Scale to assess the usability of telehealth to deliver the intervention. Responses are interpreted qualitatively.
Time Frame
Immediately after the intervention
Title
Acceptability of Intervention Measure (AIM)
Description
Rating scale assessing intervention acceptability; scores range from 4-20 with higher scores indicating higher levels of acceptability.
Time Frame
Immediately after the intervention
Title
Intervention Appropriateness Measure (IAM)
Description
Rating scale assessing intervention appropriateness; scores range from 4-20 with higher scores indicating higher levels of appropriateness.
Time Frame
Immediately after the intervention
Secondary Outcome Measure Information:
Title
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Description
Self-report scale assessing Subjective level of disability. Scores range from 0-100, where 0 = no disability; 100 = full disability.
Time Frame
Immediately before and immediately after the intervention
Title
Independent Living Skills Survey (ILSS)
Description
Self-report scale assessing independent living skills; standardized scores ranging from 20 to 39 suggest maximum (full-time) supervision for daily living, scores from 40 to 49 suggest moderate supervision, and scores from 50 to 63 suggest minimum supervision, or independent living.
Time Frame
Immediately before and immediately after the intervention
Title
Quality of Life Inventory (QOLI)
Description
Self-report scale assessing quality of life. Higher scores indicating better quality of life/satisfaction.
Time Frame
Immediately before and immediately after the intervention
Title
Quality of Life in Neurological Disorders (Neuro-QOL) cognition scale
Description
Self-report scales assessing subjective cognitive complaints and subjective everyday functioning. Each response option is assigned a value (e.g., 1=Not at all). To find the total raw score, sum the values of the response to each question. For example, for an 8-item form that includes items with 5 response options ranging from 1 to 5, the lowest possible raw score is 8 (8 x 1) ; the highest possible raw score is 40 (8 x 5). Conversion tables are used to translate the total raw score into an IRT-based T score for each participant. A higher Neuro-QoL T-score represents more of the concept being measured - higher scores indicate worse functioning for the cognition scale.
Time Frame
Immediately before and immediately after the intervention
Title
Everyday Cognition Scale (ECoG)
Description
Collateral measure of cognitive and everyday functioning. Is a 39 item questionnaire used to measure a patient's cognitive function and aid in the detection and diagnosis of dementia and other neurodegenerative diseases that are associated with aging. The final score is an average of the individual scores for each item answered out of the 39 items in the questionnaire and ranges from 1 to 4.
Time Frame
Immediately before and immediately after the intervention
Title
Insomnia Severity Index (ISI)
Description
Self-report scale assessing perceived insomnia severity; scores range from 0-28 with higher scores indicating more severe insomnia.
Time Frame
Immediately before the intervention, weekly during the intervention, and immediately after the intervention
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Self-report scale assessing sleep quality over a 1-month interval. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of "5"or greater indicates a "poor" sleeper
Time Frame
Immediately before and immediately after the intervention
Title
Hopkins Verbal Learning Test-Revised
Description
Performance based measure of verbal list learning and memory. Higher scores indicate better performance.
Time Frame
Immediately before and immediately after the intervention
Title
Brief Visuospatial Memory Test-Revised
Description
Performance based measure of Visual design learning and memory. Scores are based on individual performance. Higher scores indicate better performance/memory.
Time Frame
Immediately before and immediately after the intervention
Title
Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span
Description
Performance based measure of auditory attention; raw scores range from 0-48 with higher scores indicating better performance.
Time Frame
Immediately before and immediately after the intervention
Title
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test
Description
Performance based measures of attention, processing speed, and executive function. Scores are based on the time (number of seconds) to complete the task for the trail making test. Raw scores are converted to age-based scaled scores with higher scaled scores indicating better performance.
Time Frame
Immediately before and immediately after the intervention
Title
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test
Description
Performance based measures of executive function. Scores are based on the number of words generated for the verbal fluency task. Raw scores are converted to age-based scaled scores with higher scaled scores indicating better performance.
Time Frame
Immediately before and immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Almklov, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161-0002
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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