Sleep-SMART for Veterans

Mild Cognitive Impairment Clinical Trial

— Sleep-SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05016960
• Other study ID #: D3721-P
• Status: Completed
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Insomnia
• Mild Cognitive Impairment
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Sleep-SMART
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.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Immediately after the intervention
Primary	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.	Immediately after the intervention
Primary	Telehealth Usability Questionnaire (TUQ)	Scale to assess the usability of telehealth to deliver the intervention. Responses are interpreted qualitatively.	Immediately after the intervention
Primary	Acceptability of Intervention Measure (AIM)	Rating scale assessing intervention acceptability; scores range from 4-20 with higher scores indicating higher levels of acceptability.	Immediately after the intervention
Primary	Intervention Appropriateness Measure (IAM)	Rating scale assessing intervention appropriateness; scores range from 4-20 with higher scores indicating higher levels of appropriateness.	Immediately after the intervention
Secondary	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.	Immediately before and immediately after the intervention
Secondary	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.	Immediately before and immediately after the intervention
Secondary	Quality of Life Inventory (QOLI)	Self-report scale assessing quality of life. Higher scores indicating better quality of life/satisfaction.	Immediately before and immediately after the intervention
Secondary	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.	Immediately before and immediately after the intervention
Secondary	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.	Immediately before and immediately after the intervention
Secondary	Insomnia Severity Index (ISI)	Self-report scale assessing perceived insomnia severity; scores range from 0-28 with higher scores indicating more severe insomnia.	Immediately before the intervention, weekly during the intervention, and immediately after the intervention
Secondary	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	Immediately before and immediately after the intervention
Secondary	Hopkins Verbal Learning Test-Revised	Performance based measure of verbal list learning and memory. Higher scores indicate better performance.	Immediately before and immediately after the intervention
Secondary	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.	Immediately before and immediately after the intervention
Secondary	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.	Immediately before and immediately after the intervention
Secondary	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.	Immediately before and immediately after the intervention
Secondary	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.	Immediately before and immediately after the intervention