Insomnia, Mild Cognitive Impairment
Conditions
Keywords
Insomnia, Mild Cognitive Impairment, Veterans, Behavioral Sleep treatment, CBT for Insomnia, CogSMART, Feasibility, Acceptability
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.
Interventions
BEHAVIORALSleep-SMART
Sleep-SMART is a telehealth delivered treatment for insomnia that follows the standard 6 session 50-minute Cognitive Behavioral Therapy for Insomnia (CBT-I) format. Sleep-SMART delivers CBT-I treatment along with training in select cognitive strategies from CogSMART to enhance intervention learning and adherence.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction Questionnaire (CSQ-8) | 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. | Self-report scale to assess level of client satisfaction for the intervention. Scores range from 8-32, higher score indicates higher satisfaction. Mean scores were calculated at post-treatment. No statistical analyses were performed. |
| Telehealth Usability Questionnaire (TUQ) | 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. | Scale to assess the usability of telehealth to deliver the intervention. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree To determine the usability of the telehealth system, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the telehealth system. |
| Acceptability of Intervention Measure (AIM) | 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. | Rating scale assessing intervention acceptability; scores range from 1-5 with higher scores indicating higher levels of acceptability. Ratings were collected at post-treatment. Mean scores were calculated. No statistical analyses were performed. |
| Intervention Appropriateness Measure (IAM) | 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. | Rating scale assessing intervention appropriateness; scores range from 1-5 with higher scores indicating higher levels of appropriateness. Mean scores were calculated. No statistical analyses were performed. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORErin Almklov, PhD
VA San Diego Healthcare System, San Diego, CA
Participant flow
Recruitment details
Veterans aged 60 or older with MCI and insomnia were recruited from VA San Diego health clinics between 12/07/2021 and 12/31/2023.
Pre-assignment details
Enrolled participants were excluded from the treatment phase (phase 2) if they did not meet study eligibility criteria at pre-treatment assessment.
Participants by arm
| Arm | Count |
|---|---|
| Phase 2 - Sleep-SMART Treatment Participants in Phase 2 received the Sleep-SMART treatment intervention and were administered baseline measures. Baseline and outcome measures were not collected as part of Phase 1. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Phase 2 - Sleep-SMART Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 12 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Insomnia Severity Index | 19.40 units on a scale STANDARD_DEVIATION 4.95 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 25 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Acceptability of Intervention Measure (AIM)
Rating scale assessing intervention acceptability; scores range from 1-5 with higher scores indicating higher levels of acceptability. Ratings were collected at post-treatment. Mean scores were calculated. No statistical analyses were performed.
Time frame: 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.
Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Acceptability of Intervention Measure (AIM) | 4.39 score on a scale | Standard Deviation 0.59 |
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. Mean scores were calculated at post-treatment. No statistical analyses were performed.
Time frame: 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.
Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Client Satisfaction Questionnaire (CSQ-8) | 29.43 score on a scale | Standard Deviation 2.95 |
Primary
Intervention Appropriateness Measure (IAM)
Rating scale assessing intervention appropriateness; scores range from 1-5 with higher scores indicating higher levels of appropriateness. Mean scores were calculated. No statistical analyses were performed.
Time frame: 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.
Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Intervention Appropriateness Measure (IAM) | 4.41 score on a scale | Standard Deviation 0.66 |
Primary
Telehealth Usability Questionnaire (TUQ)
Scale to assess the usability of telehealth to deliver the intervention. In this questionnaire, 1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 - agree, 7 - strongly agree To determine the usability of the telehealth system, calculate the total and determine the average of the responses to all statements. The higher the overall average, the higher the usability of the telehealth system.
Time frame: 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.
Population: Note: Data was analyzed for 13 participants as 3 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Telehealth Usability Questionnaire (TUQ) | 5.92 score on a scale | Standard Deviation 1.15 |
Other Pre-specified
Brief Visuospatial Memory Test-Revised (Delayed Recall Raw Score)
Performance based measure of Visual design learning and memory. Scores are based on individual performance and range from 0 to 12. Higher scores indicate better performance/memory.
Time frame: 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.
Population: Note: Data was analyzed for 9 participants as 7 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Brief Visuospatial Memory Test-Revised (Delayed Recall Raw Score) | Pre-treatment | 5.44 correctly recalled elements | Standard Deviation 2.5 |
| Phase 2 - Sleep-SMART Treatment | Brief Visuospatial Memory Test-Revised (Delayed Recall Raw Score) | Post-treatment | 6.56 correctly recalled elements | Standard Deviation 2.3 |
p-value: 0.062t-test, 2 sided
Other Pre-specified
Brief Visuospatial Memory Test-Revised (Total Recall Raw Score)
Performance based measure of Visual design learning and memory. Scores are based on individual performance and range from 0-36 with higher scores indicating better performance/memory.
Time frame: 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.
Population: Note: Data was analyzed for 9 participants as 7 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Brief Visuospatial Memory Test-Revised (Total Recall Raw Score) | Pre-treatment | 14.33 score on a scale | Standard Deviation 5.454 |
| Phase 2 - Sleep-SMART Treatment | Brief Visuospatial Memory Test-Revised (Total Recall Raw Score) | Post-treatment | 16.00 score on a scale | Standard Deviation 5.074 |
p-value: 0.134t-test, 2 sided
Other Pre-specified
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Letter Sequencing)
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 presented in seconds with lower scores indicating better performance.
Time frame: 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.
Population: Note: Data was analyzed for 9 participants as 7 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Letter Sequencing) | Pre-treatment | 65.22 seconds | Standard Deviation 32.82 |
| Phase 2 - Sleep-SMART Treatment | Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Letter Sequencing) | Post-treatment | 46.44 seconds | Standard Deviation 15.75 |
p-value: 0.064t-test, 2 sided
Other Pre-specified
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number-letter Switching) Raw Score
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 and range from \<3 seconds to 240 seconds. Raw scores are presented in seconds with lower scores indicating better performance.
Time frame: 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.
Population: Note: Data was analyzed for 8 participants as 8 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number-letter Switching) Raw Score | Pre-treatment | 146.63 seconds | Standard Deviation 46.745 |
| Phase 2 - Sleep-SMART Treatment | Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number-letter Switching) Raw Score | Post-treatment | 140.13 seconds | Standard Deviation 54.038 |
p-value: 0.515t-test, 2 sided
Other Pre-specified
Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number Sequencing)
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 presented in seconds with lower scores indicating better performance.
Time frame: 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.
Population: Note: Data was analyzed for 9 participants as 7 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number Sequencing) | Pre-treatment | 53.11 seconds | Standard Deviation 17.43 |
| Phase 2 - Sleep-SMART Treatment | Delis-Kaplan Executive Function System (D-KEFS) Trail Making Test (Condition: Number Sequencing) | Post-treatment | 47.33 seconds | Standard Deviation 25.96 |
p-value: 0.38t-test, 2 sided
Other Pre-specified
Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (Category Switching)
Performance based measures of executive function (i.e., category switching total raw score). The task requires participants to alternate between generating words from two different semantic categories. Scores are based on the number of correct words generated. Total raw scores range from 0 to \>21, with higher scores indicating better performance.
Time frame: 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.
Population: Note: Data was analyzed for 12 participants as 4 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (Category Switching) | Pre-treatment | 12.25 words generated | Standard Deviation 2.417 |
| Phase 2 - Sleep-SMART Treatment | Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test (Category Switching) | Post-treatment | 11.75 words generated | Standard Deviation 1.712 |
p-value: 0.41t-test, 2 sided
Other Pre-specified
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. Each item is answered on a 1-4 point scale with a minimum total raw score of 39 and a maximum score of 156. Higher score are indicative of worse functioning.
Time frame: 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.
Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Everyday Cognition Scale (ECoG) | Post treatment | 83.71 score on a scale | Standard Deviation 30.19 |
| Phase 2 - Sleep-SMART Treatment | Everyday Cognition Scale (ECoG) | Pre Treatment | 89.86 score on a scale | Standard Deviation 34.576 |
p-value: 0.061t-test, 2 sided
Other Pre-specified
Hopkins Verbal Learning Test-Revised (Delayed Recall Raw Score)
Performance based measure of verbal list learning and memory (i.e., delayed recall raw score). Scores range from 0 to 12 with higher scores indicating better performance.
Time frame: 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.
Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Hopkins Verbal Learning Test-Revised (Delayed Recall Raw Score) | Pre-treatment | 6.93 words recalled | Standard Deviation 3.13 |
| Phase 2 - Sleep-SMART Treatment | Hopkins Verbal Learning Test-Revised (Delayed Recall Raw Score) | Post-treatment | 7.14 words recalled | Standard Deviation 2.69 |
p-value: 0.706t-test, 2 sided
Other Pre-specified
Hopkins Verbal Learning Test-Revised (Total Immediate Recall Raw Score)
Performance based measure of verbal list learning and memory (i.e., immediate recall raw score). Scores range from 0 to 36 with higher scores indicating better performance.
Time frame: 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.
Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Hopkins Verbal Learning Test-Revised (Total Immediate Recall Raw Score) | Pre-treatment | 22.00 words recalled | Standard Deviation 5.55 |
| Phase 2 - Sleep-SMART Treatment | Hopkins Verbal Learning Test-Revised (Total Immediate Recall Raw Score) | Post-treatment | 21.0 words recalled | Standard Deviation 2.37 |
p-value: 0.39t-test, 2 sided
Other Pre-specified
Insomnia Severity Index (ISI)
Self-report scale assessing perceived insomnia severity; scores range from 0-28 with higher scores indicating more severe insomnia.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Insomnia Severity Index (ISI) | End of treatment | 8.87 score on a scale | Standard Deviation 6.89 |
| Phase 2 - Sleep-SMART Treatment | Insomnia Severity Index (ISI) | Pre-treatment | 19.40 score on a scale | Standard Deviation 4.95 |
p-value: <0.001t-test, 2 sided
Other Pre-specified
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. The Global PSQI score ranges from 0 to 21 with higher scores indicating poorer sleep quality.
Time frame: 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.
Population: Note: Data was analyzed for 13 participants as 3 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Pittsburgh Sleep Quality Index (PSQI) | Pre-treatment | 11.69 score on a scale | Standard Deviation 5.1 |
| Phase 2 - Sleep-SMART Treatment | Pittsburgh Sleep Quality Index (PSQI) | Post-treatment | 8.85 score on a scale | Standard Deviation 3.16 |
p-value: 0.01t-test, 2 sided
Other Pre-specified
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. A higher Neuro-QoL score represents more of the concept being measured - higher scores indicate worse functioning for the cognition scale.
Time frame: 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.
Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Quality of Life in Neurological Disorders (Neuro-QOL) Cognition Scale | Pre treatment | 24.86 score on a scale | Standard Deviation 8.047 |
| Phase 2 - Sleep-SMART Treatment | Quality of Life in Neurological Disorders (Neuro-QOL) Cognition Scale | Post treatment | 26.57 score on a scale | Standard Deviation 5.734 |
p-value: 0.23t-test, 2 sided
Other Pre-specified
Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span (Total Raw Score)
Performance based measure of auditory attention; raw scores range from 0-48 with higher scores indicating better performance.
Time frame: 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.
Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span (Total Raw Score) | Pre-treatment | 22.79 score on a scale | Standard Deviation 6.841 |
| Phase 2 - Sleep-SMART Treatment | Wechsler Adult Intelligence Scale-IV (WAIS-IV) Digit Span (Total Raw Score) | Post-treatment | 22.21 score on a scale | Standard Deviation 6.739 |
p-value: 0.625t-test, 2 sided
Other Pre-specified
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.
Time frame: 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.
Population: Note: Data was analyzed for 14 participants as 2 of the 16 treatment completers from phase 2 did not complete the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 2 - Sleep-SMART Treatment | WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) | Post treatment | 63.79 score on a scale | Standard Deviation 16.192 |
| Phase 2 - Sleep-SMART Treatment | WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) | Pre treatment | 62.50 score on a scale | Standard Deviation 17.105 |
p-value: 0.503t-test, 2 sided