Study of Telemedicine Stress Management and Lifestyle Group Intervention for HCV Patients

Study Overview
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Brief Summary
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A pilot feasibility study of a small randomized controlled trial (RCT) comparing a video-conferencing cognitive behavioral coping skills (VC-CBCS) group to standard of care (SC) for symptomatic patients previously diagnosed with chronic hepatitis C to evaluate feasibility, patient satisfaction and differences in symptoms, quality of life and liver markers.

Detailed Description
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This is a pilot feasibility study of a small randomized controlled trial (RCT) to evaluate a cognitive behavioral coping skills (CBCS) delivered via videoconferencing, referred to as the VC-CBCS compared to standard of care (SC). The study included a representative sample of 32 symptomatic patients who have/had chronic hepatitis C. Patients (n=32) were randomized in a 1:3 ratio to (1) standard of care (SC) or (2) to participate in 14, two hour VC-CBCS sessions. Four groups of patients were randomized and consisted of 7-9 patients each. The groups were as follows: Group 1: 7 patients with 5 randomized to VC-CBCS and 2 to SC; Group 2: 9 patients with 7 randomized to VC-CBCS and 2 to SC; Groups 3 and 4: 8 patients each with 6 randomized to VC-CBCS and 2 to SC each group. Each wave of VC-CBCS patients formed a group to join the Group Facilitator via a WebEx platform on a weekly basis using iPads from their homes. The telehealth intervention provided group-based education, skills and practices involving stress management, coping with symptoms, and support for healthy lifestyle changes. The researchers examined: (1) the feasibility of delivering a group intervention via telehealth technology remotely using iPads, (2) participant satisfaction with the intervention, and (3) whether differences are observed in several outcomes between the two conditions on quality of life, physical and mental symptoms, and liver markers. Participants completed patient-reported outcome (PRO) surveys at four time points during the study, with main outcomes being change from pre-intervention to post-intervention.

Official Title
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Pilot Feasibility Testing of a Small Randomized Controlled Trial to Evaluate a Telemedicine Stress Management and Lifestyle Group Intervention for Patients With Symptomatic Chronic Hepatitis C

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Behavioral: VC-CBCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 and older; Medically cleared by hepatology Patients who are currently or were previously diagnosed with chronic Hepatitis C Viral (HCV) infection; Evidence of ongoing symptoms, stress, or unhealthy lifestyle habits, defined as a score of greater than or equal to 4 on a scale 0(none) - 10 (severe) on two or more numeric rating scale questions (see Screening Form 1); Able to read and speak English. Exclusion Criteria: Decompensated liver disease (Childs Pugh C) judged by hepatologist or recorded in patient medical record; Life expectancy of <12 months estimated by hepatologist; Has had a liver transplant or is on the wait list for a transplant Severe alcohol or substance use disorder, psychiatric disorder or cognitive impairment that is likely to interfere with the ability to participate in telehealth groups and follow guidelines about group participation as judged by the Hepatology provider or research staff; Lack of private, quiet space in home in which to participate in VC-CBCS sessions Unwilling to have intervention sessions audio-recorded

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants (n=32) were assigned by 3:1 randomization to VC-CBCS or SC. Participants were recruited in 4 cohorts (Wave 1: n=7, Wave 2: n=9, Waves 3, 4: n=8 each). In Wave 1, 5 participants were randomized to VC-CBCS and 2 to SC. In Wave 2, 7 participants were randomized to VC-CBCS and 2 to SC. In Waves 3 and 4, 6 participants were randomized to VC-CBCS and 2 to SC.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VC-CBCS Intervention<br>The VC-CBCS intervention was delivered via WebEx videoconferencing technology and included 14, 2-hour long sessions that involved group-based psychoeducation, cognitive and behavioral skills training, stress management, relaxation practice and healthy lifestyle habits to support overall health and liver health. Intervention materials included a hard copy Patient Workbook and audio-recorded relaxation techniques. | Behavioral: VC-CBCS<br>* A 14-module stress management and lifestyle group-based intervention delivered via videoconferencing WebEx technology to participants who have/had chronic hepatitis C and experience symptoms, stress or lifestyle requirements to promote liver health.<br>|
| No Intervention: Standard of Care (SC)<br>Participants randomized to SC received no intervention and were followed by medical providers in clinic per clinical practice guidelines and clinicians discretion. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Consented Versus Approached | One feasibility measure was to evaluate the percentage of patients consented compared to those approached for participation in the study. | Six Months | 
| Percentage of Participants Consented Versus Randomized | One feasibility measure was to evaluate the percentage of participants randomized for the study compared to those consented. | Six Months | 
| Percentage of Standard of Care Condition Participants Retained vs Enrolled | Percentage of standard of care condition participants retained in the study compared to those enrolled. Retention is defined as participants who submitted PRO assessments up through T4 (end of study). | Six Months | 
| Percentage of VC-CBCS Intervention Condition Participants Retained vs Enrolled | Percentage of VC-CBCS Intervention participants retained in the study compared to those enrolled. Retention is defined as participants who completed at least 3 intervention sessions. | Six Months | 
| Percentage of Surveys Completed by Participants Who Completed the Study | Percentage of surveys over time completed by participants who completed the study. Surveys included 12 patient-reported primary and secondary outcome measures. Completion was defined as submission of each of the 12 surveys at Time 1 (T1) through Time 4 (T4). | Baseline (T1) to Week 14 (T4) | 
| Global Health Status Physical Health Mean T-Score | The Patient Reported Outcome Measurement Information System (PROMIS) Global Health Status measure is a 10-item short form that was used to measure an individual's physical, mental, and social health. Item responses range from 5 = None to 1 = Very Severe. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 16.2 to 67.7. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation better (more healthy) than the general population. | Baseline (T1), Week 14 (T4) | 
| Global Health Status Mental Health Mean T-Score | The PROMIS Global Health Status measure is a 10-item short form that was used to measure an individual's physical, mental, and social health. Item responses range from 5 = None to 1 = Very Severe. The adult PROMIS Global Health measure produces two scores: Physical Health and Mental Health. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 21.2 to 67.7. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation better (more healthy) than the general population. | Baseline (T1), Week 14 (T4) | 
| Depression Mean T-score | The PROMIS Depression measure is an 8-item short form that was used to measure patient-reported depression. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 41.0 to 79.4. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more (more Depression) than the general population. | Baseline (T1), Week 14 (T4) | 
| Anger Mean T-score | The PROMIS Anger measure is a 5-item short form that was used to measure patient-reported anger. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 32.9 to 82.9. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Anger and T-score=40 is 1 standard deviation less Anger than the general population. | Baseline (T1), Week 14 (T4) | 
| Anxiety Mean T-score | The PROMIS Anxiety measure is a 4-item short form that was used to measure patient-reported anxiety. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 40.3 to 81.6. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Anxiety and T-score=40 is 1 standard deviation less Anxiety than the general population. The Anxiety T-score can range from 40.3 - 81.6. | Baseline (T1), Week 14 (T4) | 
| Fatigue Mean T-score | The PROMIS Fatigue measure is a 7-item short form that was used to measure patient-reported fatigue. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 29.4 to 83.2. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Fatigue and T-score=40 is 1 standard deviation less Fatigue than the general population. | Baseline (T1), Week 14 (T4) | 
| Sleep Disturbance Mean T-score | The PROMIS Sleep Disturbance measure is an 8-item short form that was used to measure patient-reported sleep disturbance. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 32.0 to 73.3. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Sleep Disturbance and T-score=40 is 1 standard deviation less Sleep Disturbance than the general population. | Baseline (T1), Week 14 (T4) | 
| Pain Interference Mean T-score | The PROMIS Pain Interference measure is an 8-item short form that was used to measure patient-reported pain interference. Item responses range from 1 = Never to 5 = Always. The raw scores are converted into a T-score. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. The minimum and maximum T-scores ranged from 41.6 to 75.6. Higher T- scores indicate more of that construct, for example, a T-score=60 is 1 standard deviation more Pain Interference and T-score=40 is 1 standard deviation less Pain Interference than the general population. | Baseline (T1), Week 14 (T4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Mean Score | The Perceived Stress Scale (PSS) is a widely used survey to measure stress perception. The scale includes 10 items, rated using a 5-point scale, from 0 (never) to 4 (very often) where patients report the frequency of stress symptoms in the past month. Items are summed with a minimum and maximum ranging from 0 to 40. Higher PSS scores reflect higher subjective stress. | Baseline (T1), Week 14 (T4) | 
| Coping Skills Confidence Mean Score | The Measure of Current Status (MOCS)-Part A measured participant confidence in performing multiple skills including stress awareness, relaxation, assertiveness, and coping skills. The scale contains 13 items rated on a scale from 0 = I cannot do this at all to 4 = I can do this extremely well. A Total Coping Skills score is created by taking the average of the 13 items. The Total Coping Skill score can range from a minimum of 0 to a maximum of 4. | Baseline (T1), Week 14 (T4) | 
| Participant Satisfaction With VC-CBCS Intervention Mean Score | After each VC-CBCS intervention session, participants completed a 14-item acceptability/satisfaction survey about their impressions with the current intervention session. Items are scored on a scale from 1= not at all to 5=extremely useful. Data across all VC-CBCS participants and all intervention sessions were averaged into a Total Patient Satisfaction score that could range from a minimum of 1 to a maximum of 5 with higher scores indicating greater satisfaction. | Baseline (T1) to Week 14 (T4) | 
| Aspartate Aminotransferase (AST) Mean Score for Females | Liver enzyme level (AST U/L). Reference range for females is 14-38 U/L. Numbers higher than these reference ranges are considered in the abnormal range and can suggest liver damage or inflammation. These comparisons were only made for participants who had already achieved viral cure at baseline and who were not on medical treatment for chronic hepatitis C at baseline. | Baseline (T1), Week 14 (T4) | 
| Aspartate Aminotransferase (AST) Mean Score for Males | Liver enzyme level (AST U/L). Reference range for males is 19-55 U/L. Numbers higher than these reference ranges are considered in the abnormal range and can suggest liver damage or inflammation. These comparisons were only made for participants who had already achieved viral cure at baseline and who were not on Hepatitis C Virus (HCV) treatment at baseline. | Baseline (T1), Week 14 (T4) | 
| Alanine Aminotransferase (ALT) Mean Score for Females | Liver enzyme level (ALT U/L). Reference range for females is <35 U/L. Numbers higher than these reference ranges are considered in the abnormal range and can suggest liver damage or inflammation. These comparisons were only made for participants who had already achieved viral cure at baseline and who were not on HCV treatment at baseline. | Baseline (T1), Week 14 (T4) | 
| Alanine Aminotransferase (ALT) Mean Score for Males | Liver enzyme level (ALT U/L). Reference range for males is <50 U/L. Numbers higher than these reference ranges are considered in the abnormal range and can suggest liver damage or inflammation. These comparisons were only made for participants who had already achieved viral cure at baseline and who were not on HCV treatment at baseline. | Baseline (T1), Week 14 (T4) | 
| Pittsburgh Sleep Quality Index (PSQI) Sleep Quality Mean Score | Item 9 from the Pittsburgh Sleep Quality Index (PSQI) was used to measure sleep quality. All participants completed this measure at PRO time points T1 and T4 that covered 30 days prior to assessment. During the past month, how would you rate your sleep quality overall? The response set ranged from a minimum of 0 (Very Good) to a maximum of 3 (Very Bad). Higher scores indicated worse sleep quality. | Baseline (T1), Week 14 (T4) | 
| Percentage of Overall Medication Adherence | Medication Adherence Visual Analog Scales (VAS) was used to evaluate medication adherence for up to five daily medications for multiple comorbidities in the past 7 days in participants who were prescribed medications at baseline. Participants reported the average adherence over the course of 7 days for each medication on a scale from 0% to 100% adherence for each medication. The average percent adherence was created for all medications for each patient and could range from 0% to 100%. Overall medication adherence adherence was assessed at T1 and T4. | Baseline (T1), Week 14 (T4) | 
| Alcohol Total Mean Score | Three items from the Substance Abuse and Mental Illness Symptoms Screener (SAMISS) Survey was administered at baseline (T1) and Week 14 (T4) to evaluate self-reported alcohol use in all participants. The three items evaluated frequency, amount of alcohol consumption, and binge drinking. Individual scores could range from 0 to 4, with higher scores indicating higher consumption. | Baseline (T1), Week 14 (T4) | 
| Percentage of Participants Who Improved Fruit Consumption by One or More Categories | Behavioral Risk Factor Surveillance System (BRFSS) items assessed fruit intake as a health behavior - Over the past 12 months, how often did you eat fruits? Original 8-point response scale ranged from 1 time per month to 2 or more times/day. Recoded 8 categories into 4 categories, ranging from Daily consumption to Less than weekly. The percentage shown is the number of participants who improved by 1 or more categories based on the 4 category levels from T1 to T4. | Baseline (T1) to Week 14 (T4) | 
| Percentage of Participants Who Improved Vegetable Consumption by One or More Categories | Behavioral Risk Factor Surveillance System (BRFSS) items measured vegetable intake as a health behavior - Over the past 12 months, how often did you eat vegetables? Original 8-point response scale ranged from 1 time per month to 2 or more times/day. Recoded 8 categories into 4 categories, ranging from Daily consumption to Less than weekly. The percentage is the number of participants who improved by 1 or more categories on the 4 category levels from T1 to T4. | Baseline (T1) to Week 14 (T4) | 
| Percentage of Participants Who Complete Moderate Activity for at Least 10 Minutes at a Time | Behavioral Risk Factor Surveillance System (BRFSS) items measured moderate activity as a health behavior in all participants at T1 (baseline) and T4 (week 14) and will cover 30 days prior to assessment. BRFSS item asks Do you do moderate activity for at least 10 minutes at a time? Response options: Yes/No. Percentage is participants who indicate Yes to doing moderate activity for at least 10 minutes at a time | Baseline (T1), Week 14 (T4) | 
| Mean Number of Minutes of Moderate Activity Per Week | Behavioral Risk Factor Surveillance System (BRFSS) items measured moderate activity as a health behavior by combining two BRFSS items: If yes, how many days per week do you do these moderate activities for at least 10 minutes at a time and If yes, how much total time per day do you spend doing these activities? Total number of minutes of moderate activity per week calculated as number of days x number of minutes. | Baseline (T1) , Week 14 (T4) | 
| Percentage of Participants Who Complete Vigorous Activity for at Least 10 Minutes at a Time | Behavioral Risk Factor Surveillance System (BRFSS) items measured vigorous activity as a health behavior - BRFSS Item Do you do vigorous activity for at least 10 minutes at a time? Response option: Yes/No. Percentage is participants who indicate Yes to doing vigorous activity for at least 10 minutes at a time | Baseline (T1), Week 14 (T4) | 
| Mean Number of Minutes of Vigorous Activity Per Week | Behavioral Risk Factor Surveillance System (BRFSS) items measured vigorous activity as a health behavior by combining two BRFSS items: If yes, How many days per week do you do these vigorous activities for at least 10 minutes at a time and If yes, how much total time per day do you spend doing these activities? Total number of minutes of vigorous activity per week calculated as number of days x number of minutes. | Baseline (T1), Week 14 (T4) | 
| Mean Time Spent Sitting on the Weekdays | Behavioral Risk Factor Surveillance System (BRFSS) items measured sedentarism as a health behavior - BRFSS item What is the total number of hours you spend siting on a weekday? The mean can range from a minimum of 0 to maximum of 24 hours. Average numbers of hours spent sitting on the weekday was assessed at T1 to T4. | Baseline (T1), Week 14 (T4) | 
| Mean Time Spent Sitting on the Weekends | Behavioral Risk Factor Surveillance System (BRFSS) items measured sedentarism as a health behavior - BRFSS Item What is the total number of hours you spend sitting on a weekend day? Mean ranges from a minimum of 0 to maximum of 24 hours. Average numbers of hours spent sitting on the weekends assessed at T1 and T4. | Baseline (T1), Week 14 (T4) | 
| Percentage of Participants Who Reduced Regular Soda Intake by One or More Categories | Behavioral Risk Factor Surveillance System (BRFSS) items measured soda intake as a health behavior - BRFSS item During the past 30 days, how often did you drink regular soda or pop that contains sugar? Do not include diet soda or diet pop. Original 9-point response scale ranged from Never to 6 more more per day. Recoded 9 categories into 5 categories, ranging from Never to Daily. The percentage is the number of participants who improved (consumed less) by 1 or more categories on the 5 category levels from T1 to T4. | Baseline (T1) to Week 14 (T4) | 
| Percentage of Participants Who Reduced Diet Soda Intake by One or More Categories | Behavioral Risk Factor Surveillance System (BRFSS) items measured diet soda intake as a health behavior - BRFSS item During the past 30 days, how often did you drink diet soda or diet pop that contains an artificial sweeter? Original 9-point response scale ranged from Never to 6 or more per day. Recoded 9 categories into 5, ranging from Never to Daily. The percentage is the number of patients who improved (consumed less) by 1 or more categories on the 5 recoded category level from T1 to T4. | Baseline (T1) to Week 14 (T4) | 
| Percentage of Participants Who Reduced Fruit Juice Intake by One or More Categories | Behavioral Risk Factor Surveillance System (BRFSS) items measured fruit juice intake as a health behavior - BRFSS item During the past month, how many times per day, week or month did you drink 100% pure fruit juices? Original 9-point response scale ranged from Never to 6 or more per day. Recoded 9 categories into 5, ranging from Never to Daily. The percentage is the number of participants who improved (consumed less) by 1 or more categories on the 5 recoded category levels from T1 to T4. | Baseline (T1) to Week 14 (T4) | 
| Percentage of Participants Who Reduced Meals From Fast Food Restaurants by One or More Categories | Behavioral Risk Factor Surveillance System (BRFSS) items measured fast food intake as a health behavior - BRFSS item In a typical week, how many of your own meals come from fast food restaurants? Original 9-point response scale ranged from Never to 6 or more per day. Recoded 9 categories into 5, ranging from Never to Daily. The percentage is the number of participants who improved (reduced) by 1 or more categories on the 5 recoded category levels from T1 to T4. | Baseline (T1) to Week 14 (T4) | 
| Percentage of Participants Who Increased Dinners Prepared at Home by 1 or More Days | Behavioral Risk Factor Surveillance System (BRFSS) items measured food prepared at home as a health behavior - BRFSS item On how many days per week do you usually eat a dinner that is prepared at home? 7-point response scale ranged from 0 to 7 days. The percentage is the number of patients who improved (increased) by 1 or more days from T1 to T4. | Baseline (T1) to Week 14 (T4) | 
| Change in Weight (Lbs) | Change in weight (lbs) among those who had pre-intervention BMI > 24.9 (obese and above) from T1 to T4. | Baseline (T1) to Week 14 (T4) | 
| Change in Percent Weight Change | Change in percent weight (lbs) among those who had pre-intervention BMI > 24.9 (obese and above) from T1 to T4. | Baseline (T1) to Week 14 (T4) | 
| Change in Body Mass Index (BMI) | Change in Body Mass Index (BMI) among those who had pre-intervention BMI > 24.9 (obese and above) from T1 to T4. | Baseline (T1) to Week 14 (T4) | 
| Prescription Drug Misuse Total Mean Score | Surveys administered at baseline (T1) and Week 14 (T4) evaluated self-reported prescription drug misuse in all participants. One item from the Substance Abuse and Mental Illness Symptoms Screener (SAMISS) Survey evaluated misuse of prescription drugs in the last year. The response options ranged from a minimum of 0=Never to a maximum of 4=Daily/Almost Daily. Higher scores indicate higher consumption. | Baseline (T1), Week 14 (T4) | 
| Non-prescription Street Drug Use Total Mean Score | Surveys administered at baseline (T1) and Week 14 (T4) evaluated self-reported non-prescription street drug use in all participants. One item from the Substance Abuse and Mental Illness Symptoms Screener (SAMISS) Survey evaluated non-prescription street drug use in the last year. The response options ranged from a minimum of 0=Never to a maximum of 4=Daily/Almost Daily. Higher scores indicate higher consumption. | Baseline (T1), Week 14 (T4) | 
| Pittsburgh Sleep Quality Index (PSQI) Sleep Efficiency Composite Mean Score | Items 1, 3 and 4 from the Pittsburgh Sleep Quality Index (PSQI) were used to create a Sleep Efficiency composite score. All participants completed this measure at T1 and T4 that covered 30 days prior to assessment. The sleep efficiency score = (# hours slept/# hours in bed) X 100% .The sleep efficiency composite score ranged from: 0 = >85% efficiency, 1 = 75-84% efficiency, 2= 65-74% efficiency, and 3= <65%. Lower scores indicate better sleep efficiency. | Baseline (T1), Week 14 (T4) | 
| Healthy Sleep Behaviors Mean Score | One item In the last month, how often did you engage in healthy sleep behaviors before bedtime? evaluated healthy sleep behaviors. All participants completed this measure at T1 and T4. The response set ranged from 0 (not at all) to 4 (almost every night). Higher scores indicated better sleep behaviors. | Baseline (T1), Week 14 (T4) |