Cancer Survivor, Insomnia, Malignant Neoplasm
Conditions
Brief summary
This randomized phase III trial compares yoga, survivorship health education program, and cognitive behavioral therapy in reducing sleep disturbance (insomnia) in cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as the biological clock) to be disrupted and decrease quality of life. Yoga may improve circadian rhythms, physical and immune function, and improve insomnia and sleep quality in cancer survivors. It is not yet known whether yoga is more effective at treating insomnia than a health education program or cognitive behavioral therapy program.
Detailed description
PRIMARY OBJECTIVES: I. To determine if Yoga for Cancer Survivors (YOCAS) is effective for improving patient-reported insomnia (Insomnia Severity Index) compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) and a health education control immediately post intervention. SECONDARY OBJECTIVES: I. To examine if YOCAS is effective for improving objective symptoms of insomnia (sleep latency, sleep efficiency, wake after sleep onset, sleep duration, and daytime napping via actigraphy) and global sleep quality impairment (Pittsburgh Sleep Quality Index) compared to CBT-I and a health education control. II. To examine if YOCAS and CBT-I are effective for maintaining improvements in insomnia (Insomnia Severity Index) 3 and 6 months post intervention compared to a health education control. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks. ARM II: Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks. ARM III: Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, Cancer Survivorship Next Steps for Patients and Their Families. After completion of intervention, patients are followed up at 3 and 6 months.
Interventions
BEHAVIORALBehavioral Intervention
Undergo yoga intervention
OTHERCognitive Intervention
Undergo CBT-I intervention
OTHEREducational Intervention
Receive health education
OTHERLaboratory Biomarker Analysis
Correlative studies
DEVICEMonitoring Device
Correlative studies
OTHERQuality-of-Life Assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
University of Rochester NCORP Research Base
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a confirmed diagnosis of cancer * Have received surgery, chemotherapy, and/or radiation therapy * Have completed all surgery, chemotherapy and/or radiation therapy within the last 2-60 months * Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria for insomnia and score \>= 10 on the Insomnia Severity Index * Be able to read and understand English * Be able to provide written informed consent
Exclusion criteria
* Have contraindications to functional testing or yoga participation according to the treating physician * Have practiced yoga \>= 1 day a week within the 3 months prior to enrolling in the study * Be planning to start yoga on their own during the time they are enrolled in the study * Have a confirmed diagnosis of sleep apnea or restless leg syndrome * Be receiving any form of treatment for cancer with the exception of hormonal or biologic therapy * Have distant metastases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in the ISI Comparing YOCAS vs. CBT-I | Baseline up to post intervention (approximately 4 to 8 weeks) | The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. Means and 95% confidence intervals for YOCAS and CBT-I will be calculated and plotted and examined in comparison with the a priori specified non-inferiority margin of 1.15. |
| Mean Change in the ISI Comparing YOCAS vs. Health Education | Baseline up to post intervention (approximately 4 to 8 weeks) | The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education | Baseline up to post intervention (approximately 4 to 8 weeks) | The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. |
| Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I. | Baseline up to post intervention (approximately 4 to 8 weeks) | The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. |
| Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education | Baseline up to post intervention (approximately 4 to 8 weeks) | Actigraphy will measure the number of minutes of actual sleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. |
| Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I | Baseline up to post intervention (approximately 4 to 8 weeks) | Actigraphy will measure the number of minutes of actual sleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. |
| Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education | Baseline up to post intervention (approximately 4 to 8 weeks) | Actigraphy will measure total minutes of wake time after sleep onset. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. The transformation of the log base 10 of the original measurement was used for the analysis. |
| Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I | Baseline up to post intervention (approximately 4 to 8 weeks) | Actigraphy will measure total minutes of wake time after sleep onset. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. The transformation of log base 10 of the original measurement was used for the analysis. |
| Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education | Baseline up to post intervention (approximately 4 to 8 weeks) | Actigraphy will measure the percent of time actually slept compared to intended time sleeping. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. |
| Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I | Baseline up to post intervention (approximately 4 to 8 weeks) | Actigraphy will measure the percent of time actually slept compared to intended time sleeping. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. |
| Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education | Baseline up to post intervention (approximately 4 to 8 weeks) | Actigraphy will measure the minutes it takes for the participant to fall asleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. The transformation of log base 10 of the (measurement + 1) was used in the analysis. |
| Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I | Baseline up to post intervention (approximately 4 to 8 weeks) | Actigraphy will measure the minutes it takes for the participant to fall asleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. The transformation of the log base 10 of the (measure + 1) was used in the analysis. |
| Mean Change in the ISI Comparing YOCAS and Health Education (3 Month) | Baseline to 3 months | The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. |
| Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month) | Baseline to 3 months | The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. |
| Mean Change in the ISI Comparing YOCAS and Health Education (6 Month) | Baseline to 6 months | The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. |
| Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month) | Baseline to 6 months | The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. |
Countries
United States
Participant flow
Pre-assignment details
6 participants were registered but not eligible.
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Behavioral Intervention-yoga) Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks.
Behavioral Intervention: Undergo yoga intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies | 251 |
| Arm II (Cognitive Intervention-CBT-I) Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks.
Cognitive Intervention: Undergo CBT-I intervention
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies | 238 |
| Arm III (Educational Intervention) Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, Cancer Survivorship Next Steps for Patients and Their Families.
Educational Intervention: Receive health education
Laboratory Biomarker Analysis: Correlative studies
Monitoring Device: Correlative studies
Quality-of-Life Assessment: Ancillary studies | 251 |
| Total | 740 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Disliked Intervention | 0 | 3 | 3 |
| Overall Study | Disliked Study Procedure | 1 | 1 | 4 |
| Overall Study | Medical | 12 | 13 | 9 |
| Overall Study | Other | 19 | 29 | 17 |
| Overall Study | Too time consuming | 21 | 26 | 26 |
| Overall Study | Withdrawal by Subject | 13 | 18 | 17 |
Baseline characteristics
| Characteristic | Arm I (Behavioral Intervention-yoga) | Arm II (Cognitive Intervention-CBT-I) | Arm III (Educational Intervention) | Total |
|---|---|---|---|---|
| Age, Continuous | 55 years | 56 years | 57 years | 56 years |
| ISI at Baseline | 15.41 units on a scale STANDARD_DEVIATION 4.34 | 15.57 units on a scale STANDARD_DEVIATION 4.35 | 15.39 units on a scale STANDARD_DEVIATION 4.39 | 15.45 units on a scale STANDARD_DEVIATION 4.35 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 3 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 26 Participants | 28 Participants | 83 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) White | 213 Participants | 207 Participants | 214 Participants | 634 Participants |
| Region of Enrollment United States | 251 participants | 238 participants | 251 participants | 740 participants |
| Sex: Female, Male Female | 234 Participants | 216 Participants | 236 Participants | 686 Participants |
| Sex: Female, Male Male | 17 Participants | 22 Participants | 15 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 251 | 0 / 238 | 0 / 251 |
| other Total, other adverse events | 0 / 251 | 0 / 238 | 0 / 251 |
| serious Total, serious adverse events | 3 / 251 | 1 / 238 | 1 / 251 |
Outcome results
Primary
Mean Change in the ISI Comparing YOCAS vs. CBT-I
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. Means and 95% confidence intervals for YOCAS and CBT-I will be calculated and plotted and examined in comparison with the a priori specified non-inferiority margin of 1.15.
Time frame: Baseline up to post intervention (approximately 4 to 8 weeks)
Population: The overall number of participants analyzed is higher than the number of participants who completed the study because the timeframe for this outcome measure was from baseline up to post-intervention. Some participants withdrew after the post-intervention assessment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in the ISI Comparing YOCAS vs. CBT-I | -3.61 units on a scale |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in the ISI Comparing YOCAS vs. CBT-I | -7.22 units on a scale |
| Arm III (Educational Intervention) | Mean Change in the ISI Comparing YOCAS vs. CBT-I | -2.19 units on a scale |
Comparison: Constructed a 95% confidence interval on the mean change of ISI from baseline between the arms (YOCAS - CBT-I). If the lower bound of the interval is less than 1.5 then we conclude that YOCAS is non-inferior.p-value: <0.000195% CI: [2.66, 4.37]Mixed Models Analysis
Primary
Mean Change in the ISI Comparing YOCAS vs. Health Education
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Time frame: Baseline up to post intervention (approximately 4 to 8 weeks)
Population: The overall number of participants analyzed is higher than the number of participants who completed the study because the timeframe for this outcome measure was from baseline up to post-intervention. Some participants withdrew after the post-intervention assessment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in the ISI Comparing YOCAS vs. Health Education | -3.61 units on a scale |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in the ISI Comparing YOCAS vs. Health Education | -7.22 units on a scale |
| Arm III (Educational Intervention) | Mean Change in the ISI Comparing YOCAS vs. Health Education | -2.19 units on a scale |
Comparison: The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.p-value: 0.000995% CI: [-2.23, -0.58]Mixed Models Analysis
Secondary
Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I.
The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
Time frame: Baseline up to post intervention (approximately 4 to 8 weeks)
Population: The overall number of participants analyzed is higher than the number of participants who completed the study because the timeframe for this outcome measure was from baseline up to post-intervention. Some participants withdrew after the post-intervention assessment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I. | -1.59 units on a scale |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I. | -3.82 units on a scale |
| Arm III (Educational Intervention) | Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I. | -1.11 units on a scale |
Comparison: The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.p-value: <0.000195% CI: [1.7, 2.75]Mixed Models Analysis
Secondary
Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education
The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Time frame: Baseline up to post intervention (approximately 4 to 8 weeks)
Population: The overall number of participants analyzed is higher than the number of participants who completed the study because the timeframe for this outcome measure was from baseline up to post-intervention. Some participants withdrew after the post-intervention assessment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education | -1.59 units on a scale |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education | -3.82 units on a scale |
| Arm III (Educational Intervention) | Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education | -1.11 units on a scale |
Comparison: The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.p-value: 0.0795% CI: [-0.98, 0.04]Mixed Models Analysis
Secondary
Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I
Actigraphy will measure the number of minutes of actual sleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
Time frame: Baseline up to post intervention (approximately 4 to 8 weeks)
Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I | 395.99 minutes |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I | 380.06 minutes |
| Arm III (Educational Intervention) | Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I | 376.27 minutes |
p-value: 0.025895% CI: [1.93, 29.94]Mixed Models Analysis
Secondary
Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education
Actigraphy will measure the number of minutes of actual sleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Time frame: Baseline up to post intervention (approximately 4 to 8 weeks)
Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education | 395.99 minutes |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education | 380.06 minutes |
| Arm III (Educational Intervention) | Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education | 376.27 minutes |
Comparison: The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.p-value: 0.005295% CI: [5.91, 33.54]Mixed Models Analysis
Secondary
Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I
Actigraphy will measure the percent of time actually slept compared to intended time sleeping. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
Time frame: Baseline up to post intervention (approximately 4 to 8 weeks)
Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I | 81.65 percent of time |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I | 82.42 percent of time |
| Arm III (Educational Intervention) | Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I | 79.38 percent of time |
Comparison: The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.p-value: 0.4995% CI: [-2.97, 1.43]Mixed Models Analysis
Secondary
Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education
Actigraphy will measure the percent of time actually slept compared to intended time sleeping. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Time frame: Baseline up to post intervention (approximately 4 to 8 weeks)
Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education | 81.65 percent of time |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education | 82.42 percent of time |
| Arm III (Educational Intervention) | Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education | 79.38 percent of time |
Comparison: The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.p-value: 0.0495% CI: [0.09, 4.44]Mixed Models Analysis
Secondary
Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I
Actigraphy will measure the minutes it takes for the participant to fall asleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. The transformation of the log base 10 of the (measure + 1) was used in the analysis.
Time frame: Baseline up to post intervention (approximately 4 to 8 weeks)
Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I | 0.76 minutes |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I | 0.74 minutes |
| Arm III (Educational Intervention) | Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I | 0.80 minutes |
Comparison: The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.p-value: 0.795% CI: [-0.07, 0.11]Mixed Models Analysis
Secondary
Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education
Actigraphy will measure the minutes it takes for the participant to fall asleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. The transformation of log base 10 of the (measurement + 1) was used in the analysis.
Time frame: Baseline up to post intervention (approximately 4 to 8 weeks)
Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education | 0.76 minutes |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education | 0.74 minutes |
| Arm III (Educational Intervention) | Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education | 0.80 minutes |
Comparison: The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.p-value: 0.4395% CI: [-0.13, 0.05]Mixed Models Analysis
Secondary
Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I
Actigraphy will measure total minutes of wake time after sleep onset. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. The transformation of log base 10 of the original measurement was used for the analysis.
Time frame: Baseline up to post intervention (approximately 4 to 8 weeks)
Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I | 1.85 minutes |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I | 1.81 minutes |
| Arm III (Educational Intervention) | Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I | 1.86 minutes |
Comparison: The comparison of YOCAS to the CBT-I control is a traditional null hypothesis of no difference with a two-sided alpha.p-value: 0.0795% CI: [-0.004, 0.098]Mixed Models Analysis
Secondary
Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education
Actigraphy will measure total minutes of wake time after sleep onset. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. The transformation of the log base 10 of the original measurement was used for the analysis.
Time frame: Baseline up to post intervention (approximately 4 to 8 weeks)
Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to the actigraphy device malfunction or battery issue and participant non-compliance.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education | 1.85 minutes |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education | 1.81 minutes |
| Arm III (Educational Intervention) | Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education | 1.86 minutes |
p-value: 0.9295% CI: [-0.053, 0.048]Mixed Models Analysis
Secondary
Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month)
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
Time frame: Baseline to 3 months
Population: The overall number of participants analyzed in arms I \& II is higher than the number of participants who completed the study. This difference is due to some participants withdrew after this outcome measure was collected. The overall number of participants analyzed in arm III is lower than the number of participants who completed the study. This difference is due to participant non-compliance.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month) | -5.02 units on a scale |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month) | -7.59 units on a scale |
| Arm III (Educational Intervention) | Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month) | -3.56 units on a scale |
Comparison: The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.p-value: <0.000195% CI: [1.61, 3.81]Mixed Models Analysis
Secondary
Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month)
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.
Time frame: Baseline to 6 months
Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to participant non-compliance.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month) | -5.29 units on a scale |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month) | -7.93 units on a scale |
| Arm III (Educational Intervention) | Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month) | -3.91 units on a scale |
Comparison: The comparison of YOCAS to CBT-I is a traditional null hypothesis of no difference with a two-sided alpha.p-value: <0.000195% CI: [1.54, 4.02]Mixed Models Analysis
Secondary
Mean Change in the ISI Comparing YOCAS and Health Education (3 Month)
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Time frame: Baseline to 3 months
Population: The overall number of participants analyzed in arms I \& II is higher than the number of participants who completed the study. This difference is due to some participants withdrew after this outcome measure was collected. The overall number of participants analyzed in arm III is lower than the number of participants who completed the study. This difference is due to participant non-compliance.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in the ISI Comparing YOCAS and Health Education (3 Month) | -5.02 units on a scale |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in the ISI Comparing YOCAS and Health Education (3 Month) | -7.59 units on a scale |
| Arm III (Educational Intervention) | Mean Change in the ISI Comparing YOCAS and Health Education (3 Month) | -3.56 units on a scale |
Comparison: The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.p-value: 0.004195% CI: [-2.65, -0.5]Mixed Models Analysis
Secondary
Mean Change in the ISI Comparing YOCAS and Health Education (6 Month)
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.
Time frame: Baseline to 6 months
Population: The overall number of participants analyzed is lower than the number of participants who completed the study. This difference is due to participant non-compliance.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Arm I (Behavioral Intervention-yoga) | Mean Change in the ISI Comparing YOCAS and Health Education (6 Month) | -5.29 units on a scale |
| Arm II (Cognitive Intervention-CBT-I) | Mean Change in the ISI Comparing YOCAS and Health Education (6 Month) | -7.93 units on a scale |
| Arm III (Educational Intervention) | Mean Change in the ISI Comparing YOCAS and Health Education (6 Month) | -3.91 units on a scale |
Comparison: The comparison of YOCAS to the health education control is a traditional null hypothesis of no difference with a two-sided alpha.p-value: 0.010895% CI: [-2.78, -0.36]Mixed Models Analysis