End Stage Renal Disease, Insomnia
Conditions
Keywords
Hemodialysis, Kidney disease, Trazodone, Cognitive behavioral therapy
Brief summary
Insomnia is a common and distressing symptom for patients on hemodialysis (HD), and there is evidence for a much larger impact on the health of patients. Chronic insomnia is disrupted sleep that occurs at least three nights per week and lasts at least three months. The SLEEP-HD study is a randomized open-label clinical trial to compare two types of treatment for insomnia in participants who have end-stage renal disease on HD, and who have been diagnosed with chronic insomnia. The two types of treatment involved in the study are Cognitive Behavioral Therapy for Insomnia (CBT-I) or treatment with a drug (trazodone vs placebo). 126 participants will be enrolled who are undergoing HD in two study locations (Seattle, Washington and Albuquerque, New Mexico).
Detailed description
Most HD patients have significant impairments in quality of life, largely from the high frequency of disabling symptoms. Insomnia is one of the most frequently reported symptoms and studies of HD patients and/or other populations suggest that it is a significant contributor to other common symptoms and poor health outcomes. There are unique contributors to chronic insomnia in HD patients and these include the biologic effects of residual uremia after partial correction as is achieved with current dialysis technology, maladaptation to treatment schedules, and patients' napping during treatments. There is a compelling need to identify effective treatments for insomnia in HD patients and the interventions being studied in this clinical trial, telehealth cognitive behavioral therapy for insomnia (CBT-I) and trazodone, have a strong scientific premise. If telehealth (web-based) CBT-I is effective for insomnia in HD patients, it will make a treatment that is presently inaccessible available to patients. Trazodone is widely used but the data on efficacy for insomnia are limited; no such data exist for HD patients. SLEEP-HD is a parallel group randomized controlled trial wherein 125 HD patients with chronic insomnia, treated in community-based dialysis facilities in Seattle and Albuquerque, will be randomized 1:1:1 over 31 months to 6-week treatment with telehealth CBT-I, trazodone, or medication placebo.
Interventions
BEHAVIORALCognitive Behavioral Therapy for Insomnia
Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
DRUGTrazodone
trazodone tablet
DRUGPlacebo
Inactive pill manufactured to mimic trazodone tablets.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The investigator, the participant, and the care provider will be blinded to the drug assignment (trazodone vs. placebo) for those subjects randomized into the medication intervention arm.
Intervention model description
SLEEP-HD is a parallel group randomized controlled trial wherein 125 HD patients with chronic insomnia, treated in community-based dialysis facilities in Seattle and Albuquerque, will be randomized 1:1:1 over 31 months to 6-week treatment with telehealth CBT-I, trazodone, or medication placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing thrice-weekly maintenance hemodialysis for ≥ 3 months * Able to speak English * ISI score ≥ 10 at pre-screening with sleep disturbances for ≥ 3 nights per week for ≥ 3 months
Exclusion criteria
* Severe cognitive impairment on Mini-COG cognitive test (score \< 3) * Severe depression assessed by Patient Health Questionnaire (PHQ)-2 and if appropriate, PHQ-9 * Suicidal Ideation * Alcohol abuse on CAGE alcohol assessment questionnaire (score ≥ 2) or substance abuse on Drug Abuse Screening Test (DAST)-10 questionnaire (score \> 5) * Severe restless leg syndrome * Treatment with trazodone in the past one month * Known allergy to trazodone (self-report or by chart review) * Current treatment with monoamine oxidase inhibitors or in the preceding 14 days * Current treatment with linezolid (self-report or by chart review) * Current treatment with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), antipsychotic medications (ziprasidone, chlorpromazine, thioridazine), and quinolone antibiotics * Pregnancy, or lactation, or women of childbearing potential not willing to use adequate birth control * Life Expectancy \< 3 months * Expected to receive a kidney transplant or transition to home dialysis (peritoneal dialysis or home hemodialysis) within 6 months * Any other condition that, in the opinion of the investigator, should preclude patient participation in the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) Short-term | Week 7 | summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 7 describing the short-term effect of the intervention |
| Insomnia Severity Index (ISI) Long-term | Week 25 | summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 25 describing the long-term effect of the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term | Week 7 | Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 7 describing the short-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term | Week 25 | Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 25 describing the long-term effect of the intervention |
| Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term | Week 7 | Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 7 describing the short-term effect of the intervention |
| Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term | Week 25 | Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 25 describing the long-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term | Week 7 | Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 7 describing the short-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term | Week 25 | Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 25 describing the long-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term | Week 7 | Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 7 describing the short-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term | Week 25 | Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 25 describing the long-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term | Week 7 | Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 7 describing the short-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term | Week 25 | Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 25 describing the long-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term | Week 7 | Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 7 describing the short-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term | Week 25 | Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 25 describing the long-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term | Week 7 | Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term | Week 25 | Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term | Week 7 | Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term | Week 25 | Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention |
| Cumulative Weekly Use of Sedatives/Hypnotics - Short-term | Week 7 | This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 7 describing the short-term effect of the intervention |
| Cumulative Weekly Use of Sedatives/Hypnotics - Long-term | Week 25 | This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 25 describing the long-term effect of the intervention |
| Objective Measure of Sleep - Short-term | Week 7 | Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 7 describing the short-term effect of the intervention |
| Objective Measure of Sleep - Long-term | Week 25 | Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 25 describing the long-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term | Week 7 | Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 7 describing the short-term effect of the intervention |
| Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term | Week 25 | Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 25 describing the long-term effect of the intervention |
Countries
United States
Participant flow
Recruitment details
923 patients screened with Insomnia Severity Index (ISI). Of 411 identified as having insomnia (ISI score \>=10),179 declined study participation and 106 met exclusion criteria.
Pre-assignment details
126 participants completed baseline measures before group assignment, including patient reported outcomes collected via Computer Assisted Telephone Interview (CATI) and nights using sleep aid on sedatives&hypnotics CRF. Most (115) also completed baseline Actigraphy, although this was not required for study entry (randomization).
Participants by arm
| Arm | Count |
|---|---|
| CBT-I Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks.
Cognitive Behavioral Therapy for Insomnia: Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform. | 43 |
| Medication- Trazodone Trazodone (50-100 mg):
Trazodone: trazodone tablet | 42 |
| Medication- Placebo Placebo (for trazodone)
Placebo: Inactive pill manufactured to mimic trazodone tablets. | 41 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 3 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 0 | 0 |
Baseline characteristics
| Characteristic | CBT-I | Total | Medication- Placebo | Medication- Trazodone |
|---|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 15.2 | 58.1 years STANDARD_DEVIATION 13.9 | 57.2 years STANDARD_DEVIATION 12.7 | 56.2 years STANDARD_DEVIATION 13.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 26 Participants | 8 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 100 Participants | 33 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 7 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 8 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 27 Participants | 9 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 4 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 28 Participants | 78 Participants | 23 Participants | 27 Participants |
| Sex: Female, Male Female | 22 Participants | 63 Participants | 19 Participants | 22 Participants |
| Sex: Female, Male Male | 21 Participants | 63 Participants | 22 Participants | 20 Participants |
| Time since starting dialysis, months | 26.4 months | 30.9 months | 28.2 months | 36.3 months |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 43 | 3 / 42 | 3 / 41 |
| other Total, other adverse events | 14 / 43 | 20 / 42 | 14 / 41 |
| serious Total, serious adverse events | 10 / 43 | 16 / 42 | 15 / 41 |
Outcome results
Primary
Insomnia Severity Index (ISI) Long-term
summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 25 describing the long-term effect of the intervention
Time frame: Week 25
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Insomnia Severity Index (ISI) Long-term | 11.34 score on a scale |
| Medication- Trazodone | Insomnia Severity Index (ISI) Long-term | 12.2 score on a scale |
| Medication- Placebo | Insomnia Severity Index (ISI) Long-term | 11.85 score on a scale |
Comparison: Null hypothesis: average CBT-I=Trazodone=Placebo at week 25p-value: 0.8375Mixed Models Analysis
Primary
Insomnia Severity Index (ISI) Short-term
summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 7 describing the short-term effect of the intervention
Time frame: Week 7
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Insomnia Severity Index (ISI) Short-term | 12.47 score on a scale |
| Medication- Trazodone | Insomnia Severity Index (ISI) Short-term | 11.97 score on a scale |
| Medication- Placebo | Insomnia Severity Index (ISI) Short-term | 13.05 score on a scale |
Comparison: Null hypothesis: average CBT-I=Trazodone=Placebo at week 7p-value: 0.6761Mixed Models Analysis
Secondary
Cumulative Weekly Use of Sedatives/Hypnotics - Long-term
This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 25 describing the long-term effect of the intervention
Time frame: Week 25
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CBT-I | Cumulative Weekly Use of Sedatives/Hypnotics - Long-term | 1.58 days |
| Medication- Trazodone | Cumulative Weekly Use of Sedatives/Hypnotics - Long-term | 2.62 days |
| Medication- Placebo | Cumulative Weekly Use of Sedatives/Hypnotics - Long-term | 2.42 days |
Secondary
Cumulative Weekly Use of Sedatives/Hypnotics - Short-term
This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 7 describing the short-term effect of the intervention
Time frame: Week 7
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CBT-I | Cumulative Weekly Use of Sedatives/Hypnotics - Short-term | 1.65 days |
| Medication- Trazodone | Cumulative Weekly Use of Sedatives/Hypnotics - Short-term | 1.29 days |
| Medication- Placebo | Cumulative Weekly Use of Sedatives/Hypnotics - Short-term | 1.01 days |
Secondary
Objective Measure of Sleep - Long-term
Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 25 describing the long-term effect of the intervention
Time frame: Week 25
Population: N=119 participants had at least one time point (week 0, week 7, or week 25) with actigraphy data and were included in model to estimate means at week 7 and week 25. Seven had no actigraphy collected: 4 declined to wear the watch; 3 had data that could not be scored due to inconsistent use.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Objective Measure of Sleep - Long-term | 68.99 percentage of time in bed asleep |
| Medication- Trazodone | Objective Measure of Sleep - Long-term | 71.6 percentage of time in bed asleep |
| Medication- Placebo | Objective Measure of Sleep - Long-term | 71.57 percentage of time in bed asleep |
Secondary
Objective Measure of Sleep - Short-term
Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 7 describing the short-term effect of the intervention
Time frame: Week 7
Population: N=119 participants had at least one time point (week 0, week 7, and/or week 25) with actigraphy data and were included in model to estimate means at week 7 and week 25. Seven had no actigraphy collected: 4 declined to wear the watch; 3 had data that could not be scored due to inconsistent use.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Objective Measure of Sleep - Short-term | 68.03 percentage of time in bed asleep |
| Medication- Trazodone | Objective Measure of Sleep - Short-term | 70.94 percentage of time in bed asleep |
| Medication- Placebo | Objective Measure of Sleep - Short-term | 70.87 percentage of time in bed asleep |
Secondary
Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term
Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 25 describing the long-term effect of the intervention
Time frame: Week 25
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term | 7.27 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term | 8.12 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term | 7.94 score on a scale |
Secondary
Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term
Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 7 describing the short-term effect of the intervention
Time frame: Week 7
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term | 7.67 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term | 8.46 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term | 7.5 score on a scale |
Secondary
Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term
Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 25 describing the long-term effect of the intervention
Time frame: Week 25
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term | 32.65 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term | 28.53 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term | 30.7 score on a scale |
Secondary
Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term
Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 7 describing the short-term effect of the intervention
Time frame: Week 7
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term | 32.55 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term | 28.76 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term | 28.5 score on a scale |
Secondary
Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term
Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 25 describing the long-term effect of the intervention
Time frame: Week 25
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term | 5.27 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term | 6.35 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term | 6.29 score on a scale |
Secondary
Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term
Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 7 describing the short-term effect of the intervention
Time frame: Week 7
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term | 5.18 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term | 6.18 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term | 7.04 score on a scale |
Secondary
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term
Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 25 describing the long-term effect of the intervention
Time frame: Week 25
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term | 3.88 units on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term | 3.71 units on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term | 4.30 units on a scale |
Secondary
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term
Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 7 describing the short-term effect of the intervention
Time frame: Week 7
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term | 4.18 units on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term | 4.07 units on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term | 3.61 units on a scale |
Secondary
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term
Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 25 describing the long-term effect of the intervention
Time frame: Week 25
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term | 4.14 units on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term | 4.32 units on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term | 4.80 units on a scale |
Secondary
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term
Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 7 describing the short-term effect of the intervention
Time frame: Week 7
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term | 4.50 units on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term | 4.53 units on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term | 4.21 units on a scale |
Secondary
Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term
Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 25 describing the long-term effect of the intervention
Time frame: Week 25
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term | 6.61 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term | 8.04 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term | 7.34 score on a scale |
Secondary
Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term
Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 7 describing the short-term effect of the intervention
Time frame: Week 7
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term | 6.98 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term | 7.93 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term | 8.27 score on a scale |
Secondary
Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term
Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 25 describing the long-term effect of the intervention
Time frame: Week 25
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term | 9.15 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term | 10.49 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term | 9.95 score on a scale |
Secondary
Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term
Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 7 describing the short-term effect of the intervention
Time frame: Week 7
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term | 9.44 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term | 11.09 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term | 12.39 score on a scale |
Secondary
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term
Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention
Time frame: Week 25
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term | 50.44 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term | 49.23 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term | 51.38 score on a scale |
Secondary
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term
Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention
Time frame: Week 7
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term | 49.53 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term | 47.77 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term | 48.29 score on a scale |
Secondary
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term
Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention
Time frame: Week 25
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term | 33.21 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term | 32.07 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term | 31.85 score on a scale |
Secondary
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term
Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention
Time frame: Week 7
Population: The model used to estimate means at week 7 and week 25 included all time points (weeks 0, 4, 7, 13, 25). All N=126 participants had the outcome on at least one time point. Thus the model included all participants, even those missing outcome at week 7 or week 25.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| CBT-I | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term | 31.87 score on a scale |
| Medication- Trazodone | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term | 32.37 score on a scale |
| Medication- Placebo | Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term | 32.80 score on a scale |