Chronic Low-back Pain, Chronic Pain
Conditions
Keywords
Low-back Pain, Hypnosis, Chronic Pain, Digital Health
Brief summary
This ClinicalTrials.gov posting contains two randomized controlled trials. The study procedures were identical, except Study 1 was funded by NIH and enrolled adults with chronic low back pain, whereas Study 2 was funded by the UW Department of Rehabilitation Medicine and enrolled adults with any type of chronic pain. Study 1 and 2 each enrolled 50 adults (N = 100 total across the two studies). Although Study 2 did not use NIH funds, we are including the results here because the studies were conducted simultaneously by the same PI (Dr. Jensen) with the same study procedures. Participants enrolled in the studies for a duration of 8 weeks. The studies test the feasibility and efficacy of a therapeutic hypnosis digital application (website), called Rose. The investigators wanted to determine if the Rose application was user-friendly and effective at improving quality of life and reducing pain for adults with chronic pain. If successfuly, the investigators hope to develop the Rose application into a mobile app that will be publicly available and managed by HypnoScientific Inc., a company that is co-owned by the investigators. Participants completed brief (15-20min) self-report surveys that ask about pain and mental health at three timepoints: Baseline (week 0), 4 weeks, and 8 weeks.
Detailed description
Pain is a major public health problem that affects over 100 million adults in the United States. While pain can have profound negative impacts, current treatment remains inadequate. A focus on opioid treatments has led to over-prescription, harmful side effects, and the overuse crisis. To address this problem, the study investigators, and others, have developed and adapted hypnosis to empower individuals to self-manage pain. Findings from the investigators' research supports hypnosis as an effective non-pharmacological technique. However, a significant limitation of hypnosis treatment is access, given that hypnosis treatment is provided by a very limited number of clinicians with training in its use, as well as the significant costs of in-person treatment. The main goal of this study is to pilot test the efficacy of hypnosis content for pain management as provided via recordings in the Rose web application.
Interventions
BEHAVIORALHypnosis audio recordings
A web application (Rose) that contains hypnosis audio recordings created by the investigators.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study 1 and 2 are both 2-arm randomized controlled trials in which individuals are randomly assigned to a treatment group (8 weeks of access to hypnosis recordings) or a waitlist group (4 weeks of no access followed by 4 weeks of access to hypnosis recording access).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(self-report online and telephone screening by study staff): * 18 years old or older * Chronic Pain or Chronic Low Back Pain (i.e., pain in the low back that has been an ongoing problem for 3 months or more for at least half the days, as disclosed during self-report screening. The pain can be a primary condition or secondary to another health condition. * Average pain intensity in the past week ≥ 4 on a 0-10 scale * Reads, speaks, and understands English as noted in the medical record or disclosed during self-report screening * Has regular access to the internet * Has access to devices (phone, desktop, or other) with features (browsers, audio capabilities, etc.) that are congruent with the requirements of the digital therapeutic, as assessed by staff members during self-report screening.
Exclusion criteria
* History of (within past 5 years) or current diagnosis of primary psychotic or major thought disorder with active symptoms as noted in the medical record or disclosed during self-report screening * Psychiatric hospitalization within the past 6 months as noted in the medical record or disclosed during self-report screening * Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months as noted in the medical record or disclosed during self-report screening; * Any psychiatric or behavioral issues as noted in the medical record or disclosed/observed during self-report screening that would indicate subject may be inappropriate for study; * Presenting symptoms at the time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or others or active delusional or psychotic thinking; * Active malignancy (e.g., cancer not in remission) as noted in the medical record or disclosed during self-report screening; * Pain condition for which surgery is recommended and/or planned in the next six months as disclosed during self-report screening; * Currently receiving or have received hypnosis treatment for any pain condition as disclosed during self-report screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Using Rose Application | During the 8 weeks of study participation | Total # of hypnosis sessions listened to by participants |
| Continued Interest in Using Rose Application | 8 week assessment | Participants reporting how interested they would be in continuing to use the Rose application: If the Rose web/phone application were available to download, how interested would you be in downloading and using this application? 4 - Extremely interested 3 - Very interested 2 - Somewhat interested 1 - Little interested 0 - Not interested |
| Willingness to Pay for Continued Use of Rose Application | 8 week assessment | Participants that reported a willingness to pay for continued access to the Rose application (results available for Study 2 only): Would you be willing to pay some amount for a monthly subscription to Rose, to have continued access? 1 - Yes 0 - No |
| Participant Satisfaction | 4 Week, 8 Week timepoints | Participants answered a Global Satisfaction question about their satisfaction with using the Rose application Taking all things into account, how satisfied are you with using the Rose web application? 4 - Very Satisfied 3 - Somewhat Satisfied 2 - Neutral 1 - Somewhat Dissatisfied 0 - Very Dissatisfied |
| System Usability Scale (SUS) | 8 Week Timepoint | Scale title: System Usability Scale. Minimum - Maximum range: 0 to 100. Higher scores indicate more usability (ease of use). There are no subscale scores for this measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Using Opioids | Baseline (week 0), 4 week assessment, 8 week assessment | Domain assessed: Opioid Use How assessed: Single item asking participants to indicate whether or not they currently using any opioid mediations. Unit of measure is the number and rate of participants who indicated that they are currently using at least one opioid medication. |
| PROMIS Anxiety Short Form 7a | Baseline (week 0), 4 week assessment, 8 week assessment | Domain assessed: Anxiety. Ratings are summed and converted to T scores (Mean = 50 and SD = 10 in the normative sample). Higher scores indicate more anxiety. Scores that are \>= 55 (i.e., one half a SD above the normative mean) are considered clinically elevated. |
| Average Pain - Past Week | Baseline, 4 Weeks, 8 Weeks | A 0-10 Numerical Rating scale of average pain in the past week: Please rate your pain by choosing the one number that best describes your pain at its WORST in the PAST WEEK, where 0 is no pain and 10 is pain as bad as you can imagine |
| Worst Pain - Past Week | Baseline, 4 Weeks, 8 Weeks | A 0-10 Numerical Rating scale of worst pain in the past week: Please rate your pain by choosing the one number that best describes your pain at its WORST in the PAST WEEK, where 0 is no pain and 10 is pain as bad as you can imagine |
| PROMIS Sleep Disturbance Short Form 8a | Baseline (week 0), 4 week assessment, 8 week assessment | Domain assessed: Sleep Disturbance. Ratings are summed and converted to T scores (Mean = 50 and SD = 10 in the normative sample). Higher scores indicate more sleep disturbance. Scores that are \>= 55 (i.e., one half a SD above the normative mean) are considered clinically elevated. |
| PROMIS Pain Interference Short Form | Baseline (week 0), 4 week assessment, 8 week assessment | Domain assessed: Pain interference. Ratings are summed and converted to T scores (Mean = 50 and SD = 10 in the normative sample). Higher scores indicate more pain interference. Scores that are \>= 55 (i.e., one half a SD above the normative mean) are considered clinically elevated. |
Countries
United States
Participant flow
Recruitment details
Primarily recruited from Research Match and the UW Rehabilitation Medicine Participant Pool.
Participants by arm
| Arm | Count |
|---|---|
| Study 1: 8 Week Treatment Participants that had access to the Rose application for 8 weeks. | 26 |
| Study 1: 4 Week Waitlist Participants that had access to the Rose application for 4 weeks (8 weeks total participation = 4 weeks waitlist with no access to the Rose application, then 4 weeks of access) | 24 |
| Study 2: 8 Week Treatment Participants had access to the Rose application for 8 weeks | 26 |
| Study 2: 4 Week Waitlist Participants that had access to the Rose application for 4 weeks (8 weeks total participation = 4 weeks waitlist with no access to the Rose application, then 4 weeks of access) | 24 |
| Total | 100 |
Baseline characteristics
| Characteristic | Study 1: 8 Week Treatment | Study 1: 4 Week Waitlist | Study 2: 8 Week Treatment | Study 2: 4 Week Waitlist | Total |
|---|---|---|---|---|---|
| Age, Continuous | 48.3 Years STANDARD_DEVIATION 20.8 | 49.5 Years STANDARD_DEVIATION 15.6 | 38.6 Years STANDARD_DEVIATION 12.7 | 40.6 Years STANDARD_DEVIATION 16.7 | 48.9 Years STANDARD_DEVIATION 18.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 5 Participants | 1 Participants | 3 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 19 Participants | 25 Participants | 21 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 7 Participants | 15 Participants | 13 Participants | 44 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 3 Participants | 2 Participants | 1 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 10 Participants | 11 Participants | 8 Participants | 10 Participants | 39 Participants |
| Region of Enrollment United States | 26 Participants | 24 Participants | 26 Participants | 24 Participants | 100 Participants |
| Sex/Gender, Customized Gender Female | 19 Participants | 17 Participants | 11 Participants | 12 Participants | 59 Participants |
| Sex/Gender, Customized Gender Male | 7 Participants | 6 Participants | 12 Participants | 12 Participants | 37 Participants |
| Sex/Gender, Customized Gender Non-binary | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Gender Transgender | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Sex/Gender, Customized Sex at Birth Female | 19 Participants | 18 Participants | 12 Participants | 12 Participants | 61 Participants |
| Sex/Gender, Customized Sex at Birth Male | 7 Participants | 6 Participants | 14 Participants | 12 Participants | 39 Participants |
| Years of Education 2 year college graduate | 5 Participants | 4 Participants | 3 Participants | 0 Participants | 12 Participants |
| Years of Education 4 year college graduate | 3 Participants | 6 Participants | 7 Participants | 3 Participants | 19 Participants |
| Years of Education Graduate school | 6 Participants | 1 Participants | 13 Participants | 15 Participants | 35 Participants |
| Years of Education High School Graduate/GED | 2 Participants | 2 Participants | 1 Participants | 1 Participants | 6 Participants |
| Years of Education Some college or vocational school | 10 Participants | 11 Participants | 2 Participants | 5 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 24 | 0 / 26 | 0 / 24 |
| other Total, other adverse events | 1 / 26 | 0 / 24 | 0 / 26 | 0 / 24 |
| serious Total, serious adverse events | 0 / 26 | 0 / 24 | 0 / 26 | 0 / 24 |
Outcome results
Primary
Continued Interest in Using Rose Application
Participants reporting how interested they would be in continuing to use the Rose application: If the Rose web/phone application were available to download, how interested would you be in downloading and using this application? 4 - Extremely interested 3 - Very interested 2 - Somewhat interested 1 - Little interested 0 - Not interested
Time frame: 8 week assessment
Population: The number of participants who expressed expressed am interest in continued interest access to the application was prespecified to be aggregated for all participants because the milestone for this feasibility variable was the overall rate of interest in for those who used the application at least once, collapsed across condition. We were not interested in, or anticipated, any between-group difference in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study 1 | Continued Interest in Using Rose Application | 2.5 Score on a scale | Standard Deviation 1.3 |
| Study 2 | Continued Interest in Using Rose Application | 2.8 Score on a scale | Standard Deviation 1.5 |
Primary
Frequency of Using Rose Application
Total # of hypnosis sessions listened to by participants
Time frame: During the 8 weeks of study participation
Population: The number of hypnosis sessions listened to was prespecified to be aggregated for all participants because (1) it was over the entire course of the 8-week study and participants in both arms had access and (2) the key variable of interest for feasibility was any difference in the number and rate of listening as a function of session duration (and not differences as a function of condition, as those in the waitlist condition would by default listen to fewer sessions).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study 1 | Frequency of Using Rose Application | 5 minute audio recording | 81 # of hypnosis sessions listened to |
| Study 1 | Frequency of Using Rose Application | 10 minute audio recording | 64 # of hypnosis sessions listened to |
| Study 1 | Frequency of Using Rose Application | 20 minute audio recording | 220 # of hypnosis sessions listened to |
| Study 2 | Frequency of Using Rose Application | 5 minute audio recording | 79 # of hypnosis sessions listened to |
| Study 2 | Frequency of Using Rose Application | 10 minute audio recording | 134 # of hypnosis sessions listened to |
| Study 2 | Frequency of Using Rose Application | 20 minute audio recording | 274 # of hypnosis sessions listened to |
Primary
Participant Satisfaction
Participants answered a Global Satisfaction question about their satisfaction with using the Rose application Taking all things into account, how satisfied are you with using the Rose web application? 4 - Very Satisfied 3 - Somewhat Satisfied 2 - Neutral 1 - Somewhat Dissatisfied 0 - Very Dissatisfied
Time frame: 4 Week, 8 Week timepoints
Population: The number of participants who expressed satisfaction will using the application was prespecified to be aggregated for all participants because the milestone for this feasibility variable was the overall rates of the satisfaction ratings for those who used the application at least once (i.e., participants in both conditions), collapsed across condition. We were not interested in, or anticipated, any between-group difference in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study 1 | Participant Satisfaction | 2.8 Score on a scale | Standard Deviation 0.9 |
| Study 2 | Participant Satisfaction | 3.4 Score on a scale | Standard Deviation 0.9 |
Primary
System Usability Scale (SUS)
Scale title: System Usability Scale. Minimum - Maximum range: 0 to 100. Higher scores indicate more usability (ease of use). There are no subscale scores for this measure.
Time frame: 8 Week Timepoint
Population: The system usability scores for those who used the application at least once were prespecified to be aggregated for all participants because participants in both conditions had access to the application. The feasibility milestone was overall system usability score in participants in both conditions. The two groups had access the same application, and therefore we were not interested in, or anticipated, any between-group difference in this variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study 1 | System Usability Scale (SUS) | 80.33 Score on a scale | Standard Deviation 16.05 |
| Study 2 | System Usability Scale (SUS) | 87.31 Score on a scale | Standard Deviation 12.72 |
Primary
Willingness to Pay for Continued Use of Rose Application
Participants that reported a willingness to pay for continued access to the Rose application (results available for Study 2 only): Would you be willing to pay some amount for a monthly subscription to Rose, to have continued access? 1 - Yes 0 - No
Time frame: 8 week assessment
Population: The number of participants who expressed a willingness to pay fo continued access to the application was prespecified to be aggregated for all participants because the milestone for this feasibility variable was the overall rate of willingness to pay for the application for those who used the application at least once, collapsed across condition. We were not interested in, or anticipated, any between-group difference in this variable.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 1 | Willingness to Pay for Continued Use of Rose Application | 11 Participants |
Secondary
Average Pain - Past Week
A 0-10 Numerical Rating scale of average pain in the past week: Please rate your pain by choosing the one number that best describes your pain at its WORST in the PAST WEEK, where 0 is no pain and 10 is pain as bad as you can imagine
Time frame: Baseline, 4 Weeks, 8 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study 1 | Average Pain - Past Week | Baseline | 5.81 Score on a scale | Standard Deviation 1.44 |
| Study 1 | Average Pain - Past Week | 8 Weeks | 5.38 Score on a scale | Standard Deviation 2.12 |
| Study 1 | Average Pain - Past Week | 4 Weeks | 5.69 Score on a scale | Standard Deviation 1.74 |
| Study 2 | Average Pain - Past Week | Baseline | 5.71 Score on a scale | Standard Deviation 1.88 |
| Study 2 | Average Pain - Past Week | 8 Weeks | 4.96 Score on a scale | Standard Deviation 1.72 |
| Study 2 | Average Pain - Past Week | 4 Weeks | 5.42 Score on a scale | Standard Deviation 1.79 |
| Study 2: 8 Week Treatment | Average Pain - Past Week | 4 Weeks | 5.04 Score on a scale | Standard Deviation 1.51 |
| Study 2: 8 Week Treatment | Average Pain - Past Week | Baseline | 5.92 Score on a scale | Standard Deviation 1.7 |
| Study 2: 8 Week Treatment | Average Pain - Past Week | 8 Weeks | 4.46 Score on a scale | Standard Deviation 1.84 |
| Study 2: 4 Week Waitlist | Average Pain - Past Week | Baseline | 5.83 Score on a scale | Standard Deviation 1.83 |
| Study 2: 4 Week Waitlist | Average Pain - Past Week | 8 Weeks | 3.46 Score on a scale | Standard Deviation 2.08 |
| Study 2: 4 Week Waitlist | Average Pain - Past Week | 4 Weeks | 5.17 Score on a scale | Standard Deviation 1.49 |
Secondary
Number of Participants Using Opioids
Domain assessed: Opioid Use How assessed: Single item asking participants to indicate whether or not they currently using any opioid mediations. Unit of measure is the number and rate of participants who indicated that they are currently using at least one opioid medication.
Time frame: Baseline (week 0), 4 week assessment, 8 week assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study 1 | Number of Participants Using Opioids | 10 Participants |
| Study 2 | Number of Participants Using Opioids | 2 Participants |
| Study 2: 8 Week Treatment | Number of Participants Using Opioids | 1 Participants |
| Study 2: 4 Week Waitlist | Number of Participants Using Opioids | 2 Participants |
Secondary
PROMIS Anxiety Short Form 7a
Domain assessed: Anxiety. Ratings are summed and converted to T scores (Mean = 50 and SD = 10 in the normative sample). Higher scores indicate more anxiety. Scores that are \>= 55 (i.e., one half a SD above the normative mean) are considered clinically elevated.
Time frame: Baseline (week 0), 4 week assessment, 8 week assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study 1 | PROMIS Anxiety Short Form 7a | Baseline | 58.0 T-score | Standard Deviation 10.5 |
| Study 1 | PROMIS Anxiety Short Form 7a | 8 Weeks | 58.2 T-score | Standard Deviation 11.3 |
| Study 1 | PROMIS Anxiety Short Form 7a | 4 Weeks | 60.4 T-score | Standard Deviation 11.3 |
| Study 2 | PROMIS Anxiety Short Form 7a | Baseline | 55.5 T-score | Standard Deviation 10.9 |
| Study 2 | PROMIS Anxiety Short Form 7a | 8 Weeks | 57.0 T-score | Standard Deviation 12.4 |
| Study 2 | PROMIS Anxiety Short Form 7a | 4 Weeks | 59.2 T-score | Standard Deviation 13.7 |
| Study 2: 8 Week Treatment | PROMIS Anxiety Short Form 7a | 4 Weeks | 57.4 T-score | Standard Deviation 6.7 |
| Study 2: 8 Week Treatment | PROMIS Anxiety Short Form 7a | Baseline | 57.8 T-score | Standard Deviation 4.8 |
| Study 2: 8 Week Treatment | PROMIS Anxiety Short Form 7a | 8 Weeks | 55.4 T-score | Standard Deviation 8 |
| Study 2: 4 Week Waitlist | PROMIS Anxiety Short Form 7a | Baseline | 54.0 T-score | Standard Deviation 7.4 |
| Study 2: 4 Week Waitlist | PROMIS Anxiety Short Form 7a | 8 Weeks | 54.1 T-score | Standard Deviation 10.2 |
| Study 2: 4 Week Waitlist | PROMIS Anxiety Short Form 7a | 4 Weeks | 54.8 T-score | Standard Deviation 9.6 |
Secondary
PROMIS Pain Interference Short Form
Domain assessed: Pain interference. Ratings are summed and converted to T scores (Mean = 50 and SD = 10 in the normative sample). Higher scores indicate more pain interference. Scores that are \>= 55 (i.e., one half a SD above the normative mean) are considered clinically elevated.
Time frame: Baseline (week 0), 4 week assessment, 8 week assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study 1 | PROMIS Pain Interference Short Form | Baseline | 64.3 Score on a scale | Standard Deviation 6.7 |
| Study 1 | PROMIS Pain Interference Short Form | 8 Weeks | 64.0 Score on a scale | Standard Deviation 9 |
| Study 1 | PROMIS Pain Interference Short Form | 4 Weeks | 64.4 Score on a scale | Standard Deviation 6.4 |
| Study 2 | PROMIS Pain Interference Short Form | Baseline | 64.4 Score on a scale | Standard Deviation 7.2 |
| Study 2 | PROMIS Pain Interference Short Form | 8 Weeks | 61.7 Score on a scale | Standard Deviation 7.6 |
| Study 2 | PROMIS Pain Interference Short Form | 4 Weeks | 64.9 Score on a scale | Standard Deviation 7.2 |
| Study 2: 8 Week Treatment | PROMIS Pain Interference Short Form | 4 Weeks | 59.4 Score on a scale | Standard Deviation 5.3 |
| Study 2: 8 Week Treatment | PROMIS Pain Interference Short Form | Baseline | 60.5 Score on a scale | Standard Deviation 5.3 |
| Study 2: 8 Week Treatment | PROMIS Pain Interference Short Form | 8 Weeks | 56.6 Score on a scale | Standard Deviation 8.7 |
| Study 2: 4 Week Waitlist | PROMIS Pain Interference Short Form | Baseline | 61.0 Score on a scale | Standard Deviation 4.59 |
| Study 2: 4 Week Waitlist | PROMIS Pain Interference Short Form | 8 Weeks | 56.1 Score on a scale | Standard Deviation 9.1 |
| Study 2: 4 Week Waitlist | PROMIS Pain Interference Short Form | 4 Weeks | 61.0 Score on a scale | Standard Deviation 5.9 |
Secondary
PROMIS Sleep Disturbance Short Form 8a
Domain assessed: Sleep Disturbance. Ratings are summed and converted to T scores (Mean = 50 and SD = 10 in the normative sample). Higher scores indicate more sleep disturbance. Scores that are \>= 55 (i.e., one half a SD above the normative mean) are considered clinically elevated.
Time frame: Baseline (week 0), 4 week assessment, 8 week assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study 1 | PROMIS Sleep Disturbance Short Form 8a | Baseline | 57.3 T-score | Standard Deviation 7.9 |
| Study 1 | PROMIS Sleep Disturbance Short Form 8a | 8 Weeks | 57.1 T-score | Standard Deviation 10 |
| Study 1 | PROMIS Sleep Disturbance Short Form 8a | 4 Weeks | 58.4 T-score | Standard Deviation 9.7 |
| Study 2 | PROMIS Sleep Disturbance Short Form 8a | Baseline | 58.5 T-score | Standard Deviation 8.7 |
| Study 2 | PROMIS Sleep Disturbance Short Form 8a | 8 Weeks | 53.5 T-score | Standard Deviation 10.8 |
| Study 2 | PROMIS Sleep Disturbance Short Form 8a | 4 Weeks | 57.3 T-score | Standard Deviation 9.1 |
| Study 2: 8 Week Treatment | PROMIS Sleep Disturbance Short Form 8a | 4 Weeks | 41.7 T-score | Standard Deviation 10.7 |
| Study 2: 8 Week Treatment | PROMIS Sleep Disturbance Short Form 8a | Baseline | 55.2 T-score | Standard Deviation 7.4 |
| Study 2: 8 Week Treatment | PROMIS Sleep Disturbance Short Form 8a | 8 Weeks | 50.5 T-score | Standard Deviation 10.6 |
| Study 2: 4 Week Waitlist | PROMIS Sleep Disturbance Short Form 8a | Baseline | 57.2 T-score | Standard Deviation 9.5 |
| Study 2: 4 Week Waitlist | PROMIS Sleep Disturbance Short Form 8a | 8 Weeks | 50.0 T-score | Standard Deviation 12.6 |
| Study 2: 4 Week Waitlist | PROMIS Sleep Disturbance Short Form 8a | 4 Weeks | 54.0 T-score | Standard Deviation 10.2 |
Secondary
Worst Pain - Past Week
A 0-10 Numerical Rating scale of worst pain in the past week: Please rate your pain by choosing the one number that best describes your pain at its WORST in the PAST WEEK, where 0 is no pain and 10 is pain as bad as you can imagine
Time frame: Baseline, 4 Weeks, 8 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study 1 | Worst Pain - Past Week | Baseline | 7.23 Score on a scale | Standard Deviation 1.34 |
| Study 1 | Worst Pain - Past Week | 8 Weeks | 6.69 Score on a scale | Standard Deviation 1.91 |
| Study 1 | Worst Pain - Past Week | 4 Weeks | 7.19 Score on a scale | Standard Deviation 1.6 |
| Study 2 | Worst Pain - Past Week | Baseline | 7.63 Score on a scale | Standard Deviation 1.38 |
| Study 2 | Worst Pain - Past Week | 8 Weeks | 6.91 Score on a scale | Standard Deviation 1.81 |
| Study 2 | Worst Pain - Past Week | 4 Weeks | 6.92 Score on a scale | Standard Deviation 1.47 |
| Study 2: 8 Week Treatment | Worst Pain - Past Week | 4 Weeks | 6.16 Score on a scale | Standard Deviation 1.57 |
| Study 2: 8 Week Treatment | Worst Pain - Past Week | Baseline | 7.35 Score on a scale | Standard Deviation 1.02 |
| Study 2: 8 Week Treatment | Worst Pain - Past Week | 8 Weeks | 5.73 Score on a scale | Standard Deviation 2.39 |
| Study 2: 4 Week Waitlist | Worst Pain - Past Week | Baseline | 7.29 Score on a scale | Standard Deviation 0.95 |
| Study 2: 4 Week Waitlist | Worst Pain - Past Week | 8 Weeks | 4.96 Score on a scale | Standard Deviation 2.39 |
| Study 2: 4 Week Waitlist | Worst Pain - Past Week | 4 Weeks | 6.63 Score on a scale | Standard Deviation 1.35 |