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| ID | Type | Description | Link |
|---|---|---|---|
| R41AT011996 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 8 weeks of access to Rose web application (online hypnosis recordings) |
|
| Waitlist Control | Active Comparator | 4 weeks of waitlist (no access to Rose application for 4 weeks and then 4 weeks of access to Rose web application) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnosis audio recordings | Behavioral | A web application (Rose) that contains hypnosis audio recordings created by the investigators. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Using Rose Application | Total # of hypnosis sessions listened to by participants | During the 8 weeks of study participation |
| 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 | 8 week assessment |
| 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 | 8 week assessment |
| 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 | 4 Week, 8 Week timepoints |
| 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. | 8 Week Timepoint |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | Baseline, 4 Weeks, 8 Weeks |
| Worst Pain - Past Week |
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Inclusion Criteria (self-report online and telephone screening by study staff):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Jensen, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington, School of Medicine | Seattle | Washington | 98104 | United States |
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Primarily recruited from Research Match and the UW Rehabilitation Medicine Participant Pool.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study 1: 8 Week Treatment | Participants that had access to the Rose application for 8 weeks. |
| FG001 | Study 1: 4 Week Waitlist | 4 Week Waitlist (4 weeks waitlist, then 4 weeks of Rose application access) |
| FG002 | Study 2: 8 Week Treatment | Participants had access to the Rose application for 8 weeks. |
| FG003 | Study 2: 4 Week Waitlist | 4 Week Waitlist (4 weeks waitlist, then 4 weeks of Rose application access) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Total number of participants per study group in Study 1 and Study 2
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| ID | Title | Description |
|---|---|---|
| BG000 | Study 1: 8 Week Treatment | Participants that had access to the Rose application for 8 weeks. |
| BG001 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex/Gender, Customized | Sex Assigned at Birth (Female, Male) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Using Rose Application | Total # of hypnosis sessions listened to by participants | 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). | Posted | Number | # of hypnosis sessions listened to | During the 8 weeks of study participation |
|
Enrollment until the 8 week follow up timepoint
Adverse Events were systematically assessed by including the following question at all survey timepoints: "Have you experienced any negative side effects since our last contact as a result of the study (Yes/No)". IF YES: Please specify the negative side effects.
Participants could also self-report Adverse Events when receiving a survey reminder phone call from a staff coordinator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study 1: 8 Week Treatment | Participants that had access to the Rose application for 8 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Strain | Musculoskeletal and connective tissue disorders | Systematic Assessment | AE was reported on the 4 week online self-report assessment and staff completed a follow up phone call with the participant |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark Jensen, PhD, Principal Investigator | University of Washington | +1 206 543-3185 | mjensen@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 21, 2025 | Dec 31, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Study 1 consent form | Jan 5, 2024 | Dec 9, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Study 2 consent form | Jan 5, 2024 | Dec 9, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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).
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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" |
| Baseline, 4 Weeks, 8 Weeks |
| 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. | Baseline (week 0), 4 week assessment, 8 week assessment |
| 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. | Baseline (week 0), 4 week assessment, 8 week assessment |
| 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. | Baseline (week 0), 4 week assessment, 8 week assessment |
| 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. | Baseline (week 0), 4 week assessment, 8 week assessment |
| BG002 | Study 2: 8 Week Treatment | Participants had access to the Rose application for 8 weeks |
| BG003 | 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) |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | Gender Identity (Female, Male, Transgender, Non-binary) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity (Hispanic/Latinx or Non-Hispanic/Latinx) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race (using NIH Racial Identity categories) | Count of Participants | Participants |
|
| Region of Enrollment | Geographical Region of Enrollment | Count of Participants | Participants |
|
| Years of Education | Number of years of education | Count of Participants | Participants |
|
| Age, Continuous | Age measured as a continuous variable | Mean | Standard Deviation | Years |
|
| Study 2 |
Summary scores for all participants in both the Treatment/Control groups for Study 2. |
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | Score on a scale | 8 week assessment |
|
|
|
| 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 | 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. | Posted | Count of Participants | Participants | 8 week assessment |
|
|
|
| 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" | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 4 Weeks, 8 Weeks |
|
|
|
| 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" | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 4 Weeks, 8 Weeks |
|
|
|
| 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. | Posted | Mean | Standard Deviation | T-score | Baseline (week 0), 4 week assessment, 8 week assessment |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (week 0), 4 week assessment, 8 week assessment |
|
|
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| 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 | 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. | Posted | Mean | Standard Deviation | Score on a scale | 4 Week, 8 Week timepoints |
|
|
|
| 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. | Posted | Mean | Standard Deviation | T-score | Baseline (week 0), 4 week assessment, 8 week assessment |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | 8 Week Timepoint |
|
|
|
| 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. | Posted | Count of Participants | Participants | Baseline (week 0), 4 week assessment, 8 week assessment |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 1 |
| 26 |
| EG001 | 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) | 0 | 24 | 0 | 24 | 0 | 24 |
| EG002 | Study 2: 8 Week Treatment | Participants had access to the Rose application for 8 weeks | 0 | 26 | 0 | 26 | 0 | 26 |
| EG003 | 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) | 0 | 24 | 0 | 24 | 0 | 24 |
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| D001416 | Back Pain |
| 4 Weeks |
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| 8 Weeks |
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| 4 Weeks |
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| 8 Weeks |
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| 4 Weeks |
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| 8 Weeks |
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| 4 Weeks |
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| 8 Weeks |
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| 4 Weeks |
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| 8 Weeks |
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