Digital Clinical Hypnosis for Chronic Pain Management

University of Washington100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Frequency of Using Rose Application

Total # of hypnosis sessions listened to by participants

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 8 Week Timepoint

Secondary Outcomes

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

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

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

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

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

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

Digital Clinical Hypnosis for Chronic Pain Management

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes