Digital Clinical Hypnosis for Chronic Pain Management

University of Washington

Status: Completed

Conditions: Chronic Low-back Pain; Chronic Pain

Treatments: Behavioral: Hypnosis audio recordings

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06050083

R41AT011996 (U.S. NIH Grant/Contract)

STUDY00014786

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Treatment

Experimental group

Description:

8 weeks of access to Rose web application (online hypnosis recordings)

Treatment:

Behavioral: Hypnosis audio recordings

Waitlist Control

Active Comparator group

Description:

4 weeks of waitlist (no access to Rose application for 4 weeks and then 4 weeks of access to Rose web application)

Treatment:

Behavioral: Hypnosis audio recordings