Digital Clinical Hypnosis for Chronic Pain Management

NCT06050083 | Completed Results

• 2 other identifiers: STUDY00014786R41AT011996
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain; Chronic Pain

Keywords

Low-back Pain; Hypnosis; Chronic Pain; Digital Health

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (6)

• Average Pain - Past Week

  Baseline, 4 Weeks, 8 Weeks

• Worst Pain - Past Week

  Baseline, 4 Weeks, 8 Weeks

• PROMIS Sleep Disturbance Short Form 8a

  Baseline (week 0), 4 week assessment, 8 week assessment

• PROMIS Pain Interference Short Form

  Baseline (week 0), 4 week assessment, 8 week assessment

• PROMIS Anxiety Short Form 7a

  Baseline (week 0), 4 week assessment, 8 week assessment

Study Arms (2)

Treatment

EXPERIMENTAL

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

Behavioral: Hypnosis audio 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)

Behavioral: Hypnosis audio recordings

Interventions

Hypnosis audio recordings BEHAVIORAL

A web application (Rose) that contains hypnosis audio recordings created by the investigators.

Treatment; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Washington: lead

Study Sites (1)

University of Washington, School of Medicine

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Chronic Pain; Low Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Results Point of Contact

• Title: Dr. Mark Jensen, PhD, Principal Investigator
• Organization: University of Washington

mjensen@uw.edu

+1 206 543-3185

Study Officials

• Mark Jensen, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor: School of Medicine Rehabilitation Medicine

Model Details: 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).

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: September 22, 2023
• Study Start: January 4, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: January 6, 2026
• Results First Posted: January 6, 2026

Record last verified: 2025-12

Locations

US (1)