Digital Clinical Hypnosis for Chronic Pain Management

NCT ID: NCT06050083

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-04
• Study Completion Date: 2024-09-15

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.

Conditions

Chronic Low-back Pain; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Hypnosis audio recordings

Intervention Type: BEHAVIORAL

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

Waitlist Control

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

Group Type: ACTIVE_COMPARATOR

Hypnosis audio recordings

Intervention Type: BEHAVIORAL

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

Interventions

Hypnosis audio recordings

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Mark Jensen

Professor: School of Medicine Rehabilitation Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington, School of Medicine

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Study 1 consent form

View Document

Document Type: Informed Consent Form: Study 2 consent form

View Document

Other Identifiers

R41AT011996

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00014786

Identifier Type: -

Identifier Source: org_study_id