Digital Clinical Hypnosis for Chronic Pain Management

University of Washington

Status: Active, not recruiting

Conditions: Chronic Low-back 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 study is a randomized controlled trial that plans to enroll 50 adults with chronic low back pain. Participants will be in the study for 8 weeks and the study aim is to test different combinations hypnosis audio recordings to see which recordings participants like the best and lead to greatest reductions in pain. The investigators hope to develop a mobile app using participants' feedback to make hypnosis treatment for chronic pain more widely available. The investigators plan to develop and commercialize this app through HypnoScientific Inc., a company that is co-owned by the investigators.

Participants will complete brief (15-20min) 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old or older
• Meeting criteria for having chronic low back pain (i.e., pain in the low back am having been ongoing problem for 3 months or more as disclosed during self-report screening and pain in the low back as being an ongoing problem for at least half the days in the past 3 months as disclosed during self-report screening) as a primary or secondary pain problem;
• Average pain intensity in the past week ≥ 4 on a 0-10 scale as disclosed during self-report screening
• Reads, speaks, and understands English as noted in the medical record or disclosed during self-report screening;
• Has regular access to the internet as disclosed during self-report screening;
• 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 or current of diagnosis of primary psychotic or major thought disorder within the past 5 years 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: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Treatment

Experimental group

Description:

8 weeks of access to online hypnosis recordings

Treatment:

Behavioral: Hypnosis audio recordings

Waitlist Control

Active Comparator group

Description:

4 weeks of waitlist (no access to recordings) and then 4 weeks of access to hypnosis recordings

Treatment:

Behavioral: Hypnosis audio recordings