Digital Clinical Hypnosis for Chronic Pain Management

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Behavioral: Hypnosis audio recordings

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; 8 weeks of access to online hypnosis recordings	Behavioral: Hypnosis audio recordings; Hypnosis recordings created by the investigators that guide participants through using hypnosis to manage chronic pain.
Active Comparator: Waitlist Control; 4 weeks of waitlist (no access to recordings) and then 4 weeks of access to hypnosis recordings	Behavioral: Hypnosis audio recordings; Hypnosis recordings created by the investigators that guide participants through using hypnosis to manage chronic pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of using hypnosis recordings	% of participants that use the hypnosis recordings at least 1x per week	4 week assessment, 8 week assessment
Participant Satisfaction	% of participants that report being Satisfied or Very Satisfied on a 5-point Global Satisfaction measure with the hypnosis program/recordings	4 week assessment, 8 week assessment
Continued Interest in Using Hypnosis Recordings	% of participants that report an interest in continuing to use the hypnosis recordings	8 week assessment
Willingness to Pay for Continued Use of Hypnosis Recordings	% of participants that report a willingness to pay for continued access to the hypnosis recordings	8 week assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre/Post Hypnosis Pain Intensity	A 0-10 Numerical Rating scale administered pre/post using the hypnosis audio recording	Throughout study duration (8 weeks for treatment group, 4 weeks for waitlist group)
Average Pain	A 0-10 Numerical Rating scale administered at three timepoints	Baseline (week 0), 4 week assessment, 8 week assessment
PROMIS Pain Interference	Patient Reported Outcomes Measurement Information System (PROMIS) measure examining how pain impacts daily activities for adults. 8-item survey with a 5-point Likert scale ranging from 'Not at all' to 'Very much'	Baseline (week 0), 4 week assessment, 8 week assessment
PROMIS Anxiety Short Form 7a	Patient Reported Outcomes Measurement Information System (PROMIS) measure examining anxiety in adults. 7-item survey with a 5-point Likert scale ranging from 'Never' to 'Always'	Baseline (week 0), 4 week assessment, 8 week assessment
PROMIS Sleep Disturbance 8a	Patient Reported Outcomes Measurement Information System (PROMIS) measure examining sleep disturbance in adults. 8-item survey with a 5-point Likert scale ranging from 'Not at all' to 'Very much'	Baseline (week 0), 4 week assessment, 8 week assessment
Opiod Use	Yes/No question asking if participant is currently using any opioid medications. If yes, select from a list of opioid medications. Responses will then be converted to Morphine Milligram Equivalents by study staff.	Baseline (week 0), 4 week assessment, 8 week assessment
PainDETECT	9-item questionnaire examining type of pain and what sensations make pain worse (e.g. light touch, cold/heat, etc.)	Baseline (week 0), 4 week assessment, 8 week assessment

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Mark Jensen, MD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: September 16, 2023
• First Submitted That Met QC Criteria: September 16, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Pain; Hypnosis; Digital Health; Low-back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Chronic Pain
• Other Study ID Numbers: STUDY00014786; R41AT011996 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No