Digital Clinical Hypnosis for Chronic Pain Management

• ClinicalTrials.gov Identifier: NCT06050083
• Recruitment Status: Active, not recruiting
• First Posted: September 22, 2023
• Last Update Posted: April 2, 2024
• Sponsor: University of Washington
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by (Responsible Party): Mark Jensen, University of Washington

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Chronic Low-back Pain	Behavioral: Hypnosis audio recordings	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This is a 2-arm randomized controlled trial in which individuals will be 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).
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Digital Clinical Hypnosis for Chronic Pain Management
• Actual Study Start Date: January 1, 2024
• Estimated Primary Completion Date: August 1, 2025
• Estimated Study Completion Date: August 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Pre/Post Hypnosis Pain Intensity [ Time Frame: Throughout study duration (8 weeks for treatment group, 4 weeks for waitlist group) ]
   A 0-10 Numerical Rating scale administered pre/post using the hypnosis audio recording
2. Average Pain [ Time Frame: Baseline (week 0), 4 week assessment, 8 week assessment ]
   A 0-10 Numerical Rating scale administered at three timepoints
3. PROMIS Pain Interference [ Time Frame: Baseline (week 0), 4 week assessment, 8 week assessment ]
   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'
4. PROMIS Anxiety Short Form 7a [ Time Frame: Baseline (week 0), 4 week assessment, 8 week assessment ]
   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'
5. PROMIS Sleep Disturbance 8a [ Time Frame: Baseline (week 0), 4 week assessment, 8 week assessment ]
   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'
6. Opiod Use [ Time Frame: Baseline (week 0), 4 week assessment, 8 week assessment ]
   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.
7. PainDETECT [ Time Frame: Baseline (week 0), 4 week assessment, 8 week assessment ]
   9-item questionnaire examining type of pain and what sensations make pain worse (e.g. light touch, cold/heat, etc.)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Washington

University of Washington, School of Medicine

Seattle, Washington, United States, 98104

Sponsors and Collaborators

University of Washington

National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Mark Jensen, MD; University of Washington

More Information

• Responsible Party: Mark Jensen, Professor: School of Medicine Rehabilitation Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT06050083
• Other Study ID Numbers: STUDY00014786; R41AT011996 ( U.S. NIH Grant/Contract )
• First Posted: September 22, 2023
• Last Update Posted: April 2, 2024
• Last Verified: March 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mark Jensen, University of Washington:

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

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Chronic Pain; Pain; Neurologic Manifestations