Digital Clinical Hypnosis for Chronic Pain Management

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Digital Clinical Hypnosis for Chronic Pain Management

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Behavioral: Hypnosis audio recordings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypnosis, Low-back Pain, Chronic Pain, Digital Health