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Digital Clinical Hypnosis for Chronic Pain Management

Primary Purpose

Chronic Low-back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hypnosis audio recordings
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Low-back Pain, Hypnosis, Chronic Pain, Digital Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment

    Waitlist Control

    Arm Description

    8 weeks of access to online hypnosis recordings

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Pre/Post Hypnosis Pain Intensity
    A 0-10 Numerical Rating scale administered pre/post using the hypnosis audio recording
    Average Pain
    A 0-10 Numerical Rating scale administered at three timepoints
    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'
    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'
    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'
    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.
    PainDETECT
    9-item questionnaire examining type of pain and what sensations make pain worse (e.g. light touch, cold/heat, etc.)

    Full Information

    First Posted
    September 16, 2023
    Last Updated
    September 22, 2023
    Sponsor
    University of Washington
    Collaborators
    National Center for Complementary and Integrative Health (NCCIH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06050083
    Brief Title
    Digital Clinical Hypnosis for Chronic Pain Management
    Official Title
    Digital Clinical Hypnosis for Chronic Pain Management
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2025 (Anticipated)
    Study Completion Date
    August 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington
    Collaborators
    National Center for Complementary and Integrative Health (NCCIH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Low-back Pain
    Keywords
    Low-back Pain, Hypnosis, Chronic Pain, Digital Health

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    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)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    8 weeks of access to online hypnosis recordings
    Arm Title
    Waitlist Control
    Arm Type
    Active Comparator
    Arm Description
    4 weeks of waitlist (no access to recordings) and then 4 weeks of access to hypnosis recordings
    Intervention Type
    Behavioral
    Intervention Name(s)
    Hypnosis audio recordings
    Intervention Description
    Hypnosis recordings created by the investigators that guide participants through using hypnosis to manage chronic pain.
    Primary Outcome Measure Information:
    Title
    Frequency of using hypnosis recordings
    Description
    % of participants that use the hypnosis recordings at least 1x per week
    Time Frame
    4 week assessment, 8 week assessment
    Title
    Participant Satisfaction
    Description
    % of participants that report being Satisfied or Very Satisfied on a 5-point Global Satisfaction measure with the hypnosis program/recordings
    Time Frame
    4 week assessment, 8 week assessment
    Title
    Continued Interest in Using Hypnosis Recordings
    Description
    % of participants that report an interest in continuing to use the hypnosis recordings
    Time Frame
    8 week assessment
    Title
    Willingness to Pay for Continued Use of Hypnosis Recordings
    Description
    % of participants that report a willingness to pay for continued access to the hypnosis recordings
    Time Frame
    8 week assessment
    Secondary Outcome Measure Information:
    Title
    Pre/Post Hypnosis Pain Intensity
    Description
    A 0-10 Numerical Rating scale administered pre/post using the hypnosis audio recording
    Time Frame
    Throughout study duration (8 weeks for treatment group, 4 weeks for waitlist group)
    Title
    Average Pain
    Description
    A 0-10 Numerical Rating scale administered at three timepoints
    Time Frame
    Baseline (week 0), 4 week assessment, 8 week assessment
    Title
    PROMIS Pain Interference
    Description
    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'
    Time Frame
    Baseline (week 0), 4 week assessment, 8 week assessment
    Title
    PROMIS Anxiety Short Form 7a
    Description
    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'
    Time Frame
    Baseline (week 0), 4 week assessment, 8 week assessment
    Title
    PROMIS Sleep Disturbance 8a
    Description
    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'
    Time Frame
    Baseline (week 0), 4 week assessment, 8 week assessment
    Title
    Opiod Use
    Description
    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.
    Time Frame
    Baseline (week 0), 4 week assessment, 8 week assessment
    Title
    PainDETECT
    Description
    9-item questionnaire examining type of pain and what sensations make pain worse (e.g. light touch, cold/heat, etc.)
    Time Frame
    Baseline (week 0), 4 week assessment, 8 week assessment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aaron Flaster
    Phone
    206-616-7934
    Email
    aflaster@uw.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joy Chan
    Phone
    206-744-3626
    Email
    joychan@uw.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark Jensen, MD
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Digital Clinical Hypnosis for Chronic Pain Management

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