Clinical trial NCT06050083: Digital Clinical Hypnosis for Chronic Pain Management
Official title: Digital Clinical Hypnosis for Chronic Pain Management
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Low-back Pain
Hypnosis
Chronic Pain
Digital Health
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frequency of using hypnosis recordings
timeFrame: 4 week assessment, 8 week assessment
measure: Participant Satisfaction
timeFrame: 4 week assessment, 8 week assessment
measure: Continued Interest in Using Hypnosis Recordings
timeFrame: 8 week assessment
measure: Willingness to Pay for Continued Use of Hypnosis Recordings
timeFrame: 8 week assessment
Secondary outcomes:
measure: Pre/Post Hypnosis Pain Intensity
timeFrame: Throughout study duration (8 weeks for treatment group, 4 weeks for waitlist group)
measure: Average Pain
timeFrame: Baseline (week 0), 4 week assessment, 8 week assessment
measure: PROMIS Pain Interference
timeFrame: Baseline (week 0), 4 week assessment, 8 week assessment
measure: PROMIS Anxiety Short Form 7a
timeFrame: Baseline (week 0), 4 week assessment, 8 week assessment
measure: PROMIS Sleep Disturbance 8a
timeFrame: Baseline (week 0), 4 week assessment, 8 week assessment
measure: Opiod Use
timeFrame: Baseline (week 0), 4 week assessment, 8 week assessment
measure: PainDETECT
timeFrame: Baseline (week 0), 4 week assessment, 8 week assessment
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington, School of Medicine
state: Washington
Study officials:
affiliation: University of Washington
name: Mark Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References: