Status:
COMPLETED
Digital Clinical Hypnosis for Chronic Pain Management
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Chronic Low-back Pain
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This ClinicalTrials.gov posting contains two randomized controlled trials. The study procedures were identical, except Study 1 was funded by NIH and enrolled adults with chronic low back pain, whereas...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (self-report online and telephone screening by study staff):
- 18 years old or older
- Chronic Pain or Chronic Low Back Pain (i.e., pain in the low back that has been an ongoing problem for 3 months or more for at least half the days, as disclosed during self-report screening. The pain can be a primary condition or secondary to another health condition.
- Average pain intensity in the past week ≥ 4 on a 0-10 scale
- Reads, speaks, and understands English as noted in the medical record or disclosed during self-report screening
- Has regular access to the internet
- 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 of (within past 5 years) or current diagnosis of primary psychotic or major thought disorder with active symptoms 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
Exclusion
Key Trial Info
Start Date :
January 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06050083
Start Date
January 4 2024
End Date
September 15 2024
Last Update
January 6 2026
Active Locations (1)
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1
University of Washington, School of Medicine
Seattle, Washington, United States, 98104