Digital Clinical Hypnosis for Chronic Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frequency of Using Rose Application
研究概览
简要总结
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 Study 2 was funded by the UW Department of Rehabilitation Medicine and enrolled adults with any type of chronic pain. Study 1 and 2 each enrolled 50 adults (N = 100 total across the two studies). Although Study 2 did not use NIH funds, we are including the results here because the studies were conducted simultaneously by the same PI (Dr. Jensen) with the same study procedures.
Participants enrolled in the studies for a duration of 8 weeks. The studies test the feasibility and efficacy of a therapeutic hypnosis digital application (website), called Rose. The investigators wanted to determine if the Rose application was user-friendly and effective at improving quality of life and reducing pain for adults with chronic pain. If successfuly, the investigators hope to develop the Rose application into a mobile app that will be publicly available and managed by HypnoScientific Inc., a company that is co-owned by the investigators.
Participants completed brief (15-20min) self-report surveys that ask about pain and mental health at three timepoints: Baseline (week 0), 4 weeks, and 8 weeks.
详细描述
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 in the Rose web application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •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
结局指标
主要结局
Frequency of Using Rose Application
时间窗: During the 8 weeks of study participation
Total # of hypnosis sessions listened to by participants
Continued Interest in Using Rose Application
时间窗: 8 week assessment
Participants reporting how interested they would be in continuing to use the Rose application: "If the Rose web/phone application were available to download, how interested would you be in downloading and using this application?" 4 - Extremely interested 3 - Very interested 2 - Somewhat interested 1 - Little interested 0 - Not interested
Willingness to Pay for Continued Use of Rose Application
时间窗: 8 week assessment
Participants that reported a willingness to pay for continued access to the Rose application (results available for Study 2 only): "Would you be willing to pay some amount for a monthly subscription to Rose, to have continued access?" 1 - Yes 0 - No
Participant Satisfaction
时间窗: 4 Week, 8 Week timepoints
Participants answered a Global Satisfaction question about their satisfaction with using the Rose application "Taking all things into account, how satisfied are you with using the Rose web application?" 4 - Very Satisfied 3 - Somewhat Satisfied 2 - Neutral 1 - Somewhat Dissatisfied 0 - Very Dissatisfied
System Usability Scale (SUS)
时间窗: 8 Week Timepoint
Scale title: System Usability Scale. Minimum - Maximum range: 0 to 100. Higher scores indicate more usability (ease of use). There are no subscale scores for this measure.
次要结局
- PROMIS Anxiety Short Form 7a(Baseline (week 0), 4 week assessment, 8 week assessment)
- Average Pain - Past Week(Baseline, 4 Weeks, 8 Weeks)
- PROMIS Sleep Disturbance Short Form 8a(Baseline (week 0), 4 week assessment, 8 week assessment)
- Worst Pain - Past Week(Baseline, 4 Weeks, 8 Weeks)
- PROMIS Pain Interference Short Form(Baseline (week 0), 4 week assessment, 8 week assessment)
- PROMIS Anxiety Short Form 7a(Baseline (week 0), 4 week assessment, 8 week assessment)
- Number of Participants Using Opioids(Baseline (week 0), 4 week assessment, 8 week assessment)
研究者
Mark Jensen
Professor: School of Medicine Rehabilitation Medicine
University of Washington