Toward Thriving: A Set of Reflective Tools to Empower Chronic Pain Patients and Help Them Envision a Personal Path to Thriving.
- Conditions
- Chronic Pain
- Interventions
- Behavioral: Self-guided at home activities
- Registration Number
- NCT05847881
- Lead Sponsor
- University of Michigan
- Brief Summary
The purpose of this study is to introduce and test the usefulness of a reflective process meant to empower people with chronic pain and help support participant's resiliency and thriving.
The study team hypothesizes that:
-Greater or equal to 80 percent of participants will report that the intervention was relatively easy to understand after orientation, low burden, potentially effective, and will have completed at least 2 of the 3 reflective tools.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- Persistent or recurrent pain lasting longer than 3 months
- Able to read and write English
- Cancer (History of any bone-related cancer or cancer that metastasized to the bone; Currently in treatment for any cancer or plan to start cancer treatment in the next 12 months; History of any cancer treatment in the last 24 months)
- Active substance abuse
- Uncontrolled depression or psychosis
- Visual or hearing difficulties that would preclude participation
- Individuals started receiving disability or compensation within the past year, or currently involved in litigation
- Current/planned (in the next 2 years) enrollment in another study of a device or investigational drug that would interfere with this study, this may include participation in a blinded trial.
- Any other diseases or conditions that would make a patient unsuitable for study participation as determined by the site principal investigators. This would include but not be limited to severe psychiatric disorders, active suicidal ideations or history of suicide attempts, and an uncontrolled drug and/or alcohol addiction)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Reflective process group Self-guided at home activities -
- Primary Outcome Measures
Name Time Method Participants Engaged in the Interventions Baseline (T1) to Exit Interview (T4), up to 68 days The timepoints were as follows: consent and survey (T1), Kick-off Meeting (T2), Workshop (T3), and Exit Interview (T4). Participants had to attend the Kick-off Meeting (T2) to be considered engaged in the intervention. Participants who did not attend the Kick-off Meeting (T2) were withdrawn. Participants who did not attend the Workshop (T3) could still attend the Exit Interview (T4).
- Secondary Outcome Measures
Name Time Method Patient Global Impression of Change (PGIC) at T4 Exit Interview at T4 Exit Interview, up to 68 days Participants completed the PGIC at the exit interview. The PGIC had one question with seven options ranging from -3 to 3: very much worse (-3), much worse (-2), minimally worse (-1), no change (0), minimally improved (1), much improved (2), very much improved (3). A higher score indicated greater improvement since the start of the study.
Change in Pain Interference Based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Version 2.0 Between Baseline (t1) and Approximately 68 Days (t4 Exit Interview) Up to 68 days There were 4 questions in this questionnaire. For each question, participants selected one of five options, ranging from "not at all" (1) to "very much" (5). Total scores ranged from 4 to 20 points, where higher scores indicated more pain interference. Since this survey was discussing the change in the pain interference, a negative score indicated less pain interfering with day-to-day activities.The change betwen the baseline (T1 and Exit Interview (t4) is reported.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States