N/A
N=23
Toward Thriving: A Set of Reflective Tools to Empower Chronic Pain Patients and Help Them Envision a Personal Path to Thriving.
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT05847881 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Participants Engaged in the Interventions — 23; 14; 12; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Self-guided at home activities (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Engaged in the Interventions |
23; 14; 12; 13 | — |
| SECONDARY Patient Global Impression of Change (PGIC) at T4 Exit Interview |
0; 4; 5; 2; 0; 1 | — |
| SECONDARY 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) |
13.833; -1.583 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Persistent or recurrent pain lasting longer than 3 months
- Able to read and write English
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT05847881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.