Chronic Pain
Conditions
Keywords
Positive psychology intervention
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.
Interventions
BEHAVIORALSelf-guided at home activities
After the kick-off meeting participants will complete the cultural probe kit for 3 weeks. This kit is a design research tool, to prompt participants to document, map, journal, and reflect on various aspects of daily lives. Following this, participants will attend a facilitated workshop and then complete the next at-home kits.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Reflective Process Group Self-guided at home activities: After the kick-off meeting participants will complete the cultural probe kit for 3 weeks. This kit is a design research tool, to prompt participants to document, map, journal, and reflect on various aspects of daily lives. Following this, participants will attend a facilitated workshop and then complete the next at-home kits. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Principal Investigator Decision | 8 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Reflective Process Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 23 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Participants Engaged in the Interventions
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).
Time frame: Baseline (T1) to Exit Interview (T4), up to 68 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Reflective Process Group | Participants Engaged in the Interventions | Consent and Survey (T1) | 23 Participants |
| Reflective Process Group | Participants Engaged in the Interventions | Kick off Meeting (T2) | 14 Participants |
| Reflective Process Group | Participants Engaged in the Interventions | Workshop (T3) | 12 Participants |
| Reflective Process Group | Participants Engaged in the Interventions | Exit Interview | 13 Participants |
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)
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.
Time frame: Up to 68 days
Population: The difference between the number of participants at baseline and in the results here is because of participant attrition and incomplete responses from participants that could not be included in the final results data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Reflective Process Group | 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) | Baseline | 13.833 score on a scale | Standard Deviation 2.791 |
| Reflective Process Group | 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) | Change from Baseline to Exit Interview | -1.583 score on a scale | Standard Deviation 3.753 |
Secondary
Patient Global Impression of Change (PGIC) at T4 Exit Interview
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.
Time frame: at T4 Exit Interview, up to 68 days
Population: Results reflect the participants who attended the T4 exit interview and completed the PGIC. Of the 13 participants who attended the exit interview, 1 did not complete the PGIC.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Reflective Process Group | Patient Global Impression of Change (PGIC) at T4 Exit Interview | Very much improved | 0 Participants |
| Reflective Process Group | Patient Global Impression of Change (PGIC) at T4 Exit Interview | Much Improved | 4 Participants |
| Reflective Process Group | Patient Global Impression of Change (PGIC) at T4 Exit Interview | Minimally Improved | 5 Participants |
| Reflective Process Group | Patient Global Impression of Change (PGIC) at T4 Exit Interview | No change | 2 Participants |
| Reflective Process Group | Patient Global Impression of Change (PGIC) at T4 Exit Interview | Minimally worse | 0 Participants |
| Reflective Process Group | Patient Global Impression of Change (PGIC) at T4 Exit Interview | Much worse | 1 Participants |
| Reflective Process Group | Patient Global Impression of Change (PGIC) at T4 Exit Interview | Very much worse | 0 Participants |