Toward Thriving: A Set of Reflective Tools to Empower Chronic Pain Patients and Help Them Envision a Personal Path to Thriving.

Chronic Pain Clinical Trial

Official title:

Toward Thriving: A Set of Reflective Tools to Empower Chronic Pain Patients and Help Them Envision a Personal Path to Thriving.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05847881
• Other study ID #: HUM00176302
• Secondary ID: UM1TR004404
• Status: Completed
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: July 25, 2023

Study information

• Verified date: March 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of participants engaged in the interventions	Feasibility and acceptability of the behavioral intervention (cultural probe kit related activities) as noted by the participants engagement in the interventions.	Baseline (t1) to approximately 45 days (t4 exit interview)
Secondary	Change in Patient Global Impression of Change (PGIC) at visit approximately 45 days (t4 exit interview)	This is a 1 question item that participants will rate overall pain from 1(very much improved) to 7 (very much worse) from the start of treatment.	approximately 45 days (t4 exit interview)
Secondary	Change in pain intensity based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 between baseline (t1) and approximately 45 days (t4 exit interview)	There is one question that participants select 0 (no pain) - 10 (worst imaginable pain).	Baseline (t1), approximately 45 days (t4 exit interview)
Secondary	Change in the physical function based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2 between baseline (t1) approximately 45 days (t4 exit interview)	There are 4 questions that participants will select from without any difficulty (5) to unable to do (1). There are a total of 20 points where higher scores indicate higher physical function.	Baseline (t1), approximately 45 days (t4 exit interview)
Secondary	Change in anxiety based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 between baseline (t1) and approximately 45 days (t4 exit interview)	There are 4 questions that participants will select from never (1) to always (5). There are a total of 20 points where lower scores indicate lower levels of anxiety.	Baseline (t1), approximately 45 days (t4 exit interview)
Secondary	Change in depression based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2 between baseline (t1) and approximately 45 days (t4 exit interview)	There are 4 questions that participants will select from never (1) to always (5). There are a total of 20 points where higher scores indicate higher levels of depression.	Baseline (t1), approximately 45 days (t4 exit interview)
Secondary	Change in fatigue based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 between baseline (t1) and approximately 45 days (t4 exit interview)	There are 4 questions that participants will select from not at all (1) to very much (5). There are a total of 20 points where higher scores indicate higher levels of fatigue.	Baseline (t1), approximately 45 days (t4 exit interview)
Secondary	Change in sleep disturbance based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 between baseline (t1) and approximately 45 days (t4 exit interview)	There are 4 questions that participants will select from. Question 1 participants will select from Very poor (5) to very good. Questions 2-4 participants will select from not all (5) to very much (1). There are a total of 20 points where higher scores indicate higher sleep disturbances.	Baseline (t1), approximately 45 days (t4 exit interview)
Secondary	Change in ability to participate in social roles and activities based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 between baseline (t1) approximately 45 days (t4 exit interview)	There are 4 questions that participants will select from never (5) to always (1). There are a total of 20 points where lower scores indicate more difficulty participating in social roles.	Baseline (t1), approximately 45 days (t4 exit interview)
Secondary	Change in pain interference based on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 version 2.0 between baseline (t1) and approximately 45 days (t4 exit interview)	There are 4 questions that participants will select from not at all (1) to very much (5). There are a total of 20 points where lower scores indicate less pain interference.	Baseline (t1), approximately 45 days (t4 exit interview)