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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Self-guided at home activities

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sana Shaikh; Phone Number: 734-763-5226; Email: skazi@med.umich.edu
• Study Contact Backup: Name: Hannah Smotrich; Phone Number: 734-763-0497; Email: smotrich@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reflective process group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Hannah Smotrich, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Positive psychology intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: HUM00176302; UM1TR004404 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No