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

NCT05847881 | Completed Results

• 2 other identifiers: HUM00176302UM1TR004404
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Positive psychology intervention

Outcome Measures

Primary Outcomes (1)

• 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 Participants who did not attend the Kick-off Meeting (T2) were withdrawn.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).

  Baseline (T1) to Exit Interview (T4), up to 68 days

Secondary Outcomes (2)

• Patient Global Impression of Change (PGIC) at T4 Exit Interview

  at T4 Exit Interview, up to 68 days

• 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

Study Arms (1)

Reflective process group

EXPERIMENTAL

Behavioral: Self-guided at home activities

Interventions

Self-guided at home activities BEHAVIORAL

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.

Reflective process group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persistent or recurrent pain lasting longer than 3 months
• Able to read and write English

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Michigan: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Afton L. Hassett, PsyD
• Organization: Back & Pain Center Clinical Research

afton@med.umich.edu

734-763-5226

Study Officials

• Hannah Smotrich

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Art and Design

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 8, 2023
• Study Start: April 25, 2023
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)