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

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Self-guided at home activities

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Positive psychology intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of MichiganRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Reflective process group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

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.

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT05847881

First Posted

April 25, 2023

Last Updated

May 5, 2023

Sponsor

University of Michigan

Collaborators

National Center for Advancing Translational Sciences (NCATS)

1. Study Identification

Unique Protocol Identification Number

NCT05847881

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 25, 2023 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pain

Keywords

Positive psychology intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Reflective process group

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Self-guided at home activities

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percent of participants engaged in the interventions

Description

Feasibility and acceptability of the behavioral intervention (cultural probe kit related activities) as noted by the participants engagement in the interventions.

Time Frame

Baseline (t1) to approximately 45 days (t4 exit interview)

Secondary Outcome Measure Information:

Title

Change in Patient Global Impression of Change (PGIC) at visit approximately 45 days (t4 exit interview)

Description

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.

Time Frame

approximately 45 days (t4 exit interview)

Title

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)

Description

There is one question that participants select 0 (no pain) - 10 (worst imaginable pain).

Time Frame