NCT05847881

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

Completed NA Results posted Last updated 23 October 2024

What this trial tests

NA trial testing Self-guided at home activities in Chronic Pain in 23 participants. Completed in 25 July 2023.

Timeline

25 April 2023

Primary endpoint
25 July 2023

25 July 2023

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	25 April 2023
Primary completion	25 July 2023
Estimated completion	25 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Self-guided at home activities

Conditions studied

• Chronic Pain — all drugs for Chronic Pain →

Sponsor

University of Michigan

Who can join

18 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Participants Engaged in the Interventions Primary · 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 Participants who did not attend the Kick-off Meeting (T2) were withdrawn.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).

Consent and Survey (T1)

Group	Value	95% CI
Reflective Process Group	23

Kick off Meeting (T2)

Group	Value	95% CI
Reflective Process Group	14

Workshop (T3)

Group	Value	95% CI
Reflective Process Group	12

Exit Interview

Group	Value	95% CI
Reflective Process Group	13

Patient Global Impression of Change (PGIC) at T4 Exit Interview Secondary · 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.

Very much improved

Group	Value	95% CI
Reflective Process Group	0

Much Improved

Group	Value	95% CI
Reflective Process Group	4

Minimally Improved

Group	Value	95% CI
Reflective Process Group	5

No change

Group	Value	95% CI
Reflective Process Group	2

Minimally worse

Group	Value	95% CI
Reflective Process Group	0

Much worse

Group	Value	95% CI
Reflective Process Group	1

Very much worse

Group	Value	95% CI
Reflective Process Group	0

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) Secondary · 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.

Baseline

Group	Value	95% CI
Change in Reflective Process Group	13.833	± 2.791

Change from Baseline to Exit Interview

Group	Value	95% CI
Change in Reflective Process Group	-1.583	± 3.753

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.