A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions

Study Overview
=================
Brief Summary
-----------------
This study examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. Half the participants will receive the intervention, and half the participants will receive usual care with education. Intervention subjects are hypothesized to have significantly less pain-related disability versus usual care subjects after 24 weeks.

Detailed Description
-----------------
This study examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. We propose that emotion regulation is the mechanism of change through which PATH-Pain improves pain and pain-related disability (outcomes). This pilot study will provide initial evidence of the: a) feasibility and acceptability of PATH-Pain; b) effects of PATH-Pain on emotion regulation (mechanism of change) and outcomes (pain and pain-related disability); and c) mediating effect of emotion regulation (mechanism of change) on outcomes (pain and pain-related disability). We will randomize 120 older adults (60 years or older) with chronic non-cancer related pain and negative emotions to PATH-Pain vs. Usual Care with Education (UCE). PATH-Pain will be administered by licensed mental health clinicians. Research assessments will be conducted at the Wright Center at study entry (baseline), and at 6, 12 (end of treatment), and 24 weeks. Additionally 20 providers of patients will be interviewed for feedback regarding the intervention.

Official Title
-----------------
A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions

Conditions
-----------------
Pain, Chronic, Negative Emotions

Intervention / Treatment
-----------------
* Behavioral: Path Pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patient Participants: 60 and older chronic pain (pain on most days in past 2 months) negative emotions MoCA score 16 or higher Provider Participants: providers 18 or over that took care of patient participant Exclusion Criteria - Patient Participants: MoCA score <16 cancer related pain can not provide capacity to consent

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Path Pain<br>Path Pain participants will be receiving 8 weekly therapy session by license clinicians trained in the Path Pain intervention. They will also receive 4, 15-minute phone booster sessions, on a monthly basis after their final therapy session. They will also be invited to monthly group educational sessions. Both intervention and usual care participants will be receiving a pain educational booklet. | Behavioral: Path Pain<br>* The intervention examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. This intervention consists of 8 weekly therapy sessions by a licensed clinician trained in Path Pain, 4 monthly boosters upon completion of therapy, and optional monthly group educational sessions.<br>|
| No Intervention: Usual Care with Education<br>Usual Care with Education (UCE) will receive a pain educational booklet. Following completion of their 24 weeks in the study, they will also be invited to attend the monthly group educational sessions. | |
| No Intervention: Provider Feedback<br>Providers of patients in the study will take part in a short interview on their impressions of the intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current Pain Intensity on an 11 point scale | Reduction in Pain intensity on an 11-item scale asking the question Using a scale of 0-10 (0 = no pain, 10 = pain as bad as you can imagine), please indicate the number that best describes: How much pain do you have right now?. | 24 weeks | 
| Pain-related disability (RMDQ) | Reduction of pain-related disability as measured by the Roland-Morris Disability Questionnaire (RMDQ) comparing intervention to usual care participants. This measure has a range of 0-24, with a higher score indicating higher disability. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotion Regulation Mediation (ERQ) | The Emotion Regulation Questionnaire (ERQ) has a range of 7-70 with a higher score indicating higher emotion regulation strategy. | 24 weeks |