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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 2020

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.

Interventions

  • Behavioral: Path Pain
    • 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.

Arms, Groups and Cohorts

  • Experimental: Path Pain
    • 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.
  • No Intervention: Usual Care with Education
    • 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
    • Providers of patients in the study will take part in a short interview on their impressions of the intervention.

Clinical Trial Outcome Measures

Primary Measures

  • Current Pain Intensity on an 11 point scale
    • Time Frame: 24 weeks
    • 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?”.
  • Pain-related disability (RMDQ)
    • Time Frame: 24 weeks
    • 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.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Weill Medical College of Cornell University
  • Collaborator
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cary Reid, MD, PhD, Principal Investigator, Weill Cornell Medicine
    • Dimitris Kiosses, PhD, Principal Investigator, Weill Cornell Medicine

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