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

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487822
• Other study ID #: 1509016564
• Secondary ID: 28540451
• Status: Completed
• Phase: N/A
• Start date: August 8, 2017
• Est. completion date: July 26, 2019

Study information

• Verified date: May 2021
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: July 26, 2019
• Est. primary completion date: July 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Negative Emotions
• Pain, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Center on Aging (formerly Wright Center on Aging)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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