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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03487822
Other study ID # 1509016564
Secondary ID 28540451
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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