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

Primary Purpose

Pain, Chronic, Negative Emotions

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Path Pain
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Chronic

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Center on Aging (formerly Wright Center on Aging)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Path Pain

Usual Care with Education

Provider Feedback

Arm Description

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.

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.

Providers of patients in the study will take part in a short interview on their impressions of the intervention.

Outcomes

Primary Outcome Measures

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?".
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.

Secondary Outcome Measures

Emotion Regulation Mediation (ERQ)
The Emotion Regulation Questionnaire (ERQ) has a range of 7-70 with a higher score indicating higher emotion regulation strategy.

Full Information

First Posted
March 19, 2018
Last Updated
May 4, 2021
Sponsor
Weill Medical College of Cornell University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03487822
Brief Title
A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions
Official Title
A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
July 26, 2019 (Actual)
Study Completion Date
July 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Negative Emotions

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The co-investigators performing assessments will be blind to the participant's arm.
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Path Pain
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care with Education
Arm Type
No Intervention
Arm Description
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.
Arm Title
Provider Feedback
Arm Type
No Intervention
Arm Description
Providers of patients in the study will take part in a short interview on their impressions of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Path Pain
Intervention Description
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.
Primary Outcome Measure Information:
Title
Current Pain Intensity on an 11 point scale
Description
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?".
Time Frame
24 weeks
Title
Pain-related disability (RMDQ)
Description
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.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Emotion Regulation Mediation (ERQ)
Description
The Emotion Regulation Questionnaire (ERQ) has a range of 7-70 with a higher score indicating higher emotion regulation strategy.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cary Reid, MD, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dimitris Kiosses, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center on Aging (formerly Wright Center on Aging)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

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

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