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

NCT03487822

Last updated date
Study Location
Wright Center on Aging
New York, New York, 10075, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Pain, Negative Emotions
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Patient Participants:


- MoCA score <16


- cancer related pain


- can not provide capacity to consent

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Chronic Pain, Negative EmotionsA Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions
NCT03487822
  1. New York, New York
ALL GENDERS
60 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions
Official Title  ICMJE A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description:
The co-investigators performing assessments will be blind to the participant's arm.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pain, Chronic
  • Negative Emotions
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Path Pain
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 27, 2020)
140
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2018)
120
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03487822
Other Study ID Numbers  ICMJE 1509016564
28540451 ( Other Grant/Funding Number: Pfizer )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Cary Reid, MD, PhDWeill Cornell Medicine
Principal Investigator:Dimitris Kiosses, PhDWeill Cornell Medicine
PRS Account Weill Medical College of Cornell University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP