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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487822
Recruitment Status : Suspended (Temporarily paused due to COVID-19, will resume based on guidance of public health authorities. This is not a suspension of IRB approval.)
First Posted : April 4, 2018
Last Update Posted : April 29, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Pain, Chronic Negative Emotions Behavioral: Path Pain Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
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
Official Title: A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions
Actual Study Start Date : August 8, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
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.
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.

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.



Primary Outcome Measures :
  1. 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?".

  2. 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 Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487822


Locations
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United States, New York
Center on Aging (formerly Wright Center on Aging)
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Pfizer
Investigators
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Principal Investigator: Cary Reid, MD, PhD Weill Cornell Medicine
Principal Investigator: Dimitris Kiosses, PhD Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03487822    
Other Study ID Numbers: 1509016564
28540451 ( Other Grant/Funding Number: Pfizer )
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms