A Personalized Self-Management Program for Older Adults With Chronic Pain and Negative Emotions
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|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
|Condition or disease||Intervention/treatment||Phase|
|Pain, Chronic Negative Emotions||Behavioral: Path Pain||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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?".
- 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.
- 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.
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
|United States, New York|
|Center on Aging (formerly Wright Center on Aging)|
|New York, New York, United States, 10065|
|Principal Investigator:||Cary Reid, MD, PhD||Weill Cornell Medicine|
|Principal Investigator:||Dimitris Kiosses, PhD||Weill Cornell Medicine|