Clinical trial NCT03487822: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Negative Emotions
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2018-04-04
Enrollment: 157
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. The investigators 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). The investigators 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 5, 10 (end of treatment), and 24 weeks.

Additionally, 20 providers of patients will be interviewed for feedback regarding the intervention.

Edits were made in November 2024 to better align with the study protocol regarding timing and measures.

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

Primary outcomes:
measure: Change in Current Pain Intensity on an 11 point scale
timeFrame: Baseline, 10 weeks
measure: Change in Pain-related disability (RMDQ)
timeFrame: Baseline, 10 weeks
Secondary outcomes:
measure: Change in Emotion Regulation Mediation (ERQ)
timeFrame: Baseline, 10 and 24 weeks
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 24 weeks
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline, 10 and 24 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Center on Aging (formerly Wright Center on Aging)
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Cary Reid, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: Dimitris Kiosses, PhD
role: PRINCIPAL_INVESTIGATOR
References: