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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
157
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.
Center on Aging (formerly Wright Center on Aging)
New York, New York, United States
Change in Current Pain Intensity on an 11 point scale
Pain intensity is an 11 item scale with a range of 0-11 with a higher score indicating higher pain.
Time frame: Baseline, 10 weeks
Change in Pain-related disability (RMDQ)
Pain-related disability as measured by the Roland-Morris Disability Questionnaire (RMDQ). This measure has a range of 0-24, with a higher score indicating higher disability.
Time frame: Baseline, 10 weeks
Change in Emotion Regulation Mediation (ERQ)
The Emotion Regulation Questionnaire (ERQ) has a range of 7-70 with a higher score indicating higher emotion regulation strategy.
Time frame: Baseline, 10 and 24 weeks
Client Satisfaction Questionnaire (CSQ)
Investigators will use 3 of the 8 questions in the Client Satisfaction Questionnaire (CSQ) which has a range of 3-12; a higher score indicating higher satifaction
Time frame: 24 weeks
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
The Montgomery-Asberg Depression Rating Scale (MADRS) has a range of 0-60 with a higher score indicating higher depression
Time frame: Baseline, 10 and 24 weeks
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