Negative Emotions, Pain, Chronic
Conditions
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.
Interventions
BEHAVIORALPath 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.
Sponsors
Pfizer
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
The co-investigators performing assessments will be blind to the participant's arm.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Current Pain Intensity on an 11 point scale | Baseline, 10 weeks | Pain intensity is an 11 item scale with a range of 0-11 with a higher score indicating higher pain. |
| Change in Pain-related disability (RMDQ) | Baseline, 10 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Emotion Regulation Mediation (ERQ) | Baseline, 10 and 24 weeks | The Emotion Regulation Questionnaire (ERQ) has a range of 7-70 with a higher score indicating higher emotion regulation strategy. |
| Client Satisfaction Questionnaire (CSQ) | 24 weeks | 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 |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) | Baseline, 10 and 24 weeks | The Montgomery-Asberg Depression Rating Scale (MADRS) has a range of 0-60 with a higher score indicating higher depression |
Countries
United States
Outcome results
None listed