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

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Pain, Chronic; Negative Emotions

Treatments: Behavioral: Path Pain

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03487822

1509016564

28540451 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 157 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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157 participants in 3 patient groups

Path Pain

Experimental group

Description:

Path Pain participants will be receiving 8 weekly therapy session by license clinicians trained in the Path Pain intervention. Participants will also receive 4, 15-minute phone booster sessions, on a monthly basis after their final therapy session. Participants will also be invited to monthly group educational sessions. Both intervention and usual care participants will be receiving a pain educational booklet.

Treatment:

Behavioral: Path Pain

Usual Care with Education

No Intervention group

Description:

Usual Care with Education (UCE) will receive a pain educational booklet. Following completion of 24 weeks in the study, participants will also be invited to attend the monthly group educational sessions.

Provider Feedback

No Intervention group

Description:

Providers of patients in the study will take part in a short interview on their impressions of the intervention.