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

Not Applicable

Completed

• Conditions: Pain, Chronic; Negative Emotions
• Interventions: Behavioral: Path Pain

• Registration Number: NCT03487822
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-08-08
• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-04-02
• Study First Posted: 2018-04-04
• Primary Completion: 2019-07-26
• Study Completion: 2019-07-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Path Pain	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Center on Aging (formerly Wright Center on Aging); 🇺🇸 New York, New York, United States