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Completed

NCT Number: NCT03487822

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

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.

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Key information

Conditions

Pain, Chronic Chronic Pain Negative Emotions Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center on Aging (formerly Wright Center on Aging)

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Path Pain

Behavioral

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.

Primary outcomes

  1. Change in Current Pain Intensity on an 11 point scale

    Time frame: Baseline, 10 weeks

    Pain intensity is an 11 item scale with a range of 0-11 with a higher score indicating higher pain.

  2. Change in Pain-related disability (RMDQ)

    Time frame: 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 outcomes

  1. Change in Emotion Regulation Mediation (ERQ)

    Time frame: 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.

  2. Client Satisfaction Questionnaire (CSQ)

    Time frame: 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

  3. Change in Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Pfizer

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2018
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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