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

NCT03487822 | Completed DMC

• 2 other identifiers: 150901656428540451
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Negative Emotions

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 10 weeks

Secondary Outcomes (3)

• Change in Emotion Regulation Mediation (ERQ)

  Baseline, 10 and 24 weeks

• Client Satisfaction Questionnaire (CSQ)

  24 weeks

• Change in Montgomery-Asberg Depression Rating Scale (MADRS)

  Baseline, 10 and 24 weeks

Study Arms (3)

Path Pain

EXPERIMENTAL

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.

Behavioral: Path Pain

Usual Care with Education

NO INTERVENTION

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

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

Interventions

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.

Path Pain

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient Participants:
• 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

You may not qualify if:

• MoCA score \<16
• cancer related pain
• can not provide capacity to consent

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Pfizer: collaborator

Study Sites (1)

Center on Aging (formerly Wright Center on Aging)

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cary Reid, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Dimitris Kiosses, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The co-investigators performing assessments will be blind to the participant's arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 4, 2018
• Study Start: August 8, 2017
• Primary Completion: July 26, 2019
• Study Completion: July 26, 2019
• Last Updated: December 18, 2024

Record last verified: 2024-12

Locations

US (1)