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

NCT ID: NCT03487822

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-08

Study Completion Date

2019-07-26

Brief Summary

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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

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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.

Conditions

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Pain, Chronic Negative Emotions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators
The co-investigators performing assessments will be blind to the participant's arm.

Study Groups

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Path Pain

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.

Group Type EXPERIMENTAL

Path Pain

Intervention Type 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.

Usual Care with Education

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Provider Feedback

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Path 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* MoCA score \<16
* cancer related pain
* can not provide capacity to consent
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cary Reid, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Dimitris Kiosses, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Center on Aging (formerly Wright Center on Aging)

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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28540451

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1509016564

Identifier Type: -

Identifier Source: org_study_id