Pain With Dementia (PWD)

Caregiver-assisted Pain Coping Skills Training for Dementia Pilot Study

The purpose of the study is to develop a caregiver-assisted pain coping skills training program for older adults who have pain and mild to moderate dementia and are living at home with a family caregiver. The investigators are planning to recruit 30 patient-caregiver dyads (60 individuals).

Study Overview

• Status: Recruiting
• Conditions: Pain; Dementia, Mild; Dementia, Moderate
• Intervention / Treatment: Behavioral: Caregiver-Assisted Pain Coping Skills Training (CG-PCST)

Detailed Description

Involving caregivers in a pain coping skills protocol is likely to optimize treatment outcomes in several ways.

First, people with dementia (PWD) are likely to have difficulty learning and remembering pain coping skills; training the caregiver to coach the patient in the use of the skills is likely to improve the patients' acquisition and ongoing use of learned skills.

Second, caregiver involvement in pain coping skills training may increase their understanding of how to gauge how much pain the PWD is experiencing and the impact of pain management strategies. This understanding is increasingly important as the patient's disease progresses, and s/he is less able to report pain verbally.

Third, caregiver-assisted pain management training may enhance caregivers' self-confidence for managing the patient's pain.

Finally, by participating in the pain coping skills training protocol, caregivers may learn coping skills (such as relaxation) that can help them manage the stress associated with caring for a PWD and pain which can be significant.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Porter, Ph.D; Phone Number: 919-416-3436; Email: Laura.Porter@duke.edu
• Study Contact Backup: Name: Katherine Ramos, Ph.D; Phone Number: 919-416-3434; Email: Katherine.Ramos@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Recruiting
      • Duke University Medical Center
      • Contact: Laura Porter, Ph.D; Phone Number: 919-416-3436; Email: porte008@mc.duke.edu
      • Principal Investigator: Laura Porter, Ph.D
      • Principal Investigator: Katherine Ramos, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Patients:

• Mild or moderate dementia
• Pain on most days for at least 3 months that interferes with function
• Living at home (non-institutional)
• Age ≥ 50
• English Speaking

Caregivers:

• Provides on average at least 4 hours/day of care/assistance to the patient
• Age ≥ 18
• English Speaking

Exclusion Criteria:

Patient and caregivers

• Lacking capacity for interview or unable to provide informed consent/assent.
• Visual or hearing impairments or severe behavioral problems that preclude participation.
• Too sick to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Patient-Caregiver Dyads; Patient and caregiver dyads will receive five 45-60 minute sessions over 6-8 week period. This will be over videoconference with a masters-level therapist. All sessions will be audio recorded.

Behavioral: Caregiver-Assisted Pain Coping Skills Training (CG-PCST); Patient-caregiver dyads will receive five, forty-to-sixty-minute sessions over a six-to-eight-week period with a therapist to learn pain coping skills. These include training caregivers in strategies for assessing patient pain, including nonverbal pain behaviors (e.g., grimacing, bodily tension, labored breathing), which will become increasingly important as the patient's ability to express pain verbally decreases. The therapist will also train the caregiver to coach the patient in the use of the skills during activities that are challenging because of pain. We will focus on increasing positive patient-caregiver interactions and patient engagement in valued activities. Throughout the training, the therapist will help the patient and caregiver learn strategies for fostering regular home practice and application of the skills, identify challenges in using the skills, and find strategies for coping with challenges.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire	Caregiver completes. Score range: 1-4; higher score indicates better outcome	Post-intervention (approximately 8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life in Alzheimer's Disease Caregiver version and Patient version	Patient and Caregiver will complete Patient QOL. Score range: 13-52; higher score indicates better outcome	Baseline and post-intervention (approximately 8 weeks)
Brief Pain Inventory-Interference Items	Patient and Caregiver will complete Patient pain interference. Score range: 0-10; higher score indicates worse outcome	Baseline and post-intervention (approximately 8 weeks)
Caregiver Self-Efficacy in Pain Management	Caregiver will complete caregiver self-efficacy. Score range: 0-10; higher score indicates better outcome	Baseline and post-intervention (approximately 8 weeks)
Numeric pain scale & verbal descriptor	Patient will complete patient pain intensity. Score range: 0-19; higher score indicates worse outcome	Baseline and post-intervention (approximately 8 weeks)
Checklist of nonverbal pain indicators	Caregiver will complete patient pain intensity. Score range: 0-10; higher score indicates worse outcome	Baseline and post-intervention (approximately 8 weeks)
Zarit burden interview	Caregivers will complete caregiver burden. Score range: 0-88; higher score indicates worse outcome	Baseline and post-intervention (approximately 8 weeks)
Caregiver appraisal-satisfaction scale	Caregiver will complete caregiver satisfaction. Score range: 0-10; higher score indicates worse outcome	Baseline and post-intervention (approximately 8 weeks)
Neuropsychiatric inventory	Caregiver will complete patient neuropsychiatry behaviors. Score range: 0-144; higher score indicates worse outcome	Baseline and post-intervention (approximately 8 weeks)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Laura Porter, Ph.D, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 25, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Neurocognitive Disorders; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Pain; Lymphoma, Follicular; Dementia
• Other Study ID Numbers: Pro00116129; 1R61AG088938-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No