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NCT Number: NCT06854718

Pain With Dementia

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).

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Katherine Ramos, Ph.D

PRINCIPAL_INVESTIGATOR

Laura Porter, Ph.D

CONTACT

[email protected]

919-416-3436

Laura Porter, Ph.D

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Caregiver-Assisted Pain Coping Skills Training (CG-PCST)

Behavioral

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.

Primary outcomes

  1. Client Satisfaction Questionnaire

    Time frame: Post-intervention (approximately 8 weeks)

    Caregiver completes. Score range: 1-4; higher score indicates better outcome

Secondary outcomes

  1. Quality of life in Alzheimer's Disease Caregiver version and Patient version

    Time frame: Baseline and post-intervention (approximately 8 weeks)

    Patient and Caregiver will complete Patient QOL. Score range: 13-52; higher score indicates better outcome

  2. Brief Pain Inventory-Interference Items

    Time frame: Baseline and post-intervention (approximately 8 weeks)

    Patient and Caregiver will complete Patient pain interference. Score range: 0-10; higher score indicates worse outcome

  3. Caregiver Self-Efficacy in Pain Management

    Time frame: Baseline and post-intervention (approximately 8 weeks)

    Caregiver will complete caregiver self-efficacy. Score range: 0-10; higher score indicates better outcome

  4. Numeric pain scale & verbal descriptor

    Time frame: Baseline and post-intervention (approximately 8 weeks)

    Patient will complete patient pain intensity. Score range: 0-19; higher score indicates worse outcome

  5. Checklist of nonverbal pain indicators

    Time frame: Baseline and post-intervention (approximately 8 weeks)

    Caregiver will complete patient pain intensity. Score range: 0-10; higher score indicates worse outcome

  6. Zarit burden interview

    Time frame: Baseline and post-intervention (approximately 8 weeks)

    Caregivers will complete caregiver burden. Score range: 0-88; higher score indicates worse outcome

  7. Caregiver appraisal-satisfaction scale

    Time frame: Baseline and post-intervention (approximately 8 weeks)

    Caregiver will complete caregiver satisfaction. Score range: 0-10; higher score indicates worse outcome

  8. Neuropsychiatric inventory

    Time frame: Baseline and post-intervention (approximately 8 weeks)

    Caregiver will complete patient neuropsychiatry behaviors. Score range: 0-144; higher score indicates worse outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine Ramos, Ph.D

CONTACT

[email protected]

919-416-3434

Laura Porter, Ph.D

CONTACT

[email protected]

919-416-3436

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Aging (NIA)
  • National Institutes of Health (NIH)

Registry information

Official study title

Caregiver-assisted Pain Coping Skills Training for Dementia Pilot Study

Acronym: PWD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2025
Registry last updated
Dec 3, 2025

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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