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Caregiver-assisted Pain Coping Skills Training for Dementia Pilot Study

NCT ID: NCT06854718Sponsor: Duke UniversityLast updated: 2025-12-03

Summary

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).

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.

Arms & interventions

  • BehavioralCaregiver-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.

Outcome measures

Primary

  • Client Satisfaction Questionnaire

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

    Time frame: Post-intervention (approximately 8 weeks)

Secondary

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

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

  • Brief Pain Inventory-Interference Items

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

  • Caregiver Self-Efficacy in Pain Management

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

  • Numeric pain scale & verbal descriptor

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

  • Checklist of nonverbal pain indicators

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

  • Zarit burden interview

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

  • Caregiver appraisal-satisfaction scale

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

  • Neuropsychiatric inventory

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

Eligibility criteria

Sex: AllAge: 50 Years and olderHealthy volunteers: Yes
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 locations (1)

Duke University Medical Center

Durham, North Carolina, 27705

Recruiting
Laura Porter, Ph.D · Contact
Laura Porter, Ph.D · Principal Investigator
Katherine Ramos, Ph.D · Principal Investigator