Recruiting

Pain Coping Skills

Sponsor:

Duke University

Code:

NCT06854718

Conditions

Pain

Dementia, Mild

Dementia, Moderate

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief 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).

Conditions

Pain

Dementia, Mild

Dementia, Moderate

Study ID

NCT06854718

Start date

Aug 13, 2025

Status verified date

Aug, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Client Satisfaction Questionnaire [ Time Frame: Post-intervention (approximately 8 weeks) ]

Central Contacts and Locations

Central contacts

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Principal Investigator:

Laura Porter, Ph.D

More Information

Sponsor

Duke University

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-05.