Caregiver-Assisted Pain Coping for Dementia

(PWD Trial)

Overseen By Katherine Ramos, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Severe behavioral problems, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 6-8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial develops a program to help caregivers assist older adults with pain management. It specifically targets those with ongoing pain and mild to moderate dementia who live at home. The trial involves the caregiver and patient working together with a therapist through online sessions. This program, called Caregiver-Assisted Pain Coping Skills Training (CG-PCST), suits those with dementia who experience pain disrupting daily activities and have a caregiver providing significant daily support. As an unphased trial, it offers patients a unique opportunity to contribute to innovative solutions in pain management and dementia care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that this caregiver-assisted pain coping skills training is safe for dementia patients?

Research shows that the Caregiver-Assisted Pain Coping Skills Training (CG-PCST) is both well-received and safe. In an earlier study, 82% of caregiver-patient pairs completed all the training sessions. Caregivers rated their satisfaction highly, with an average score of 3.4 out of 4, indicating they found the program helpful and safe.

Participants did not report any major issues during the sessions. Feedback from participants improved the program, emphasizing safety and effectiveness. No reports of negative effects suggest the training is well-tolerated. Overall, these findings provide confidence in the safety of this coping skills program for people with dementia and their caregivers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Caregiver-Assisted Pain Coping Skills Training (CG-PCST) for dementia because it involves a unique, holistic approach that actively engages caregivers in the treatment process. Unlike standard treatments that often focus on medication to manage pain and behavioral symptoms, this method empowers caregivers with coping strategies to help manage the patient's pain through guided sessions. Delivered via videoconference with a trained therapist, this method not only provides flexibility and accessibility for caregivers and patients but also strengthens the caregiver-patient relationship, which can enhance overall care and outcomes.

What evidence suggests that Caregiver-Assisted Pain Coping Skills Training is effective for dementia-related pain?

Research has shown that training caregivers in pain management can effectively assist people with dementia who experience pain. In earlier studies, caregivers felt more confident in noticing and discussing pain symptoms. Specifically, 67% felt more confident in recognizing pain, and 83% felt more confident in discussing it. Caregivers also reported high satisfaction with the program, giving it a score of 3.4 out of 4. In this trial, patient-caregiver dyads will receive Caregiver-Assisted Pain Coping Skills Training (CG-PCST) to enhance caregivers' ability to manage pain in dementia patients. ^{1 2 4 6 7}

Who Is on the Research Team?

Laura Porter, Ph.D

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for individuals aged 50 or older with mild to moderate dementia experiencing daily pain for at least three months that disrupts their daily life. They must live at home, speak English, and have a caregiver who assists them for at least four hours per day. Caregivers must be 18 or older.

Inclusion Criteria

I provide at least 4 hours of care daily to the patient.

I live in my own home, not in a care facility.

I am 50 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patient-caregiver dyads receive five 45-60 minute sessions over a 6-8 week period via videoconference with a masters-level therapist

6-8 weeks

5 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study aims to test a program where caregivers help patients with dementia develop skills to manage pain better. It involves training sessions designed specifically for patient-caregiver pairs, focusing on coping strategies tailored to the challenges of dementia.

How Is the Trial Designed?

Group I: Patient-Caregiver Dyads Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

An educational intervention based on the Progressively Lowered Stress Threshold (PLST) model significantly improved the knowledge and caregiving practices of 38 caregivers for people with dementia over a two-year period in Isfahan, Iran.

The study demonstrated that tailored educational content, considering cultural and religious backgrounds, effectively enhanced caregivers' skills in managing challenging behaviors associated with dementia, as indicated by statistically significant increases in their knowledge and practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of educational intervention based on the Progressively Lowered Stress Threshold extended model on the process of caregiving for people with dementia. Zamani-Alavijeh, F., Zahed, S., Emami, M., et al.[2023]

The Pain Identification and Communication Toolkit (PICT) was successfully implemented in a pilot trial with family caregivers of 34 individuals with dementia, showing that 100% of participants completed the intervention and 94% completed follow-up assessments.

Caregivers who used PICT reported increased confidence in recognizing (67%) and communicating about pain symptoms (83%), indicating that the toolkit may effectively enhance caregivers' skills in managing pain in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing the Feasibility and Acceptability of a Caregiver Targeted Intervention to Improve Pain Assessment Among Persons With Dementia. Riffin, C., Brody, L., Mukhi, P., et al.[2023]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11197599

Caregiver-assisted pain coping skills training for dementia Aims of the proposed study are: (1) To refine the caregiver-assisted PCST intervention specifically for patients with mild-moderate dementia and determine the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06854718

Study Details | 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10032330/

Partnering to cope with pain: A pilot study of a caregiver ... Caregivers reported high levels of confidence in using the PAINAD, pain thermometer, pleasant activities, and music (3.4–3.8, very to extremely confident).

4. withpower.com withpower.com/trial/phase-alzheimer-disease-3-2025-1c6b7

Caregiver-Assisted Pain Coping for Dementia (PWD Trial) Caregivers who used PICT reported increased confidence in recognizing (67%) and communicating about pain symptoms (83%), indicating that the toolkit may ...

5. researchgate.net researchgate.net/publication/357138277_Caregiver-Assisted_Pain_Coping_Skills_Training_for_Patients_With_Dementia_A_Pilot_Study

Caregiver-Assisted Pain Coping Skills Training for Patients ... Nine dyads (82%) completed all five sessions. Caregivers reported high levels of satisfaction with the intervention (mean=3.4 on 1-4 scale) and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8679282/

Caregiver-Assisted Pain Coping Skills Training for Patients ... Nine dyads (82%) completed all five sessions. Caregivers reported high levels of satisfaction with the intervention (mean=3.4 on 1-4 scale) and frequent use of ...

7. escholarship.org escholarship.org/content/qt0m1996p2/qt0m1996p2.pdf

A pilot study of a caregiver-assisted pain coping skills ... Results: Dyads responded positively to the pain coping skills presented in the interviews; their feedback was used to refine the intervention.