PainPWDNCT06854718
Pain With Dementia
A study testing Caregiver-Assisted Pain Coping Skills Training (CG-PCST) in people with Pain and Dementia, Mild, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Dementia, Mild, Dementia, Moderate
- What is being tested?
- Caregiver-Assisted Pain Coping Skills Training (CG-PCST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Caregivers:
- Provides on average at least 4 hours/day of care/assistance to the patient
- Age ≥ 18
- English Speaking
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27705
Laura Porter, Ph.D, 919-416-3436, porte008@mc.duke.edu
Laura Porter, Ph.D
About this study
Official title: 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).
Read the 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.
- Conditions
- Pain, Dementia, Mild, Dementia, Moderate
- Being tested
- Caregiver-Assisted Pain Coping Skills Training (CG-PCST)
- Medical subject headings
- Pain, Dementia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver-Assisted Pain Coping Skills Training (CG-PCST)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient-Caregiver Dyads | Other | 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. Receives: Behavioral: Caregiver-Assisted Pain Coping Skills Training (CG-PCST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire
Caregiver completes. Score range: 1-4; higher score indicates better outcome
Measured: Post-intervention (approximately 8 weeks)
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and post-intervention (approximately 8 weeks)
Zarit burden interview
Caregivers will complete caregiver burden. Score range: 0-88; higher score indicates worse outcome
Measured: 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
Measured: Baseline and post-intervention (approximately 8 weeks)
Neuropsychiatric inventory
Caregiver will complete patient neuropsychiatry behaviors. Score range: 0-144; higher score indicates worse outcome
Measured: Baseline and post-intervention (approximately 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start13 Aug 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Laura Porter, Ph.D, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854718
- Sponsor's protocol ID
- Pro00116129
- Other IDs
- 1R61AG088938-01
- Acronym
- PWD
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2025
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver-assisted Pain Coping Skills Training for Dementia Pilot Study
- ClinicalTrials.gov ID
- NCT06854718
- Acronym / sponsor ID
- PWD / Pro00116129
- Conditions
- Pain, Dementia, Mild, Dementia, Moderate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient-Caregiver Dyads | Other | Behavioral: Caregiver-Assisted Pain Coping Skills Training (CG-PCST)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 may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Patient-Caregiver Dyads |
Primary outcome
Client Satisfaction Questionnaire
Time frame: Post-intervention (approximately 8 weeks)
Caregiver completes. Score range: 1-4; higher score indicates better outcome
8 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura Porter, Ph.D principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver-Assisted Pain Coping Skills Training (CG-PCST) in people with Pain and Dementia, Mild, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Porter, Ph.D (919-416-3436, Laura.Porter@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire (time frame: Post-intervention (approximately 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.