PATH-Care for Caregiver Burden

(PATH-Care Trial)

Overseen By Patricia Kim, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Paid caregiver, Hospice, Severe depression, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program called PATH-Care designed to assist caregivers of individuals with Alzheimer's and related dementias. It focuses on teaching skills such as managing emotions, staying active, and problem-solving, with additional education tailored for caregivers. The trial seeks English-speaking caregivers who live with or near someone with Alzheimer's, have provided care for at least 10 hours a week for six months or more, and often feel stressed or upset. As an unphased trial, this study offers caregivers a unique opportunity to gain valuable skills and support.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a psychosocial intervention, so it's unlikely that medication changes are required, but you should confirm with the trial organizers.

What prior data suggests that this protocol is safe for caregivers?

Research shows that Problem Adaptation Therapy (PATH), the basis for PATH-Care, is safe for older adults with depression and memory problems. Studies have found that PATH is well-tolerated by individuals with mild to moderate dementia, with no reports of serious side effects. This suggests that PATH-Care, designed for caregivers of people with Alzheimer’s, is likely safe as well. However, discussing any concerns with the trial team is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

PATH-Care stands out because it adapts Problem Adaptation Therapy (PATH) specifically for caregivers, addressing their unique mental health needs. Unlike standard treatments that might focus only on the person receiving care, PATH-Care includes tailored therapeutic exercises delivered via a tablet, making it more accessible and interactive. Researchers are excited about this approach as it not only supports caregivers' mental well-being but also leverages technology to enhance therapy sessions, potentially leading to better outcomes and increased engagement.

What evidence suggests that PATH-Care is effective for reducing caregiver burden in Alzheimer's Disease and Related Dementias?

Research has shown that Problem Adaptation Therapy (PATH) can reduce stress and improve coping skills. Studies have found PATH effective in helping caregivers manage emotional and mental health challenges. It benefits both English and Spanish speakers, making it accessible to many. PATH has supported caregivers of people with dementia, aiding them in handling their responsibilities more effectively. This therapy focuses on managing emotions, taking positive actions, and solving problems, which may reduce the burden on caregivers of individuals with Alzheimer's and similar conditions. Participants in this trial will receive PATH-Care, an adaptation of PATH specifically designed for caregivers, along with tablet-based exercises to enhance and reinforce the therapy sessions. ^{3 6 7 8 9}

Who Is on the Research Team?

Cary Reid, MD PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults who have been caring for someone with Alzheimer's or related dementias for at least 6 months, providing a minimum of 10 hours of care per week. They must be English-speaking and score above certain levels on cognitive and emotional assessments. Paid caregivers, those caring for non-ADRD individuals, or anyone with severe depression are excluded.

Inclusion Criteria

Score of ≥ 12 on the Negative Affect Scale of Positive and Negative Affect Schedule OR at least one significant negative emotion (score of ≥ 3)

English speaking

Provides at least 10 hours of care per week to a person with ADRD

Exclusion Criteria

The person I care for does not have Alzheimer's or dementia.

Paid caregiver

I have been providing care for less than 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline assessment before starting the intervention

1 week

Treatment

Participants undergo 8 PATH-Care sessions with short feedback interviews and tablet-based exercises

8 weeks

Post-intervention Assessment

Participants complete a post-intervention assessment to evaluate changes in affect, depression, and caregiver burden

1 week

Follow-up

Participants are monitored for changes in affect, depression, and caregiver burden after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PATH-Care

Trial Overview The study tests an adapted version of Problem Adaptation Therapy (PATH) enhanced with caregiver education to help caregivers manage the emotional and practical challenges of caring for someone with Alzheimer's Disease or Related Dementias.

How Is the Trial Designed?

Group I: PATH-Care Experimental Treatment 1 Intervention

Problem Adaptation THerapy (PATH) adapted for caregivers along with tablet based exercises to enhance and reinforce the therapy sessions.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Cornell University

Collaborator

Trials

179

Recruited

14,090,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2962702/

Home-delivered Problem Adaptation Therapy (PATH) for ... This preliminary study examines the efficacy of 12-week home-delivered Problem Adaptation Therapy (PATH) vs. home-delivered Supportive Therapy (ST) in ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748119301162

THE EFFECTIVENESS OF PROBLEM ADAPTATION ... In this study, our objective was to assess if PATH worked equally well in English and Spanish speakers. Variables of interest include presence of suicidal ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7302999/

Effectiveness of Powerful Tools for Caregivers on ... Intent-to-treat analyses found PTC reduced caregiver burden (d= −0.48) ... Our primary outcomes were caregiver burden and the BPSD in the care recipient.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S106474812030364X

Adapting and Optimizing Problem Adaptation Therapy ... To adapt and optimize problem adaptation therapy for depression in dementia by grounding it in the lives of people with dementia, caregivers and clinicians.

5. academic.oup.com academic.oup.com/innovateage/article/9/5/igaf033/8090388

Speed of Processing Training for Stress Adaptation in ... This study aimed to identify effects of computerized cognitive training on cognitive and emotion indicators of caregivers' capacity for stress adaptation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4583822/

Problem Adaptation Therapy (PATH) for Older Adults with ... PATH is a treatment for older adults with major depression, cognitive impairment (from mild cognitive deficits to moderate dementia) and disability.

7. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.13766

Adapted problem adaptation therapy for depression in mild to ... Problem Adaptation Therapy (PATH) aims to improve emotion regulation through situation selection and modification, attentional deployment, ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/13607863.2025.2558882?src=

Adaptation and psychometric validation of treatment ... We report high floor effects observed across all 15 items indicating that a substantial proportion of caregivers reported no burden for several survey items.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10262169/

Problem Adaptation Therapy (PATH): Origins, Current ... An intervention designed to help reduce depression and disability in older adults with major depression and cognitive impairment.