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

Trial Summary

What is the purpose of this trial?

The proposed pre-pilot project seeks to adapt an evidence-based psychosocial intervention-Pain Adaptation Therapy (PATH)-that employs emotion regulation, behavioral activation, and problem-solving skills training, that will be augmented with a caregiver (CG) education component, for use by CGs of individuals with Alzheimer's Disease and Related Dementias (ADRD).

Research Team

Cary Reid, MD PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+