NCT05567120

Pre-Pilot: Problem Adaptation THerapy in Caregivers

Pre-Pilot: Adapting and Testing an Evidence-Based Emotion Regulation Therapy for Use by Caregivers of Individuals With Alzheimer's Disease and Related Dementias (ADRD)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

The study team will conduct an uncontrolled pre-pilot test of an adapted PATH-Care intervention with family CGs of persons with ADRD (target N=15). Following the informed consent process, screening, and enrollment, participants will complete a baseline assessment, 8 PATH-Care sessions with short feedback interviews, tablet-based exercises, and a post-intervention assessment. Primary Objective(s): To adapt the existing PATH intervention as a tool to mitigate negative emotions and stress experienced by informal CGs of individuals with ADRD, by employing an evidence-based user-center design protocol and obtaining additional suggestions for program refinement through an uncontrolled usability study.

Conditions

• Caregiver Burden

Interventions

Type	Name	Description
OTHER	PATH-Care	Individuals will receive the 8-session PATH-Care intervention, delivered virtually (via videoconference or phone) to mitigate negative emotions and stress experienced by informal caregivers of individuals with ADRD. The therapist in the first session will also guide the participant in the tablet-based exercises (WELLPath).

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-10-05
• Last updated: 2025-01-31

Locations

1 site across 1 country: United States