Pre-Pilot: Problem Adaptation THerapy in Caregivers (PATH-Care)

Weill Cornell Medicine (WCM)

Status: Withdrawn

Conditions: Caregiver Burden

Treatments: Other: PATH-Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05567120

21-12024235

22-08-535-380 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 18
• English speaking
• Informal caregiver of an individual with ADRD diagnosis
• Lives with or near the care recipient
• Provides at least 10 hours of care per week to a person with ADRD
• Has provided care to a person with ADRD for 6 months or more, prior to enrollment
• Cognitively intact (Score of ≥ 26 on adjusted MoCA-Blind)
• Score of ≥ 12 on the Negative Affect Scale of Positive and Negative Affect Schedule OR at least one significant negative emotion (score of ≥ 3)

Exclusion criteria

• Age ≤ 18
• Non-English speaking
• Paid caregiver
• Care recipient does not have ADRD diagnosis
• Provides care for less than 10 hours per week
• Has provided care for less than 6 months, prior to enrollment
• Care recipient is currently enrolled in hospice
• Meets criteria for severe Major Depression (Montgomery Asberg Depression Rating Scale ≥ 30) that may require hospitalization
• Significant Cognitive impairment (Score of < 26 on adjusted MoCA-Blind)
• Score of < 12 on the Negative Affect Scale of Positive and Negative Affect Schedule or no significant negative emotion

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

PATH-Care

Other group

Description:

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

Treatment:

Other: PATH-Care