Pre-Pilot: Problem Adaptation THerapy in Caregivers

Weill Medical College of Cornell University

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Conditions

Caregiver Burden

Interventions

PATH-CareOTHER

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).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

NewYork-Presbyterian - Weill Cornell Medicine

New York, New York, United States

Outcomes

Primary Outcomes

Change in Positive and Negative Affect as Measured by the Positive and Negative Affect Scale (PANAS)

The 20-item self-report Positive and Negative Affect Scale (PANAS-GEN) asks participants to describe to what extent they feel different feelings and emotions on average. Respondents answer on a five-point scale: 1=Very slightly or not at all, 2=A little, 3=Moderately, 4=Quite a bit, 5=Extremely. There are different subscales within this measure with 10 questions measuring positive affect, and 10 measuring negative affect. These have scores ranging from 10-50 with a higher score indicating higher positive affect, and a lower score indicating lower negative affect respectively.

Time frame: At baseline; at week 10 (post-intervention)

Change in depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS-S)

The 9-item self-report Montgomery-Asberg Depression Rating Scale asks participants about items like sadness, inner tension, sleep, and concentration. Respondents answer on a 7-point scale loosely by: 0=Normal, 2=Slight reduction, 4=Moderate reduction, and 6=Completely unable. These responses are personalized to the question a little more specifically. Scores range from 0-54 with a higher score indicating higher depression.

Time frame: At baseline; at week 10 (post-intervention)

Change in caregiver burden as measured by Zarit Burden Interveiw (ZBI-12)

The 12-item self-report Zarit Burden Interview Scale asks participants "do you feel...?" with responses about caregiver burden like anger, stress, and social life. Respondents answer on a 5-point scale: 0= Never, 1=Rarely, 2=Sometimes, 3=Quite Frequently, 4=Nearly Always. Scores range from 0-48 with a higher score indicating higher burden.

Time frame: At baseline; at week 10 (post-intervention)

Secondary Outcomes

Change in efficacy and preparedness as measured by the Preparedness Caregiving Scale (PCS)

This 8-item likert questions with 1 open-ended question measures efficacy and preparedness for caregiving. Respondents answer the likert questions on a 5-point scale: 0=not at all prepared, 1=not too well prepared, 2=somewhat well prepared, 3=pretty well prepared, and 4=very well prepared. The mean score is calculated with these 8 questions and a higher score indicates higher preparedness. The open-ended question asks, "Is there anything specific you would like to be better prepared for?"

Data from ClinicalTrials.gov

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