Clinical trial NCT05567120: Pre-Pilot: Problem Adaptation THerapy in Caregivers
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Caregiver Burden
Keywords: Caregiver
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Cornell University
First posted: 2022-10-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Positive and Negative Affect as Measured by the Positive and Negative Affect Scale (PANAS)
timeFrame: At baseline; at week 10 (post-intervention)
measure: Change in depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS-S)
timeFrame: At baseline; at week 10 (post-intervention)
measure: Change in caregiver burden as measured by Zarit Burden Interveiw (ZBI-12)
timeFrame: At baseline; at week 10 (post-intervention)
Secondary outcomes:
measure: Change in efficacy and preparedness as measured by the Preparedness Caregiving Scale (PCS)
timeFrame: At baseline; at week 10 (post-intervention)
measure: Change in emotion regulatory ability as measured by the Emotion Regulation Questionnaire (CERQ)
timeFrame: At baseline; at week 10 (post-intervention)
measure: Change in positive aspects of caregiving as measured by the Positive Aspects of Caregiving scale (PAC)
timeFrame: At baseline; at week 10 (post-intervention)
measure: Feasibility, Acceptability, and Usability of PATH-Care intervention
timeFrame: At week 10 (post-intervention)
measure: Satisfaction as measured by Client Satisfaction Questionnaire (CSQ-3)
timeFrame: At week 10 (post-intervention)
measure: Usable intervention as measured by the System Usability Scale
timeFrame: At week 10 (post-intervention)
Other outcomes:
Locations:
city: New York
country: United States
facility: NewYork-Presbyterian - Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Cary Reid, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: