Pre-Pilot: Problem Adaptation THerapy in Caregivers

NCT05567120 | Withdrawn

• 2 other identifiers: 21-1202423522-08-535-380
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Caregiver Burden

Keywords

Caregiver

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At baseline; at week 10 (post-intervention)

Secondary Outcomes (6)

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

  At baseline; at week 10 (post-intervention)

• Change in emotion regulatory ability as measured by the Emotion Regulation Questionnaire (CERQ)

  At baseline; at week 10 (post-intervention)

• Change in positive aspects of caregiving as measured by the Positive Aspects of Caregiving scale (PAC)

  At baseline; at week 10 (post-intervention)

• Feasibility, Acceptability, and Usability of PATH-Care intervention

  At week 10 (post-intervention)

• Satisfaction as measured by Client Satisfaction Questionnaire (CSQ-3)

  At week 10 (post-intervention)

Study Arms (1)

PATH-Care

OTHER

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

Other: PATH-Care

Interventions

PATH-Care OTHER

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).

PATH-Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Cornell University: collaborator

Study Sites (1)

NewYork-Presbyterian - Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Cary Reid, MD PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 5, 2022
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)