Back to resultsPre-Pilot: Problem Adaptation THerapy in Caregivers (PATH-Care)
Primary Purpose
Caregiver Burden
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PATH-Care
Sponsored by
About this trial
This is an interventional other trial for Caregiver Burden focused on measuring Caregiver
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
Sites / Locations
- NewYork-Presbyterian - Weill Cornell Medicine
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
PATH-Care
Arm Description
Problem Adaptation THerapy (PATH) adapted for caregivers along with tablet based exercises to enhance and reinforce the therapy sessions.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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?"
Change in emotion regulatory ability as measured by the Emotion Regulation Questionnaire (CERQ)
The 10-item self-report Emotion Regulation Questionnaire measures cognitive reappraisal and expressive suppression measured separately. Respondents answer on a seven-point scale: 1=strongly disagree, 4=neutral, and 7=strongly agree. The six cognitive reappraisal questions are calculated with a mean score and a higher score indicated higher cognitive reappraisal. The four expressive suppression questions are calculated with a mean score and a higher score indicates higher expressive suppression.
Change in positive aspects of caregiving as measured by the Positive Aspects of Caregiving scale (PAC)
The 9-item self-report scale measures positive aspects of caregiving. Respondents answer on a 5-point scale: 1=disagree a lot, 2=disagree a little, 3=neither agree or disagree, 4=agree a little, and 5=agree a lot. The questions are summed with a range of 9-45 with a higher score indicating more positive caregiving experiences.
Feasibility, Acceptability, and Usability of PATH-Care intervention
Feasibility, acceptability, and usability will be measured by 6 open-ended questions during the post-intervention assessment. Questions include "What were your overall impressions of the therapy?," "What would you change about the therapy?," and "Would you recommend this treatment to people who are caregivers like yourself?"
Satisfaction as measured by Client Satisfaction Questionnaire (CSQ-3)
This 3-item Client Satisfaction Questionnaire measures the self-reported satisfaction of the intervention. Respondents report levels of satisfaction on a 4-point scale with 4 having "almost all of my needs have been met" "very satisfied" and "yes, definitely" and 1 having "none of my needs have been met", "quite dissatisfied", and "no, definitely not". Scores range from 3-12 with a higher score indicating higher satisfaction.
Usable intervention as measured by the System Usability Scale
This 10-item adapted measure of the System Usability Scale will measure usability of the intervention. Respondents rank each question from 1 to 5 based on how much they agree with the statement with 5 being "strongly agree" and 1 being "strongly disagree". Scores are converted to a 100-point scale with a higher score indicating higher usability.
Full Information
NCT ID
NCT05567120
First Posted
September 30, 2022
Last Updated
September 29, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT05567120
Brief Title
Pre-Pilot: Problem Adaptation THerapy in Caregivers
Acronym
PATH-Care
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2024 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden
Keywords
Caregiver
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PATH-Care
Arm Type
Other
Arm Description
Problem Adaptation THerapy (PATH) adapted for caregivers along with tablet based exercises to enhance and reinforce the therapy sessions.
Intervention Type
Other
Intervention Name(s)
PATH-Care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Positive and Negative Affect as Measured by the Positive and Negative Affect Scale (PANAS)
Description
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)
Title
Change in depression as measured by Montgomery-Asberg Depression Rating Scale (MADRS-S)
Description
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)
Title
Change in caregiver burden as measured by Zarit Burden Interveiw (ZBI-12)
Description
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 Outcome Measure Information:
Title
Change in efficacy and preparedness as measured by the Preparedness Caregiving Scale (PCS)
Description
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?"
Time Frame
At baseline; at week 10 (post-intervention)
Title
Change in emotion regulatory ability as measured by the Emotion Regulation Questionnaire (CERQ)
Description
The 10-item self-report Emotion Regulation Questionnaire measures cognitive reappraisal and expressive suppression measured separately. Respondents answer on a seven-point scale: 1=strongly disagree, 4=neutral, and 7=strongly agree. The six cognitive reappraisal questions are calculated with a mean score and a higher score indicated higher cognitive reappraisal. The four expressive suppression questions are calculated with a mean score and a higher score indicates higher expressive suppression.
Time Frame
At baseline; at week 10 (post-intervention)
Title
Change in positive aspects of caregiving as measured by the Positive Aspects of Caregiving scale (PAC)
Description
The 9-item self-report scale measures positive aspects of caregiving. Respondents answer on a 5-point scale: 1=disagree a lot, 2=disagree a little, 3=neither agree or disagree, 4=agree a little, and 5=agree a lot. The questions are summed with a range of 9-45 with a higher score indicating more positive caregiving experiences.
Time Frame
At baseline; at week 10 (post-intervention)
Title
Feasibility, Acceptability, and Usability of PATH-Care intervention
Description
Feasibility, acceptability, and usability will be measured by 6 open-ended questions during the post-intervention assessment. Questions include "What were your overall impressions of the therapy?," "What would you change about the therapy?," and "Would you recommend this treatment to people who are caregivers like yourself?"
Time Frame
At week 10 (post-intervention)
Title
Satisfaction as measured by Client Satisfaction Questionnaire (CSQ-3)
Description
This 3-item Client Satisfaction Questionnaire measures the self-reported satisfaction of the intervention. Respondents report levels of satisfaction on a 4-point scale with 4 having "almost all of my needs have been met" "very satisfied" and "yes, definitely" and 1 having "none of my needs have been met", "quite dissatisfied", and "no, definitely not". Scores range from 3-12 with a higher score indicating higher satisfaction.
Time Frame
At week 10 (post-intervention)
Title
Usable intervention as measured by the System Usability Scale
Description
This 10-item adapted measure of the System Usability Scale will measure usability of the intervention. Respondents rank each question from 1 to 5 based on how much they agree with the statement with 5 being "strongly agree" and 1 being "strongly disagree". Scores are converted to a 100-point scale with a higher score indicating higher usability.
Time Frame
At week 10 (post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cary Reid, MD PhD
Phone
212-746-1378
Email
mcr2004@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Kim, MSW
Phone
212-746-1758
Email
pak2020@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cary Reid, MD PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NewYork-Presbyterian - Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pre-Pilot: Problem Adaptation THerapy in Caregivers
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