Caregiver BurdenPATH-CareNCT05567120
Pre-Pilot: Problem Adaptation THerapy in Caregivers
A study testing PATH-Care in people with Caregiver Burden, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- PATH-Care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
NewYork-Presbyterian - Weill Cornell Medicine
New York, New York, 10065
About this study
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)
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).
Read the 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.
- Conditions
- Caregiver Burden
- Being tested
- PATH-Care
- Keywords
- Caregiver
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| PATH-Care | Other | Problem Adaptation THerapy (PATH) adapted for caregivers along with tablet based exercises to enhance and reinforce the therapy sessions. Receives: Other: PATH-Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline; at week 10 (post-intervention)
Secondary outcomes (6)
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?"
Measured: At baseline; at week 10 (post-intervention)
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.
Measured: At baseline; at week 10 (post-intervention)
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.
Measured: At baseline; at week 10 (post-intervention)
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?"
Measured: At week 10 (post-intervention)
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.
Measured: At week 10 (post-intervention)
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.
Measured: At week 10 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Study not started, investigators opted to focus on other projects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University
- Responsible party
- Sponsor
- Investigators
- Cary Reid, MD PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567120
- Sponsor's protocol ID
- 21-12024235
- Other IDs
- 22-08-535-380
- Acronym
- PATH-Care
- Status last verified
- Jan 2025
- First submitted
- 30 Sep 2022
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05567120
- Acronym / sponsor ID
- PATH-Care / 21-12024235
- Conditions
- Caregiver Burden
- Keywords
- Caregiver
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not started, investigators opted to focus on other projects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Cornell University
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PATH-Care | Other | Other: PATH-CareProblem Adaptation THerapy (PATH) adapted for caregivers along with tablet based exercises to enhance and reinforce the therapy sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- Age ≤ 18
- Non-English speaking
- Paid caregiver
- Care recipient does not have ADRD diagnosis
- Provides care for less than 10 hours per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PATH-CareIndividuals 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). | Other | PATH-Care |
Primary outcome
Change in Positive and Negative Affect as Measured by the Positive and Negative Affect Scale (PANAS)
Time frame: At baseline; at week 10 (post-intervention)
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)
Time frame: At baseline; at week 10 (post-intervention)
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)
Time frame: At baseline; at week 10 (post-intervention)
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.
6 secondary outcomes
Change in efficacy and preparedness as measured by the Preparedness Caregiving Scale (PCS)
Time frame: At baseline; at week 10 (post-intervention)
Change in emotion regulatory ability as measured by the Emotion Regulation Questionnaire (CERQ)
Time frame: At baseline; at week 10 (post-intervention)
Change in positive aspects of caregiving as measured by the Positive Aspects of Caregiving scale (PAC)
Time frame: At baseline; at week 10 (post-intervention)
Feasibility, Acceptability, and Usability of PATH-Care intervention
Time frame: At week 10 (post-intervention)
Satisfaction as measured by Client Satisfaction Questionnaire (CSQ-3)
Time frame: At week 10 (post-intervention)
Usable intervention as measured by the System Usability Scale
Time frame: At week 10 (post-intervention)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cary Reid, MD PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PATH-Care in people with Caregiver Burden, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Positive and Negative Affect as Measured by the Positive and Negative Affect Scale (PANAS) (time frame: At baseline; at week 10 (post-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025; AzTrials last refreshed its copy on 28 Oct 2026.