RecruitingNot Applicable

Caring for the Carer

United States60 participantsStarted 2025-09-11

Plain-language summary

The purpose of the present study is to investigate the acceptability and feasibility of implementing a novel, Cognitive Behavioral Therapy (CBT) intervention to caregivers and supporters of individuals who have experienced psychosis, regardless of their relative's engagement in treatment specific to psychosis (i.e., coordinated specialty care (CSC) services). Additionally, the investigators will assess the secondary aim of impact on well-being as a result of the intervention.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The participants must be a parent, caregiver, or supporter of a young person who has been referred to a CSC program for First Episode Psychosis (FEP) in the past 3 years. A parent or supporter is considered eligible for the study if their young person was referred to the program but chose not or was unable to engage in CSC or is currently on the waitlist for FEP treatment. * Parent, caregiver, or supporter must be at least 18 years of age * Participants recruited from UNC CSC programs * Parent, caregiver, or supporter must be able to engage in research assessments and consent to audio recording sessions for fidelity ratings Exclusion Criteria: * Parent, caregiver, or supporter is currently engaged in legal action against the loved one receiving services/experiencing psychosis * Parent, caregiver, or supporter's loved one has never experienced psychosis * Parent, caregiver, or supporter does not speak English

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change in the Experience of Caregiving (ECI) Score

Timeframe: Baseline, Month 6

Mean Change in UCLA Loneliness Scale Score

Timeframe: Baseline, Month 6

Mean Change in Modified PTSD Checklist for DSM-5

Timeframe: Baseline, Month 6

Mean Change in the Patient Health Questionnaire-8 Score

Timeframe: Baseline, Month 6

Mean Change in the General Anxiety Disorder-7 Score

Timeframe: Baseline, Month 6

Mean Change in the Self-Compassion Scale Short Form

Timeframe: Baseline, Month 6

Mean Change in Working Alliance Inventory Short Revised

Timeframe: Baseline, Month 6

Trial details

NCT IDNCT07167641

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31

Contact for this trial

David J Rauscher, BA

919-348-9779 david_rauscher@med.unc.edu

View on ClinicalTrials.gov More Care Burden trials

Plain-language summary

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean Change in the Experience of Caregiving (ECI) Score

Timeframe: Baseline, Month 6

Mean Change in UCLA Loneliness Scale Score

Timeframe: Baseline, Month 6

Mean Change in Modified PTSD Checklist for DSM-5

Timeframe: Baseline, Month 6

Mean Change in the Patient Health Questionnaire-8 Score

Timeframe: Baseline, Month 6

Mean Change in the General Anxiety Disorder-7 Score

Timeframe: Baseline, Month 6

Mean Change in the Self-Compassion Scale Short Form

Timeframe: Baseline, Month 6

Mean Change in Working Alliance Inventory Short Revised

Timeframe: Baseline, Month 6