| NCT ID | NCT07167641 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Care Burden |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-11 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-09-11 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Kelsey A Ludwig, PhD
PRINCIPAL INVESTIGATOR
UNC Chapel Hill
Frequently Asked Questions
Who can join the NCT07167641 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Care Burden. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07167641 currently recruiting?
Yes, NCT07167641 is actively recruiting participants. Contact the research team at david_rauscher@med.unc.edu for enrollment information.
Where is the NCT07167641 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT07167641 clinical trial?
NCT07167641 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Kelsey A Ludwig, PhD at UNC Chapel Hill. The trial plans to enroll 60 participants.