What this study is
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.
What's being tested
- Cognitive Behavioral Therapy for Caregivers
Intervention · OTHER
The intervention includes four "Foundational Sessions" delivered to all participants: Orientation and Engagement, Narrative Exploration, and Goal Setting Sessions at the beginning of treatment, followed by a structured Closing Session at the end of treatment. Beyond the four foundational sessions, caregiver clients complete an additional module based on their top area of need. These modules are called "Core Sessions" and are selected through a collaborative process that draws on caregiver preferences, clinical judgment, and assessment results to ensure treatment is tailored to each caregiver's unique experiences, interests, and goals.
Study details
- Sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Care Burden · Care Giving Burden · Caregiver Burnout · Caregiver Wellbeing
- Enrolling
- 60 people
- Starts
- 2025-09-11
- Est. completion
- 2027-03-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 99 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
- David J Rauscher, BA · ContactDavid_Rauscher@med.unc.edu
- Kelsey A Ludwig, PhD · Principal investigator
Recruiting
Study team
Sponsor
University of North Carolina, Chapel Hill
Study ID 25-1695
Principal investigator
Kelsey A Ludwig, PhD
UNC Chapel Hill
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.