Caring for the Carer

NCT ID: NCT07167641

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-11
• Study Completion Date: 2026-08-31

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.

Detailed Description

Purpose: 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.

Participants: 30 caregivers or supporters of individuals who have experienced psychosis and have been referred to or are actively engaged in treatment with two CSC clinics (OASIS and Encompass) Procedures (methods): All participants will be recruited on a rolling basis from two CSC clinics. Participants will engage in a novel, CBT therapy intervention co-developed by Kelsey Ludwig, PhD, and David Penn, PhD. Participants will receive the individual therapy intervention once per week or bi-weekly, for 20 sessions, over the course of 6 months. All therapy sessions will be conducted by trained Masters' or Doctorate level therapists and will be recorded to score treatment fidelity for each therapist. Experiences, wellbeing, and support measures will be taken at baseline and post-treatment, participants will be compensated for these assessments.

Conditions

Care Burden; Care Giving Burden; Caregiver Burnout; Caregiver Wellbeing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Caring for the Carer Participants

Participants (caregivers and supporters) will participate in four foundational sessions (orientation, goal-setting) and up to 16 CBT-focused sessions. A maximum of 20 individual therapy sessions will be delivered to all participants from their date of enrollment up to 6 months.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy for Caregivers

Intervention Type: 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.

Interventions

Cognitive Behavioral Therapy for Caregivers

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

North Carolina Department of Health and Human Services

OTHER_GOV

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelsey A Ludwig, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David J Rauscher, BA

Role: CONTACT

david_rauscher@med.unc.edu

919-348-9779

Facility Contacts

David J Rauscher, BA

Role: primary

David_Rauscher@med.unc.edu

Other Identifiers

25-1695

Identifier Type: -

Identifier Source: org_study_id