Recruiting

CBT

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT07167641

Conditions

Care Burden

Care Giving Burden

Caregiver Burnout

Caregiver Wellbeing

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Cognitive Behavioral Therapy for Caregivers

Study Details

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.

Conditions

Care Burden

Care Giving Burden

Caregiver Burnout

Caregiver Wellbeing

Study ID

NCT07167641

Start date

Sep 11, 2025

Status verified date

Sep, 2025

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Mean Change in the Experience of Caregiving (ECI) Score [ Time Frame: Baseline, Month 6 ]
  • Mean Change in UCLA Loneliness Scale Score [ Time Frame: Baseline, Month 6 ]
  • Mean Change in Modified PTSD Checklist for DSM-5 [ Time Frame: Baseline, Month 6 ]
  • Mean Change in the Patient Health Questionnaire-8 Score [ Time Frame: Baseline, Month 6 ]
  • Mean Change in the General Anxiety Disorder-7 Score [ Time Frame: Baseline, Month 6 ]
  • Mean Change in the Self-Compassion Scale Short Form [ Time Frame: Baseline, Month 6 ]
  • Mean Change in Working Alliance Inventory Short Revised [ Time Frame: Baseline, Month 6 ]
  • Number of Participants Withdrawn or Discontinued [ Time Frame: Up to 6 months ]
  • Percentage of Referred Participants Who Enroll [ Time Frame: Up to 6 Months ]

Central Contacts and Locations

Central contacts

David J Rauscher, BA

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

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

David J Rauscher, BA

David_Rauscher@med.unc.edu

Principal Investigator:

Kelsey A Ludwig, PhD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

May 27, 2026

Last verified

Sep, 2025

Keywords

  • Cognitive Behavioral Therapy
  • Supporters
  • Caregiving
  • Caregiver Support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2026-05-27.