RecruitingNot Applicable

Caring for the Carer

United States30 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 range18 Years – 99 Years

SexALL

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

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

Number of Participants Withdrawn or Discontinued

Timeframe: Up to 6 months

Trial details

NCT IDNCT07167641

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

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 range18 Years – 99 Years

SexALL

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

Number of Participants Withdrawn or Discontinued

Timeframe: Up to 6 months