Caring for the Carer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Behavioral Therapy for Caregivers.
- Who it may be relevant to
- Registry conditions: Care Burden, Care Giving Burden, Caregiver Burnout, Caregiver Wellbeing. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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 prefer
Primary outcome measures
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of North Carolina at Chapel Hill — Chapel Hill
Identifiers
NCT: NCT07167641 · 25-1695