Health TrialsbyHealthPanel

Caring for the Carer

ConditionsCare BurdenCare Giving BurdenCaregiver BurnoutCaregiver Wellbeing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Cognitive Behavioral Therapy for Caregivers

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Caring for the Carer ParticipantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean Change in the Experience of Caregiving (ECI) Score

The Experience of Caregiving (ECI) Scale is a 66-item scale. Answers are on a 5-point scale starting at 0 with options "never," "rarely," "sometimes," "often," and "nearly always". Possible scores range from 0 to 264. Higher scores indicate greater feelings of preparedness for caregiving whereas lower scores reflect feeling less prepared to provide caregiving.

Time frame
Baseline, Month 6
2

Mean Change in UCLA Loneliness Scale Score

The UCLA Loneliness scale is a 20-item scale. Answers are on a 4-point scale with options "I often feel this way," "I sometimes feel this way," "I rarely feel this way," and "I never feel this way." Possible scores range from 20 to 80. Higher scores reflect worse outcomes (greater feelings of loneliness). The UCLA Loneliness Scale is a part of the PhenX Toolkit.

Time frame
Baseline, Month 6
3

Mean Change in Modified PTSD Checklist for DSM-5

The Modified PTSD Checklist for DSM-5 is a 38-item scale. Answers are on a 5-point scale starting at 0 with options "not at all," "a little bit," "moderately," "quite a bit," and "extremely." Possible scores range from 0 to 80. Higher scores indicate a greater severity of PTSD symptoms.

Time frame
Baseline, Month 6
4

Mean Change in the Patient Health Questionnaire-8 Score

The Patient Health Questionnaire-8 (PHQ-8) is an 8-item scale. Answers are on a 4-point scale ranging from 0 "not at all" to 3 "nearly every day." Possible scores range from 0 to 24. Higher scores reflect worse outcomes (more depressive symptoms).

Time frame
Baseline, Month 6

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

North Carolina Department of Health and Human Services

Collaborator

Source ClinicalTrials.gov
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