Care Burden, Caregiver Burnout, Caregiver Wellbeing, Care Giving Burden
Conditions
Keywords
Cognitive Behavioral Therapy, Supporters, Caregiving, Caregiver Support
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.
Interventions
OTHERCognitive 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.
Sponsors
University of North Carolina, Chapel Hill
North Carolina Department of Health and Human Services
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in the Experience of Caregiving (ECI) Score | Baseline, Month 6 | 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. |
| Mean Change in UCLA Loneliness Scale Score | Baseline, Month 6 | 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. |
| Mean Change in Modified PTSD Checklist for DSM-5 | Baseline, Month 6 | 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. |
| Mean Change in the Patient Health Questionnaire-8 Score | Baseline, Month 6 | 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). |
| Mean Change in the General Anxiety Disorder-7 Score | Baseline, Month 6 | The General Anxiety Disorder-7 (GAD-7) is a 7-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 21. Higher scores reflect worse outcomes (more symptoms of anxiety). |
| Mean Change in the Self-Compassion Scale Short Form | Baseline, Month 6 | The Self-Compassion Scale Short Form (SCS-SF) is a 12-item scale. Answers are on a 5-point scale ranging from 1 "almost never" to 5 "almost always." Possible scores range from 12-60, with higher scores reflecting higher self-compassion. |
| Mean Change in Working Alliance Inventory Short Revised | Baseline, Month 6 | The Working Alliance Inventory Short Revised (WAI-SR) is a 12-item scale. Answers are on a 5-point scale ranging from 1 "seldom" to 5 "always." Possible scores range from 12-60, with higher scores indicating greater feelings of alliance between participant and clinician. |
| Number of Participants Withdrawn or Discontinued | Up to 6 months | The number of participants who withdraw or discontinue from the study before completing all therapy sessions and providing complete data. |
| Percentage of Referred Participants Who Enroll | Up to 6 Months | The percent of potential participants who are referred that enroll, complete all therapy sessions, and provide complete data. |
Countries
United States
Contacts
CONTACTDavid J Rauscher, BA
PRINCIPAL_INVESTIGATORKelsey A Ludwig, PhD
UNC Chapel Hill
Outcome results
None listed