Caring for the Carer

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

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• Number of Participants Withdrawn or Discontinued [Срок оценки: Up to 6 months]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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• University of North Carolina at Chapel Hill — Chapel Hill

Идентификаторы

NCT: NCT07167641 · 25-1695

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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