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NCT Number: NCT07167641

Caring for the Carer

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.

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Key information

Conditions

Care Burden Behavior Behavioral Symptoms Care Giving Burden Caregiver Burden Caregiver Burnout Caregiver Wellbeing Stress, Psychological

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

David J Rauscher, BA

CONTACT

[email protected]

Kelsey A Ludwig, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy for Caregivers

Other

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.

Primary outcomes

  1. Mean Change in the Experience of Caregiving (ECI) Score

    Time frame: 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.

  2. Mean Change in UCLA Loneliness Scale Score

    Time frame: 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.

  3. Mean Change in Modified PTSD Checklist for DSM-5

    Time frame: 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.

  4. Mean Change in the Patient Health Questionnaire-8 Score

    Time frame: 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).

  5. Mean Change in the General Anxiety Disorder-7 Score

    Time frame: 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).

  6. Mean Change in the Self-Compassion Scale Short Form

    Time frame: 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.

  7. Mean Change in Working Alliance Inventory Short Revised

    Time frame: 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.

  8. Number of Participants Withdrawn or Discontinued

    Time frame: Up to 6 months

    The number of participants who withdraw or discontinue from the study before completing all therapy sessions and providing complete data.

  9. Percentage of Referred Participants Who Enroll

    Time frame: Up to 6 Months

    The percent of potential participants who are referred that enroll, complete all therapy sessions, and provide complete data.

Study contacts

Contact information is provided by the study sponsor or research team.

David J Rauscher, BA

CONTACT

[email protected]

919-348-9779

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • North Carolina Department of Health and Human Services

Registry information

Acronym: CFC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2025
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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