Caring for the Carer

NCT07167641 | Recruiting

• 1 other identifier: 25-1695
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Care Burden; Care Giving Burden; Caregiver Burnout; Caregiver Wellbeing

Keywords

Cognitive Behavioral Therapy; Supporters; Caregiving; Caregiver Support

Outcome Measures

Primary Outcomes (9)

• 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.

  Baseline, Month 6

• 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.

  Baseline, Month 6

• 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.

  Baseline, Month 6

• 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).

  Baseline, Month 6

• Mean Change in the General Anxiety Disorder-7 Score

  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).

  Baseline, Month 6

• Mean Change in the Self-Compassion Scale Short Form

  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.

  Baseline, Month 6

• Mean Change in Working Alliance Inventory Short Revised

  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.

  Baseline, Month 6

• Number of Participants Withdrawn or Discontinued

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

  Up to 6 months

• Percentage of Referred Participants Who Enroll

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

  Up to 6 Months

Study Arms (1)

Caring for the Carer Participants

EXPERIMENTAL

Participants (caregivers and supporters) will participate in four foundational sessions (orientation, goal-setting) and up to 16 CBT-focused sessions. A maximum of 20 individual therapy sessions will be delivered to all participants from their date of enrollment up to 6 months.

Other: Cognitive Behavioral Therapy for Caregivers

Interventions

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.

Caring for the Carer Participants

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Department of Health and Human Services: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Caregiver Burden

Interventions

Cognitive Behavioral Therapy; Caregivers

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Kelsey A Ludwig, PhD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David J Rauscher, BA

CONTACT

919-348-9779; david_rauscher@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)