Care BurdenCFCNCT07167641
Caring for the Carer
A study testing Cognitive Behavioral Therapy for Caregivers in people with Care Burden and Care Giving Burden, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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.… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Care Burden, Care Giving Burden, Caregiver Burnout
- What is being tested?
- Cognitive Behavioral Therapy for Caregivers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
David J Rauscher, BA, David_Rauscher@med.unc.edu
Kelsey A Ludwig, PhD
About this study
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.
Read the 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.
- Being tested
- Cognitive Behavioral Therapy for Caregivers
- Keywords
- Cognitive Behavioral Therapy, Supporters, Caregiving, Caregiver Support
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for CaregiversOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cognitive Behavioral Therapy for Caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start11 Sep 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Kelsey A Ludwig, PhD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167641
- Sponsor's protocol ID
- 25-1695
- Acronym
- CFC
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for the Carer
- ClinicalTrials.gov ID
- NCT07167641
- Acronym / sponsor ID
- CFC / 25-1695
- Keywords
- Cognitive Behavioral Therapy, Supporters, Caregiving, Caregiver Support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Department of Health and Human Services
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caring for the Carer Participants | Experimental | Other: Cognitive Behavioral Therapy for CaregiversParticipants (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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for CaregiversThe 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. | Other | Caring for the Carer Participants |
Primary outcome
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.
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.
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.
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).
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).
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kelsey A Ludwig, PhD principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Caregivers in people with Care Burden and Care Giving Burden, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David J Rauscher, BA (919-348-9779, david_rauscher@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in the Experience of Caregiving (ECI) Score (time frame: Baseline, Month 6). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.