Trauma, BrainCG-WellNCT05307640
Caregiver Wellness After Traumatic Brain Injury (CG-WELL): An Intervention Designed to Promote Well-being in Caregivers of Acute Moderate to Severe Traumatic Brain Injuries
A study testing CG-Well and Information Support & Referral (ISR) in people with Trauma, Brain, run by Natalie Kreitzer at 1 site in United States.
Trial summary
After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma, Brain
- What is being tested?
- CG-Well and Information Support & Referral (ISR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2021to 1 Oct 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Survivor and caregiver ≥18 years old
- Survivor GCS 3-12 after resuscitation
- Survivor < 2 weeks post injury
- English Speaking - survivor and caregiver
Who cannot join
- Patient not expected to survive.
- Pregnant - survivor or caregiver
- Prisoner - survivor or caregiver
- History of pre-existing condition that would interfere with follow-up in caregiver or survivor (e.g., substance abuse, alcoholism, end-stage cancers)
- Major prior debilitating neurological or mental health disorder in caregiver or survivor (e.g., schizophrenia, bipolar, stroke, dementia).
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 Cincinnati
Cincinnati, Ohio, 45267
Emily Werff, 513-307-2963, werffel@ucmail.uc.edu
Stephanie Thomas, 513-315-4001, notlins@ucmail.uc.edu
About this study
After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. Periods of care transitions, such as ICU discharge, are most difficult. The majority (93%) of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information or practical skills to either survivors, or to long-term caregivers (>6 months post injury), rather than education, support, and skill-building that the new caregiver may use proactively that will benefit the dyad acutely after injury. The Aims of this proposal are to: (1) Determine feasibility, satisfaction, and data trends of CG-Well; and (2) Understand how baseline psychosocial risk factors affect response to CG-Well compared to an Information, Support, and Referral control group. To accomplish this, I will first enroll 6-10 caregivers and tailor CG-well until each finds the intervention acceptable, appropriate, and feasible. I will then enroll 100 (50/group) dyads and determine satisfaction ratings, recruitment, retention, and treatment fidelity of CG-Well. Additionally, I will determine if caregivers report reductions in depressive symptoms and improvements in life changes as a result of improvements in task difficulty and threat appraisal in CG-Well compared to ISR at six months. Information obtained in Aims 1 and 2 will be used to plan a larger Phase III trial of CG-Well. Completing these Aims and the training plan will improve outcomes of caregivers and downstream outcomes of survivors of msTBI, and provide me with the skillset necessary to become an independent researcher who can develop and test high-impact, high-fidelity, sustainable interventions.
- Conditions
- Trauma, Brain
- Being tested
- CG-Well, Information Support & Referral (ISR)
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG-WellBehavioural
CG-Well is a web \& phone based psychosocial intervention that teaches caregivers how to obtain information, education \& support
Information Support & Referral (ISR)Behavioural
Attention control group that receives phone calls and modules from the Brain Injury Association of America.
| Study group | Role | What they receive |
|---|---|---|
| CG-Well | Experimental | CG-Well is a web \& phone based psychosocial intervention that teaches caregivers how to obtain information, education \& support Receives: Behavioral: CG-Well |
| Information Support and Referral | Placebo comparator | Attention control group that receives phone calls and modules from the Brain Injury Association of America. Receives: Behavioral: Information Support & Referral (ISR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Satisfaction
Scale Title: Caregiver Intervention Satisfaction Scale. Likert's scale of usability, ease of use, and acceptability of INR or CG-Well A higher score indicates greater satisfaction; 1-5 scale (strongly disagree=1; strongly agree=5)
Measured: 6 months
Secondary outcomes (10)
Brief Symptom Inventory-18 (BSI-18)
Quantifies symptoms of somatization, depression, and anxiety. The BSI-18 consists of 18 items on a 5-point (0-4) Likert scale and is designed to assess current psychological distress (over the past 7 days). In addition to a total score, referred to as the Global Severity Index (GSI; max = 72), a separate score can be calculated on a depressive subscale: with six questions contributing to the subscale (max = 24). Raw scores will be converted to t-scores. Higher scores reflect greater distress.
Measured: 6 months
Bakas Caregiver Outcomes Scale (BCOS)
Measures life changes specifically resulting from providing care, such as negative social, emotional, health-related, financial wellbeing, level of energy, and role functioning effects. Each change is rated on a seven-point Likert scale (-3=changed for the worst to +3=changed for the best).
Measured: 6 months
Oberst Caregiving Burden Scale
Measures time and difficulty associated with caregiving tasks, such as providing personal care, managing emotions of the TBI survivor, and dealing with finances. Task difficulty is measured on a seven-point Likert scale (-3 extremely difficult to +3 extremely easy), and time is rated on a five-point Likert scale (5 = great amount, 1 = none).
Measured: 6 months
Appraisal of Caregiving Scale Threat Subscale
Measures the caregiver appraisal of their current situation (threat and worry) by focusing on perceived threat. The ACS uses a five-point Likert scale to determine stress in the current situation (5 = strongly agree, 1 = strongly disagree).
Measured: 6 months
Feasibility of CG-Well (Recruitment)
Measurements of recruitment: Will look at how many caregivers were approached vs. consented.
Measured: up to 30 months
Feasibility of CG-Well (Retention)
Measurements of Retention: Will look at how many caregivers were still active in the study at the 6 month mark.
Measured: 6 months
Feasibility of CG-Well (Treatment Fidelity)
Measurements of Treatment Fidelity: We will report the proportion of participants who have all elements of fidelity checklist (Borrelli Treatment Fidelity Checklist: Checklist makes sure the following is completed: Standardized research coordinator training, Documentation of study activity at each session, Audio recorded calls, PI, mentor and third party coordinator review 20% of recorded sessions and Team meetings to discuss treats to fidelity.
These checklists are reviewed on a weekly basis.
Measured: up to 36 months
Feasibility of CG-Well (Number of Log Ins to the website)
Participant reported number of times they log into the study website each month.
Reported during study visit calls.
Measured: up to 36 months
Feasibility of CG-Well (Time that the participant spent in modules)
Participant reported length of time spent each month on the website or in modules.
Reported during study visit calls.
Measured: up to 36 months
Feasibility of CG-Well (Time spent in monthly phone calls with the study team)
Study phone calls are recorded and time stamped.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start16 Aug 2021
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trauma, BrainStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natalie Kreitzer
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Natalie Kreitzer, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307640
- Sponsor's protocol ID
- 2020-1198
- Acronym
- CG-Well
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kreitzer N, Fink S, Adeoye O, Kurowski G B, Wade S, Sucharew H, Bakas T. Caregiver Wellness after Traumatic Brain Injury (CG-Well): Protocol for a randomized clinical trial. Contemp Clin Trials Commun. 2024 Aug 24;41:101356. doi: 10.1016/j.conctc.2024.101356. eCollection 2024 Oct.
PubMed 39280784
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Wellness After Traumatic Brain Injury (CG-WELL): An Intervention Designed to Promote Well-being in Caregivers of Acute Moderate to Severe Traumatic Brain Injuries
- ClinicalTrials.gov ID
- NCT05307640
- Acronym / sponsor ID
- CG-Well / 2020-1198
- Conditions
- Trauma, Brain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Natalie KreitzerUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 1 Apr 2022 (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.
After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. Periods of care transitions, such as ICU discharge, are most difficult. The majority (93%) of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information or practical skills to either survivors, or to long-term caregivers (>6 months post injury), rather than education, support, and skill-building that the new caregiver may use proactively that will benefit the dyad acutely after injury. The Aims of this proposal are to: (1) Determine feasibility, satisfaction, and data trends of CG-Well; and (2) Understand how baseline psychosocial risk factors affect response to CG-Well compared to an Information, Support, and Referral control group. To accomplish this, I will first enroll 6-10 caregivers and tailor CG-well until each finds the intervention acceptable, appropriate, and feasible. I will then enroll 100 (50/group) dyads and determine satisfaction ratings, recruitment, retention, and treatment fidelity of CG-Well. Additionally, I will determine if caregivers report reductions in depressive symptoms and improvements in life changes as a result of improvements in task difficulty and threat appraisal in CG-Well compared to ISR at six months. Information obtained in Aims 1 and 2 will be used to plan a larger Phase III trial of CG-Well. Completing these Aims and the training plan will improve outcomes of caregivers and downstream outcomes of survivors of msTBI, and provide me with the skillset necessary to become an independent researcher who can develop and test high-impact, high-fidelity, sustainable interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CG-Well | Experimental | Behavioral: CG-WellCG-Well is a web \& phone based psychosocial intervention that teaches caregivers how to obtain information, education \& support |
| Information Support and Referral | Placebo comparator | Behavioral: Information Support & Referral (ISR)Attention control group that receives phone calls and modules from the Brain Injury Association of America. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Survivor and caregiver ≥18 years old
- Survivor GCS 3-12 after resuscitation
- Survivor < 2 weeks post injury
- English Speaking - survivor and caregiver
Key exclusion criteria (5 listed)
- Patient not expected to survive.
- Pregnant - survivor or caregiver
- Prisoner - survivor or caregiver
- History of pre-existing condition that would interfere with follow-up in caregiver or survivor (e.g., substance abuse, alcoholism, end-stage cancers)
- Major prior debilitating neurological or mental health disorder in caregiver or survivor (e.g., schizophrenia, bipolar, stroke, dementia).
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 |
|---|---|---|
| CG-WellCG-Well is a web \& phone based psychosocial intervention that teaches caregivers how to obtain information, education \& support | Behavioural | CG-Well |
| Information Support & Referral (ISR)Attention control group that receives phone calls and modules from the Brain Injury Association of America. | Behavioural | Information Support and Referral |
Primary outcome
Intervention Satisfaction
Time frame: 6 months
Scale Title: Caregiver Intervention Satisfaction Scale. Likert's scale of usability, ease of use, and acceptability of INR or CG-Well A higher score indicates greater satisfaction; 1-5 scale (strongly disagree=1; strongly agree=5)
10 secondary outcomes
Brief Symptom Inventory-18 (BSI-18)
Time frame: 6 months
Bakas Caregiver Outcomes Scale (BCOS)
Time frame: 6 months
Oberst Caregiving Burden Scale
Time frame: 6 months
Appraisal of Caregiving Scale Threat Subscale
Time frame: 6 months
Feasibility of CG-Well (Recruitment)
Time frame: up to 30 months
Feasibility of CG-Well (Retention)
Time frame: 6 months
Feasibility of CG-Well (Treatment Fidelity)
Time frame: up to 36 months
Feasibility of CG-Well (Number of Log Ins to the website)
Time frame: up to 36 months
Feasibility of CG-Well (Time that the participant spent in modules)
Time frame: up to 36 months
Feasibility of CG-Well (Time spent in monthly phone calls with the study team)
Time frame: up to 36 months
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 26 Mar 2025.
- Derived from this study: PubMed 39280784Kreitzer N, Fink S, Adeoye O, Kurowski G B, Wade S, Sucharew H, Bakas T. Caregiver Wellness after Traumatic Brain Injury (CG-Well): Protocol for a randomized clinical trial. Contemp Clin Trials Commun. 2024 Aug 24;41:101356. doi: 10.1016/j.conctc.2024.101356. eCollection 2024 Oct.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CG-Well and Information Support & Referral (ISR) in people with Trauma, Brain, run by Natalie Kreitzer 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 5 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 26 Mar 2025. 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. Some participants in this study may receive a placebo. 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 Emily Werff (513-307-2963, werffel@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Satisfaction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05307640, which also lists 1 linked publication.
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 26 Mar 2025.