Well-Beans Program for Caregiver Stress in Tuberous Sclerosis

(TANDem-2 Trial)

Enrolling by invitation at 1 trial location

Overseen By Nola Chambers, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vrije Universiteit Brussel

Disqualifiers: Not an adult caregiver

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new, short online program, the Well-Beans for Caregivers Program, can improve the well-being of caregivers for individuals with tuberous sclerosis complex (TSC). Researchers seek to assess the program's ease of online delivery, its perceived helpfulness by caregivers, and its impact on their lives. The trial seeks adult caregivers currently caring for someone with TSC. Participants will engage with the program and provide feedback on their experience. As an unphased trial, this study offers caregivers the chance to contribute to research that could enhance support for others in similar situations.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on a behavioral program, so it's unlikely that medication changes are required.

What prior data suggests that the "Well-Beans for Caregivers" program is safe for caregivers?

Research has shown that the "Well-Beans for Caregivers" program is based on the World Health Organization's Caregiver Skills Training module. This program has been tested and helps caregivers manage stress and improve well-being. Early results suggest that most participants report a positive experience.

The program offers emotional support and practical skills, which are generally safe. No harmful side effects have been reported. As a behavioral program, it does not involve medication or physical treatments, which typically enhances its safety.

Overall, previous studies and its nature as a non-medical intervention indicate that the program is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Well-Beans for Caregivers Program because it specifically addresses the stress experienced by caregivers of individuals with Tuberous Sclerosis, a need that is often overlooked by standard medical treatments. Unlike traditional approaches that focus on the patient, this program prioritizes the well-being of the caregiver through a structured, supportive framework. It aims to improve caregiver mental health and resilience, which can lead to better care for the patient. This novel focus on caregiver support rather than direct medical intervention is what makes the Well-Beans program stand out.

What evidence suggests that the "Well-Beans for Caregivers" program might be effective for caregiver stress in tuberous sclerosis?

Research has shown that the Well-Beans for Caregivers Program, which participants in this trial will experience, might improve caregivers' well-being and mental health. An earlier study found the program practical, well-received, and possibly helpful when used with a small group of caregivers. This short program focuses on boosting caregivers' emotional health, potentially reducing stress for those caring for individuals with tuberous sclerosis complex (TSC). While these results are encouraging, further research is needed to determine its effectiveness for larger groups. ^{2 3 6 7 8}

Who Is on the Research Team?

Anna Jansen, MD, PhD

Principal Investigator

Vrije Universiteit Brussel

Petrus J de Vries, MD PhD

Principal Investigator

University of Cape Town

Are You a Good Fit for This Trial?

This trial is for adult caregivers of individuals with Tuberous Sclerosis Complex (TSC), regardless of the age of the person they care for. It aims to support their well-being.

Inclusion Criteria

I care for someone with Tuberous Sclerosis Complex.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo the 'Well-Beans for Caregivers' program, consisting of three weekly sessions delivered online

3 weeks

3 sessions (online)

Follow-up

Participants are monitored for changes in psychological flexibility, depression, anxiety, general wellbeing, and resilience

6 months

Data collection at 3 and 6 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Well-Beans for Caregivers Program

Trial Overview The 'Well-Beans for Caregivers' program, a brief behavioral intervention designed to improve caregiver well-being, is being tested. The study will assess its feasibility and impact when delivered online.

How Is the Trial Designed?

Group I: Feasibility of "Well-Beans for Caregivers" Experimental Treatment 1 Intervention

Pre-post- quazi-experimental pilot intervention of the feasibility, acceptability and impact of the "Well-Beans for Caregivers" Program

Who Is Running the Clinical Trial?

Vrije Universiteit Brussel

Lead Sponsor

Trials

213

Recruited

272,000+

University of Cape Town

Collaborator

Trials

257

Recruited

458,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. withpower.com withpower.com/trial/phase-tuberous-sclerosis-6-2025-45e1e

Well-Beans Program for Caregiver Stress in Tuberous ... The goal of this pilot study is to determine the feasibility, acceptability and impact of a brief behavioral intervention - the "Well-Beans for Caregivers" ...

2. journals.sagepub.com journals.sagepub.com/doi/pdf/10.1177/13623613221133182?download=true

Findings from a brief caregiver well-being programme in ... In this study, we found that the Well-Beans programme was feasible, acceptable, and potentially effective when delivered to a group of 10 car- egivers in a low- ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36352758/

Findings from a brief caregiver well-being programme in ... A brief, three-session module that focuses on improving caregivers' well-being and mental health. This well-being programme is based on acceptance and ...

4. valueinhealthjournal.com valueinhealthjournal.com/article/S1098-3015(23)00806-9/pdf

EE405 A Systematic Review of Healthcare Resource ... Objectives: Tuberous sclerosis complex (TSC), a rare genetic disorder affects over. 50,000 people in the United States (US). The disease burden of facial ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ped4.12447

Enhancing the utility of tuberous sclerosis complex ... The tuberous sclerosis complex (TSC)-associated neuropsychiatric disorders (TAND) Checklist is a reliable global screening tool for TAND in clinical settings.

6. tsa.org.au tsa.org.au/research/the-challenges-and-unmet-needs-of-families-and-caregivers-of-people-living-with-tsc/

The challenges and unmet needs of families and ... Caregivers of people living with TSC can face heavy and sustained emotional, physical, financial, and social burden. Their challenges arise not ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11427900/

Enhancing the utility of tuberous sclerosis complex ... The tuberous sclerosis complex (TSC)‐associated neuropsychiatric disorders (TAND) Checklist is a reliable global screening tool for TAND in clinical settings.

8. tsa.org.au tsa.org.au/tsa-news/tsa-selected-to-participate-in-the-well-beans-for-caregivers-study/

TSA selected to participate in the Well-Beans for ... Data will be collected before, during and after the sessions. More details about this amazing opportunity will follow very soon. Watch this ...