An interventional study of Well-Beans for Caregivers Program in Adult Caregivers of Individuals With TSC and Tuberous Sclerosis Complex (TSC), sponsored by Vrije Universiteit Brussel. Enrolling by invitation at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Vrije Universiteit Brussel · Not applicable, Interventional, and Treatment
The goal of this pilot study is to determine the feasibility, acceptability and impact of a brief behavioral intervention - the "Well-Beans for Caregivers" program, for adult caregivers of individuals with tuberous sclerosis complex (TSC) of any age. The main questions of the study are:
The investigators hypothesize that an innovative, ultra-brief caregiver wellbeing intervention developed for caregivers of children with developmental disabilities can be adapted as a universal caregiver wellbeing intervention in tuberous sclerosis complex (TSC), that it can be delivered feasibly in an online modality, and will result in changes in key caregiver wellbeing factors. To test these hypotheses, the researchers will adapt the 3-session 'Well-Beans for Caregivers' program through a participatory method with the TAND consortium (the TAND consortium is an international group of clinical and research professionals as well as family members living with individuals with TSC - TAND stands for TSC-Associated Neuropsychiatric Disorders - see tandconsortium.org). The input from the TAND Consortium will be augmented by members of TSCi (Tuberous Sclerosis International), the global network of TSC non-profit organizations.
For step 2 (pilot intervention), two specialist facilitators and four trainee observers will deliver the 3-session program using ZoomPro, a secure online platform to two groups of 10-12 caregivers. Caregivers are those who provide long-term, day-to-day support and care, and this group includes parents, partners, relatives, or other family members (not paid professional caregivers). These sessions will not be recorded to ensure that participants can join the program without feeling concerned about being recorded. Data collection will use a quasi-experimental pre-post-test design. Eligible and consented participants will therefore complete baseline data as 'pre-test' and then 'post-test' data after the 3-week intervention. Following this, they will complete 3-month and 6-month data collection. Caregiver wellbeing measures will only include open access and freely available measures. The program as well as data collection will be conducted in English.
115 studies on the registry are indexed under Tuberous Sclerosis; 27 are open to participants now.
This study's planned enrollment of 30 is below the median of 52 across 73 interventional studies indexed under Tuberous Sclerosis.
Browse Tuberous Sclerosis studies →Vrije Universiteit Brussel is the lead sponsor of 158 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pre-post- quazi-experimental pilot intervention of the feasibility, acceptability and impact of the "Well-Beans for Caregivers" Program
Behavioral: Well-Beans for Caregivers Program
This is a brief behavioral intervention consisting of 3 weekly 2-hour sessions. The sessions are based on Acceptance and Commitment Therapy (ACT) and are designed to improve psychological flexibility in caregivers. This in turn is designed to help them connect with their difficult emotions and experiences in a flexible way, and improve emotional well-being.
Attendance rates to assess feasibility
Attendance rates at each of the three weekly intervention sessions will be tracked as a measure of feasibility of the intervention program.
Time frame: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)
Feasibility Feedback Forms for caregivers, facilitators and observers
Caregivers, facilitators and observers will complete bespoke Feasibility Feedback Forms to assess whether the intervention could be implemented as designed.
Time frame: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)
Acceptability Feedback Forms for caregivers, facilitators and observers
Caregivers, facilitators and observers will complete bespoke Acceptability Feedback Forms to assess their experience and acceptability of the program.
Time frame: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)
Change in psychological flexibility on the Psy-Flex measure
Changes in scores on the Psy-Flex (Gloster, 2021) will be used to assess changes in caregiver psychological flexibility from before to after treatment. The Psy-Flex consists of 6 items with a minimum score of 6 and a maximum score of 30. Higher scores indicate better psychological flexibility (better outcome).
Time frame: Change from baseline to immediately post-treatment, and at 3 and 6 months post-treatment
Change in depression on the Patient Health Questionnaire-9 (PHQ-9)
Changes in participant levels of depression will be measured via changes in scores on the Patient Health Questionnaire (PHQ-9) from before to after the intervention and at two follow-up intervals. The PHQ consists of 9 items with a minimum score of 0 and a maximum score of 27. Higher scores indicate higher levels of depression.
Time frame: Change from baseline to immediately post-, and 3 and 6-month post treatment
Change in anxiety on the Generalized Anxiety Disorder-7 Scale (GAD-7)
Changes in anxiety will be assessed via changes in scores on the Generalized Anxiety Disorder-7 Scale (GAD-7). This is a 7-item scale with a minimum score of 0 and a maximum score of 21. Higher scores indicate higher levels of anxiety.
Time frame: Change from baseline to immediately post-, and 3 and 6-month post treatment
Change in general wellbeing scores on the World Health Organization Wellbeing Index (WHO-5)
Changes in general wellbeing will be assessed via changes in scores on the WHO-5 Wellbeing Index (WHO-5). This is a 5-item scale with a minimum score of 0 and a maximum score of 25. Higher scores indicate higher levels of well-being.
Time frame: Change from baseline to immediately post-, and 3 and 6-month post treatment
Change in resilience as measured on the Brief Resilience Scale
Changes in resilience will be assessed via changes in scores on the Brief Resilience Scale (BRS). The BRS is a 6-item scale with a minimum score of 6 and a maximum score of 30. Higher scores indicate higher levels of resilience.
Time frame: Change from baseline to immediately post-, and 3 and 6-month post treatment
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.