TANDem-2: Closing the Gap to Interventions for TAND
Part of paid clinical trials in Silver Spring, Maryland.
- Sponsor
- Vrije Universiteit Brussel
- Study ID
- NCT06879665
- Status
- Enrolling By Invitation
Conditions
- Adult Caregivers of Individuals With TSC
- Tuberous Sclerosis Complex (TSC)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Well-Beans for Caregivers Program — BEHAVIORALThis 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.
Study Details
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: 1. Can this innovative, ultra-brief caregiver well-being intervention be delivered feasibly to caregivers via an online modality? 2. How do the caregivers experience the program (acceptability)? 3. Does limited efficacy testing suggest the program has an impact on caregiver's well-being?
Key Dates
- Start date
- Jul 15, 2025
- Status verified
- Sep 2025
- Primary completion
- Dec 31, 2026
- Completion
- Jul 15, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Other: Feasibility of "Well-Beans for Caregivers"Pre-post- quazi-experimental pilot intervention of the feasibility, acceptability and impact of the "Well-Beans for Caregivers" Program
Primary Outcome Measure
Attendance rates to assess feasibility [ Time Frame: At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| TSC Alliance | Silver Spring | Maryland | 20910 | - |