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 — BEHAVIORAL
    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.

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)

FacilityCityStateZIPSite coordinators
TSC AllianceSilver SpringMaryland20910-

Find similar trials in Silver Spring, MD