MedTrace Logo

TANDem-2: Closing the Gap to Interventions for TAND

NCT06879665 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-22

No results posted yet for this study

Summary

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?

Conditions

  • Adult Caregivers of Individuals With TSC
  • Tuberous Sclerosis Complex (TSC)

Interventions

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.

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • United States Department of Defense

    collaborator FED

  • Vrije Universiteit Brussel

    lead OTHER

Principal Investigators

  • Anna Jansen, MD, PhD · Vrije Universiteit Brussel

  • Petrus J de Vries, MD PhD · University of Cape Town

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2026-12-31
Completion
2027-07-15

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06879665 on ClinicalTrials.gov