TANDem-2: Closing the Gap to Interventions for TAND

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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?

Eligibility

Primary outcome measure(s)

• Attendance rates to assess feasibility — At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)
  Attendance rates at each of the three weekly intervention sessions will be tracked as a measure of feasibility of the intervention program.
• Feasibility Feedback Forms for caregivers, facilitators and observers — At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)
  Caregivers, facilitators and observers will complete bespoke Feasibility Feedback Forms to assess whether the intervention could be implemented as designed.
• Acceptability Feedback Forms for caregivers, facilitators and observers — At the end of cycle 1, cycle 2 and cycle 3 (each cycle is 7 days)
  Caregivers, facilitators and observers will complete bespoke Acceptability Feedback Forms to assess their experience and acceptability of the program.

Trial sites (2)

Other trials for the same condition