NCT05999448: WellCAST

Promoting the Well Being of Caregivers Via Telehealth

Status unknown NA Last updated 21 August 2023

What this trial tests

NA trial testing Acceptance and Commitment Therapy (ACT) in Caregivers in 800 participants. Status unknown.

Timeline

28 June 2023

Primary endpoint
8 September 2025

29 December 2025

Quick facts

Lead sponsor	Purdue University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	double
Primary purpose	treatment
Enrollment	800
Start date	28 June 2023
Primary completion	8 September 2025
Estimated completion	29 December 2025
Sites	1 location across United States

Drugs / interventions tested

• Acceptance and Commitment Therapy (ACT)
• Culturally Informed Cognitive Behavioral Therapy (CICBT), Individual
• Culturally Informed Cognitive Behavioral Therapy (CICBT), Group
• Dialectical Behavioral Therapy (DBT)
• Durand Sleep Intervention
• RUBI Intervention
• Naturalistic Communication Intervention (NCI)
• Self-Guided Resources
• Participation Enhancement Intervention (PEI)

Conditions studied

• Caregivers — all drugs for Caregivers →
• Parents — all drugs for Parents →

Sponsor

Purdue University

Who can join

Adults 18 to 70, any sex, with Caregivers or Parents. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to learn which types of telehealth-based treatments best fit the needs of caregivers of people with rare neurogenetic conditions. The main questions it plans to answer are:

* Which telehealth support programs best meet the needs of rare disorder caregivers?
* How can individuals be matched to support programs that are right for them? What aspects of an individual (e.g., demographics, mental health symptoms, family characteristics, lifestyle) predict whether treatment will be a good fit?
* Does peer-to-peer coaching help improve patients' experiences during telehealth treatment?

Participants will be asked to complete a 12-week treatment program, which may include self-guided resources, individual therapies, group therapies, and/or peer-to-peer coaching.

Before, during, and after treatment, participants will complete questionnaires to help researchers understand their experiences, symptoms, and impressions of their support program. Questionnaires will include both standard forms (administered up to 5 times throughout the study) and brief "snapshot surveys" that participants complete on their smartphones up to 3 times per day.

Some participants will be assigned to a waitlist control, which means that they will provide data while they are not yet completing a support program. These participants will be assigned to a support program in the next treatment phase.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. CASCADE: a community-engaged action model for generating rapid, patient-engaged decisions in clinical research.
   Kelleher BL. · · 2025 · cited 1× · PMID 40597746 · DOI 10.1186/s12874-025-02565-7
2. Optimizing a Personalized Health Approach for Virtually Treating High-Risk Caregivers of Children With Neurogenetic Conditions (Project WellCAST): Protocol for a Randomized Controlled Trial.
   Kelleher B, Emerson K, Graham LN, Vozka V, et al · · 2025 · PMID 40560646 · DOI 10.2196/64360
3. Measuring Patient-Reported Acceptability Outcomes via the Program Acceptability Tool for Telehealth.
   Kelleher BL, Vozka V, Emerson K, Naughton R, et al · · 2025 · PMID 40129027 · DOI 10.1089/tmj.2024.0536
4. CASCADE: A Community-Engaged Action Model for Generating Rapid, Patient-Engaged Decisions in Clinical Research
   Kelleher BL. · · 2024 · DOI 10.21203/rs.3.rs-4790564/v1