Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy
Randomized Controlled Clinical Trial of Telematic Cognitive Training and Mindfulness in Pediatric Patients After CAR-T Cell Therapy, Single Hematopoietic Allogeneic Transplant or Chemotherapy. The PsyCARTkids Project
Hospital Universitario La Paz
40 participants
Dec 19, 2025
INTERVENTIONAL
Conditions
Summary
This randomized controlled clinical trial evaluates neurocognitive, biopsychological, and brain connectome outcomes in children and adolescents with acute lymphoblastic leukemia who have previously received Chimeric Antigen Receptor T-cell therapy (CAR T-cell therapy), chemotherapy, and/or hematopoietic stem cell transplantation (HSCT). Participants will receive a multimodal, telematic psychological intervention combining digital cognitive training and an adapted mindfulness-based emotional regulation program. Outcomes will be compared with a waitlist control group and intervention sequences will be counterbalanced: (1) cognitive training followed by mindfulness; and (2) mindfulness followed by cognitive training. Neurocognitive performance, emotional-behavioral functioning, executive functioning and EEG-based functional connectivity will be assessed at baseline, post-intervention and at 6 months follow-up.
Eligibility
Inclusion Criteria5
- Diagnosis of acute B-cell lymphoblastic leukemia.
- Previous treatment with CAR-T therapy, chemotherapy, and/or hematopoietic stem cell transplantation.
- Age between 8 and 18 years.
- Native Spanish speaker or high proficiency in Spanish sufficient to understand study procedures and complete assessment instruments.
- Access to a computer, tablet, or smartphone with an Internet connection.
Exclusion Criteria2
- Diagnosis of intellectual disability, autism spectrum disorder, or acquired brain injury.
- Presence of uncontrolled or unstable medical or psychiatric conditions unrelated to leukemia.
Interventions
Adaptive exercises targeting attention, processing speed, memory and executive functions. Twelve-week intervention via Sincrolab online platform (4 practices per week, 15 minutes each), with a weekly online group session to encourage adherence.
Adapted Mindfulness-Based Stress Reduction (MBSR) program for children and adolescents. Twelve weekly online group sessions with guided home practice (4 practices, 15 minutes each) using audio materials.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07479927