NCT07479927

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Children and adolescents treated for acute lymphoblastic leukemia are at increased risk of long-term neurocognitive, emotional, and psychosocial difficulties, particularly following intensive treatments such as CAR T-cell therapy, chemotherapy, and hematopoietic stem cell transplantation. Despite increasing survival rates, evidence-based psychological interventions targeting these sequelae remain limited. This single-center randomized controlled clinical trial aims to evaluate the efficacy of a multimodal psychological intervention delivered remotely. The intervention combines digital cognitive training with a mindfulness-based stress reduction (MBSR) program adapted for pediatric populations. Participants will be randomly assigned either to an immediate intervention group or to a waitlist control group. Within the intervention group, participants will be further allocated to one of two counterbalanced intervention sequences: (1) cognitive training followed by mindfulness or (2) mindfulness followed by cognitive training. Assessments will include standardized neurocognitive tests administered in person, parent- and self-report questionnaires completed online via secure platforms, and electroencephalography (EEG) recordings to evaluate functional brain connectivity. Outcome measurements will be conducted at baseline, immediately following the intervention, and at a 6-month follow-up.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BEHAVIORAL	Digital cognitive training	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.
BEHAVIORAL	Online Mindfulness-Based Intervention	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.

Timeline

• Start date: 2025-12-19
• Primary completion: 2027-07-30
• Completion: 2027-12-30
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

1 site across 1 country: Spain