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.
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.
Diagnosis of intellectual disability, autism spectrum disorder, or acquired brain injury.
Presence of uncontrolled or unstable medical or psychiatric conditions unrelated to leukemia.
Hospital Universitario La Paz
Lead sponsor
Instituto de Investigación Hospital Universitario La Paz
Collaborator