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| ID | Type | Description | Link |
|---|---|---|---|
| 2023.832 | Other Identifier | Hospital Universitario La Paz |
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| Name | Class |
|---|---|
| Instituto de Investigación Hospital Universitario La Paz | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Training → Mindfulness | Experimental | Participants receive digital cognitive training followed by a mindfulness-based intervention delivered online. |
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| Mindfulness → Cognitive Training | Experimental | Participants receive a mindfulness-based intervention delivered online followed by digital cognitive training. |
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| Waitlist Control | No Intervention | Participants do not receive the intervention during the main study period and are offered the full program after study completion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital cognitive training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Symbol Digit Modalities Test (SDMT). | It assesses processing speed based on the total number of items completed in 90 seconds. Scores range from 0 to a maximum determined by the speed of task completion. Higher scores indicate better processing speed. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | Baseline |
| Continuous Performance Test, third edition (CPT-3) | It assesses sustained visual attention, impulsivity, and vigilance through continuous performance tasks that require responses to target stimuli and inhibition of non-target stimuli. Outcome measures include omission errors, commission errors, reaction time, and variability, which are expressed as standardized T-scores. Higher T-scores indicate poorer performance. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | Baseline |
| Clinical Assessment of Memory (ECM) | It assesses working memory and immediate memory in auditory-verbal and visuospatial modalities. Scores are expressed as standardized scores based on Spanish norms. Higher scores indicate better memory performance. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | Baseline |
| Verbal Fluency Test (VFT) | Assesses linguistic and executive functions, including phonological and semantic fluency. The score is the total number of correct words generated in 60 seconds. Higher scores indicate better performance. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | Baseline |
| Stroop. Test of Colors and Words. Revised edition. |
| Measure | Description | Time Frame |
|---|---|---|
| Behavior Rating Inventory of Executive Function, second edition (BRIEF-2) | 63-item questionnaire that assesses the patient's executive functions (completed by parents). Higher scores in each domain indicate a worse outcome. Spanish norms in T scores (mean = 50; standard deviation = 10). The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo Fernandez Jimenes, Phd | Contact | +34917277417 | eduferjim.psyc@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Recruiting | Madrid | Madrid | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36140387 | Background | Ragoonanan D, Sheikh IN, Gupta S, Khazal SJ, Tewari P, Petropoulos D, Li S, Mahadeo KM. The Evolution of Chimeric Antigen Receptor T-Cell Therapy in Children, Adolescents and Young Adults with Acute Lymphoblastic Leukemia. Biomedicines. 2022 Sep 14;10(9):2286. doi: 10.3390/biomedicines10092286. | |
| 33249502 | Background |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2026 | Mar 3, 2026 |
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Randomized block design (based on the BRIEF-2 Emotional Regulation Index score), waitlist control group and counterbalanced intervention sequences.
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| Online Mindfulness-Based Intervention | Behavioral | 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. |
|
It measures attention and executive functioning, specifically the ability to inhibit automatic responses and resist interference from established behavior patterns. Scores are based on the number of correct responses completed in 45 seconds, depending on the condition. Higher scores indicate better executive functioning. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. |
| Baseline |
| Symbol Digit Modalities Test (SDMT) | It assesses processing speed based on the total number of items completed in 90 seconds. Scores range from 0 to a maximum determined by the speed of task completion. Higher scores indicate better processing speed. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 6 months |
| Continuous Performance Test, third edition (CPT-3) | It assesses sustained visual attention, impulsivity, and vigilance through continuous performance tasks that require responses to target stimuli and inhibition of non-target stimuli. Outcome measures include omission errors, commission errors, reaction time, and variability, which are expressed as standardized T-scores. Higher T-scores indicate poorer performance. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 6 months |
| Clinical Assessment of Memory (ECM) | It assesses working memory and immediate memory in auditory-verbal and visuospatial modalities. Scores are expressed as standardized scores based on Spanish norms. Higher scores indicate better memory performance. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 6 months |
| Stroop. Test of Colors and Words. Revised edition | It measures attention and executive functioning, specifically the ability to inhibit automatic responses and resist interference from established behavior patterns. Scores are based on the number of correct responses completed in 45 seconds, depending on the condition. Higher scores indicate better executive functioning. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 6 months |
| Verbal Fluency Test (VFT) | Assesses linguistic and executive functions, including phonological and semantic fluency. The score is the total number of correct words generated in 60 seconds. Higher scores indicate better performance. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 6 months |
| Baseline |
| Behavior Assessment System for Children, third edition (BASC-3) | It measures patients' emotional and behavioral problems, both in the version completed by the patient's legal guardians and in the self-assessment carried out by the patient themselves. It is a report of 139 items, scored on a 4-point Likert frequency scale. High scores indicate problematic levels of functioning. Scores are reported as T-scores (mean = 50; standard deviation = 10). The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | Baseline |
| Brief Pain Inventory (BPI) | This 10-question questionnaire includes questions (from 0 to 10, referring to the last 7 days) covering two dimensions: pain intensity (the most intense and mildest pain of the week, average pain, and current pain) and pain interference (in general activity, mood, walking, school, sleep, and enjoyment of life). Higher scores on a Likert scale of 0 to 10 indicate more pain. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | Baseline |
| Adolescent Insomnia Questionnaire (AIQ) | This is a 13-item questionnaire, the original version of which is in English. In this study, the questionnaire will be adapted and validated in Spanish. Higher scores on a Likert scale of 0 to 4 indicate greater insomnia. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | Baseline |
| Pediatric Sleep Disturbances Short Form (PROMIS) | A 4-question questionnaire that assesses problems falling asleep and staying asleep over the past 7 days. Higher scores on a Likert scale of 1 to 5 indicate poorer sleep. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | Baseline |
| Child and Adolescent Mindfulness Measure (CAMM). | Assesses mindfulness skills related to present moment awareness and nonjudgmental acceptance. Total scores range from 0 to 40. Higher scores indicate greater mindfulness ability. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | Baseline |
| Brain Functional Connectivity | EEG-based measures including spectral power, frequency analysis, functional connectivity indices, and graph theory metrics. | Baseline |
| Biomarkers | White blood cells, platelets, and C-reactive protein. | Baseline |
| Behavior Assessment System for Children, third edition (BASC-3) | It measures patients' emotional and behavioral problems, both in the version completed by the patient's legal guardians and in the self-assessment carried out by the patient themselves. It is a report of 139 items, scored on a 4-point Likert frequency scale. High scores indicate problematic levels of functioning. Scores are reported as T-scores (mean = 50; standard deviation = 10). The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 3 months |
| Brief Pain Inventory (BPI) | This 10-question questionnaire includes questions (from 0 to 10, referring to the last 7 days) covering two dimensions: pain intensity (the most intense and mildest pain of the week, average pain, and current pain) and pain interference (in general activity, mood, walking, school, sleep, and enjoyment of life). Higher scores on a Likert scale of 0 to 10 indicate more pain. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 3 months |
| Adolescent Insomnia Questionnaire (AIQ) | This is a 13-item questionnaire, the original version of which is in English. In this study, the questionnaire will be adapted and validated in Spanish. Higher scores on a Likert scale of 0 to 4 indicate greater insomnia. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 3 months |
| Pediatric Sleep Disturbances Short Form (PROMIS) | A 4-question questionnaire that assesses problems falling asleep and staying asleep over the past 7 days. Higher scores on a Likert scale of 1 to 5 indicate poorer sleep. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 3 months |
| Child and Adolescent Mindfulness Measure (CAMM) | Assesses mindfulness skills related to present moment awareness and nonjudgmental acceptance. Total scores range from 0 to 40. Higher scores indicate greater mindfulness ability. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 3 months |
| Behavior Rating Inventory of Executive Function, second edition (BRIEF-2) | 63-item questionnaire that assesses the patient's executive functions (completed by parents). Higher scores in each domain indicate a worse outcome. Spanish norms in T scores (mean = 50; standard deviation = 10). The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 6 months |
| Behavior Assessment System for Children, third edition (BASC-3) | It measures patients' emotional and behavioral problems, both in the version completed by the patient's legal guardians and in the self-assessment carried out by the patient themselves. It is a report of 139 items, scored on a 4-point Likert frequency scale. High scores indicate problematic levels of functioning. Scores are reported as T-scores (mean = 50; standard deviation = 10). The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 6 months |
| Brief Pain Inventory (BPI) | This 10-question questionnaire includes questions (from 0 to 10, referring to the last 7 days) covering two dimensions: pain intensity (the most intense and mildest pain of the week, average pain, and current pain) and pain interference (in general activity, mood, walking, school, sleep, and enjoyment of life). Higher scores on a Likert scale of 0 to 10 indicate more pain. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 6 months |
| Adolescent Insomnia Questionnaire (AIQ) | This is a 13-item questionnaire, the original version of which is in English. In this study, the questionnaire will be adapted and validated in Spanish. Higher scores on a Likert scale of 0 to 4 indicate greater insomnia. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 6 months |
| Pediatric Sleep Disturbances Short Form (PROMIS) | A 4-question questionnaire that assesses problems falling asleep and staying asleep over the past 7 days. Higher scores on a Likert scale of 1 to 5 indicate poorer sleep. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 6 months |
| Child and Adolescent Mindfulness Measure (CAMM) | Assesses mindfulness skills related to present moment awareness and nonjudgmental acceptance. Total scores range from 0 to 40. Higher scores indicate greater mindfulness ability. The scores will be converted to z-scores (mean = 0; standard deviation = 1) to equate and compare the values of instruments with different units of measurement. | 6 months |
| Brain Functional Connectivity | EEG-based measures including spectral power, frequency analysis, functional connectivity indices, and graph theory metrics. | 6 months |
| Biomarkers | White blood cells, platelets, and C-reactive protein. | 6 months |
| Caes L, Dick B, Duncan C, Allan J. The Cyclical Relation Between Chronic Pain, Executive Functioning, Emotional Regulation, and Self-Management. J Pediatr Psychol. 2021 Mar 18;46(3):286-292. doi: 10.1093/jpepsy/jsaa114. |
| 33965176 | Background | Kamal M, Joseph J, Greenbaum U, Hicklen R, Kebriaei P, Srour SA, Wang XS. Patient-Reported Outcomes for Cancer Patients with Hematological Malignancies Undergoing Chimeric Antigen Receptor T Cell Therapy: A Systematic Review. Transplant Cell Ther. 2021 May;27(5):390.e1-390.e7. doi: 10.1016/j.jtct.2021.01.003. Epub 2021 Jan 7. |
| 31605820 | Background | Ruark J, Mullane E, Cleary N, Cordeiro A, Bezerra ED, Wu V, Voutsinas J, Shaw BE, Flynn KE, Lee SJ, Turtle CJ, Maloney DG, Fann JR, Bar M. Patient-Reported Neuropsychiatric Outcomes of Long-Term Survivors after Chimeric Antigen Receptor T Cell Therapy. Biol Blood Marrow Transplant. 2020 Jan;26(1):34-43. doi: 10.1016/j.bbmt.2019.09.037. Epub 2019 Oct 9. |
| 33890409 | Background | Thompson J, Fisher B, Sung L, Dvorak C, Dang H, Lo T, Alexander S. Musculoskeletal impairments in children receiving intensive therapy for acute leukemia or undergoing hematopoietic stem cell transplant: A report from the Children's Oncology Group. Pediatr Blood Cancer. 2021 Aug;68(8):e29053. doi: 10.1002/pbc.29053. Epub 2021 Apr 23. |
| 35580732 | Background | Barata A, Hoogland AI, Kommalapati A, Logue J, Welniak T, Hyland KA, Eisel SL, Small BJ, Jayani RV, Booth-Jones M, Oswald LB, Gonzalez BD, Kirtane KS, Jain MD, Mokhtari S, Chavez JC, Lazaryan A, Shah BD, Locke FL, Jim HSL. Change in Patients' Perceived Cognition Following Chimeric Antigen Receptor T-Cell Therapy for Lymphoma. Transplant Cell Ther. 2022 Jul;28(7):401.e1-401.e7. doi: 10.1016/j.jtct.2022.05.015. Epub 2022 May 14. |
| 36208728 | Background | Taylor MR, Steineck A, Lahijani S, Hall AG, Jim HSL, Phelan R, Knight JM. Biobehavioral Implications of Chimeric Antigen Receptor T-cell Therapy: Current State and Future Directions. Transplant Cell Ther. 2023 Jan;29(1):19-26. doi: 10.1016/j.jtct.2022.09.029. Epub 2022 Oct 5. |
| 33495553 | Background | Shalabi H, Gust J, Taraseviciute A, Wolters PL, Leahy AB, Sandi C, Laetsch TW, Wiener L, Gardner RA, Nussenblatt V, Hill JA, Curran KJ, Olson TS, Annesley C, Wang HW, Khan J, Pasquini MC, Duncan CN, Grupp SA, Pulsipher MA, Shah NN. Beyond the storm - subacute toxicities and late effects in children receiving CAR T cells. Nat Rev Clin Oncol. 2021 Jun;18(6):363-378. doi: 10.1038/s41571-020-00456-y. Epub 2021 Jan 25. |
| 31980743 | Background | Di Giuseppe G, Thacker N, Schechter T, Pole JD. Anxiety, depression, and mental health-related quality of life in survivors of pediatric allogeneic hematopoietic stem cell transplantation: a systematic review. Bone Marrow Transplant. 2020 Jul;55(7):1240-1254. doi: 10.1038/s41409-020-0782-z. Epub 2020 Jan 24. |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: ADULT PARTICIPANTS | Feb 26, 2026 | Feb 26, 2026 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: PARTICIPANTS AGED 12-17 YEARS OLD | Feb 26, 2026 | Feb 26, 2026 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: PATIENT'S PARENT(S), LEGAL GUARDIAN | Feb 26, 2026 | Feb 27, 2026 | ICF_003.pdf |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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