NCT Number: NCT07479927
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.
Interested in participating?
Request Info8 year–18 year
All sexes
Interventional
Not applicable
Madrid, 28046, Spain
Location status: Recruiting
Cristina Campoy Lacasa
CONTACT
Cristina Campoy Lacasa
SUB_INVESTIGATOR
Eduardo Fernández-Jiménez, PhD
CONTACT
Eduardo Fernández-Jiménez, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
EEG-based measures including spectral power, frequency analysis, functional connectivity indices, and graph theory metrics.
Time frame: Baseline
White blood cells, platelets, and C-reactive protein.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
EEG-based measures including spectral power, frequency analysis, functional connectivity indices, and graph theory metrics.
Time frame: 6 months
White blood cells, platelets, and C-reactive protein.
Contact information is provided by the study sponsor or research team.
Hospital Universitario La Paz
Other
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
Acronym: PsyCARTkids
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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