Efficacy of psychological intervention in children with cancer: A randomized controlled trial.

333 Background: Pediatric cancer patients often experience significant psychological distress due to their diagnosis, treatment side effects, and overall disease burden. Anxiety, depression, acute stress reaction and adjustment disorder are common mental health challenges that negatively impact treatment adherence, well-being, and long-term psychosocial outcomes. Cognitive-behavioral therapy (CBT) has shown positive effects on psychological and health-related outcomes in children with cancer; however, its effectiveness in pediatric cancer patients in Pakistan remains unexplored. Methods: This single-blinded, parallel-group, two-arm randomized controlled trial (RCT) included 80 children (aged 8-14 years) undergoing chemotherapy at the Pediatric Oncology Department of The Children's Hospital, Pakistan Institute of Medical Sciences (PIMS), Islamabad. The intervention group received five weekly, 30-35 minute individual cognitive behavioral therapy (CBT) sessions at the National Autism Center of PIMS, delivered by a consultant psychiatrist trained in CBT, focusing mainly on modifying maladaptive thoughts and promoting behavioral activation, working on coping skills through problem-solving therapy, stress management, anger management, and providing supportive therapy. The control group received usual care. Outcomes were assessed at baseline, post-intervention, and one month after post-intervention using the Revised Child Anxiety and Depression Scale (RCADS) and Pediatric Quality of Life Inventory (PedsQL) 4.0 Core Module. Results: The intervention group showed a significant reduction in anxiety (post-intervention: β = −3.58, 95% CI −9.04, −4.92, p < 0.001; one-month follow-up: β = −4.26, 95% CI −9.73, −5.26, p < 0.001) and depression (post-intervention: β = −2.39, 95% CI −7.64, −1.23, p = 0.001; one-month follow-up: β = −4.12, 95% CI −7.43, −2.94, p < 0.001), with improvements across generalized anxiety, social anxiety, and major depressive disorder domains. Quality of life (QoL) significantly improved at one-month follow-up (β = 4.07, 95% CI 1.49, 6.18, p = 0.01), particularly in emotional (p = 0.002) and school functioning (p = 0.005). Treatment and medication adherence were higher in the intervention group, with 90 % attending all scheduled chemotherapy sessions compared to 65% in the control group (p = 0.02). Additionally, intervention group experienced reduced sleep disturbances, and improved symptom management, reporting fewer instances of nausea, fatigue, and headaches (p = 0.02). Conclusions: CBT effectively reduces anxiety and depression while enhancing QoL in pediatric cancer patients. These findings support integrating CBT into national standard care protocols for pediatric cancer patients in Pakistan. Future research should explore long-term effects and scalability across diverse healthcare settings.