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Randomized Controlled Trial
Copyright: ©Author(s) 2026. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution-NonCommercial (CC BY-NC 4.0) license. No commercial re-use. See permissions. Published by Baishideng Publishing Group Inc.
World J Psychiatry. May 19, 2026; 16(5): 116043
Published online May 19, 2026. doi: 10.5498/wjp.v16.i5.116043
Short-term efficacy of cognitive behavioral therapy plus sertraline vs sertraline monotherapy for adolescent depression: A randomized controlled study
Ling-Kai Yang, Ying Ye, Lang-Lang Cheng, Xiang Li, Zhai-Xiang Ye, Yan-Hui Zhu, Zhi-Yuan Lin, Xin-Liang Chen
Ling-Kai Yang, Lang-Lang Cheng, Xiang Li, Xin-Liang Chen, Department of Child Psychiatry, Wenzhou Seventh People’s Hospital, Wenzhou 325000, Zhejiang Province, China
Ying Ye, Department of Sleep Medicine, Wenzhou Seventh People’s Hospital, Wenzhou 325000, Zhejiang Province, China
Zhai-Xiang Ye, Psychological Counseling Center, Wenzhou Seventh People’s Hospital, Wenzhou 325000, Zhejiang Province, China
Yan-Hui Zhu, Department of Geriatric Psychiatry, Wenzhou Seventh People’s Hospital, Wenzhou 325000, Zhejiang Province, China
Zhi-Yuan Lin, Department of General Psychiatry, Wenzhou Seventh People’s Hospital, Wenzhou 325000, Zhejiang Province, China
Co-first authors: Ling-Kai Yang and Ying Ye.
Author contributions: Yang LK and Ye Y designed the research study, drafted the manuscript, analyzed and interpreted the results, they contributed equally to this article, they are the co-first authors of this manuscript; Cheng LL, Li X, Ye ZX, Zhu YH, Lin ZY, and Chen XL collected the data, prepared all the tables and figures, reviewed and edited the manuscript; and all authors thoroughly reviewed and endorsed the final manuscript.
Institutional review board statement: This study was approved by the Medical Ethics Committee of Wenzhou Seventh People’s Hospital, approval No. EC-20210826-03.
Clinical trial registration statement: Not Applicable.
Informed consent statement: All study participants or their legal guardian provided informed written consent about personal and medical data collection prior to study enrolment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at Xin-Liang Chen 15868592011@163.com. Participants gave informed consent for data sharing.
Corresponding author: Xin-Liang Chen, Attending Physician, Department of Child Psychiatry, Wenzhou Seventh People’s Hospital, No. 552 Xishan East Road, Ouhai District, Wenzhou 325000, Zhejiang Province, China. 15868592011@163.com
Received: November 21, 2025
Revised: December 18, 2025
Accepted: February 10, 2026
Published online: May 19, 2026
Processing time: 159 Days and 0.5 Hours
Abstract
BACKGROUND

Depression in children and adolescents has become a serious public health problem that threatens their physical and mental health, and effective short-term interventions are particularly crucial. Most existing treatments are either pharmacological or psychotherapy, but limited studies have evaluated whether a combination of intervention models leads to superior outcomes.

AIM

To compare the short-term efficacy of cognitive behavioral therapy (CBT) plus sertraline vs pharmacological treatment alone (sertraline) in adolescents with depression.

METHODS

A single-center randomized controlled study was conducted, and a total of 100 adolescent patients with depression were included who met the diagnostic criteria based on the inclusion and exclusion criteria. The patients were randomly divided into two groups: 50 patients in the study group, who received a comprehensive intervention model (CBT treatment + sertraline treatment + ecological intervention), and 50 patients in the control group, who received only systematic sertraline monotherapy. The Children’s Depression Inventory (CDI) was used to evaluate short-term efficacy in both groups. The Adverse Reaction Symptom Scale (TESS) was used to evaluate treatment safety.

RESULTS

The results showed that there was no significant difference in CDI scores between the two groups before treatment (15.9 ± 6.5 vs 13.6 ± 7.3, P > 0.05). After 3 months of treatment, the median CDI score in the study group was 5 points (interquartile range, 3 points) and in the control group it was 7.5 points (interquartile range, 8 points), with a significant difference between the two groups (Z = -3.052, P < 0.05). After 3 months of treatment, the median TESS score in the study group was 6 points (interquartile range, 3 points) and the median TESS score in the control group was 5 points (interquartile range, 5 points). There was no statistically significant difference between the two groups (P > 0.05); the incidence of various types of side effects (such as extrapyramidal reactions and cholinergic symptoms) was similar between the two groups (all P > 0.05). The main adverse events were mild muscle stiffness (6%) and dry mouth (6%-8%). No serious adverse reactions occurred.

CONCLUSION

The comprehensive treatment model of CBT combined with sertraline and ecological intervention was significantly better than drug therapy alone in improving depression in children and adolescents in the short term, and demonstrated a good safety profile. This model should be promoted in clinical practice to improve the overall effectiveness of treatments for adolescent depression.

Keywords: Adolescent depression; Intervention; Children’s Depression Inventory; The Adverse Reaction Symptom Scale; Randomized controlled trial

Core Tip: This study showed that cognitive behavioral therapy based on ecological intervention combined with sertraline had better short-term efficacy than sertraline alone in the treatment of adolescent depression, and the safety profile was comparable. These results provide an empirical basis for the clinical selection of high-efficiency and low-risk adolescent depression treatment regimens. In the future, it is necessary to further verify the long-term effectiveness of the intervention, and explore comprehensive intervention strategies for comorbid factors such as sleep management and metabolic health.

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