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Completed

NCT Number: NCT07283419

Predictors of rTMS and Group Therapy Efficacy in Adolescent Depression

This study aims to identify baseline predictors of treatment efficacy in adolescents with Major Depressive Disorder (MDD) undergoing a combined intervention of repetitive transcranial magnetic stimulation (rTMS) and group therapy. Specifically, the study investigates the predictive value of family environment characteristics (cohesion, conflict, expressiveness) and cognitive functions (executive function, attention/inhibition).

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

Adolescent depression is a significant health concern, and while combined therapies involving neuromodulation and psychotherapy show promise, individual treatment responses vary heterogeneity. This prospective cohort study enrolled 163 adolescents aged 12-18 with MDD. All participants received a standardized 4-week intervention consisting of 20 sessions of high-frequency (10 Hz) rTMS over the left dorsolateral prefrontal cortex (DLPFC) and 8 sessions of group Cognitive Behavioral Therapy (CBT).

Baseline assessments included the Family Environment Scale (FES) and a neuropsychological battery including the Stroop Color-Word Test and Wisconsin Card Sorting Test (WCST). The primary outcome was the percentage reduction in depressive symptoms measured by the HAMD-24 scale. The study employs multiple linear regression to determine which baseline factors independently predict superior treatment outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary diagnosis of Major Depressive Disorder (MDD) according to ICD-10 criteria.
  • Score of ≥ 20 on the 24-item Hamilton Depression Rating Scale (HAMD-24).
  • Sufficient intellectual and linguistic ability to complete assessments and participate in therapy.
  • Provided written informed consent (participants and guardians).

Exclusion criteria

  • Lifetime diagnosis of a psychotic or bipolar disorder.
  • Current substance use disorder.
  • Significant neurological illness (e.g., epilepsy) or metallic implants contraindicated for rTMS.
  • Receiving concurrent formal psychotherapy outside the study protocol.

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

High-frequency (10 Hz) rTMS applied over the left dorsolateral prefrontal cortex (DLPFC), administered 5 days per week for 4 weeks (20 sessions total).

Group Cognitive Behavioral Therapy (CBT)

Behavioral

Manualized group therapy sessions focused on psychoeducation, cognitive restructuring, emotion regulation, and interpersonal skills, held twice weekly for 4 weeks (8 sessions total).

Primary outcomes

  1. Percentage Reduction in HAMD-24 Score

    Time frame: Baseline and Week 4

    Treatment efficacy is defined as the percentage reduction in the 24-item Hamilton Depression Rating Scale (HAMD-24) score from baseline to the end of treatment. The formula used is: [(HAMD-24 at Baseline - HAMD-24 at Week 4) / HAMD-24 at Baseline] × 100%. The HAMD-24 assesses the severity of depressive symptoms, with higher scores indicating more severe depression.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

Family Environment and Cognitive Function as Predictors of Efficacy for rTMS Combined With Group Therapy in Adolescent Depression: A Prospective Cohort Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2025
Registry last updated
Dec 15, 2025

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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