Predictors of rTMS and Group Therapy Efficacy in Adolescent Depression

NCT07283419 | Completed

• 1 other identifier: 2023S00133
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Major Depressive Disorder (MDD); Adolescent Depression

Outcome Measures

Primary Outcomes (1)

• Percentage Reduction in HAMD-24 Score

  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.

  Baseline and Week 4

Study Arms (1)

rTMS + Group Therapy Cohort

Adolescents diagnosed with MDD who received the standardized combined intervention.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Group Cognitive Behavioral Therapy (CBT)

Interventions

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).

rTMS + Group Therapy Cohort

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).

rTMS + Group Therapy Cohort

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients aged 12 to 18 years recruited from the Department of Mental Health at The First Hospital of Hebei Medical University between August 2023 and July 2024. All participants had a primary diagnosis of Major Depressive Disorder (MDD) according to ICD-10 criteria and received a standardized combined intervention of rTMS and group therapy.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Hospital of Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: August 1, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CN (1)