Predictors of rTMS and Group Therapy Efficacy in Adolescent Depression

December 2, 2025 updated by: Yanju Liu, The First Hospital of Hebei Medical University

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

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).

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

163

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The First Hospital of Hebei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
rTMS + Group Therapy Cohort
Adolescents diagnosed with MDD who received the standardized combined intervention.
High-frequency (10 Hz) rTMS applied over the left dorsolateral prefrontal cortex (DLPFC), administered 5 days per week for 4 weeks (20 sessions total).
Manualized group therapy sessions focused on psychoeducation, cognitive restructuring, emotion regulation, and interpersonal skills, held twice weekly for 4 weeks (8 sessions total).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Major Depressive Disorder (MDD)

Clinical Trials on Repetitive Transcranial Magnetic Stimulation (rTMS)

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