Predictors of rTMS and Group Therapy Efficacy in Adolescent Depression

NCT ID: NCT07283419

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-07-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Major Depressive Disorder (MDD) Adolescent Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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rTMS + Group Therapy Cohort

Adolescents diagnosed with MDD who received the standardized combined intervention.

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type 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)

Intervention Type BEHAVIORAL

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

Interventions

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Repetitive Transcranial Magnetic Stimulation (rTMS)

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

Intervention Type DEVICE

Group Cognitive Behavioral Therapy (CBT)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Hospital of Hebei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yanju Liu

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Countries

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China

Other Identifiers

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2023S00133

Identifier Type: -

Identifier Source: org_study_id

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