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Predictors of rTMS and Group Therapy Efficacy in Adolescent Depression

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07283419
Enrollment
163
Registered
2025-12-15
Start date
2023-08-01
Completion date
2024-07-31
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Depression, Major Depressive Disorder (MDD)

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).

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.

Interventions

DEVICERepetitive 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).

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

Sponsors

The First Hospital of Hebei Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage Reduction in HAMD-24 ScoreBaseline and Week 4Treatment 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026