Clinical Trials Directory

Trials / Completed

CompletedNCT07283419

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
Phase
Study type
Observational
Enrollment
163 (actual)
Sponsor
The First Hospital of Hebei Medical University · Academic / Other
Sex
All
Age
12 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
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).
BEHAVIORALGroup 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).

Timeline

Start date
2023-08-01
Primary completion
2024-07-31
Completion
2024-07-31
First posted
2025-12-15
Last updated
2025-12-15

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07283419. Inclusion in this directory is not an endorsement.