EEG-Triggered rTMS and Group Therapy for Adolescents With Depression and Self-Harm

NCT07047534 | Completed

• 1 other identifier: 20221425
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to evaluate the efficacy of real-time EEG-triggered repetitive transcranial magnetic stimulation (rTMS) combined with group therapy versus rTMS alone in adolescents (aged 12-18 years) diagnosed with depression and exhibiting recent self-harm behavior. The primary outcome is the change in depression severity at 4 weeks.

Conditions

Depression

Keywords

Major Depressive Disorder; Self-Harm Behavior; Adolescent Depression; Transcranial Magnetic Stimulation; Group Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Rating Scale (HAMD-24) scores

  The HAMD-24 is a clinician-rated scale to assess the severity of depressive symptoms. Higher scores indicate greater severity of depression. Change is calculated as score at week 4 minus score at baseline.

  Baseline and Week 4 (post-intervention)

Secondary Outcomes (8)

• Change in Hamilton Anxiety Rating Scale (HAMA-14) scores

  Baseline and Week 4

• Change in Suicide Probability Scale (SPS) scores

  Baseline and Week 4

• Change in Modified Self-Harm Inventory (MSHI) scores

  Baseline and Week 4

• Change in Event-Related Potential (ERP) P300 Latency

  Baseline and Week 4

• Change in Event-Related Potential (ERP) P300 Amplitude

  Baseline and Week 4

Study Arms (2)

Real-time EEG-triggered rTMS Alone

ACTIVE COMPARATOR

Participants received 20 sessions of real-time EEG-triggered rTMS over 4 weeks (5 sessions/week).

Device: Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS)

Real-time EEG-triggered rTMS + Group Therapy

EXPERIMENTAL

Participants received identical rTMS (as the control group) plus semi-closed group therapy sessions.

Device: Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Group Therapy

Interventions

Real-time EEG-triggered Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

Stimulation target: left dorsolateral prefrontal cortex (DLPFC; F3 electrode position, 10-20 EEG system); Frequency: 10 Hz; Intensity: 110% of resting motor threshold (RMT); Pulse number: 2000 pulses/session (20 trains of 100 pulses, 30-second inter-train interval); EEG triggering: Stimulation pulses synchronized to the peak of the participant's ongoing θ-wave (4-7 Hz) activity. Duration: 20 sessions over 4 weeks.

Real-time EEG-triggered rTMS + Group Therapy; Real-time EEG-triggered rTMS Alone

Group Therapy BEHAVIORAL

Semi-closed group therapy; 10 participants/group, 2 sessions/week, 90 minutes/session for 4 weeks (total 8 sessions). Content included: Sessions 1-2: Emotional recognition and expression training; Sessions 3-4: Cognitive restructuring; Sessions 5-6: Impulse control training; Sessions 7-8: Self-esteem building and future planning.

Real-time EEG-triggered rTMS + Group Therapy

Eligibility Criteria

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

You may qualify if:

• Age 12-18 years;
• Diagnosis of major depressive disorder (MDD) according to the International Classification of Diseases, 10th Revision (ICD-10 F32);
• Documented self-harm behavior within 2 weeks prior to enrollment (defined as deliberate self-injury without suicidal intent, e.g., cutting, burning);
• Hamilton Depression Rating Scale (HAMD-24) score ≥17 at baseline;
• Ability to complete self-report measures and participate in group therapy.

You may not qualify if:

• Comorbid psychotic disorders (e.g., schizophrenia), bipolar disorder, or autism spectrum disorder;
• History of neurological conditions (e.g., epilepsy, traumatic brain injury);
• Current use of electroconvulsive therapy;
• Refusal to provide informed consent.

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

Related Publications (1)

• Liu H, Liu S, Yu M, Xin B, Liu Y. Real-time EEG-triggered transcranial magnetic stimulation combined with group therapy for adolescents with depression and self-harm behavior: A randomized controlled trial. J Affect Disord. 2026 Jan 1;392:120144. doi: 10.1016/j.jad.2025.120144. Epub 2025 Aug 26.

  PMID: 40876639 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: June 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 2, 2025

Record last verified: 2024-06

Locations

CN (1)