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

NCT ID: NCT07047534

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2024-12-31

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.

Detailed Description

Adolescent depression is a prevalent and severe mood disorder, often comorbid with self-harm behavior, significantly impairing functioning. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique showing promise in depression treatment. Real-time EEG-triggered rTMS (rEEG-TMS) further refines this by synchronizing stimulation with individual neural rhythms, potentially enhancing precision and efficacy. Psychosocial interventions, such as group therapy, are crucial for adolescent mood disorders, offering peer support, emotional regulation skills, and cognitive restructuring. This study investigates whether combining rEEG-TMS with group therapy offers synergistic benefits over rEEG-TMS alone in adolescents with depression and self-harm.

This was a parallel-group randomized controlled trial. A total of 160 inpatients aged 12-18 years with a diagnosis of major depressive disorder (ICD-10 F32) and documented self-harm behavior within 2 weeks prior to enrollment were recruited. Participants were randomized 1:1 to either receive real-time EEG-triggered rTMS alone (control group, n=80) or real-time EEG-triggered rTMS plus group therapy (observation group, n=80). The rTMS intervention consisted of 20 sessions over 4 weeks (5 sessions/week), targeting the left dorsolateral prefrontal cortex (DLPFC) at 10 Hz, 110% of resting motor threshold, with 2000 pulses per session, triggered by the peak of the participant's ongoing θ-wave activity. The group therapy intervention, for the observation group, consisted of 8 semi-closed sessions (2 sessions/week for 4 weeks, 90 minutes/session) covering emotional recognition, cognitive restructuring, impulse control, and self-esteem building. Assessments were conducted at baseline and at 4 weeks post-intervention.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Real-time EEG-triggered rTMS Alone

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Group Therapy

Intervention Type: 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.

Interventions

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

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.

Intervention Type: DEVICE

Group Therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yanju Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Countries

China

References

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. 2025 Aug 26;392:120144. doi: 10.1016/j.jad.2025.120144. Online ahead of print.

Reference Type: DERIVED

PMID: 40876639 (View on PubMed)

Other Identifiers

20221425

Identifier Type: -

Identifier Source: org_study_id