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

Hebei Medical University

Status: Completed

Conditions: Depression

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07047534

20221425

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Real-time EEG-triggered rTMS Alone

Active Comparator group

Description:

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

Treatment:

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

Real-time EEG-triggered rTMS + Group Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Group Therapy

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