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Neuromodulation as an Augmentative Therapy for Psychotherapy Targeting Self-Injurious Behavior in Patients with Depressive Episodes: A Randomized Controlled Stud

Neuromodulation as an Augmentative Therapy for Psychotherapy Targeting Self-Injurious Behavior in Patients with Depressive Episodes: A Randomized Controlled Stud

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094850
Enrollment
Unknown
Registered
2024-12-30
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

depressive episodes in depressive disorder or bipolar disorder, accompanied by non-suicidal self-injury (NSSI) behaviors

Interventions

Control Group:DBT group skills training
Augmentation Group:DBT group skills training

Sponsors

Peking University Sixth Hospital (Institute of Mental Health)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 25 Years

Inclusion criteria

Inclusion criteria: 1) 16-25 years old, Han nationality, male or female; 2) According to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5), the Concise International Neuropsychiatric Disorders Interview Examination (MINI) Chinese version is used as the diagnostic tool, mainly for outpatients or inpatients with depressive disorder or bipolar disorder who currently have depressive episodes. 3) The DSM-5 lists NSSI as other conditions that may be of clinical concern and gives diagnostic recommendations, but it is not established as a stand-alone diagnosis without a disease code. Refer to their diagnostic items, use a self-made checklist to confirm the presence of NSSI behavior, and at least 1 episode of NSSI within 4 weeks prior to enrollment; 4) The patient and his/her family (if the patient is a minor under 18 years old) agree to participate in this study.

Exclusion criteria

Exclusion criteria: 1) Patients with current or recurrent/lifelong other diagnoses according to the diagnostic criteria of DSM-5, such as psychotic disorder, manic or hypomanic episodes, alcohol and drug dependence, obsessive-compulsive disorder, etc.; 2) Severe suicidal tendencies (according to the MINI suicide risk assessment module, the suicide risk in the past month is at high risk); 3) Patients who are undergoing psychotherapy; 4) Have ever received more than 8 weeks of standard DBT therapy; 5) Received transcranial magnetic or electroconvulsive therapy within one year; 6) Those who suffer from severe unstable physical diseases; 7) Those with a history of epilepsy, febrile convulsions; Pregnant or lactating women, or planning to become pregnant; 8) Patients with contraindications to magnetic resonance scanning and contraindications to transcranial magnetic therapy. 9) Imaging examination showed intracranial lesions.

Design outcomes

Primary

MeasureTime frame
Emotional regulation ability;The reduction rate of the Emotional Regulation Questionnaire score;

Secondary

MeasureTime frame
Improvement in NSSI behavior;Clinical symptoms;

Countries

China

Contacts

Public ContactHao Yan

Peking University Sixth Hospital (Institute of Mental Health)

hao_y@bjmu.edu.cn+86 10 8280 5307

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026