Transcutaneous Electrical Acupoint Stimulation Combined With Exposure and Response Prevention in the Treatment of Patients With Obsessive-Compulsive Disorder: A Randomized Controlled Trial
4 de septiembre de 2026 actualizado por: Jue CHEN, Shanghai Mental Health Center
Obsessive-compulsive disorder is a chronic and disabling mental disorder.
Among them, 40-60% of obsessive-compulsive disorder patients do not respond to the current first-line drug treatment and/or psychological therapy.
Traditional Chinese medicine treatment for obsessive-compulsive disorder has unique advantages.
Acupuncture, as a traditional Chinese treatment technique, has been increasingly applied in the treatment of mental disorders such as insomnia, anxiety, and depression.
Transcutaneous electrical acupoint stimulation (TEAS) can replace acupuncture.
With equivalent effects, it can reduce pain and fear and is a non-invasive, safe, and time-saving physical intervention method.
TEAS combined with exposure and response prevention therapy may have an additive effect in the treatment of obsessive-compulsive disorder.
We will conduct a prospective randomized design to explore the integrated and optimized treatment plan of traditional Chinese and Western medicine for obsessive-compulsive disorder, improve the treatment efficiency, and reduce the proportion of chronic patients.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
90
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Jue Chen
- Número de teléfono: +8618017311203
- Correo electrónico: chenjue2088@163.com
Ubicaciones de estudio
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Shanghai, Porcelana
- Shanghai Mental Health
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Contacto:
- Jue Chen
- Número de teléfono: +8618017311203
- Correo electrónico: chenjue2088@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age: 18 - 50 years old, gender not restricted;
- Meets the diagnostic criteria for obsessive-compulsive disorder as per the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- Yale-Brown Obsessive Compulsive Scale score ≥ 16 points;
- Has never taken medication or is currently taking medication with a stable dosage for 8 weeks or more;
- Has a junior high school education or above;
- Has signed the informed consent form.
Exclusion Criteria:
- Meets the diagnosis criteria in DSM-5 except for obsessive-compulsive disorder (excluding obsessive-compulsive personality disorder);
- Has severe obsessive symptoms that prevent the patient from completing the required assessment tests;
- Has a history of brain injury or surgery, or has an implanted cardiac pacemaker or other metal device in the body;
- Pregnant or planning to become pregnant women, breastfeeding women;
- Substance abusers within the past year;
- Have severe negative thoughts or a high risk of suicide;
- Other conditions deemed unsuitable for inclusion by the researchers.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: ERP+TEAS treatment group
ERP+TEAS treatment group has 45 OCD patients.Each patient receives 16 sessions of ERP for 50 minutes.
TEAS procedure is truly exciting and is carried out simultaneously with ERP.
The targeted stimulation points are the bilateral Neiguan acupoints.
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The first one is to establish the therapeutic relationship, mainly aimed at discussing the changes that the upcoming treatment can bring to the patient, helping the patient understand that their obsessive-compulsive symptoms are mainly due to their dysfunctional evaluation system and helping them understand the reasons for the gradual increase in their obsessive behaviors.
Normalization of anxiety and the analysis of the pros and cons of anxiety lay the groundwork for the next exposure therapy.
The therapist also needs to help the patient understand and accept the next TEAS synchronous ERP treatment.
In the last treatment, the therapist should summarize the treatment process with the patient.
In addition, the therapist needs to understand the patient's feedback on the treatment, consolidate the achieved treatment effects, and jointly discuss the prevention of recurrence with the patient.
The acupoints stimulated are bilateral Neiguan points.
The stimulation positioning is based on the "National Standard of the People's Republic of China · Acupoint Names and Locations" [GB/T 12346-2021] (2021).
The stimulation frequency is 50Hz, and the pulse width can change with the frequency.
The pulse amplitude (0-100 mA) is titrated to a "strong but comfortable" sensation level.
The ERP treatment lasts for 8 weeks, twice a week, for a total of 16 sessions, all of which are TEAS synchronized with ERP treatment.
Each treatment lasts for 50 minutes, with the first 20 minutes being the therapist's theoretical explanation, and the last 30 minutes being exposure practice.
The TEAS stimulation starts simultaneously with the patient's exposure practice, and the stimulation duration is also 30 minutes.
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Comparador falso: ERP+sham-stimulation group
ERP+sham-stimulation group has 45 patients.Each patient receives 16 sessions of ERP for 50 minutes.
TEAS intervention uses sham coils and is carried out simultaneously with ERP.
The targeted stimulation points are the bilateral Neiguan acupoints.
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The first one is to establish the therapeutic relationship, mainly aimed at discussing the changes that the upcoming treatment can bring to the patient, helping the patient understand that their obsessive-compulsive symptoms are mainly due to their dysfunctional evaluation system and helping them understand the reasons for the gradual increase in their obsessive behaviors.
Normalization of anxiety and the analysis of the pros and cons of anxiety lay the groundwork for the next exposure therapy.
The therapist also needs to help the patient understand and accept the next TEAS synchronous ERP treatment.
In the last treatment, the therapist should summarize the treatment process with the patient.
In addition, the therapist needs to understand the patient's feedback on the treatment, consolidate the achieved treatment effects, and jointly discuss the prevention of recurrence with the patient.
A transient placebo-tens simulation stimulation was adopted.
A bonding electrode pad was placed 1 cm radially from the Neiguan acupoint.
The stimulation intensity was adjusted to the minimum sensory threshold for 30 seconds, then gradually reduced over the next 15 seconds, making the stimulation active for a total of 45 seconds.
This ensured that no current was transmitted to the electrode pad while maintaining the blinding condition.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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The reduction rate of the Yale Brown Depression Scale
Periodo de tiempo: week 0（baseline）, week 8（post-intervention）, week12 (follow-up）
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Calculation: Baseline YBCOS total score - Follow-up YBOCS total score / Baseline YBCOS total score.A deduction rate of 35% or higher is considered valid.
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week 0（baseline）, week 8（post-intervention）, week12 (follow-up）
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The reduction rate of the BDI-II
Periodo de tiempo: week 0（baseline）, week 8（post-intervention）, week12（follow-up）
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BDI-II：It consists of 21 items, used to assess the severity of each depressive symptom. Each item is divided into four levels ranging from 0 to 3. The total score of the scale is the sum of the scores of the 21 items. The BDI-II is one of the most widely used self-rating depression scales at present. The Chinese version was introduced by this research group and its reliability and validity were evaluated. Calculation: Baseline BDI total score - Follow-up BDI total score / Baseline BDI total score. A reduction rate of 50% or higher is considered valid. |
week 0（baseline）, week 8（post-intervention）, week12（follow-up）
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The reduction rate of BAI
Periodo de tiempo: Time Frame: week 0（baseline）, week 8（post-intervention）, week12（follow-up）
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BAI：It consists of 21 items, each of which is divided into 0-3 levels, and is used for self-assessment of individual anxiety symptoms. The total score is the sum of the scores of each item, and the possible score range is 0 to 63 points. The higher the score, the more severe the anxiety symptoms. This scale has good internal consistency and test-retest reliability. Its Chinese version has similar reliability and validity to the original version. Calculation: Baseline BAI total score - Follow-up BAI total score / Baseline BAI total score. A reduction rate of 50% or higher is considered valid. |
Time Frame: week 0（baseline）, week 8（post-intervention）, week12（follow-up）
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jue Chen, Shanghai Mental Health Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
7 de septiembre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
4 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de septiembre de 2026
Publicado por primera vez (Actual)
10 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-OCD67
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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