An interventional study of Exposure and Response Prevention and Active Transcutaneous Acupoint Electrical Stimulation in Obsessive Compulsive Disorder (OCD), sponsored by Shanghai Mental Health Center. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Shanghai Mental Health Center · Not applicable, Interventional, and Treatment
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.
635 studies on the registry are indexed under Obsessive-Compulsive Disorder; 166 are open to participants now.
This study's planned enrollment of 90 is above the median of 45 across 520 interventional studies indexed under Obsessive-Compulsive Disorder.
Browse Obsessive-Compulsive Disorder studies →Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Exposure and Response Prevention · Device: Active Transcutaneous Acupoint Electrical Stimulation
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.
Behavioral: Exposure and Response Prevention · Device: Sham Transcutaneous Acupoint Electrical Stimulation
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.
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.
The reduction rate of the Yale Brown Depression Scale
Calculation: Baseline YBCOS total score - Follow-up YBOCS total score / Baseline YBCOS total score.A deduction rate of 35% or higher is considered valid.
Time frame: week 0(baseline), week 8(post-intervention), week12 (follow-up)
The reduction rate of the BDI-II
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.
Time frame: week 0(baseline), week 8(post-intervention), week12(follow-up)
The reduction rate of BAI
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: Time Frame: week 0(baseline), week 8(post-intervention), week12(follow-up)
Plan to share: No
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