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Not yet recruitingNCT07811778Updated Sep 10, 2026

Transcutaneous Electrical Acupoint Stimulation Combined With Exposure and Response Prevention in the Treatment of Patients With Obsessive-Compulsive Disorder: A Randomized Controlled Trial

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

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Obsessive Compulsive Disorder (OCD)
03

In context

Obsessive-Compulsive Disorder

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 →

Lead sponsor

Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: 18 - 50 years old, gender not restricted;
  2. Meets the diagnostic criteria for obsessive-compulsive disorder as per the fifth edition of the (DSM-5);
  3. Yale-Brown Obsessive Compulsive Scale score ≥ 16 points;
  4. Has never taken medication or is currently taking medication with a stable dosage for 8 weeks or more;
  5. Has a junior high school education or above;
  6. Has signed the form.

Exclusion criteria

Exclusion Criteria:

  1. Meets the diagnosis criteria in except for obsessive-compulsive disorder (excluding obsessive-compulsive personality disorder);
  2. Has severe obsessive symptoms that prevent the patient from completing the required assessment tests;
  3. Has a history of brain injury or surgery, or has an implanted cardiac pacemaker or other metal device in the body;
  4. Pregnant or planning to become pregnant women, breastfeeding women;
  5. Substance abusers within the past year;
  6. Have severe negative thoughts or a high risk of suicide;
  7. Other conditions deemed unsuitable for inclusion by the researchers.
Terms in these criteria, in plain language(2)

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (estimated)

Study arms

  • 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.

    Behavioral: Exposure and Response Prevention · Device: Active Transcutaneous Acupoint Electrical Stimulation

  • Sham comparator
    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.

    Behavioral: Exposure and Response Prevention · Device: Sham Transcutaneous Acupoint Electrical Stimulation

Interventions

  • BehavioralExposure and Response Prevention

    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.

  • DeviceActive Transcutaneous Acupoint Electrical Stimulation

    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.

  • DeviceSham Transcutaneous Acupoint Electrical Stimulation

    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.

06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07811778
Responsible party
Jue CHEN (Director of the Clinical Psychology Department, Shanghai Mental Health Center) — Principal investigator
First posted
Sep 10, 2026
Start date
Sep 7, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 10, 2026

Study contacts

Jue Chen
Contact
chenjue2088@163.com
+8618017311203
Jue Chen
principal investigator · Shanghai Mental Health Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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