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NCT Number: NCT07811778

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

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.

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Key information

Conditions

Obsessive Compulsive Disorder (OCD) Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exposure and Response Prevention

Behavioral

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.

Active Transcutaneous Acupoint Electrical Stimulation

Device

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.

Sham Transcutaneous Acupoint Electrical Stimulation

Device

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.

Primary outcomes

  1. The reduction rate of the Yale Brown Depression Scale

    Time frame: week 0（baseline）, week 8（post-intervention）, week12 (follow-up）

    Calculation: Baseline YBCOS total score - Follow-up YBOCS total score / Baseline YBCOS total score.A deduction rate of 35% or higher is considered valid.

Secondary outcomes

  1. The reduction rate of the BDI-II

    Time frame: week 0（baseline）, week 8（post-intervention）, week12（follow-up）

    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.

  2. The reduction rate of BAI

    Time frame: Time Frame: week 0（baseline）, week 8（post-intervention）, week12（follow-up）

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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