NCT07811778

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Sep 2026Dec 2027

First Submitted

Initial submission to the registry

September 4, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

September 7, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

1.3 years

First QC Date

September 4, 2026

Last Update Submit

September 4, 2026

Conditions

Obsessive Compulsive Disorder (OCD)

Outcome Measures

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.

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

Secondary Outcomes (2)

  • The reduction rate of the BDI-II

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

  • The reduction rate of BAI

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

Study Arms (2)

ERP+TEAS treatment group

EXPERIMENTAL

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 PreventionDevice: Active Transcutaneous Acupoint Electrical Stimulation

ERP+sham-stimulation group

SHAM COMPARATOR

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 PreventionDevice: Sham Transcutaneous Acupoint Electrical Stimulation

Interventions

Sham Transcutaneous Acupoint Electrical StimulationDEVICE

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.

ERP+sham-stimulation group
Active Transcutaneous Acupoint Electrical StimulationDEVICE

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.

ERP+TEAS treatment group
Exposure and Response PreventionBEHAVIORAL

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.

ERP+TEAS treatment groupERP+sham-stimulation group

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health

Shanghai, China

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Jue Chen

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jue Chen

CONTACT

+8618017311203chenjue2088@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Clinical Psychology Department

Study Record Dates

First Submitted

September 4, 2026

First Posted

September 10, 2026

Study Start

September 7, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 10, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)