Obsessive Compulsive Disorder (OCD)NCT07811778
Transcutaneous Electrical Acupoint Stimulation Combined With Exposure and Response Prevention in the Treatment of Patients With Obsessive-Compulsive Disorder: A Randomized Controlled Trial
A study testing Exposure and Response Prevention and Active Transcutaneous Acupoint Electrical Stimulation in people with Obsessive Compulsive Disorder (OCD), run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- Exposure and Response Prevention and Active Transcutaneous Acupoint Electrical Stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Mental Health
Shanghai
Jue Chen, +8618017311203, chenjue2088@163.com
About this study
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.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- Exposure and Response Prevention, Active Transcutaneous Acupoint Electrical Stimulation, Sham Transcutaneous Acupoint Electrical Stimulation
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure and Response PreventionBehavioural
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 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exposure and Response Prevention; Device: 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. Receives: Behavioral: Exposure and Response Prevention; Device: Sham Transcutaneous Acupoint Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 0（baseline）, week 8（post-intervention）, week12 (follow-up）
Secondary outcomes (2)
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.
Measured: 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.
Measured: Time Frame: week 0（baseline）, week 8（post-intervention）, week12（follow-up）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start7 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jue CHEN, Shanghai Mental Health Center
- Investigators
- Jue Chen, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811778
- Sponsor's protocol ID
- 2026-OCD67
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Acupoint Stimulation Combined With Exposure and Response Prevention in the Treatment of Patients With Obsessive-Compulsive Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07811778
- Acronym / sponsor ID
- 2026-OCD67
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERP+TEAS treatment group | Experimental | Behavioral: Exposure and Response Prevention, Device: Active Transcutaneous Acupoint Electrical StimulationERP+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. |
| ERP+sham-stimulation group | Sham comparator | Behavioral: Exposure and Response Prevention, Device: Sham Transcutaneous Acupoint Electrical StimulationERP+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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure and Response PreventionThe 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. | Behavioural | ERP+TEAS treatment group, ERP+sham-stimulation group |
| Active Transcutaneous Acupoint Electrical StimulationThe 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. | Device | ERP+TEAS treatment group |
| Sham Transcutaneous Acupoint Electrical StimulationA 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. | Device | ERP+sham-stimulation group |
Primary outcome
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.
2 secondary outcomes
The reduction rate of the BDI-II
Time frame: week 0（baseline）, week 8（post-intervention）, week12（follow-up）
The reduction rate of BAI
Time frame: Time Frame: week 0（baseline）, week 8（post-intervention）, week12（follow-up）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jue Chen principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure and Response Prevention and Active Transcutaneous Acupoint Electrical Stimulation in people with Obsessive Compulsive Disorder (OCD), run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jue Chen (+8618017311203, chenjue2088@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reduction rate of the Yale Brown Depression Scale (time frame: week 0（baseline）, week 8（post-intervention）, week12 (follow-up）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.