Transcutaneous Electrical Acupoint Stimulation Combined With Exposure and Response Prevention in the Treatment of Patients With Obsessive-Compulsive Disorder: A Randomized Controlled Trial
2026년 9월 4일 업데이트: Jue CHEN, Shanghai Mental Health Center
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.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
90
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jue Chen
- 전화번호: +8618017311203
- 이메일: chenjue2088@163.com
연구 장소
-
-
-
Shanghai, 중국
- Shanghai Mental Health
-
연락하다:
- Jue Chen
- 전화번호: +8618017311203
- 이메일: chenjue2088@163.com
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
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.
|
|
가짜 비교기: 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.
|
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.
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The reduction rate of the Yale Brown Depression Scale
기간: 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.
|
week 0（baseline）, week 8（post-intervention）, week12 (follow-up）
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The reduction rate of the BDI-II
기간: 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. |
week 0（baseline）, week 8（post-intervention）, week12（follow-up）
|
|
The reduction rate of BAI
기간: 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. |
Time Frame: week 0（baseline）, week 8（post-intervention）, week12（follow-up）
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jue Chen, Shanghai Mental Health Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 7일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2027년 12월 31일
연구 등록 날짜
최초 제출
2026년 9월 4일
QC 기준을 충족하는 최초 제출
2026년 9월 4일
처음 게시됨 (실제)
2026년 9월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 4일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .