Obsessive Compulsive Disorder (OCD)
Conditions
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.
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.
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.
Sponsors
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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 Diagnostic and Statistical Manual of Mental Disorders (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 informed consent form.
Exclusion criteria
1. Meets the diagnosis criteria in DSM-5 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The reduction rate of the Yale Brown Depression Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| The reduction rate of the BDI-II | 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. |
| The reduction rate of BAI | 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. |
Countries
China
Contacts
CONTACTJue Chen
PRINCIPAL_INVESTIGATORJue Chen
Shanghai Mental Health Center
Outcome results
None listed