Status unknownNCT02602886Updated Nov 29, 2016

Exposure and Response Prevention Therapy for Obsessive-compulsive Disorder

An interventional study of Exposure and Response Prevention Therapy in Obsessive-Compulsive Disorder, sponsored by Ruijin Hospital. Status unknown at 5 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-29.

Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 48
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

Read the detailed description

The purpose of this research study is to evaluate whether Exposure and Response Prevention Therapy (ERP) can help adults with obsessive-compulsive disorder (OCD) in China following a training of professionals and ongoing consultation.The treatment time for each participant is approximately 12 weeks. This includes the time between the referral and the beginning of treatment, the treatment sessions, and the 1-month follow-up time. Therapy sessions will take place twice per week for 15 sessions total and last about 90 minutes each. In addition to the therapy sessions, participants will have 3 separate assessments. These assessments will occur (1) right after they agree to participate in the study, (2) immediately after ERP ends, and (3) 1 month after ERP ends. The assessments will take about 1 ½ hours each.

Conditions studied

Obsessive-Compulsive Disorder

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In context

Compulsive Personality Disorder

367 studies on the registry are indexed under Compulsive Personality Disorder; 67 are open to participants now.

This study's planned enrollment of 48 is above the median of 37 across 306 interventional studies indexed under Compulsive Personality Disorder.

Browse Compulsive Personality Disorder studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Minimum score of >16 on the Y-BOCS; this score indicates clinically significant OCD symptom severity;
Medically healthy
Outpatient men and women age 18 years and older;
Meets DSM-IV criteria for a diagnosis of OCD as determined by the MINI. OCD is the primary psychiatric diagnosis (i.e., it is defined by the patient as the most important source of current distress);
Able to communicate meaningfully with the investigators and competent to provide written informed consent. IQ estimate > 85 standard score.

Exclusion criteria

Exclusion Criteria:

Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within the past 12 months will be excluded and referred for appropriate clinical intervention;
Presence of any clinical features requiring a higher level of care (inpatient or partial hospital treatment);
Current or past DSM-IV bipolar disorder (Current or past unipolar depression is not an exclusion criterion. We will allow comorbid depression, to ensure that we are treating a representative OCD sample. Depression is the most common complication in OCD, and about one third of the OCD clinical samples are depressed.)
Schizophrenia, schizoaffective disorder, or any other current or lifetime DSM-IV psychotic disorder;
Current or recent (within 3 months of study entry) DSM-V alcohol or drug dependence or abuse (other than nicotine), or a positive urine drug screen for any illicit substances of abuse;
Estimated IQ \<85 on the WASI, mental retardation, dementia, brain damage, or other cognitive impairment that would interfere with the capacity to participate in the study and complete self-report measures;
Any medical conditions that might contraindicate use of the study treatments, as determined by medical physical and laboratory tests by the study physicians;
Presence of any significant and/or unstable medical illness which might lead to hospitalization during the study duration; subjects with a stable medical condition may participate with the agreement of the subject's physician and the study physician who performs the study physical exam;
Concurrent psychotherapy of any type (e.g., CBT/ERP, supportive, psychodynamic) and duration;
History of adequately-delivered exposure-based cognitive-behavioral therapy (i.e., 10 or more sessions of specific and regular exposure and/or response prevention assignments; as needed and with patients' written permission we will confer with prior treatment providers).

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 48 participants (estimated)

Study arms

Experimental
Exposure and Response Prevention Therapy
Behavioral: Exposure and Response Prevention Therapy

Interventions

BehavioralExposure and Response Prevention Therapy
The treatment includes both therapist-supervised and self-controlled exposure and ritual prevention exercises. 2 sessions per week, up to 15 sessions in total. Session time is 90 minutes. The majority of in-session time is spent conducting in vivo exposures. When engaging in E/RP tasks, patients are instructed to refrain from ritual engagement. Between-session homework is given the patient practicing the within-session E/RP task up to 90 minutes each day. Clinicians supplement E/RP with other cognitive-behavioral interventions including motivational strategies for resistant patients, Socratic dialogue, and behavioral experiments to test the validity of erroneous cognitions.

What researchers measure

Primary outcomes

Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score
Time frame: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion

Secondary outcomes

Change in Florida Obsessive-Compulsive Inventory (FOCI) Score
Time frame: Baseline, after every session(average 3.5 days), upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Change in Obsessive-Compulsive Inventory-Revised (OCI-R) Score
Time frame: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score
Time frame: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Change in Obsessional beliefs questionnaire (OBQ-44) Score
Time frame: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Change in Patient EX/RP Adherence Scale (PEAS) Score
Time frame: From the fourth session(average 1.5 weeks), upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Disability: Change in Sheehan Disability Scale
Time frame: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Disability: Change in WHO disability assessment 2.0
Time frame: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Treatment Ambivalence Questionnaire (TAQ)
Time frame: Baseline

Study locations

5 of 5 sites recruiting

Shanghai Ruijin Hospital
Shanghai, Shanghai 200025, China
- Haiyan Jin, MD,PhD · Contact · hyjin603@163.com
- Chencheng Zhang, MD,PhD · Contact · i@cczhang.org · +8618217122884
Recruiting
West China Hospital
Chengdu, Sichuan 610041, China
- Bin Li, MD,PhD · Contact · libinjia@163.com
Recruiting
Shanghai Hongkou Mental Health Center
Shanghai Shi, China
- Fang Fang, MD · Contact
Recruiting
Suzhou Guangji Hospital
Suzhou, China
- Feng Zhu, MD · Contact
Recruiting
The First Hospital affiliated to XinJiang Medical University
Wulumuqi, China
- Xiao Luo, MD · Contact
Recruiting

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02602886
Lead sponsor: Ruijin Hospital
Collaborators: Shanghai Hongkou Mental Health Center, West China Hospital, Suzhou Guangji Hospital, First Affiliated Hospital of Xinjiang Medical University, The SHSMU-ION Research Center for Brain Disorders
Responsible party: Bomin Sun (Director of Functional Neurosurgery Department, Ruijin Hospital) — Principal investigator
First posted: Nov 11, 2015
Start date: Nov 2016
Primary completion: Dec 2017 (estimated)
Completion: Dec 2017 (estimated)
Last update: Nov 29, 2016

Study contacts

ChenCheng Zhang, MD

Contact

i@cczhang.com

18217122884

Haiyan Jin, MD, PhD

Contact

hyjin603@163.com

Bomin Sun, MD, PhD

study director · Ruijin Hospital

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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