Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exposure and Response Prevention Therapy for Obsessive-compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02602886
Recruitment Status : Unknown
Verified November 2016 by Bomin Sun, Ruijin Hospital.
Recruitment status was:  Recruiting
First Posted : November 11, 2015
Last Update Posted : November 29, 2016
Sponsor:
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
Information provided by (Responsible Party):
Bomin Sun, Ruijin Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: Exposure and Response Prevention Therapy Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exposure and Response Prevention Therapy for Obsessive-compulsive Disorder
Study Start Date : November 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exposure and Response Prevention Therapy Behavioral: Exposure 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. Change in Obsessive-Compulsive Inventory-Revised (OCI-R) Score [ Time Frame: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion ]
  3. 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 ]
  4. Change in Obsessional beliefs questionnaire (OBQ-44) Score [ Time Frame: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion ]
  5. 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 ]
  6. Disability: Change in Sheehan Disability Scale [ Time Frame: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion ]
  7. Disability: Change in WHO disability assessment 2.0 [ Time Frame: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion ]
  8. Treatment Ambivalence Questionnaire (TAQ) [ Time Frame: Baseline ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602886


Contacts
Layout table for location contacts
Contact: ChenCheng Zhang, MD 18217122884 i@cczhang.com
Contact: Haiyan Jin, MD, PhD hyjin603@163.com

Locations
Layout table for location information
China, Shanghai
Shanghai Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Haiyan Jin, MD,PhD       hyjin603@163.com   
Contact: Chencheng Zhang, MD,PhD    +8618217122884    i@cczhang.org   
China, Sichuan
West China Hospital Recruiting
Chengdu, Sichuan, China, 610041
Contact: Bin Li, MD,PhD       libinjia@163.com   
China
Shanghai Hongkou Mental Health Center Recruiting
Shanghai Shi, China
Contact: Fang Fang, MD         
Suzhou Guangji Hospital Recruiting
Suzhou, China
Contact: Feng Zhu, MD         
The First Hospital affiliated to XinJiang Medical University Recruiting
Wulumuqi, China
Contact: Xiao Luo, MD         
Sponsors and Collaborators
Ruijin Hospital
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
Investigators
Layout table for investigator information
Study Director: Bomin Sun, MD, PhD Ruijin Hospital
Layout table for additonal information
Responsible Party: Bomin Sun, Director of Functional Neurosurgery Department, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02602886    
Other Study ID Numbers: OCD#020
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders