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Exposure and Response Prevention Therapy for Obsessive-compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Exposure and Response Prevention Therapy
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Shanghai Ruijin HospitalRecruiting
  • West China HospitalRecruiting
  • Shanghai Hongkou Mental Health CenterRecruiting
  • Suzhou Guangji HospitalRecruiting
  • The First Hospital affiliated to XinJiang Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exposure and Response Prevention Therapy

Arm Description

Outcomes

Primary Outcome Measures

Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score

Secondary Outcome Measures

Change in Florida Obsessive-Compulsive Inventory (FOCI) Score
Change in Obsessive-Compulsive Inventory-Revised (OCI-R) Score
Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score
Change in Obsessional beliefs questionnaire (OBQ-44) Score
Change in Patient EX/RP Adherence Scale (PEAS) Score
Disability: Change in Sheehan Disability Scale
Disability: Change in WHO disability assessment 2.0
Treatment Ambivalence Questionnaire (TAQ)

Full Information

First Posted
November 5, 2015
Last Updated
November 27, 2016
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
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1. Study Identification

Unique Protocol Identification Number
NCT02602886
Brief Title
Exposure and Response Prevention Therapy for Obsessive-compulsive Disorder
Official Title
Exposure and Response Prevention Therapy for Obsessive-compulsive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposure and Response Prevention Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Exposure and Response Prevention Therapy
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
Title
Change in Obsessive-Compulsive Inventory-Revised (OCI-R) Score
Time Frame
Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Title
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
Title
Change in Obsessional beliefs questionnaire (OBQ-44) Score
Time Frame
Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Title
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
Title
Disability: Change in Sheehan Disability Scale
Time Frame
Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Title
Disability: Change in WHO disability assessment 2.0
Time Frame
Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Title
Treatment Ambivalence Questionnaire (TAQ)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ChenCheng Zhang, MD
Phone
18217122884
Email
i@cczhang.com
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyan Jin, MD, PhD
Email
hyjin603@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bomin Sun, MD, PhD
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyan Jin, MD,PhD
Email
hyjin603@163.com
First Name & Middle Initial & Last Name & Degree
Chencheng Zhang, MD,PhD
Phone
+8618217122884
Email
i@cczhang.org
Facility Name
West China Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Li, MD,PhD
Email
libinjia@163.com
Facility Name
Shanghai Hongkou Mental Health Center
City
Shanghai Shi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Fang, MD
Facility Name
Suzhou Guangji Hospital
City
Suzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Zhu, MD
Facility Name
The First Hospital affiliated to XinJiang Medical University
City
Wulumuqi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Luo, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Exposure and Response Prevention Therapy for Obsessive-compulsive Disorder

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