Exposure and Response Prevention Therapy for Obsessive-compulsive Disorder

NCT02602886 | Unknown

• 1 other identifier: OCD#020
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

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.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

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

  Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion

Secondary Outcomes (8)

• Change in Florida Obsessive-Compulsive Inventory (FOCI) Score

  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

  Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion

• Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score

  Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion

• Change in Obsessional beliefs questionnaire (OBQ-44) Score

  Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion

• Change in Patient EX/RP Adherence Scale (PEAS) Score

  From the fourth session(average 1.5 weeks), upon ERP completion(average 7.5 weeks), 1 month after ERP completion

Study Arms (1)

Exposure and Response Prevention Therapy

EXPERIMENTAL

Behavioral: Exposure and Response Prevention Therapy

Interventions

Exposure and Response Prevention Therapy BEHAVIORAL

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.

Exposure and Response Prevention Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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).

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai Hongkou Mental Health Center: collaborator
• West China Hospital: collaborator
• Suzhou Guangji Hospital: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• The SHSMU-ION Research Center for Brain Disorders: collaborator

Study Sites (5)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Shanghai Hongkou Mental Health Center

Shanghai Shi, China

RECRUITING

Suzhou Guangji Hospital

Suzhou, China

RECRUITING

The First Hospital affiliated to XinJiang Medical University

Ürümqi, China

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Bomin Sun, MD, PhD

  Ruijin Hospital

  STUDY DIRECTOR

Central Study Contacts

ChenCheng Zhang, MD

CONTACT

18217122884; i@cczhang.com

Haiyan Jin, MD, PhD

CONTACT

hyjin603@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Functional Neurosurgery Department

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 11, 2015
• Study Start: November 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)