Exposure and Response Prevention Therapy for Obsessive-compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Exposure and Response Prevention Therapy for Obsessive-compulsive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02602886
• Other study ID #: OCD#020
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2015
• Last updated: November 27, 2016
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: Ruijin Hospital
• Contact: ChenCheng Zhang, MD
• Phone: 18217122884
• Email: i[@]cczhang.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Disease
• Obsessive-Compulsive Disorder

Intervention

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.

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan
China	Shanghai Ruijin Hospital	Shanghai	Shanghai
China	Shanghai Hongkou Mental Health Center	Shanghai Shi
China	Suzhou Guangji Hospital	Suzhou
China	The First Hospital affiliated to XinJiang Medical University	Wulumuqi

Sponsors (6)

Lead Sponsor	Collaborator
Ruijin Hospital	Shanghai Hongkou Mental Health Center, Suzhou Guangji Hospital, The First Hospital affiliated to XinJiang Medical University, The SHSMU-ION Research Center for Brain Disorders, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score		Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion	No
Secondary	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	No
Secondary	Change in Obsessive-Compulsive Inventory-Revised (OCI-R) Score		Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion	No
Secondary	Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score		Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion	No
Secondary	Change in Obsessional beliefs questionnaire (OBQ-44) Score		Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion	No
Secondary	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	No
Secondary	Disability: Change in Sheehan Disability Scale		Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion	No
Secondary	Disability: Change in WHO disability assessment 2.0		Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion	No
Secondary	Treatment Ambivalence Questionnaire (TAQ)		Baseline	No