Obsessive-Compulsive DisorderNCT02602886
Exposure and Response Prevention Therapy for Obsessive-compulsive Disorder
A study testing Exposure and Response Prevention Therapy in people with Obsessive-Compulsive Disorder, run by Ruijin Hospital at 5 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Exposure and Response Prevention Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesChina
- Study dates
- Nov 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
5 sites in 1 country.
Haiyan Jin, MD, PhD contact
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Bin Li, MD,PhD, libinjia@163.com
- Recruiting
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Haiyan Jin, MD,PhD, hyjin603@163.com
Chencheng Zhang, MD,PhD, +8618217122884, i@cczhang.org
- Recruiting
Shanghai Hongkou Mental Health Center
Shanghai Shi
Fang Fang, MD
- Recruiting
Suzhou Guangji Hospital
Suzhou
Feng Zhu, MD
- Recruiting
The First Hospital affiliated to XinJiang Medical University
Ürümqi
Xiao Luo, MD
About this study
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.
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
- Obsessive-Compulsive Disorder
- Being tested
- Exposure and Response Prevention Therapy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure and Response Prevention TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exposure and Response Prevention Therapy | Experimental | Not described Receives: Behavioral: Exposure and Response Prevention Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score
Measured: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Secondary outcomes (8)
Change in Florida Obsessive-Compulsive Inventory (FOCI) Score
Measured: 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
Measured: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Change in Hamilton Anxiety Scale, Hamilton Depression Scale-17 Score
Measured: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Change in Obsessional beliefs questionnaire (OBQ-44) Score
Measured: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Change in Patient EX/RP Adherence Scale (PEAS) Score
Measured: 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
Measured: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Disability: Change in WHO disability assessment 2.0
Measured: Baseline, upon ERP completion(average 7.5 weeks), 1 month after ERP completion
Treatment Ambivalence Questionnaire (TAQ)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startNov 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Bomin Sun, Ruijin Hospital
- Investigators
- Bomin Sun, MD, PhD, Study director, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602886
- Sponsor's protocol ID
- OCD#020
- Status last verified
- Nov 2016
- First submitted
- 5 Nov 2015
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure and Response Prevention Therapy for Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT02602886
- Acronym / sponsor ID
- OCD#020
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- 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
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exposure and Response Prevention Therapy | Experimental | Behavioral: Exposure and Response Prevention Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure and Response Prevention TherapyThe 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. | Behavioural | Exposure and Response Prevention Therapy |
Primary outcome
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
8 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haiyan Jin, MD, PhD contact
Bomin Sun, MD, PhD study director
Ruijin Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure and Response Prevention Therapy in people with Obsessive-Compulsive Disorder, run by Ruijin Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ChenCheng Zhang, MD (18217122884, i@cczhang.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.