Intensive Cognitive-Behavioral Therapy For Obsessive-Compulsive Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of California, Los Angeles
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joseph O'Neill, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01368510
First received: June 6, 2011
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

Even with the best available treatments for obsessive-compulsive disorder (OCD), most patients only partially recover and many patients do not respond at all. Such incomplete and inadequate response contributes to greater public health costs in terms of morbidity and patient care expenses. This study aims for a better understanding of abnormal brain chemistry in OCD and how it is affected by cognitive-behavioral therapy (CBT) in order to develop novel therapies and improve the success of existing therapies. The main hypothesis is that CBT will change levels of the excitatory neurotransmitter glutamate in OCD patients in a region of the brain involved in OCD known as the cingulate cortex.


Condition Intervention
Obsessive-Compulsive Disorder (OCD)
Behavioral: Intensive Cognitive Behavioral Therapy (CBT)
Behavioral: Waitlist

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Therapy and Glutamate in Cingulate Gyrus in OCD

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • MRSI glutamate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Regional concentration of glutamate in brain, as measured by magnetic resonance spectroscopic imaging (MRSI)


Secondary Outcome Measures:
  • Y-BOCS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Severity of core obsessive-compulsive clinical symptoms as measured with the Yale-Brown Obsessive-Compulsive Scale score


Estimated Enrollment: 75
Study Start Date: July 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OCD Active CBT
Adults with obsessive-compulsive disorder (OCD) will be treated with cognitive-behavioral therapy (CBT) from the time of enrollment.
Behavioral: Intensive Cognitive Behavioral Therapy (CBT)
Nondrug psychotherapy administered daily 5 days/week for 4 weeks
Other Name: Exposure and Response Prevention (ERP)
Active Comparator: OCD Waitlist
Adults with OCD will receive waitlist treatment at enrollment. Nonresponders will cross over to CBT.
Behavioral: Intensive Cognitive Behavioral Therapy (CBT)
Nondrug psychotherapy administered daily 5 days/week for 4 weeks
Other Name: Exposure and Response Prevention (ERP)
Behavioral: Waitlist
Minimal contact waitlist weekly for 4 weeks
No Intervention: Healthy Control
Healthy control adults will be given no intervention.

Detailed Description:

This study will characterize the neurochemical abnormalities in important brain circuits underlying obsessive-compulsive disorder (OCD) symptoms and the effects of cognitive-behavioral therapy (CBT). Identification of such metabolite biomarkers will provide an important foundation for translational clinical studies to maximize the ability of CBT to reduce symptoms and to design medications that target core features of the disease, which is particularly important for those who do not respond to, or have access to, CBT.

OCD is an often disabling and chronic psychiatric condition that affects approximately 2% of the world's population. Most patients respond only incompletely to current treatments and many do not respond at all. CBT, a form of psychotherapy, is one of the most effective treatments for OCD, yet its mechanism of action is not fully understood. The objective of this study is to use neuroimaging to understand how neurometabolite abnormalities in neural circuits relate to OCD symptoms, and how these are affected by CBT. In OCD, dysfunction is suspected in several subregions of the cingulate gyrus, a brain region involved in relevant neural circuits. This study will use magnetic resonance spectroscopic imaging (MRSI) to measure concentrations of brain metabolites, including glutamate (Glu), in the cingulate. Glu is an important excitatory neurotransmitter that is suspected to be disturbed in OCD. In this study, MRSI scans will be performed on 25 adult OCD patients before and after 4 weeks of daily CBT. They will be compared to 25 untreated healthy controls scanned 4 weeks apart. A third group of 25 OCD patients will be scanned before and after 4 weeks while on the waitlist, will then receive 4 weeks of CBT, and will be scanned a third time at its completion. The specific aims of this study are: 1) Determine if levels of the Glu in the "emotional" and "cognitive" subregions of the cingulate differ between OCD patients and controls; 2) Determine if Glu changes after CBT or waitlist in the OCD patients and if they change in the controls after simple passage of time; 3) Determine if there are relationships between Glu and clinical and neurocognitive symptoms of OCD before and after CBT.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • meets DSM-IV-TR diagnostic criteria for OCD as primary (most severe) diagnosis based on Anxiety Disorders Interview Schedule (ADIS) Clinical Severity Rating
  • reported DSM-IV-TR-threshold OCD symptom onset age 18 or later
  • Yale-Brown Obsessive-Compulsive total score greater than or equal to 16
  • fluent English speaker
  • signed informed consent

Exclusion Criteria:

  • IQ of less than 80 on the Wechsler Abbreviated Scales of Intelligence
  • lifetime DSM-IV diagnosis of pervasive developmental disorder, mania, psychosis, conduct disorder, or substance dependence assessed through ADIS
  • current DSM-IV diagnosis of major depressive disorder if ADIS CSR rating is 4 or higher (severe) or attention-deficit hyperactivity disorder
  • primary compulsive hoarding
  • any changes (dose or agent) in psychotropic medication for OCD or other psychiatric condition within 12 weeks prior to enrollment
  • severe illness that requires immediate inpatient psychiatric intervention
  • any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current study
  • any body metal (other than dental fillings), positive pregnancy test, or other MR scan contraindications
  • prior trial of CBT for OCD, regardless of outcome
  • medical conditions that affect cerebral metabolism (e.g., thyroid disorders or diabetes)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368510

Contacts
Contact: Jamie D Feusner, MD (310) 206-4951 jfeusner@mednet.ucla.edu
Contact: Courtney Sheen (310) 206-0468 csheen@mednet.ucla.edu

Locations
United States, California
UCLA Obsessive-Compulsive Disorder Intensive Treatment Program Recruiting
Los Angeles, California, United States, 90024
Principal Investigator: Joseph O'Neill, PhD         
Principal Investigator: Jamie D Feusner, MD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Joseph O'Neill, PhD UCLA Child Psychiatry
  More Information

No publications provided

Responsible Party: Joseph O'Neill, PhD, Assoc Prof Child Psychiatry, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01368510     History of Changes
Other Study ID Numbers: R01MH085900, R01MH085900
Study First Received: June 6, 2011
Last Updated: May 24, 2013
Health Authority: United States: Federal Government

Keywords provided by University of California, Los Angeles:
obsessive-compulsive disorder (OCD)
cognitive-behavioral therapy (CBT)
magnetic resonance spectroscopy (MRS)
glutamate
cingulate gyrus

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on August 20, 2014