Intensive Cognitive-Behavioral Therapy For Obsessive-Compulsive Disorder

March 23, 2020 updated by: Joseph O'Neill, PhD, University of California, Los Angeles

Cognitive-Behavioral Therapy and Glutamate in Cingulate Gyrus in OCD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90024
        • UCLA Obsessive-Compulsive Disorder Intensive Treatment Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRSI glutamate
Time Frame: 4 weeks
Regional concentration of glutamate in brain, as measured by magnetic resonance spectroscopic imaging (MRSI)
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Y-BOCS
Time Frame: 4 weeks
Severity of core obsessive-compulsive clinical symptoms as measured with the Yale-Brown Obsessive-Compulsive Scale score
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Joseph O'Neill, PhD, UCLA Child Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 6, 2011

First Submitted That Met QC Criteria

June 6, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH085900 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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