Obsessive-Compulsive Disorder (OCD)NCT01368510
Intensive Cognitive-Behavioral Therapy For Obsessive-Compulsive Disorder
A study testing Intensive Cognitive Behavioral Therapy (CBT) and Waitlist in people with Obsessive-Compulsive Disorder (OCD), run by University of California, Los Angeles at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-Compulsive Disorder (OCD)
- What is being tested?
- Intensive Cognitive Behavioral Therapy (CBT) and Waitlist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Jun 2015
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Obsessive-Compulsive Disorder Intensive Treatment Program
Los Angeles, California, 90024
About this study
Official title: 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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Being tested
- Intensive Cognitive Behavioral Therapy (CBT), Waitlist
- Keywords
- obsessive-compulsive disorder (OCD), cognitive-behavioral therapy (CBT), magnetic resonance spectroscopy (MRS), glutamate, cingulate gyrus
- 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.
Intensive Cognitive Behavioral Therapy (CBT)Behavioural
Also called Exposure and Response Prevention (ERP)
Nondrug psychotherapy administered daily 5 days/week for 4 weeks
WaitlistBehavioural
Minimal contact waitlist weekly for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| OCD Active CBT | Experimental | Adults with obsessive-compulsive disorder (OCD) will be treated with cognitive-behavioral therapy (CBT) from the time of enrollment. Receives: Behavioral: Intensive Cognitive Behavioral Therapy (CBT) |
| OCD Waitlist | Active comparator | Adults with OCD will receive waitlist treatment at enrollment. Nonresponders will cross over to CBT. Receives: Behavioral: Intensive Cognitive Behavioral Therapy (CBT); Behavioral: Waitlist |
| Healthy Control | No intervention | Healthy control adults will be given no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRSI glutamate
Regional concentration of glutamate in brain, as measured by magnetic resonance spectroscopic imaging (MRSI)
Measured: 4 weeks
Secondary outcomes (1)
Y-BOCS
Severity of core obsessive-compulsive clinical symptoms as measured with the Yale-Brown Obsessive-Compulsive Scale score
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Joseph O'Neill, PhD, University of California, Los Angeles
- Investigators
- Joseph O'Neill, PhD, Principal investigator, UCLA Child Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368510
- Sponsor's protocol ID
- R01MH085900
- Other IDs
- R01MH085900
- Status last verified
- Mar 2020
- First submitted
- 6 Jun 2011
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Reggente N, Moody TD, Morfini F, Sheen C, Rissman J, O'Neill J, Feusner JD. Multivariate resting-state functional connectivity predicts response to cognitive behavioral therapy in obsessive-compulsive disorder. Proc Natl Acad Sci U S A. 2018 Feb 27;115(9):2222-2227. doi: 10.1073/pnas.1716686115. Epub 2018 Feb 12.
PubMed 29440404Moody TD, Morfini F, Cheng G, Sheen C, Tadayonnejad R, Reggente N, O'Neill J, Feusner JD. Mechanisms of cognitive-behavioral therapy for obsessive-compulsive disorder involve robust and extensive increases in brain network connectivity. Transl Psychiatry. 2017 Sep 5;7(9):e1230. doi: 10.1038/tp.2017.192.
PubMed 28872637
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral Therapy and Glutamate in Cingulate Gyrus in OCD
- ClinicalTrials.gov ID
- NCT01368510
- Acronym / sponsor ID
- R01MH085900
- Conditions
- Obsessive-Compulsive Disorder (OCD)
- Keywords
- obsessive-compulsive disorder (OCD), cognitive-behavioral therapy (CBT), magnetic resonance spectroscopy (MRS), glutamate, cingulate gyrus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Jun 2011 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OCD Active CBT | Experimental | Behavioral: Intensive Cognitive Behavioral Therapy (CBT)Adults with obsessive-compulsive disorder (OCD) will be treated with cognitive-behavioral therapy (CBT) from the time of enrollment. |
| OCD Waitlist | Active comparator | Behavioral: Intensive Cognitive Behavioral Therapy (CBT), Behavioral: WaitlistAdults with OCD will receive waitlist treatment at enrollment. Nonresponders will cross over to CBT. |
| Healthy Control | No intervention | –Healthy control adults will be given no intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| Intensive Cognitive Behavioral Therapy (CBT)Also: Exposure and Response Prevention (ERP)Nondrug psychotherapy administered daily 5 days/week for 4 weeks | Behavioural | OCD Active CBT, OCD Waitlist |
| WaitlistMinimal contact waitlist weekly for 4 weeks | Behavioural | OCD Waitlist |
Primary outcome
MRSI glutamate
Time frame: 4 weeks
Regional concentration of glutamate in brain, as measured by magnetic resonance spectroscopic imaging (MRSI)
1 secondary outcome
Y-BOCS
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Derived from this study: PubMed 29440404Reggente N, Moody TD, Morfini F, Sheen C, Rissman J, O'Neill J, Feusner JD. Multivariate resting-state functional connectivity predicts response to cognitive behavioral therapy in obsessive-compulsive disorder. Proc Natl Acad Sci U S A. 2018 Feb 27;115(9):2222-2227. doi: 10.1073/pnas.1716686115. Epub 2018 Feb 12.
- Derived from this study: PubMed 28872637Moody TD, Morfini F, Cheng G, Sheen C, Tadayonnejad R, Reggente N, O'Neill J, Feusner JD. Mechanisms of cognitive-behavioral therapy for obsessive-compulsive disorder involve robust and extensive increases in brain network connectivity. Transl Psychiatry. 2017 Sep 5;7(9):e1230. doi: 10.1038/tp.2017.192.
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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.
Joseph O'Neill, PhD principal investigator
UCLA Child Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Cognitive Behavioral Therapy (CBT) and Waitlist in people with Obsessive-Compulsive Disorder (OCD), run by University of California, Los Angeles at 1 site in United States.
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: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRSI glutamate (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01368510, which also lists 2 linked publications.
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 24 Mar 2020.