Obsessive Compulsive DisorderNCT02467374
Fear Extinction and Mechanisms of Change in Obsessive Compulsive Disorder
A study testing Behavior Therapy in people with Obsessive Compulsive Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to find out more about how the brain stores emotional learning in obsessive-compulsive disorder (OCD). In particular, we would like to understand how human beings learn not to fear. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 22 Jul 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Outpatient men and women age 18 to 60, proficient in English, and able to give informed consent
- For OCD patients only: Primary OCD that causes at least moderate distress and/or impairment (Y-BOCS total score > 16)
Who cannot join
- Current clinically significant suicidality and/or BDI-II suicide item (#9) score >1
- Current or history of neurologic or psychiatric disease (e.g., mental retardation, dementia, brain damage, or other cognitive impairment) that would interfere with ability to engage in BT
- Psychopathology not appropriate for the treatment (such as substance abuse or dependence within the past 3 months; current manic episode; psychosis)
- Previous treatment with ≥4 sessions of BT for OCD
- Currently receiving any other psychotherapy or planning to initiate such treatment during the study
- Use of conventional antipsychotic medications or medications that would lower seizure threshold in high doses or may otherwise affect cerebral metabolism (other than to those required for stabilization of OCD).
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- Use of benzodiazepines within 2 weeks prior to study is not allowed. Use of other psychotropic medications (e.g., SSRIs and atypical antipsychotics) will be allowed provided the dose has been stable for > 8 weeks. Planning on initiation or dose change of psychotropic medication during the study.
- Impaired (or uncorrected) vision, medical illness, or medical treatment that would likely interfere with participation.
- History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae; History of seizures; History of stroke; Signs of increased intracranial pressure; Prior neurosurgical procedure
- Metal in the body, metal injury to the eyes; Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
- Pregnancy; breastfeeding or nursing; if the patient cannot rule out the possibility of pregnancy, a pregnancy test (to be ruled out by urine ß-HCG) will be conducted prior to study
- Weight > 250 lbs
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot: Fear Extinction and Mechanisms of Change in Obsessive Compulsive Disorder
The purpose of this study is to find out more about how the brain stores emotional learning in obsessive-compulsive disorder (OCD). In particular, we would like to understand how human beings learn not to fear. We are also interested in learning about how behavioral therapy (BT) for OCD affects emotional learning in the brain. We hope this study will help us understand why people with OCD cannot control unwanted fear and to develop better treatments for adults with OCD. Patients will be randomly assigned (like the flip of a coin) to receive 12 weeks of BT or 12 weeks of waitlist, followed by 12 weeks of BT. We are seeking individuals 18-60 with OCD and individuals with no psychiatric history. Participation includes a diagnostic evaluation, 12 weeks of BT or 12 weeks of waitlist followed by BT, questionnaires, and up to six (6) MRI scans. You may receive up to $500 for your participation and reimbursement for parking.
Read the detailed description
The purpose of this study is to find out more about how the brain forms and stores emotional learning. Emotional learning refers to our ability to form an association between sounds or places with emotional events. In particular, we would like to understand how human beings learn not to fear and whether individuals with OCD use certain areas of the brain differently than control individuals. We hope this study will help us understand why people with OCD cannot control unwanted fear. We are also interested in learning about how behavioral therapy (BT) for OCD affects emotional learning in the brain. Patients in this study will have an equal chance of undergoing 12 weeks of BT immediately or being placed on a 12-week "waitlist," and then partaking in BT. They will be asked to participate in tasks while in an MRI that takes pictures of the brain. This study will also use mild, half-second electric shocks to fingers. The electric current will be generated from a 9V battery (e.g., battery in a smoke alarm). In order to set the level of the current to be used during the study, we will begin at a level below what patients will be able to feel, and then increase in gradual steps with permission. Patients will be asked to stop the increase at a level of the current that they find highly annoying but not painful. The level of current that patients select during this trial procedure, and no higher level, will be used during the study so that they will not receive any painful electric shocks. The purpose of the electric shock is to create a situation in which emotional learning may occur. Patients will receive no more than ten of these electric shocks.
If patients are assigned to immediate BT, participation in this study includes about 20-22 visits to our two clinics at MGH and the Charlestown Navy Yard over the span of 6 months. This includes an initial assessment visit (2.5-3 hours), 12 therapy visits (each session lasting 60-90 minutes long), and 1 booster session at the MGH OCD and Related Disorders Clinic. During the course of therapy, patients will receive weekly practice work between sessions, which should take around 30 minutes to an hour each day to complete. Additionally, patients will participate in 3 MRI scanning sessions at the Charlestown Navy Yard Campus: 2 scans over a two-day period during baseline visit, 2 scans over a two-day period during week 4 visit, and 2 scans over a two-day period during 3-month follow-up (week 24) appointment.
If patients are assigned to the 12-week waiting period before starting BT, participation will include about 21 visits to our clinics, including an initial assessment visit (2.5-3 hours), 12 therapy visits (after the waiting period ends), and 1 booster session at the MGH OCD and Related Disorders Clinic. Patients will be asked to come to the clinic for assessments during weeks 4 and 6 and after the waiting period (week 12). Patients will also participate in 2 MRI scanning sessions at the Charlestown Navy Yard Campus: 2 scans over a two-day period during baseline visit and 2 scans over a two-day period during week 4 visit. Patients may NOT begin any new therapy or medication while on the waiting list.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Behavior Therapy
- Keywords
- OCD, Neuroimaging, Fear Extinction, Behavior 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.
Behavior TherapyBehavioural
Also called Exposure and Response Prevention
BT for OCD focuses primarily on "exposure with response prevention (ERP)." "ERP" involves gradual exposure to anxiety-provoking situations (things or situations that frighten or disturb some people), and will help to prevent compulsions (repetitive behaviors).
| Study group | Role | What they receive |
|---|---|---|
| Immediate Behavior Therapy | Active comparator | If assigned to the immediate BT condition, patients will be asked to make about 24 visits to our clinics at MGH, including an initial assessment, 12 therapy visits over 12 weeks, and 1 booster session (Week 16). Patients will be asked to come to the clinic for assessments during weeks 4 and 6 and after the treatment (week 12), as well as 1 follow-up visit (week 24). Additionally, patients will participate in 6 MRI scanning sessions at the Charlestown Navy Yard. Receives: Behavioral: Behavior Therapy |
| Waitlist Behavior Therapy | Active comparator | Patients will wait for 12 weeks before starting BT. In this case, they will be asked to make about 21 visits to our clinics, including an initial assessment visit, 12 therapy visits, and 1 booster session. Patients will be asked to come to the clinic for assessments during (weeks 4 and 6) and after the waiting period (week 12). Additionally, patients will participate in 6 MRI scanning sessions at the Charlestown Navy Yard. Receives: Behavioral: Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsessive compulsive symptoms as measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
We assesed reduction in OCD symptom severity over a 24 week period. Efficacy was again compared in the follow-up phase of the study in from week 24 to week 36.
Measured: 24-36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startDec 2014
- Primary completion22 Jul 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabine Wilhelm, PhD, Massachusetts General Hospital
- Investigators
- Sabine Wilhelm, Ph.D., Principal investigator, Massachusetts General Hospital: Department of PsychiatryMohammed Milad, Ph.D., Principal investigator, Massachusetts General Hospital: Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467374
- Sponsor's protocol ID
- 2014P002325
- Status last verified
- Mar 2022
- First submitted
- 1 Jun 2015
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jacoby RJ, Greenberg JL, Hurtado A, Pedersen W, Ellard KK, Pace-Schott EF, Oliver KI, Milad MR, Wilhelm S, Camprodon JA. Neural mechanisms underlying exposure and response prevention for obsessive compulsive disorder: A randomized controlled trial. Behav Res Ther. 2025 Nov;194:104858. doi: 10.1016/j.brat.2025.104858. Epub 2025 Sep 17.
PubMed 41005270
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot: Fear Extinction and Mechanisms of Change in Obsessive Compulsive Disorder
- ClinicalTrials.gov ID
- NCT02467374
- Acronym / sponsor ID
- 2014P002325
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- OCD, Neuroimaging, Fear Extinction, Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 10 Jun 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 study is to find out more about how the brain stores emotional learning in obsessive-compulsive disorder (OCD). In particular, we would like to understand how human beings learn not to fear. We are also interested in learning about how behavioral therapy (BT) for OCD affects emotional learning in the brain. We hope this study will help us understand why people with OCD cannot control unwanted fear and to develop better treatments for adults with OCD. Patients will be randomly assigned (like the flip of a coin) to receive 12 weeks of BT or 12 weeks of waitlist, followed by 12 weeks of BT. We are seeking individuals 18-60 with OCD and individuals with no psychiatric history. Participation includes a diagnostic evaluation, 12 weeks of BT or 12 weeks of waitlist followed by BT, questionnaires, and up to six (6) MRI scans. You may receive up to $500 for your participation and reimbursement for parking.
Detailed description
The purpose of this study is to find out more about how the brain forms and stores emotional learning. Emotional learning refers to our ability to form an association between sounds or places with emotional events. In particular, we would like to understand how human beings learn not to fear and whether individuals with OCD use certain areas of the brain differently than control individuals. We hope this study will help us understand why people with OCD cannot control unwanted fear. We are also interested in learning about how behavioral therapy (BT) for OCD affects emotional learning in the brain. Patients in this study will have an equal chance of undergoing 12 weeks of BT immediately or being placed on a 12-week "waitlist," and then partaking in BT. They will be asked to participate in tasks while in an MRI that takes pictures of the brain. This study will also use mild, half-second electric shocks to fingers. The electric current will be generated from a 9V battery (e.g., battery in a smoke alarm). In order to set the level of the current to be used during the study, we will begin at a level below what patients will be able to feel, and then increase in gradual steps with permission. Patients will be asked to stop the increase at a level of the current that they find highly annoying but not painful. The level of current that patients select during this trial procedure, and no higher level, will be used during the study so that they will not receive any painful electric shocks. The purpose of the electric shock is to create a situation in which emotional learning may occur. Patients will receive no more than ten of these electric shocks.
If patients are assigned to immediate BT, participation in this study includes about 20-22 visits to our two clinics at MGH and the Charlestown Navy Yard over the span of 6 months. This includes an initial assessment visit (2.5-3 hours), 12 therapy visits (each session lasting 60-90 minutes long), and 1 booster session at the MGH OCD and Related Disorders Clinic. During the course of therapy, patients will receive weekly practice work between sessions, which should take around 30 minutes to an hour each day to complete. Additionally, patients will participate in 3 MRI scanning sessions at the Charlestown Navy Yard Campus: 2 scans over a two-day period during baseline visit, 2 scans over a two-day period during week 4 visit, and 2 scans over a two-day period during 3-month follow-up (week 24) appointment.
If patients are assigned to the 12-week waiting period before starting BT, participation will include about 21 visits to our clinics, including an initial assessment visit (2.5-3 hours), 12 therapy visits (after the waiting period ends), and 1 booster session at the MGH OCD and Related Disorders Clinic. Patients will be asked to come to the clinic for assessments during weeks 4 and 6 and after the waiting period (week 12). Patients will also participate in 2 MRI scanning sessions at the Charlestown Navy Yard Campus: 2 scans over a two-day period during baseline visit and 2 scans over a two-day period during week 4 visit. Patients may NOT begin any new therapy or medication while on the waiting list.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Behavior Therapy | Active comparator | Behavioral: Behavior TherapyIf assigned to the immediate BT condition, patients will be asked to make about 24 visits to our clinics at MGH, including an initial assessment, 12 therapy visits over 12 weeks, and 1 booster session (Week 16). Patients will be asked to come to the clinic for assessments during weeks 4 and 6 and after the treatment (week 12), as well as 1 follow-up visit (week 24). Additionally, patients will participate in 6 MRI scanning sessions at the Charlestown Navy Yard. |
| Waitlist Behavior Therapy | Active comparator | Behavioral: Behavior TherapyPatients will wait for 12 weeks before starting BT. In this case, they will be asked to make about 21 visits to our clinics, including an initial assessment visit, 12 therapy visits, and 1 booster session. Patients will be asked to come to the clinic for assessments during (weeks 4 and 6) and after the waiting period (week 12). Additionally, patients will participate in 6 MRI scanning sessions at the Charlestown Navy Yard. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Outpatient men and women age 18 to 60, proficient in English, and able to give informed consent
- For OCD patients only: Primary OCD that causes at least moderate distress and/or impairment (Y-BOCS total score > 16)
Key exclusion criteria (12 listed)
- Current clinically significant suicidality and/or BDI-II suicide item (#9) score >1
- Current or history of neurologic or psychiatric disease (e.g., mental retardation, dementia, brain damage, or other cognitive impairment) that would interfere with ability to engage in BT
- Psychopathology not appropriate for the treatment (such as substance abuse or dependence within the past 3 months; current manic episode; psychosis)
- Previous treatment with ≥4 sessions of BT for OCD
- Currently receiving any other psychotherapy or planning to initiate such treatment during the study
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 |
|---|---|---|
| Behavior TherapyAlso: Exposure and Response PreventionBT for OCD focuses primarily on "exposure with response prevention (ERP)." "ERP" involves gradual exposure to anxiety-provoking situations (things or situations that frighten or disturb some people), and will help to prevent compulsions (repetitive behaviors). | Behavioural | Immediate Behavior Therapy, Waitlist Behavior Therapy |
Primary outcome
Obsessive compulsive symptoms as measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 24-36 weeks
We assesed reduction in OCD symptom severity over a 24 week period. Efficacy was again compared in the follow-up phase of the study in from week 24 to week 36.
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 31 Mar 2022.
- Derived from this study: PubMed 41005270Jacoby RJ, Greenberg JL, Hurtado A, Pedersen W, Ellard KK, Pace-Schott EF, Oliver KI, Milad MR, Wilhelm S, Camprodon JA. Neural mechanisms underlying exposure and response prevention for obsessive compulsive disorder: A randomized controlled trial. Behav Res Ther. 2025 Nov;194:104858. doi: 10.1016/j.brat.2025.104858. Epub 2025 Sep 17.
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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.
Sabine Wilhelm, Ph.D. principal investigator
Massachusetts General Hospital: Department of Psychiatry
Mohammed Milad, Ph.D. principal investigator
Massachusetts General Hospital: Department of 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 Behavior Therapy in people with Obsessive Compulsive Disorder, run by Massachusetts General Hospital 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 2 inclusion and 12 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 31 Mar 2022. 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?
Obsessive compulsive symptoms as measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (time frame: 24-36 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 NCT02467374, which also lists 1 linked publication.
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 31 Mar 2022.