Compulsive BehaviorNCT04580043
Theta Burst Stimulation Plus Habit Override Training for Compulsive Behaviors
A study testing Habit Override Practice and Transcranial Magnetic Stimulation in people with Compulsive Behavior and Obsessive-Compulsive Disorder, run by Rebecca Price at 1 site in United States.
Trial summary
This project seeks to identify causal neural mechanisms underlying unwanted, repetitive behaviors (compulsions). Using non-invasive brain stimulation coupled with practice in a computer task, we will modulate activity in a target brain region and measure effects on compulsive behaviors and related measures. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Compulsive Behavior, Obsessive-Compulsive Disorder
- What is being tested?
- Habit Override Practice and Transcranial Magnetic Stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2020to 15 Dec 2025
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Participants will:
- Be between the ages of 18 and 60 years
- Endorse problematic compulsive behaviors, per self-report and clinician-administered measures.
- Agree to video taping of structured clinical interview
- Report that they will reside in the Pittsburgh area for at least 5 weeks
Who cannot join
- Failure to meet standard MRI inclusion criteria: those who endorse claustrophobia, those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, implanted uterine devices, metal braces, or other metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results. Pregnancy, determined by pregnancy tests on females.
- Medical contraindications for Transcranial Magnetic Stimulation (TMS):
- Presence of a neurologic disorder or medication therapy known to alter seizure threshold (e.g., stroke, aneurysm, brain surgery, structural brain lesion, brain injury, frequent/severe headaches)
- Recurrent seizures or epilepsy in participant or family history of hereditary epilepsy
- Pregnancy
- Metallic implants in body or other devices that may be affected by magnetic field
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- Significant heart disease or cerebrovascular disease
- Medications with strong seizure threshold lowering potential or which may interfere with the efficacy of TMS (e.g., clozapine, stimulants)
- Acute suicidality or other psychiatric crises requiring treatment escalation
- Changes made to treatment regimen within 4 weeks of baseline assessment
- Reading level <6th grade as per participant self-report
- Presence of bipolar, psychotic, autism spectrum, or substance use disorder (i.e. current problematic use of mood altering drugs such as cocaine, opiates, amphetamines, and barbiturates)
- Presence of movement disorder or tics affecting manual responses
- Inability to read text from 2 feet away (corrective lenses allowed)
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Experimental Manipulation of OFC Function and Behavioral Context: Towards an Integrative Translational Model of Compulsive Behaviors
This project seeks to identify causal neural mechanisms underlying unwanted, repetitive behaviors (compulsions). Using non-invasive brain stimulation coupled with practice in a computer task, we will modulate activity in a target brain region and measure effects on compulsive behaviors and related measures. This work could ultimately lead to the ability to treat compulsions more effectively by targeting the regions of the brain that can help or hinder attempts to overcome compulsions.
- Conditions
- Compulsive Behavior, Obsessive-Compulsive Disorder
- Being tested
- Habit Override Practice, Transcranial Magnetic Stimulation, Sham Training, Sham Transcranial Magnetic Stimulation
- Medical subject headings
- Compulsive Behavior, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Habit Override PracticeBehavioural
Computerized "brain training" to provide practice in overriding avoidance habits.
Transcranial Magnetic StimulationDevice
Also called cTBS
Non-invasive method for temporary, focal stimulation of brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.
Sham TrainingBehavioural
Computer-based task practice in a non-active/inert task.
Sham Transcranial Magnetic StimulationDevice
Also called Sham cTBS
Sham stimulation of non-brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.
| Study group | Role | What they receive |
|---|---|---|
| cTBS + Habit Override Training | Experimental | Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Habit Override Training. Receives: Behavioral: Habit Override Practice; Device: Transcranial Magnetic Stimulation |
| Sham TBS + Habit Override Training | Active comparator | Sham Transcranial Magnetic Stimulation, paired with Habit Override Training. Receives: Behavioral: Habit Override Practice; Device: Sham Transcranial Magnetic Stimulation |
| cTBS + Sham Training | Active comparator | Transcranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Sham Training. Receives: Device: Transcranial Magnetic Stimulation; Behavioral: Sham Training |
| Sham TBS + Sham Training | Sham comparator | Sham Transcranial Magnetic Stimulation, paired with Sham Training. Receives: Behavioral: Sham Training; Device: Sham Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activation in target region
Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)
Measured: 10-60min post-intervention
Effort to resist compulsive behaviors in response to laboratory triggers
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported effort needed to resist (0-100 scale)
Measured: 60min post-intervention
Duration of compulsive behaviors in response to laboratory triggers
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance (% of total time allotted)
Measured: 60min post-intervention
Intensity of urges to perform compulsive behaviors in response to laboratory triggers
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity (0-100 scale)
Measured: 60min post-intervention
Secondary outcomes (8)
Goal-directed cognition
Neuropsychological test of flexible goal-directed cognition (two-step task): switch score (higher score=better performance)
Measured: 90min-1 week
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Clinician-administered measurement of obsessions and compulsions (range: 0-40; higher score=worse outcome)
Measured: 1 week
WHO Disability Assessment Scale 2.0
Self-report measure of general functioning and disability (0-100; higher score=worse outcome)
Measured: 1 week
Obsessive Compulsive Inventory-Revised (OCI-R)
Self-report measure of obsessions and compulsions (0-72; higher score=worse outcome)
Measured: 1 week
Effort to resist compulsive behaviors in response to laboratory triggers
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported effort needed to resist (0-100 scale)
Measured: 1 week
Duration of compulsive behaviors in response to laboratory triggers
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance (% of total time allotted)
Measured: 1 week
Intensity of urges to perform compulsive behaviors in response to laboratory triggers
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity (0-100 scale)
Measured: 1 week
Brain activation in target region
Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start28 Dec 2020
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compulsive BehaviorStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rebecca Price
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor-investigator, Rebecca Price, University of Pittsburgh
- Investigators
- Rebecca B Price, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580043
- Sponsor's protocol ID
- STUDY19090219 (Part 2)
- Other IDs
- R01MH124707
- Status last verified
- Feb 2026
- First submitted
- 1 Oct 2020
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Manipulation of OFC Function and Behavioral Context: Towards an Integrative Translational Model of Compulsive Behaviors
- ClinicalTrials.gov ID
- NCT04580043
- Acronym / sponsor ID
- STUDY19090219 (Part 2)
- Conditions
- Compulsive Behavior, Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Rebecca PriceUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 28 Dec 2020 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 8 Oct 2020 (actual)
- 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.
This project seeks to identify causal neural mechanisms underlying unwanted, repetitive behaviors (compulsions). Using non-invasive brain stimulation coupled with practice in a computer task, we will modulate activity in a target brain region and measure effects on compulsive behaviors and related measures. This work could ultimately lead to the ability to treat compulsions more effectively by targeting the regions of the brain that can help or hinder attempts to overcome compulsions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cTBS + Habit Override Training | Experimental | Behavioral: Habit Override Practice, Device: Transcranial Magnetic StimulationTranscranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Habit Override Training. |
| Sham TBS + Habit Override Training | Active comparator | Behavioral: Habit Override Practice, Device: Sham Transcranial Magnetic StimulationSham Transcranial Magnetic Stimulation, paired with Habit Override Training. |
| cTBS + Sham Training | Active comparator | Device: Transcranial Magnetic Stimulation, Behavioral: Sham TrainingTranscranial Magnetic Stimulation delivered in a continuous Theta Burst Stimulation (cTBS) pattern, paired with Sham Training. |
| Sham TBS + Sham Training | Sham comparator | Behavioral: Sham Training, Device: Sham Transcranial Magnetic StimulationSham Transcranial Magnetic Stimulation, paired with Sham Training. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be between the ages of 18 and 60 years
- Endorse problematic compulsive behaviors, per self-report and clinician-administered measures.
- Agree to video taping of structured clinical interview
- Report that they will reside in the Pittsburgh area for at least 5 weeks
Key exclusion criteria (14 listed)
- Failure to meet standard MRI inclusion criteria: those who endorse claustrophobia, those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, implanted uterine devices, metal braces, or other metal objects in their body, especially in the eye. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. History of significant injury or surgery to the brain or spinal cord that would impair interpretation of results. Pregnancy, determined by pregnancy tests on females.
- Medical contraindications for Transcranial Magnetic Stimulation (TMS):
- Acute suicidality or other psychiatric crises requiring treatment escalation
- Changes made to treatment regimen within 4 weeks of baseline assessment
- Reading level <6th grade as per participant self-report
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 |
|---|---|---|
| Habit Override PracticeComputerized "brain training" to provide practice in overriding avoidance habits. | Behavioural | Sham TBS + Habit Override Training, cTBS + Habit Override Training |
| Transcranial Magnetic StimulationAlso: cTBSNon-invasive method for temporary, focal stimulation of brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern. | Device | cTBS + Habit Override Training, cTBS + Sham Training |
| Sham TrainingComputer-based task practice in a non-active/inert task. | Behavioural | Sham TBS + Sham Training, cTBS + Sham Training |
| Sham Transcranial Magnetic StimulationAlso: Sham cTBSSham stimulation of non-brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern. | Device | Sham TBS + Habit Override Training, Sham TBS + Sham Training |
Primary outcome
Brain activation in target region
Time frame: 10-60min post-intervention
Mean Cerebral Blood Flow (CBF) in orbitofrontal cortex collected via functional Magnetic Resonance Imaging (fMRI)
Effort to resist compulsive behaviors in response to laboratory triggers
Time frame: 60min post-intervention
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported effort needed to resist (0-100 scale)
Duration of compulsive behaviors in response to laboratory triggers
Time frame: 60min post-intervention
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: duration of compulsive behavior performance (% of total time allotted)
Intensity of urges to perform compulsive behaviors in response to laboratory triggers
Time frame: 60min post-intervention
Custom-made laboratory assessment of ability to override compulsive behaviors in response to idiographic triggers: self-reported urge intensity (0-100 scale)
8 secondary outcomes
Goal-directed cognition
Time frame: 90min-1 week
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 1 week
WHO Disability Assessment Scale 2.0
Time frame: 1 week
Obsessive Compulsive Inventory-Revised (OCI-R)
Time frame: 1 week
Effort to resist compulsive behaviors in response to laboratory triggers
Time frame: 1 week
Duration of compulsive behaviors in response to laboratory triggers
Time frame: 1 week
Intensity of urges to perform compulsive behaviors in response to laboratory triggers
Time frame: 1 week
Brain activation in target region
Time frame: 1 week
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 10 Feb 2026.
- 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.
Rebecca B Price, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Habit Override Practice and Transcranial Magnetic Stimulation in people with Compulsive Behavior and Obsessive-Compulsive Disorder, run by Rebecca Price 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 14 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 10 Feb 2026. 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. Some participants in this study may receive a placebo. 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?
Brain activation in target region (time frame: 10-60min post-intervention). The study lists 4 primary outcomes in all. 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 10 Feb 2026.