OCDABOVENCT03459456
Measuring Automated Behavioral Observations & Vocal Expressions (ABOVE)
An observational study of OCD and Obsessive-Compulsive Disorder, run by Baylor College of Medicine at 3 sites in United States.
Trial summary
The investigators propose to synchronize automated measurements of behavior - head, body, and face dynamics, gaze, and vocal prosody - with simultaneous recordings of brain activity in clinically relevant contexts. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- OCD, Obsessive-Compulsive Disorder
- What is being tested?
- Provocation OC task (Provoc), Trier Social Stress Test (TSST) and Exposure provocation task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Jun 2018to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The primary source of OCD subjects will be self-referrals generated through BCM Clinicaltrials website, Clinicaltrials.gov, and BCM Psychiatry Clinic. The investigators also anticipate referrals from local area clinicians in addition to affiliate entities.
Who may be able to join
- OCD subjects:
- The subject has a minimum score of ≥16 on the Y-BOCS;
- If applicable, on a stable pharmacologic regimen;
- Sample will be enriched with OCD subjects having contamination obsessions and handwashing compulsions, and scores on items 9 and 10 of the Y-BOCS reflecting difficulty resisting and controlling compulsions;
- Healthy Control Subjects:
- Men and women will be age/gender matched with subjects
- Absence of any psychiatric disorder determined by the MINI^53 for DSM-5 with the exception of non-impairing specific phobia.
- Low scores on measures of contamination concerns and disgust sensitivity based on Y-BOCS scores below 10 and the Disgust Scale-Revised (total score <8).
Who cannot join
- OCD Subjects:
- Subject has a documented lifetime diagnosis of psychotic disorders such as schizophrenia;
- Alcohol or substance abuse/dependence reported within 6 months, excluding nicotine;
- The subject is deemed at high risk of suicidal behavior or impulsivity. The Beck Depression Inventory^52 (BDI) will be completed by all subjects and responses reviewed by a clinician.
- Healthy Control Subjects:
- Those not meeting the inclusion criteria described in the inclusion section above.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Baylor College of Medicine
Houston, Texas, 77030
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Brown University
Providence, Rhode Island, 02912
About this study
Official title: Measuring Automated Behavioral Observations & Vocal Expressions (ABOVE) While Recording From the Brain
The investigators propose to synchronize automated measurements of behavior - head, body, and face dynamics, gaze, and vocal prosody - with simultaneous recordings of brain activity in clinically relevant contexts.
Read the detailed description
Baylor College of Medicine (BCM), University of Pittsburgh (UPitt) and Brown University will collaborate on this research project. BCM will be the only site that will enroll study subjects and perform study assessments. UPitt and Brown will supervise data management, measurement and modeling of multimodal signals and collaborate on research design and machine learning.
Following initial screening, subjects will participate in one testing session lasting about 2 hours. The addition of these preliminary studies will allow investigators to obtain information in order to differentiate and code OCD-distress versus social anxiety and identify rituals related to OCD.
Research Material, Data, and Information to be collected:
Interviews, rating scales, video, audio, behavioral assessments, and heart rate will be obtained.
Preliminary Testing in Un-implanted Subjects: Automated Behavioral Measures of OCD-related Distress (i.e., obsessions and urge to ritualize) and Overt Rituals:
The Provocation OC task (Provoc) and the Trier Social Stress Test (TSST) will be used to evoke OC-related distress and anxiety unrelated to OCD (e.g., performance anxiety), respectively. These tasks will be preceded by a neutral baseline (the subject may be asked to describe how they traveled to the clinic to the experimenter) and a positive affect induction, the Broad-Minded Affective Coping procedure (BMAC) a clinical technique that uses recalled positive autobiographical memories and mental imagery to elicit positive affect. Because anxiety and negative affect may have carryover effects, neutral baseline and BMAC will be presented prior to the non-OCD and OCD distress inductions. In the BMAC, subjects will be instructed to recall and describe a recent positive memory/experience. The order of Provoc and TSST will be counterbalanced across the subjects. Use of a conveyor belt may be used during the Provoc tasks to present the evoking stimuli. Simultaneously recorded measures are noted in the Table attached in Section S and include: AFAR, new suite of behavioral measures (shown as shaded), hand/arm movements and heart rate.
A third provocation task will be added to elicit overt rituals (e.g., handwashing) in the clinic. It will occur following the BMAC and TSST/Provoc tasks and a relaxation break.
Subjects will be asked to wash their hands at a sink in our clinic inside an exam room where their behaviors will be recorded using hardware-synchronized cameras: one, to capture frontal view of the face for AFAR; and another, to record full body movement for CPM. The investigators are aware of only one prior study of automated coding of compulsive behavior. In that study, a computer vision approach was able to discriminate subjects with OCD from healthy subjects on the basis of handwashing videos in which regions of interest (ROIs) were defined for objects (e.g., soap dispenser) used for handwashing. The investigators will combine this ROI paradigm with a CPM approach that captures hand and body movements. Dropouts from the ritual paradigm will be replaced.
These same tasks will also be performed on up to 4 subjects that have consented to receive a DBS implant on a separate protocol. Informed consent will also be collected from these implanted subjects for the purpose of completing the tasks described above on this study.
- Conditions
- OCD, Obsessive-Compulsive Disorder
- Being tested
- Provocation OC task (Provoc), Trier Social Stress Test (TSST), Exposure provocation task
- Keywords
- OCD, Obsessive-Compulsive Disorder
- 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.
Provocation OC task (Provoc)Behavioural
used to evoke OC-related distress
Trier Social Stress Test (TSST)Behavioural
used to evoke anxiety unrelated to OCD (e.g., performance anxiety)
Exposure provocation taskBehavioural
used to elicit overt OCD rituals
| Study group | Role | What they receive |
|---|---|---|
| OCD subjects | Subjects meeting inclusion/exclusion criteria with OCD will be exposed to the following:
* Provocation OC task (Provoc)
* Trier Social Stress Test (TSST)
* Exposure provocation task Receives: Behavioral: Provocation OC task (Provoc); Behavioral: Trier Social Stress Test (TSST); Behavioral: Exposure provocation task | |
| Control subjects | Subjects meeting inclusion/exclusion criteria without OCD (age and gender matched with OCD subjects) will be exposed to the following:
* Provocation OC task (Provoc)
* Trier Social Stress Test (TSST)
* Exposure provocation task Receives: Behavioral: Provocation OC task (Provoc); Behavioral: Trier Social Stress Test (TSST); Behavioral: Exposure provocation task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain activity
measured before, during and after PROVOC task, Trier Social Stress Test (TSST) and exposure task
Measured: baseline to Hour 2
Secondary outcomes (1)
Change in Heart Rate
measured before, during and after PROVOC task, Trier Social Stress Test (TSST) and exposure task
Measured: baseline to Hour 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start11 Jun 2018
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OCDStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, University of Pittsburgh
- Responsible party
- Principal investigator, Wayne Goodman MD, Baylor College of Medicine
- Investigators
- Wayne Goodman, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459456
- Sponsor's protocol ID
- H41632
- Acronym
- ABOVE
- Status last verified
- Aug 2026
- First submitted
- 1 Mar 2018
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Automated Behavioral Observations & Vocal Expressions (ABOVE) While Recording From the Brain
- ClinicalTrials.gov ID
- NCT03459456
- Acronym / sponsor ID
- ABOVE / H41632
- Conditions
- OCD, Obsessive-Compulsive Disorder
- Keywords
- OCD, Obsessive-Compulsive Disorder
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Brown University, University of Pittsburgh
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Mar 2018 (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.
The investigators propose to synchronize automated measurements of behavior - head, body, and face dynamics, gaze, and vocal prosody - with simultaneous recordings of brain activity in clinically relevant contexts.
Detailed description
Baylor College of Medicine (BCM), University of Pittsburgh (UPitt) and Brown University will collaborate on this research project. BCM will be the only site that will enroll study subjects and perform study assessments. UPitt and Brown will supervise data management, measurement and modeling of multimodal signals and collaborate on research design and machine learning.
Following initial screening, subjects will participate in one testing session lasting about 2 hours. The addition of these preliminary studies will allow investigators to obtain information in order to differentiate and code OCD-distress versus social anxiety and identify rituals related to OCD.
Research Material, Data, and Information to be collected:
Interviews, rating scales, video, audio, behavioral assessments, and heart rate will be obtained.
Preliminary Testing in Un-implanted Subjects: Automated Behavioral Measures of OCD-related Distress (i.e., obsessions and urge to ritualize) and Overt Rituals:
The Provocation OC task (Provoc) and the Trier Social Stress Test (TSST) will be used to evoke OC-related distress and anxiety unrelated to OCD (e.g., performance anxiety), respectively. These tasks will be preceded by a neutral baseline (the subject may be asked to describe how they traveled to the clinic to the experimenter) and a positive affect induction, the Broad-Minded Affective Coping procedure (BMAC) a clinical technique that uses recalled positive autobiographical memories and mental imagery to elicit positive affect. Because anxiety and negative affect may have carryover effects, neutral baseline and BMAC will be presented prior to the non-OCD and OCD distress inductions. In the BMAC, subjects will be instructed to recall and describe a recent positive memory/experience. The order of Provoc and TSST will be counterbalanced across the subjects. Use of a conveyor belt may be used during the Provoc tasks to present the evoking stimuli. Simultaneously recorded measures are noted in the Table attached in Section S and include: AFAR, new suite of behavioral measures (shown as shaded), hand/arm movements and heart rate.
A third provocation task will be added to elicit overt rituals (e.g., handwashing) in the clinic. It will occur following the BMAC and TSST/Provoc tasks and a relaxation break.
Subjects will be asked to wash their hands at a sink in our clinic inside an exam room where their behaviors will be recorded using hardware-synchronized cameras: one, to capture frontal view of the face for AFAR; and another, to record full body movement for CPM. The investigators are aware of only one prior study of automated coding of compulsive behavior. In that study, a computer vision approach was able to discriminate subjects with OCD from healthy subjects on the basis of handwashing videos in which regions of interest (ROIs) were defined for objects (e.g., soap dispenser) used for handwashing. The investigators will combine this ROI paradigm with a CPM approach that captures hand and body movements. Dropouts from the ritual paradigm will be replaced.
These same tasks will also be performed on up to 4 subjects that have consented to receive a DBS implant on a separate protocol. Informed consent will also be collected from these implanted subjects for the purpose of completing the tasks described above on this study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCD subjects | – | Behavioral: Provocation OC task (Provoc), Behavioral: Trier Social Stress Test (TSST), Behavioral: Exposure provocation taskSubjects meeting inclusion/exclusion criteria with OCD will be exposed to the following: * Provocation OC task (Provoc) * Trier Social Stress Test (TSST) * Exposure provocation task |
| Control subjects | – | Behavioral: Provocation OC task (Provoc), Behavioral: Trier Social Stress Test (TSST), Behavioral: Exposure provocation taskSubjects meeting inclusion/exclusion criteria without OCD (age and gender matched with OCD subjects) will be exposed to the following: * Provocation OC task (Provoc) * Trier Social Stress Test (TSST) * Exposure provocation task |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The primary source of OCD subjects will be self-referrals generated through BCM Clinicaltrials website, Clinicaltrials.gov, and BCM Psychiatry Clinic. The investigators also anticipate referrals from local area clinicians in addition to affiliate entities.
Key inclusion criteria (8 listed)
- The subject has a minimum score of ≥16 on the Y-BOCS;
- If applicable, on a stable pharmacologic regimen;
- Sample will be enriched with OCD subjects having contamination obsessions and handwashing compulsions, and scores on items 9 and 10 of the Y-BOCS reflecting difficulty resisting and controlling compulsions;
- Men and women will be age/gender matched with subjects
- Absence of any psychiatric disorder determined by the MINI^53 for DSM-5 with the exception of non-impairing specific phobia.
Key exclusion criteria (6 listed)
- Subject has a documented lifetime diagnosis of psychotic disorders such as schizophrenia;
- Alcohol or substance abuse/dependence reported within 6 months, excluding nicotine;
- The subject is deemed at high risk of suicidal behavior or impulsivity. The Beck Depression Inventory^52 (BDI) will be completed by all subjects and responses reviewed by a clinician.
- Those not meeting the inclusion criteria described in the inclusion section above.
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 |
|---|---|---|
| Provocation OC task (Provoc)used to evoke OC-related distress | Behavioural | Control subjects, OCD subjects |
| Trier Social Stress Test (TSST)used to evoke anxiety unrelated to OCD (e.g., performance anxiety) | Behavioural | Control subjects, OCD subjects |
| Exposure provocation taskused to elicit overt OCD rituals | Behavioural | Control subjects, OCD subjects |
Primary outcome
Change in brain activity
Time frame: baseline to Hour 2
measured before, during and after PROVOC task, Trier Social Stress Test (TSST) and exposure task
1 secondary outcome
Change in Heart Rate
Time frame: baseline to Hour 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Wayne Goodman, MD principal investigator
Baylor College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OCD and Obsessive-Compulsive Disorder, run by Baylor College of Medicine at 3 sites 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 8 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in brain activity (time frame: baseline to Hour 2). 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 2 Sep 2026.