Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Measuring Automated Behavioral Observations & Vocal Expressions (ABOVE) (ABOVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03459456
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : August 8, 2019
Sponsor:
Collaborators:
Brown University
University of Pittsburgh
Information provided by (Responsible Party):
Wayne Goodman MD, Baylor College of Medicine

Tracking Information
First Submitted Date March 1, 2018
First Posted Date March 9, 2018
Last Update Posted Date August 8, 2019
Actual Study Start Date December 11, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 7, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03459456 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 7, 2018)
Change in Heart Rate [ Time Frame: baseline to Hour 2 ]
measured before, during and after PROVOC task, Trier Social Stress Test (TSST) and exposure task
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measuring Automated Behavioral Observations & Vocal Expressions (ABOVE)
Official Title Measuring Automated Behavioral Observations & Vocal Expressions (ABOVE) While Recording From the Brain
Brief 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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.
Condition
  • OCD
  • Obsessive-Compulsive Disorder
Intervention
  • Behavioral: Provocation OC task (Provoc)
    used to evoke OC-related distress
  • Behavioral: Trier Social Stress Test (TSST)
    used to evoke anxiety unrelated to OCD (e.g., performance anxiety)
  • Behavioral: Exposure provocation task
    used to elicit overt OCD rituals
Study Groups/Cohorts
  • 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
    Interventions:
    • 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
    Interventions:
    • Behavioral: Provocation OC task (Provoc)
    • Behavioral: Trier Social Stress Test (TSST)
    • Behavioral: Exposure provocation task
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 7, 2018)
27
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Carmen Vasquez 713-798-4729 anav@bcm.edu
Contact: Gregory Vogt 713-798-4729 gsvogt@bcm.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03459456
Other Study ID Numbers H41632
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Wayne Goodman MD, Baylor College of Medicine
Study Sponsor Baylor College of Medicine
Collaborators
  • Brown University
  • University of Pittsburgh
Investigators
Principal Investigator: Wayne Goodman, MD Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date August 2019