NCT03459456

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
2mo left

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jun 2018Jul 2026

First Submitted

Initial submission to the registry

March 1, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 11, 2018

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

August 18, 2025

Status Verified

August 1, 2025

Enrollment Period

8.1 years

First QC Date

March 1, 2018

Last Update Submit

August 14, 2025

Conditions

Keywords

OCDObsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in brain activity

    measured before, during and after PROVOC task, Trier Social Stress Test (TSST) and exposure task

    baseline to Hour 2

Secondary Outcomes (1)

  • Change in Heart Rate

    baseline to Hour 2

Study Arms (2)

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

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

Behavioral: Provocation OC task (Provoc)Behavioral: Trier Social Stress Test (TSST)Behavioral: Exposure provocation task

Interventions

used to evoke OC-related distress

Control subjectsOCD subjects

used to evoke anxiety unrelated to OCD (e.g., performance anxiety)

Control subjectsOCD subjects

used to elicit overt OCD rituals

Control subjectsOCD subjects

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Wayne Goodman, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 9, 2018

Study Start

June 11, 2018

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

August 18, 2025

Record last verified: 2025-08

Locations