NCT06470893

Brief Summary

The overarching goal of this protocol is to investigate mechanisms that influence symptom outcomes of exposure and response prevention (ERP) therapy for OCD. Mechanisms may include affective processes, learning factors, cognitive factors, or other constructs that could influence treatment outcomes. The study team will conduct this research within the context of an effective online treatment for OCD called OCD-NET. OCD-NET is bibliotherapy with coaching and its content is reflective of standard care for OCD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 23, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

June 17, 2024

Last Update Submit

August 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in OCD Symptoms Measured by Yale-Brown Obsessive Compulsive Scale-Second Edition (YBOCS-II)

    YBOCS-II scores range from 0-50, and higher scores indicate more severe illness

    Baseline, up to 12 months (end of treatment)

Study Arms (1)

OCD-NET Group

EXPERIMENTAL

Participants will receive the OCD-NET intervention for up to 12 months.

Behavioral: OCD-NET

Interventions

OCD-NETBEHAVIORAL

OCD-NET is bibliotherapy with coaching and its content is reflective of standard care for OCD. OCD-NET is a self-paced intervention that participants complete entirely online with the support of an assigned individual therapist. Most participants complete this treatment in up to twelve weeks. On average, participants are expected to spend between one to five hours per week during the first half of treatment. In the second half of treatment when participants begin regular exposure and response prevention (ERP) exercises, participants are expected to spend about one hour per day.

OCD-NET Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking
  • Located within the United States
  • years old
  • Able to provide consent
  • Current diagnosis of OCD as assessed by clinical interview

You may not qualify if:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Participants currently located outside of the United States
  • Prisoners
  • Participants with hoarding as the primary OCD symptom
  • Severe mental illness (e.g. schizophrenia, substance abuse); organic brain syndrome; or serious, current suicidal/homicidal ideation (based on phone screening or initial assessment)
  • Concurrent enrollment in another psychotherapy treatment
  • Participants taking psychotropic medication may be excluded if:
  • They have started a brand new psychotropic medication within the last 12 weeks
  • They have changed the dose of their psychotropic medication within the last 4 weeks
  • They anticipate that they cannot maintain the current dose of their psychotropic medication for the duration of the study
  • Participants may be excluded if they have any cognitive or physical impairments that would interfere with their participation (e.g., significant head injury, cognitive disability, dementia).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Kiara Timpano, PhD

    University of Miami

    STUDY CHAIR
  • Amelia Dev, MS

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2024

First Posted

June 24, 2024

Study Start

September 23, 2024

Primary Completion

July 8, 2025

Study Completion

July 23, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations