NCT02378896

Brief Summary

This study will evaluate the effects of a computerized training program coupled with cognitive behavioral therapy (CBT) for OCD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration 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

Study Start

First participant enrolled

February 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

2.8 years

First QC Date

February 27, 2015

Last Update Submit

January 25, 2018

Conditions

Keywords

Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • Obsessive-compulsive symptoms measured after 3 weeks of treatment

    measured by Yale Brown Obsessive Compulsive Scale (YBOCS)

    3 weeks

Study Arms (1)

CBT + Personalized Computer Program

EXPERIMENTAL

Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy and training with a personalized computerized inhibitory training program

Behavioral: Personalized Computer ProgramBehavioral: Cognitive Behavioral Therapy

Interventions

Training with a personalized computerized inhibitory training program

CBT + Personalized Computer Program

Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy

CBT + Personalized Computer Program

Eligibility Criteria

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

You may qualify if:

  • Principal diagnosis of OCD (assessed by SCID).
  • Clinically significant OCD symptoms (Y-BOCS score of at least 16).
  • Have a history of completing a trial of at least 1 EX/RP sessions.
  • Have access to a computer or laptop.

You may not qualify if:

  • Individuals with the following disorders will excluded: bipolar, psychosis, current major depressive disorder (assessed by SCID).
  • Patients with head injury and loss of consciousness of more than five minutes or a neurological condition affecting the central nervous system.
  • Patients taking a psychiatric medication will be asked to maintain a stable dose for 6 weeks prior to study entry.
  • Vision or hearing loss (although individuals with vision corrected by glasses or contacts will not be excluded).
  • Active suicidality warranting immediate clinical care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiactic Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Helen B Simpson, M.D., PhD

    New York State Psychiactic Institute, Anxiety Disorders Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 4, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

January 29, 2018

Record last verified: 2018-01

Locations