Personalized Computerized Inhibitory Control Training for... | NCT02378896

Studies
Personalized Computerized Inhibitory Control Training for OCD

NCT02378896

Sponsor

New York State Psychiatric Institute

Status

Completed

Last Update Posted

Jan 29, 2018Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Obsessive-Compulsive Disorder

Interventions

Personalized Computer Program
Cognitive Behavioral Therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015Actual

Primary Completion Date

Dec 2017Actual

Completion Date

Jan 2018Actual

First Submitted Date

Feb 27, 2015

First Submission Date that Met QC Criteria

Mar 3, 2015

First Posted Date

Mar 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2018

Last Update Posted Date

Jan 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This study will evaluate the effectiveness of a computerized training program (called Personalized Computerized Inhibitory Training, or PCIT) coupled with cognitive behavioral therapies (CBT) consisting of Exposures and Response Prevention in treating obsessive compulsive disorder (OCD) in patients who previously underwent CBT, but still have residual symptoms.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 Program Behavioral: Cognitive Behavioral Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Personalized Computer Program	Behavioral	Training with a personalized computerized inhibitory training program	CBT + Personalized Computer Program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Obsessive-compulsive symptoms measured after 3 weeks of treatment	measured by Yale Brown Obsessive Compulsive Scale (YBOCS)	3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Helen B Simpson, M.D., PhD	New York State Psychiactic Institute, Anxiety Disorders Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York State Psychiactic Institute		New York	New York	10032	United States

Condition Browse Module

MeSH Terms

ID	Term
D009771	Obsessive-Compulsive Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015928	Cognitive Behavioral Therapy

Ancestor Terms

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided