Cognitive Training for Post Traumatic Stress Disorder: Ef... | NCT01644851

Studies
Cognitive Training for Post Traumatic Stress Disorder: Effects on Cognitive, Emotional, and Brain Function

NCT01644851

Sponsor

University of Missouri, Kansas City

Status

Unknown status

Last Update Posted

Dec 8, 2014Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Posttraumatic Stress Disorders

Interventions

Executive function training

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2015Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

Jul 17, 2012

First Submission Date that Met QC Criteria

Jul 18, 2012

First Posted Date

Jul 19, 2012Estimated

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

Dec 4, 2014

Last Update Posted Date

Dec 8, 2014Estimated

Name	Class
University of Kansas	OTHER

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

The purpose of this pilot study is to determine the effects of computer-based training in executive functioning compared to word games on cognitive and emotional aspects of combat-related PTSD.

Detailed Description

Many posttraumatic stress disorder (PTSD) patients either choose not to complete or do not achieve optimal response to current first-line behavioral and pharmacologic treatments. Neurocognitive research points to the potential of novel treatments targeting dorsal prefrontal function and inhibition, attention, and working memory processes. This study investigates effects of computer-based training in executive functions compared to word games on cognitive and emotional aspects of combat-related PTSD. Paper-and-pencil questionnaires, interviews, computer-administered testing, and magnetic resonance imaging will be complete before and after the intervention. Results from this pilot study will provide information concerning feasibility and treatment potential of cognitive training for PTSD.

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Executive function training	Experimental	Executive function training	Behavioral: Executive function training
Word game training	Placebo Comparator	Computer-based training in tasks related to verbal processing.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Executive function training	Behavioral	Computer-based training in executive functions, administered via www.lumosity.com website.	Executive function training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neural activity in prefrontal regions during cognitive and emotional processing measured by functional magnetic resonance imaging.		change from baseline to after 6 weeks of training

Secondary Outcomes

Measure	Description	Time Frame
Cognitive functioning as measured by neuropsychological assessment.		change from baseline to after 6 weeks of training

Other Outcomes

Measure	Description	Time Frame
Clinical PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS).		change from baseline to after 6 weeks of training

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

combat veterans who served in Operation Iraqi Freedom, Operation Enduring Freedom, or Operation New Dawn

Exclusion Criteria:

enrolled in other active treatment protocols
current substance abuse or dependence
current suicidal ideation
diagnosis of a neurological disorder
history of moderate to severe traumatic brain injury

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robin Aupperle, PhD	University of Missouri, Kansas City	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univesity of Missouri - Kansas City		Kansas City	Missouri	64110	United States

Type	Date	Date Unknown
Release	May 8, 2017
Reset	Oct 4, 2017

Submission Tracking

Estimated Results First Submitted Date

May 8, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 8, 2017			Oct 4, 2017

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic
D007266	Inhibition, Psychological
D014947	Wounds and Injuries
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided