NCT01644851

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

3 years

First QC Date

July 17, 2012

Last Update Submit

December 4, 2014

Conditions

Keywords

veteransneuropsychologyneuroimagingattentionworking memoryinhibitionmagnetic resonance imaging, functionaltraumastressanxietyemotionprefrontal cortex

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Cognitive functioning as measured by neuropsychological assessment.

    change from baseline to after 6 weeks of training

Other Outcomes (1)

  • Clinical PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS).

    change from baseline to after 6 weeks of training

Study Arms (2)

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

Computer-based training in executive functions, administered via www.lumosity.com website.

Executive function training

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univesity of Missouri - Kansas City

Kansas City, Missouri, 64110, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticInhibition, PsychologicalWounds and InjuriesAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavior

Study Officials

  • Robin Aupperle, PhD

    University of Missouri, Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations