NCT00850447

Brief Summary

The purpose of this study is to gather feasibility data on cognitive remediation therapy (CRT) as an alternative intervention for PTSD. CRT is a standardized intervention that involves performing cognitive exercises to improve attention, processing speed, and memory through practice. Although the primary objective will be to determine the effect of CRT on cognitive functioning in PTSD, data on PTSD symptom severity and other clinical measures will also be examined to assess whether and to what degree cognitive alterations and symptom severity might be linked. CogPack, a computer-based form of CRT, would be employed for this project. Participants will be randomized to receive CRT or to play the video game Tetris as a control condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2008

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

October 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 2, 2012

Status Verified

February 1, 2012

Enrollment Period

2.4 years

First QC Date

February 24, 2009

Last Update Submit

February 1, 2012

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic stress disorderCognitionNeuropsychological Tests

Outcome Measures

Primary Outcomes (1)

  • Cognitive functioning, assessed by Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery and portions of Wechsler Adult Intelligence Scale III (WAIS-III) and Wechsler Memory Scale III (WMS-III)

    10 weeks

Secondary Outcomes (1)

  • PTSD symptom severity, assessed by Clinician Administered PTSD Scale (CAPS)

    10 weeks

Study Arms (2)

Cognitive Remediation Therapy

EXPERIMENTAL
Other: Cognitive Remediation Therapy

Videogames

PLACEBO COMPARATOR
Other: Videogame

Interventions

Cognitive Remediation TherapyOTHER

Cognitive Remediation Therapy (CRT) is a standardized intervention that involves performing cognitive exercises to improve attention, processing speed, and memory through practice. Participants will have one 60-minute CRT session each week for ten weeks. The CRT to be used in the proposed study is CogPack (version 6.0 Marker Software, Mannheim Germany). CogPack demonstrates flexibility in terms of developing a targeted intervention plan based on the levels of baseline cognitive impairment. There are approximately 6 different exercises presented in each training session, with the starting level of difficulty individualized on the basis of baseline neuropsychological performance.

Cognitive Remediation Therapy
VideogameOTHER

Participants will play the videogame Tetris once each week for 30 minutes. Tetris is a video puzzle game that involves manipulating falling shapes. The object of the game is to manipulate these shapes, by moving them sideways or rotating them, to create a horizontal line of blocks without gaps. As the game progresses, the shapes fall faster.

Videogames

Eligibility Criteria

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

You may qualify if:

  • Male and female combat veterans with a current diagnosis of PTSD with a minimum duration of six months
  • Age 18 years and older
  • Capable of understanding, reading, and writing in English

You may not qualify if:

  • Incapable and/or unwilling to provide written informed consent prior to participation
  • Less than 11 years of formal education
  • The veteran, the veteran's physician, or the study physician thinks that the veteran's clinical state necessitates hospitalization
  • Response of 3 or 4 on the suicidality items of the Hamilton Depression Rating Scale or an assessed serious suicide risk
  • Current substance and/or alcohol abuse and/or dependence, or abuse/dependence within the previous 6 months which contraindicates participation in the judgment of the evaluating clinician
  • A lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, organic mental disorder, or dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James J. Peters Veterans Affairs Medical Center

The Bronx, New York, 10458, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Melissa Altman, PhD

    James J. Peters Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Professor of Neuroscience and Psychiatry

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 25, 2009

Study Start

October 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

February 2, 2012

Record last verified: 2012-02

Locations

US(1)