| City: |
|
Bronx |
|
State:
|
|
NY |
| Zip Code: |
|
10458 |
| Conditions: |
|
Posttraumatic Stress Disorder |
| Purpose: |
|
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.
|
| Study summary: |
|
The effects of CRT will be examined in 30 combat veterans with current PTSD, to be
randomized to either CRT or to a non-therapeutic video game. PTSD status and other clinical
data will be collected via interview to include the Clinician Administered PTSD Scale; the
Hamilton Depression Rating Scale; and the Structured Clinical Interview for DSM-IV (SCID).
Subjects will also complete self-report measures, including the Posttraumatic Stress
Disorder Checklist-Stressor Specific Version; Deployment Risk and Resilience Inventory;
Combat Exposure Scale; Trauma History Questionnaire; Childhood Trauma Questionnaire;
State-Trait Anxiety Inventory-State; Beck Depression Inventory-II; Post-Traumatic Cognitions
Inventory; Connor-Davidson Resilience Scale; and the Inventory of Daily Living. Baseline
cognitive functioning will be assessed using the Measurement and Treatment Research to
Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery; the vocabulary and
block design tasks of the Wechsler Adult Intelligence Scale-III; the Wide Range Achievement
Test-III; and the Logical Memory Test, the Letter-Number Sequencing task, and the Digit Span
tasks from the Wechsler Memory Scale-III.
After evaluation, 15 subjects will be randomized to receive 10 weekly 60-minute sessions of
CRT using CogPack Professional (version 8.2, Marker Software, Mannheim, Germany).
Approximately six different exercises will be presented in each training session, with the
starting level of difficulty individualized on the basis of baseline neuropsychological
performance and difficulty level adjusted based on the subject's performance on CogPack
exercises.
Another 15 subjects will be randomized to use a non-therapeutic video game, Tetris. 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. This game
primarily involves using visuospatial and motor abilities, rather than memory and
attentional abilities, and thus will serve as an adequate control condition to Cogpack.
Subjects will use Tetris in 10 weekly 30-minute sessions.
Subjects will again complete neuropsychological and psychiatric evaluations (with the
exception of the SCID) in addition to self-report measures after 10 weeks of CRT or video
games. Changes from baseline will be examined in the cognitive measures as well as in PTSD
symptom severity, other clinical measures, and overall functioning. |
| Criteria: |
|
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 |
|
|
|
| Study is available at: |
|
James J. Peters Veterans Affairs Medical Center
Bronx, NY 10458
United States
Primary Contact:
Melissa Altman, PhD
Email: melissa.altman2@va.gov
Phone: 718-741-4000
Secondary Contact:
Melissa Altman, PhD
Email: melissa.altman2@va.gov
Phone: 718-741-4000 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 23, 2011 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|