Cognitive Remediation in Posttraumatic Stress Disorder (PTSD)
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|ClinicalTrials.gov Identifier: NCT00850447|
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : February 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder||Other: Cognitive Remediation Therapy Other: Videogame||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Remediation in PTSD|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
|Experimental: Cognitive Remediation Therapy||
Other: Cognitive Remediation Therapy
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.
|Placebo Comparator: Videogames||
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.
- 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) [ Time Frame: 10 weeks ]
- PTSD symptom severity, assessed by Clinician Administered PTSD Scale (CAPS) [ Time Frame: 10 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850447
|United States, New York|
|James J. Peters Veterans Affairs Medical Center|
|Bronx, New York, United States, 10458|
|Principal Investigator:||Melissa Altman, PhD||James J. Peters Veterans Affairs Medical Center|