Cognitive Remediation in Posttraumatic Stress Disorder (PTSD)

Posttraumatic Stress Disorder Clinical Trial

Official title: Cognitive Remediation in PTSD

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT00850447
• Study type: Interventional
• Source: Bronx VA Medical Center
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Completion date: March 2011