Cognitive Remediation in Posttraumatic Stress Disorder (PTSD)
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Remediation Therapy
Videogame
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic stress disorder, Cognition, Neuropsychological Tests
Eligibility 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
Sites / Locations
- James J. Peters Veterans Affairs Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cognitive Remediation Therapy
Videogames
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
PTSD symptom severity, assessed by Clinician Administered PTSD Scale (CAPS)
Full Information
NCT ID
NCT00850447
First Posted
February 24, 2009
Last Updated
February 1, 2012
Sponsor
Bronx VA Medical Center
Collaborators
VISN 3 Mental Illness Research, Education and Clinical Center
1. Study Identification
Unique Protocol Identification Number
NCT00850447
Brief Title
Cognitive Remediation in Posttraumatic Stress Disorder (PTSD)
Official Title
Cognitive Remediation in PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bronx VA Medical Center
Collaborators
VISN 3 Mental Illness Research, Education and Clinical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Posttraumatic stress disorder, Cognition, Neuropsychological Tests
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Remediation Therapy
Arm Type
Experimental
Arm Title
Videogames
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Cognitive Remediation Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Videogame
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
PTSD symptom severity, assessed by Clinician Administered PTSD Scale (CAPS)
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Altman, PhD
Organizational Affiliation
James J. Peters Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
James J. Peters Veterans Affairs Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10458
Country
United States
12. IPD Sharing Statement
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Cognitive Remediation in Posttraumatic Stress Disorder (PTSD)
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