Neural Correlates of Cognitive Rehabilitation in PTSD
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| First Received Date ICMJE | April 17, 2012 | ||||
| Last Updated Date | February 12, 2013 | ||||
| Start Date ICMJE | May 2011 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Clinician Administered Posttraumatic Stress Disorder Scale (CAPS) [ Time Frame: Pre-treatment, after an average of 8 weeks of treatment, and 6 months post-treatment ] [ Designated as safety issue: No ] The CAPS is a 30-item structured interview that corresponds to the DSM-IV criteria for PTSD. The CAPS can be used to make a current (past month) or lifetime diagnosis of PTSD or to assesses symptoms over the past week. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01584349 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neural Correlates of Cognitive Rehabilitation in PTSD | ||||
| Official Title ICMJE | Neural Correlates of Cognitive Rehabilitation in Posttraumatic Stress Disorder | ||||
| Brief Summary | Posttraumatic stress disorder (PTSD) is commonly associated with deficits in attention and memory skills. As such, these deficits may negatively affect performance in other cognitive domains (e.g., memory, executive functions), leading individuals with PTSD to experience difficulties in everyday functioning and reductions in quality of life. Investigators therefore aim to examine whether U.S. Veterans with PTSD will benefit from engagement in targeted cognitive remediation by measuring longitudinal change in neuropsychological performance, neural activity, and clinical outcomes. The longitudinal research design for this project will be a three factor mixed factorial design with between subject factors of PTSD (+PTSD x -PTSD) and cognitive remediation (learning-based cognitive training [LBCT] x non-learning training [NLT]) and the within subject variable of time tested (pre-training, post-training, 3 month follow-up). Forty participants will be enrolled in four groups of 10 each: 1) +PTSD/LBCT, 2) +PTSD/NLT, 3) -PTSD/LBCT, and 4) -PTSD/NLT. All groups will receive 40 hours of computerized training. Outcomes will be measured at baseline (i.e., pre-treatment), after an average of 8 weeks of treatment, and at 6 months post-treatment. The active treatment is the Posit Science visual cognitive remediation paradigm (i.e., InSight), while the control treatment will utilize games face valid for cognitive training. This study will examine the effects of a standardized cognitive rehabilitation program on neurocognitive functioning and brain functional activation in OEF/OIF veterans with PTSD. The proposed study addresses several issues important to advancing the care of Veterans with PTSD. This project will comprehensively assess potential cognitive problems experienced by individuals with PTSD, which may benefit clinicians and researchers focused on the treatment of PTSD. It will also examine whether a sophisticated rehabilitation program that is rooted in clinical neuroscience (but also commercially available) can remediate these problems, and what structural and functional brain changes are associated with this remediation. Finally, it will examine whether changes associated with cognitive training persist over a longer-term follow-up period. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | April 2015 | ||||
| Estimated Primary Completion Date | April 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
individuals will be excluded if in the 30 days prior to the initial interview if they:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01584349 | ||||
| Other Study ID Numbers ICMJE | BS0002-01492 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | VA Connecticut Healthcare System | ||||
| Study Sponsor ICMJE | VA Connecticut Healthcare System | ||||
| Collaborators ICMJE | Yale University | ||||
| Investigators ICMJE |
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| Information Provided By | VA Connecticut Healthcare System | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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