Evaluating a Novel Working Memory Training Program to Decrease Symptoms of PTSD

Study Overview
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Brief Summary
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The study is designed to evaluate the effect of a novel computer training program on PTSD.

Detailed Description
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Post-traumatic stress Disorder (PTSD) is a chronic and debilitating disorder that affects millions of people each year (Kessler et al., 2005). Although effective psychosocial and pharmacological treatments exist for this disorder, as many as 50 percent of individuals still experience symptoms after treatment (Schottenbaeur et al., 2008). Empirical literature suggests that cognitive deficits may play a role in maintaining symptoms in individuals with PTSD through a variety of mechanisms, including decreased cognitive control over intrusive thoughts (Verwoerd et al., in press) and dysregulation in neural circuitry linking prefrontal cognitive control functions and amygdala activity (McNally, 2007). The goals of the proposed research are to improve the candidate's understanding of cognitive mechanisms of PTSD symptoms while building skills in conducting treatment research. The application aims to test a novel methodology for approaching PTSD treatment based on modification of underlying cognitive mechanisms of the disorder. To this end, 50 participants with PTSD will be randomly assigned to an 8-session executive control training condition designed to improve working memory functioning or a control condition. The aims of this study are 1) To test the effect of a working memory training program on working memory performance and 2) To examine the effects of this program on PTSD symptoms. The research plan is complemented by a set of training goals for the candidate to achieve over the proposed award period. These include 1) training in the use of fMRI and neuropsychological assessment 2) additional coursework and seminars in cognitive science and biostatistics for use in future work, 3) experience with teaching in the undergraduate and graduate setting and presenting original work for publication in preparation for a career in academic research. Taken together, the research and training components of this grant application will facilitate the candidate's long-term goal of conducting treatment outcome and basic mechanism research in PTSD. Moreover, as per the strategic plan outlined by NIMH, this application is designed develop an innovative intervention based on prior clinical research and knowledge of cognitive and neurobiological features of the disorder, and will advance knowledge of mechanisms of fear learning. It is designed to target core cognitive features of the disorder in an effort to reduce symptoms. PUBLIC HEALTH RELEVANCE: Post-traumatic stress disorder impacts millions of Americans, and is associated with significant personal distress as well as societal cost. The current application is designed to examine the effect of a novel working memory training program on PTSD symptoms. This approach is promising in that it may be a cost- effective and accessible method for decreasing symptoms associate with this disorder.

Official Title
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Evaluating a Novel Working Memory Training Program to Decrease Symptoms of PTSD

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Other: Computerized Cognitive Training - active
* Other: Computerized cognitive training - sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age 18-65 Primary DSM-IV diagnosis of PTSD secondary to sexual trauma Exclusion Criteria: Current trauma or PTSD-focused psychosocial treatment Active suicidality, evidence of substance dependence in the past 6 months Evidence of current or past schizophrenia Bipolar disorder Organic mental disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Interference Control Condition<br>Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task | Other: Computerized Cognitive Training - active<br>* Cognitive training using working memory span task<br>|
| Active Comparator: Low Interference Control Condition<br>Computerized training program requiring participants to minimally practice controlling interference on a cognitive task | Other: Computerized cognitive training - sham<br>* Sham training condition<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician Administered PTSD Scale; Re-experiencing | Model estimations of the means and standard deviation of posttreatment score at the mean level of baseline severity reported below. Scale range: 0-40, higher values indicate greater symptom severity | Baseline, Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale Total Score - Responder Status | Number of Participants Who Responded According to Clinician Administered PTSD Scale Total Score | Week 4 | 
| Change in Depression: Beck Depression Inventory | Scale Range: 0-63; higher scores indicate greater symptom severity | Baseline, Week 4 | 
| Change in General Anxiety: Spielberger State-Trait Anxiety Inventory | Range: 20-80; higher scores indicate greater symptom severity | Baseline, Week 4 | 
| Change in Functional Impairment; Sheehan Disability Scale | Range: 0-30; greater values indicate greater disability severity ratings | Baseline, Week 4 |