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Clinical Trials/NCT02139137
NCT02139137CompletedNot Applicable

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

Rick Gulizia0 sites47 target enrollmentStarted: January 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
47
Primary Endpoint
Change in Clinician Administered PTSD Scale; Re-experiencing

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Arms & Interventions

High Interference Control Condition

Experimental

Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task

Intervention: Computerized Cognitive Training - active (Other)

Low Interference Control Condition

Active Comparator

Computerized training program requiring participants to minimally practice controlling interference on a cognitive task

Intervention: Computerized cognitive training - sham (Other)

Outcomes

Primary Outcomes

Change in Clinician Administered PTSD Scale; Re-experiencing

Time Frame: Baseline, Week 4

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

Secondary Outcomes

  • Change in Depression: Beck Depression Inventory(Baseline, Week 4)
  • Change in General Anxiety: Spielberger State-Trait Anxiety Inventory(Baseline, Week 4)
  • Clinician Administered PTSD Scale Total Score - Responder Status(Week 4)
  • Change in Functional Impairment; Sheehan Disability Scale(Baseline, Week 4)

Investigators

Sponsor
Rick Gulizia
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Rick Gulizia

Director of Research Affairs

San Diego State University

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