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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139137
Recruitment Status : Completed
First Posted : May 15, 2014
Results First Posted : March 7, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Rick Gulizia, San Diego State University

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

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Other: Computerized Cognitive Training - active Other: Computerized cognitive training - sham Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating a Novel Working Memory Training Program to Decrease Symptoms of PTSD
Study Start Date : January 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: High Interference Control Condition
Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task
Other: Computerized Cognitive Training - active
Cognitive training using working memory span task

Active Comparator: Low Interference Control Condition
Computerized training program requiring participants to minimally practice controlling interference on a cognitive task
Other: Computerized cognitive training - sham
Sham training condition




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Clinician Administered PTSD Scale Total Score - Responder Status [ Time Frame: Week 4 ]
    Number of Participants Who Responded According to Clinician Administered PTSD Scale Total Score

  2. Change in Depression: Beck Depression Inventory [ Time Frame: Baseline, Week 4 ]
    Scale Range: 0-63; higher scores indicate greater symptom severity

  3. Change in General Anxiety: Spielberger State-Trait Anxiety Inventory [ Time Frame: Baseline, Week 4 ]
    Range: 20-80; higher scores indicate greater symptom severity

  4. Change in Functional Impairment; Sheehan Disability Scale [ Time Frame: Baseline, Week 4 ]
    Range: 0-30; greater values indicate greater disability severity ratings



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139137


Sponsors and Collaborators
Rick Gulizia
Investigators
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Principal Investigator: Jessica A Bomyea, M.S. San Diego State University/University of California, San Diego
Principal Investigator: Ariel J Lang, Ph.D. University of California, San Diego
Publications of Results:
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Responsible Party: Rick Gulizia, Director of Research Affairs, San Diego State University
ClinicalTrials.gov Identifier: NCT02139137    
Other Study ID Numbers: F31MH088170 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2014    Key Record Dates
Results First Posted: March 7, 2017
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders