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Completed

NCT Number: NCT02139137

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerized Cognitive Training - active

Other

Cognitive training using working memory span task

Computerized cognitive training - sham

Other

Sham training condition

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Rick Gulizia

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 15, 2014
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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