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

• 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: Rick Gulizia
• Information provided by (Responsible Party): Rick Gulizia, San Diego State University

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

Rick Gulizia

Investigators

• 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

More Information

Publications of Results:

Bomyea J, Stein MB, Lang AJ. Interference control training for PTSD: A randomized controlled trial of a novel computer-based intervention. J Anxiety Disord. 2015 Aug;34:33-42. doi: 10.1016/j.janxdis.2015.05.010. Epub 2015 Jun 10.

• 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
• 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:

Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders