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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Other: Computerized Cognitive Training - active; Other: Computerized cognitive training - sham

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 Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 15, 2014

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: F31MH088170 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO