Evaluating a Novel Working Memory Training Program to Decrease Symptoms of PTSD
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computerized Cognitive Training - active
Computerized cognitive training - sham
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Interference Control Condition
Low Interference Control Condition
Arm Description
Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task
Computerized training program requiring participants to minimally practice controlling interference on a cognitive task
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Clinician Administered PTSD Scale Total Score - Responder Status
Number of Participants Who Responded According to Clinician Administered PTSD Scale Total Score
Change in Depression: Beck Depression Inventory
Scale Range: 0-63; higher scores indicate greater symptom severity
Change in General Anxiety: Spielberger State-Trait Anxiety Inventory
Range: 20-80; higher scores indicate greater symptom severity
Change in Functional Impairment; Sheehan Disability Scale
Range: 0-30; greater values indicate greater disability severity ratings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02139137
Brief Title
Evaluating a Novel Working Memory Training Program to Decrease Symptoms of PTSD
Official Title
Evaluating a Novel Working Memory Training Program to Decrease Symptoms of PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rick Gulizia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Interference Control Condition
Arm Type
Experimental
Arm Description
Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task
Arm Title
Low Interference Control Condition
Arm Type
Active Comparator
Arm Description
Computerized training program requiring participants to minimally practice controlling interference on a cognitive task
Intervention Type
Other
Intervention Name(s)
Computerized Cognitive Training - active
Intervention Description
Cognitive training using working memory span task
Intervention Type
Other
Intervention Name(s)
Computerized cognitive training - sham
Intervention Description
Sham training condition
Primary Outcome Measure Information:
Title
Change in Clinician Administered PTSD Scale; Re-experiencing
Description
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
Time Frame
Baseline, Week 4
Secondary Outcome Measure Information:
Title
Clinician Administered PTSD Scale Total Score - Responder Status
Description
Number of Participants Who Responded According to Clinician Administered PTSD Scale Total Score
Time Frame
Week 4
Title
Change in Depression: Beck Depression Inventory
Description
Scale Range: 0-63; higher scores indicate greater symptom severity
Time Frame
Baseline, Week 4
Title
Change in General Anxiety: Spielberger State-Trait Anxiety Inventory
Description
Range: 20-80; higher scores indicate greater symptom severity
Time Frame
Baseline, Week 4
Title
Change in Functional Impairment; Sheehan Disability Scale
Description
Range: 0-30; greater values indicate greater disability severity ratings
Time Frame
Baseline, Week 4
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica A Bomyea, M.S.
Organizational Affiliation
San Diego State University/University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ariel J Lang, Ph.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26114901
Citation
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.
Results Reference
result
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Evaluating a Novel Working Memory Training Program to Decrease Symptoms of PTSD
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