search
Back to results

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
Rick Gulizia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    May 12, 2014
    Last Updated
    October 4, 2017
    Sponsor
    Rick Gulizia
    search

    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

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs