Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is designed to evaluate the effect of a novel computer training program on PTSD.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Interference Control Condition | Experimental | Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task |
|
| Low Interference Control Condition | Active Comparator | Computerized training program requiring participants to minimally practice controlling interference on a cognitive task |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Cognitive Training - active | Other | Cognitive training using working memory span task |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26114901 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
47 individuals consented to participate in the study. Of those, 42 started the study and were randomized. The remaining 5 were not assigned to either condition. Intent to treat analyses are presented using last observation carried forward for all continuous measures.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | High Interference Control Condition | Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task Computerized Cognitive Training - active: Cognitive training using working memory span task |
| FG001 | Low Interference Control Condition | Computerized training program requiring participants to minimally practice controlling interference on a cognitive task Computerized cognitive training - sham: Sham training condition |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | High Interference Control Condition | Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task Computerized Cognitive Training - active: Cognitive training using working memory span task |
| BG001 | Low Interference Control Condition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Error | units on a scale | Baseline, Week 4 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Interference Control Condition | Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task Computerized Cognitive Training - active: Cognitive training using working memory span task |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Bomyea | SDSU/UCSD Joint Doctoral Program in Clinical Psychology | 8585528585 | 3720 | jbomyea@ucsd.edu |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Computerized cognitive training - sham | Other | Sham training condition |
|
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 |
Computerized training program requiring participants to minimally practice controlling interference on a cognitive task Computerized cognitive training - sham: Sham training condition |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Clinician Administered PTSD Scale Total Score - Responder Status | Number of Participants Who Responded According to Clinician Administered PTSD Scale Total Score | Number of participants analyzed is based on the number of participants who completed the post-treatment CAPS interview. | Posted | Count of Participants | Participants | Week 4 |
|
|
|
| Secondary | Change in Depression: Beck Depression Inventory | Scale Range: 0-63; higher scores indicate greater symptom severity | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4 |
|
|
|
| Secondary | Change in General Anxiety: Spielberger State-Trait Anxiety Inventory | Range: 20-80; higher scores indicate greater symptom severity | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4 |
|
|
|
| Secondary | Change in Functional Impairment; Sheehan Disability Scale | Range: 0-30; greater values indicate greater disability severity ratings | Data at one time point for one participant in the LIC condition are not available. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 4 |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Low Interference Control Condition | Computerized training program requiring participants to minimally practice controlling interference on a cognitive task Computerized cognitive training - sham: Sham training condition | 0 | 20 | 0 | 20 |
Not provided
Not provided