Posttraumatic Stress Disorder
Conditions
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.
Interventions
Cognitive training using working memory span task
Sham training condition
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinician Administered PTSD Scale; Re-experiencing | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale Total Score - Responder Status | Week 4 | Number of Participants Who Responded According to Clinician Administered PTSD Scale Total Score |
| Change in Depression: Beck Depression Inventory | Baseline, Week 4 | Scale Range: 0-63; higher scores indicate greater symptom severity |
| Change in General Anxiety: Spielberger State-Trait Anxiety Inventory | Baseline, Week 4 | Range: 20-80; higher scores indicate greater symptom severity |
| Change in Functional Impairment; Sheehan Disability Scale | Baseline, Week 4 | Range: 0-30; greater values indicate greater disability severity ratings |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 22 |
| 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 | 20 |
| Total | 42 |
Baseline characteristics
| Characteristic | High Interference Control Condition | Low Interference Control Condition | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 42 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 20 |
| serious Total, serious adverse events | 0 / 22 | 0 / 20 |
Outcome results
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
Time frame: Baseline, Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Interference Control Condition | Change in Clinician Administered PTSD Scale; Re-experiencing | 11.78 units on a scale | Standard Error 1.14 |
| Low Interference Control Condition | Change in Clinician Administered PTSD Scale; Re-experiencing | 15.69 units on a scale | Standard Error 1.2 |
Change in Depression: Beck Depression Inventory
Scale Range: 0-63; higher scores indicate greater symptom severity
Time frame: Baseline, Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Interference Control Condition | Change in Depression: Beck Depression Inventory | 6.8 units on a scale | Standard Deviation 8.9 |
| Low Interference Control Condition | Change in Depression: Beck Depression Inventory | 4.6 units on a scale | Standard Deviation 8.9 |
Change in Functional Impairment; Sheehan Disability Scale
Range: 0-30; greater values indicate greater disability severity ratings
Time frame: Baseline, Week 4
Population: Data at one time point for one participant in the LIC condition are not available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Interference Control Condition | Change in Functional Impairment; Sheehan Disability Scale | 3.2 units on a scale | Standard Deviation 7.2 |
| Low Interference Control Condition | Change in Functional Impairment; Sheehan Disability Scale | 1.7 units on a scale | Standard Deviation 6.3 |
Change in General Anxiety: Spielberger State-Trait Anxiety Inventory
Range: 20-80; higher scores indicate greater symptom severity
Time frame: Baseline, Week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Interference Control Condition | Change in General Anxiety: Spielberger State-Trait Anxiety Inventory | 6.1 units on a scale | Standard Deviation 8.6 |
| Low Interference Control Condition | Change in General Anxiety: Spielberger State-Trait Anxiety Inventory | 3.0 units on a scale | Standard Deviation 9.3 |
Clinician Administered PTSD Scale Total Score - Responder Status
Number of Participants Who Responded According to Clinician Administered PTSD Scale Total Score
Time frame: Week 4
Population: Number of participants analyzed is based on the number of participants who completed the post-treatment CAPS interview.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Interference Control Condition | Clinician Administered PTSD Scale Total Score - Responder Status | 11 Participants |
| Low Interference Control Condition | Clinician Administered PTSD Scale Total Score - Responder Status | 6 Participants |