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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02139137
Enrollment
47
Registered
2014-05-15
Start date
2010-01-31
Completion date
2013-12-31
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

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

OTHERComputerized Cognitive Training - active

Cognitive training using working memory span task

OTHERComputerized cognitive training - sham

Sham training condition

Sponsors

Rick Gulizia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

MeasureTime frameDescription
Change in Clinician Administered PTSD Scale; Re-experiencingBaseline, Week 4Model 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

MeasureTime frameDescription
Clinician Administered PTSD Scale Total Score - Responder StatusWeek 4Number of Participants Who Responded According to Clinician Administered PTSD Scale Total Score
Change in Depression: Beck Depression InventoryBaseline, Week 4Scale Range: 0-63; higher scores indicate greater symptom severity
Change in General Anxiety: Spielberger State-Trait Anxiety InventoryBaseline, Week 4Range: 20-80; higher scores indicate greater symptom severity
Change in Functional Impairment; Sheehan Disability ScaleBaseline, Week 4Range: 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

ArmCount
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
Total42

Baseline characteristics

CharacteristicHigh Interference Control ConditionLow Interference Control ConditionTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
22 Participants20 Participants42 Participants
Sex: Female, Male
Female
22 Participants20 Participants42 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 220 / 20
serious
Total, serious adverse events
0 / 220 / 20

Outcome results

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

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
High Interference Control ConditionChange in Clinician Administered PTSD Scale; Re-experiencing11.78 units on a scaleStandard Error 1.14
Low Interference Control ConditionChange in Clinician Administered PTSD Scale; Re-experiencing15.69 units on a scaleStandard Error 1.2
Secondary

Change in Depression: Beck Depression Inventory

Scale Range: 0-63; higher scores indicate greater symptom severity

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
High Interference Control ConditionChange in Depression: Beck Depression Inventory6.8 units on a scaleStandard Deviation 8.9
Low Interference Control ConditionChange in Depression: Beck Depression Inventory4.6 units on a scaleStandard Deviation 8.9
Secondary

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.

ArmMeasureValue (MEAN)Dispersion
High Interference Control ConditionChange in Functional Impairment; Sheehan Disability Scale3.2 units on a scaleStandard Deviation 7.2
Low Interference Control ConditionChange in Functional Impairment; Sheehan Disability Scale1.7 units on a scaleStandard Deviation 6.3
Secondary

Change in General Anxiety: Spielberger State-Trait Anxiety Inventory

Range: 20-80; higher scores indicate greater symptom severity

Time frame: Baseline, Week 4

ArmMeasureValue (MEAN)Dispersion
High Interference Control ConditionChange in General Anxiety: Spielberger State-Trait Anxiety Inventory6.1 units on a scaleStandard Deviation 8.6
Low Interference Control ConditionChange in General Anxiety: Spielberger State-Trait Anxiety Inventory3.0 units on a scaleStandard Deviation 9.3
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
High Interference Control ConditionClinician Administered PTSD Scale Total Score - Responder Status11 Participants
Low Interference Control ConditionClinician Administered PTSD Scale Total Score - Responder Status6 Participants

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026