Posttraumatic Stress DisorderNCT02139137
Evaluating a Novel Working Memory Training Program to Decrease Symptoms of PTSD
A study testing Computerized Cognitive Training - active in people with Posttraumatic Stress Disorder, run by Rick Gulizia.
Trial summary
The study is designed to evaluate the effect of a novel computer training program on PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Computerized Cognitive Training - active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 18-65
- Primary DSM-IV diagnosis of PTSD secondary to sexual trauma
Who cannot join
- 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
About this study
The study is designed to evaluate the effect of a novel computer training program on PTSD.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Computerized Cognitive Training - active, Computerized cognitive training - sham
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive Training - activeOther
Cognitive training using working memory span task
Computerized cognitive training - shamOther
Sham training condition
| Study group | Role | What they receive |
|---|---|---|
| High Interference Control Condition | Experimental | Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task Receives: Other: Computerized Cognitive Training - active |
| Low Interference Control Condition | Active comparator | Computerized training program requiring participants to minimally practice controlling interference on a cognitive task Receives: Other: Computerized cognitive training - sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Week 4
Secondary outcomes (4)
Clinician Administered PTSD Scale Total Score - Responder Status
Number of Participants Who Responded According to Clinician Administered PTSD Scale Total Score
Measured: Week 4
Change in Depression: Beck Depression Inventory
Scale Range: 0-63; higher scores indicate greater symptom severity
Measured: Baseline, Week 4
Change in General Anxiety: Spielberger State-Trait Anxiety Inventory
Range: 20-80; higher scores indicate greater symptom severity
Measured: Baseline, Week 4
Change in Functional Impairment; Sheehan Disability Scale
Range: 0-30; greater values indicate greater disability severity ratings
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startJan 2010
- Primary completionAug 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rick Gulizia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rick Gulizia, San Diego State University
- Investigators
- Jessica A Bomyea, M.S., Principal investigator, San Diego State University/University of California, San DiegoAriel J Lang, Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139137
- Sponsor's protocol ID
- F31MH088170
- Status last verified
- Oct 2017
- First submitted
- 12 May 2014
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26114901
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Novel Working Memory Training Program to Decrease Symptoms of PTSD
- ClinicalTrials.gov ID
- NCT02139137
- Acronym / sponsor ID
- F31MH088170
- Conditions
- Posttraumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Rick GuliziaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 May 2014 (estimated)
- Results
- Posted 7 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Interference Control Condition | Experimental | Other: Computerized Cognitive Training - activeComputerized training program requiring participants to repeatedly practice controlling interference on a cognitive task |
| Low Interference Control Condition | Active comparator | Other: Computerized cognitive training - shamComputerized training program requiring participants to minimally practice controlling interference on a cognitive task |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Age 18-65
- Primary DSM-IV diagnosis of PTSD secondary to sexual trauma
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Cognitive Training - activeCognitive training using working memory span task | Other | High Interference Control Condition |
| Computerized cognitive training - shamSham training condition | Other | Low Interference Control Condition |
Primary outcome
Change in Clinician Administered PTSD Scale; Re-experiencing
Time frame: 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
4 secondary outcomes
Clinician Administered PTSD Scale Total Score - Responder Status
Time frame: Week 4
Change in Depression: Beck Depression Inventory
Time frame: Baseline, Week 4
Change in General Anxiety: Spielberger State-Trait Anxiety Inventory
Time frame: Baseline, Week 4
Change in Functional Impairment; Sheehan Disability Scale
Time frame: Baseline, Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26114901Bomyea 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.
- Individual participant dataSharing planned: No
Related trials for Posttraumatic Stress Disorder
RecruitingPhase 1
Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)
Traumatic Brain Injuries, TBI (Traumatic Brain Injury)
Recruiting
Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico
Post-Traumatic Stress Disorder
RecruitingPhase 3
Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression
Major Depression
RecruitingPhase 2/3
Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
PTSD - Post Traumatic Stress Disorder, PTSD
Recruiting
Exercise and Emotional Learning in Posttraumatic Stress Disorder
PTSD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica A Bomyea, M.S. principal investigator
San Diego State University/University of California, San Diego
Ariel J Lang, Ph.D. principal investigator
University of California, San Diego
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Training - active in people with Posttraumatic Stress Disorder, run by Rick Gulizia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinician Administered PTSD Scale; Re-experiencing (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02139137, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.