Posttraumatic Stress DisorderNCT03260127
Enhancement of PTSD Treatment With Computerized Executive Function Training
A study testing Computerized executive function training plus CPT (CEFT-CPT) and Word game training plus CPT (WT-CPT) in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study focuses on helping Iraq and Afghanistan Veterans with posttraumatic stress disorder (PTSD) benefit fully from therapy by first enhancing their thinking abilities. PTSD has been associated with thinking problems, including difficulty planning/organizing, thinking flexibly, and inhibiting distracting… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Computerized executive function training plus CPT (CEFT-CPT) and Word game training plus CPT (WT-CPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2018to 31 Oct 2022
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans enrolled at Veterans Affairs San Diego Healthcare System (VASDHS)
- aged 18-55
- current posttraumatic stress disorder (PTSD) diagnosis
- endorsement of cognitive complaints
- no pending medication changes
- English-speaking.
Who cannot join
- active substance use disorder in the last month
- suicidal intent or attempt within the last month
- schizophrenia, psychotic disorder and/or bipolar disorder
- dementia
- premorbid IQ < 70
- participation in other concurrent PTSD intervention studies
Show all 9Show fewer
- previous completion of more than 4 Cognitive Processing Therapy (CPT) sessions
- history of a documented neurological disorder (e.g., Parkinson's disease, multiple sclerosis, epilepsy)
- moderate to severe traumatic brain injury (TBI) (i.e., loss of consciousness greater than 30 minutes or post-traumatic amnesia greater than 24 hours).
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
This study focuses on helping Iraq and Afghanistan Veterans with posttraumatic stress disorder (PTSD) benefit fully from therapy by first enhancing their thinking abilities. PTSD has been associated with thinking problems, including difficulty planning/organizing, thinking flexibly, and inhibiting distracting emotional information. There is some evidence that computerized training programs are helpful for improving thinking. Therefore, this study tests whether computerized cognitive training will in fact improve individuals' thinking abilities and if this will in turn improve PTSD treatment outcomes and lead to more individuals completing treatment and showing greater improvements in emotional symptoms and quality of life than standard therapy (when paired with a word training condition).
Read the detailed description
PTSD affects approximately 14% of OEF/OIF Veterans and leads to considerable personal and societal costs (e.g., increased morbidity, reduced work productivity, poorer relationships). Although cognitive behavioral therapy (CBT) is one of the most effective treatments for PTSD, a substantial portion (approximately 50%) of individuals drop out prematurely, do not respond to treatment, or relapse.
Treatment engagement is worse for OEF/OIF Veterans, who attend fewer sessions and have higher dropout rates than civilians and Veterans from other eras. One likely barrier to treatment engagement and effectiveness is the executive functioning problems present in individuals with PTSD. Executive functions (EFs) are the set of higher-level cognitive skills that organize and integrate lower-level cognitive processes in order to perform complex, goal-directed tasks. PTSD has been associated with EF deficits, including impairments in inhibitory control, working memory, and cognitive flexibly, as well as dysfunction in a network of brain regions that support EFs (e.g., prefrontal cortex [PFC], cingulate).
EFs are essential for CBT in order to engage the cognitive skills involved in treatment (e.g., self-monitoring, inhibiting distorted thoughts, and flexibly generating/evaluating alternative thoughts). This is particularly true for Cognitive Processing Therapy (CPT), a frontline CBT treatment for PTSD, which involves identifying and challenging maladaptive trauma-related thoughts to alter their impact on emotions and behavior. Thus, EF deficits may lead to reduced CPT engagement and responsivity. In fact, worse EF at baseline has been associated with poorer response to CBT in several disorders (e.g., generalized anxiety disorder, obsessive compulsive disorder, and schizophrenia). Further, a study of brain functioning during an EF task demonstrated that dysfunction in EF-related brain regions including PFC and cingulate cortex at baseline predicted nonresponse to CBT for PTSD. Directly targeting EF prior to CPT via cognitive training would strengthen executive networks and likely boost treatment effectiveness, allowing Veterans to fully engage in and benefit more from components of CPT (e.g., cognitive restructuring). Evidence suggests that computerized cognitive training improves EF and functioning in EF-related brain regions, increases mental health treatment completion rates, and goal of the proposed study is to examine whether administering computerized EF training (CEFT) immediately prior to CPT will improve executive functioning and enhance treatment adherence, completion rates, and psychological and functional outcomes in OEF/OIF Veterans with PTSD.
Objective (neuropsychological) and subjective (self- report) measures of EF will be collected to determine if CEFT enhances EF and if this in turn mediates the relationship between treatment condition and PTSD symptom improvement. Functional neuroimaging during EF tasks will also be collected at baseline to determine whether functioning within an EF network predicts treatment response, above and beyond traditional paper-and-pencil measures of EF. Veterans will be randomized to either 12 weeks of CEFT-CPT or a placebo word training condition plus CPT.
Assessments will be administered at baseline, immediately after CEFT or word training (prior to CPT), and after CPT completion. The proposed research aims to reduce barriers to treatment engagement and has potential to significantly enhance current treatments for PTSD by combining cognitive and psychotherapeutic approaches. Targeting EF directly and independently represents a logical, innovative, and empirically-informed method for augmenting existing treatments for PTSD in order to optimize outcomes. Findings from the proposed study will not only directly inform clinical practice, but also have the potential to significantly improve the quality of Veterans' lives, reduce societal costs and burden, improve access to care, and reveal ways to better match individuals with treatments they are most likely to benefit from.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Computerized executive function training plus CPT (CEFT-CPT), Word game training plus CPT (WT-CPT)
- Keywords
- PTSD, treatment, posttraumatic stress disorder, therapy, cognition, thinking, executive function, computer, training
- 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 executive function training plus CPT (CEFT-CPT)Behavioural
Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
Word game training plus CPT (WT-CPT)Behavioural
Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
| Study group | Role | What they receive |
|---|---|---|
| CEFT-CPT | Experimental | Computerized executive function training plus Cognitive Processing Therapy for PTSD Receives: Behavioral: Computerized executive function training plus CPT (CEFT-CPT) |
| WT-CPT | Active comparator | Word game training plus Cognitive Processing Therapy for PTSD Receives: Behavioral: Word game training plus CPT (WT-CPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wisconsin Card Sorting Test (WCST)
Wisconsin Card Sorting Test (WCST) is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -22 to 15, higher scores mean a worse outcome
Measured: change from baseline to completion of computerized cognitive training (6 weeks)
Paced Auditory Serial Addition Test (PASAT)
Paced Auditory Serial Addition Test (PASAT) is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -22 to 47, higher scores mean a better outcome
Measured: change from baseline to completion of computerized cognitive training (6 weeks)
Delis Kaplan Executive Function System (D-KEFS)
Delis Kaplan Executive Function System (D-KEFS) is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -39 to 27, higher scores mean a worse outcome
Measured: change from baseline to completion of computerized cognitive training (6 weeks)
Behavior Rating Inventory of Executive Function (BRIEF)
Behavior Rating Inventory of Executive Function (BRIEF) is a self-report measure of executive functioning, items are summed to create a total score, range: -32 to 30, higher scores mean a worse outcome
Measured: change in subjective executive functioning from baseline to completion of computerized cognitive training (6 weeks)
WAIS-IV Digit Span Sequencing Subtest
Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) Digit Span Sequencing subtest is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -3 to 3, higher scores mean a better outcome
Measured: change from baseline to completion of computerized cognitive training (6 weeks)
N-Back Task Performance
N-Back is a task that tests executive functioning, range: -.25 to .28, higher scores means a better outcome
Measured: change from baseline to completion of computerized cognitive training (6 weeks)
Go/No-Go Task Performance
Go/No-Go is a task that tests executive functioning, range: -.04 to .02, higher scores mean a worse outcome
Measured: change from baseline to completion of computerized cognitive training (6 weeks)
Secondary outcomes (5)
Clinician-Administered PTSD Scale for DSM 5 (CAPS-5)
Clinician-Administered PTSD Scale for DSM 5 (CAPS-5) is a clinical interview assessing PTSD symptoms that will be administered at 3 time points: baseline, after completion of cognitive training, and after completion of Cognitive Processing Therapy, range: -38 to 18, higher scores mean a worse outcome
Measured: change in PTSD symptoms from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment
PTSD Checklist for DSM-5 (PCL-5)
PTSD Checklist for DSM-5 (PCL-5) is a self-report questionnaire that will be administered at 15 time points: at baseline, after completion of cognitive training, at each of the 12 therapy sessions, and after completion of Cognitive Processing Therapy, range: -49 to 28, higher scores mean a worse outcome
Measured: change in PTSD symptoms from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment
World Health Organization Quality of Life - BREF
World Health Organization Quality of Life - BREF (WHOQOL-BREF) is a self-report questionnaire assessing quality of life that will be administered at 3 time points: baseline, after completion of cognitive training, and after completion of Cognitive Processing Therapy. Four subscales are computed (range 4-20): physical health, psychological, social relationships, and environment, range: -2.7 to 6.7, higher scores mean a better outcome
Measured: change in quality of life from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment
Time (in Minutes) Spent Completing Cognitive Processing Therapy Homework
At each of the CPT sessions, participants will report how much time they spent completing homework since the previous session
Measured: time (in minutes) spent completing homework from CPT session 1 to CPT session 12 (across approximately 6 weeks, weeks 7-12 after baseline)
Number of CPT Sessions Completed
Number of CPT sessions completed out of a possible total of 12 sessions
Measured: CPT sessions completed (out of a possible 12) after completing the cognitive training (across approximately 6 weeks, weeks 7-12 after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start2 Jul 2018
- Primary completion30 Sep 2022
- Study completion31 Oct 2022
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.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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, Care provider, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Laura D. Crocker, PhD, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260127
- Sponsor's protocol ID
- F2459-W
- Other IDs
- IK2RX002459
- Status last verified
- Sep 2023
- First submitted
- 9 Aug 2017
- Last updated
- 1 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset will be created and shared. Requests for access must be made in writing signed by a requestor from the United States and include an email address for delivery and an assurance that the recipient will not attempt to identify or re-identify any individual. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. If the investigator leaves the VA San Diego Healthcare System, the requests may be sent to the Associate Chief of Staff for Research.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of PTSD Treatment With Computerized Executive Function Training
- ClinicalTrials.gov ID
- NCT03260127
- Acronym / sponsor ID
- F2459-W
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, treatment, posttraumatic stress disorder, therapy, cognition, thinking, executive function, computer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Posted 1 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study focuses on helping Iraq and Afghanistan Veterans with posttraumatic stress disorder (PTSD) benefit fully from therapy by first enhancing their thinking abilities. PTSD has been associated with thinking problems, including difficulty planning/organizing, thinking flexibly, and inhibiting distracting emotional information. There is some evidence that computerized training programs are helpful for improving thinking. Therefore, this study tests whether computerized cognitive training will in fact improve individuals' thinking abilities and if this will in turn improve PTSD treatment outcomes and lead to more individuals completing treatment and showing greater improvements in emotional symptoms and quality of life than standard therapy (when paired with a word training condition).
Detailed description
PTSD affects approximately 14% of OEF/OIF Veterans and leads to considerable personal and societal costs (e.g., increased morbidity, reduced work productivity, poorer relationships). Although cognitive behavioral therapy (CBT) is one of the most effective treatments for PTSD, a substantial portion (approximately 50%) of individuals drop out prematurely, do not respond to treatment, or relapse.
Treatment engagement is worse for OEF/OIF Veterans, who attend fewer sessions and have higher dropout rates than civilians and Veterans from other eras. One likely barrier to treatment engagement and effectiveness is the executive functioning problems present in individuals with PTSD. Executive functions (EFs) are the set of higher-level cognitive skills that organize and integrate lower-level cognitive processes in order to perform complex, goal-directed tasks. PTSD has been associated with EF deficits, including impairments in inhibitory control, working memory, and cognitive flexibly, as well as dysfunction in a network of brain regions that support EFs (e.g., prefrontal cortex [PFC], cingulate).
EFs are essential for CBT in order to engage the cognitive skills involved in treatment (e.g., self-monitoring, inhibiting distorted thoughts, and flexibly generating/evaluating alternative thoughts). This is particularly true for Cognitive Processing Therapy (CPT), a frontline CBT treatment for PTSD, which involves identifying and challenging maladaptive trauma-related thoughts to alter their impact on emotions and behavior. Thus, EF deficits may lead to reduced CPT engagement and responsivity. In fact, worse EF at baseline has been associated with poorer response to CBT in several disorders (e.g., generalized anxiety disorder, obsessive compulsive disorder, and schizophrenia). Further, a study of brain functioning during an EF task demonstrated that dysfunction in EF-related brain regions including PFC and cingulate cortex at baseline predicted nonresponse to CBT for PTSD. Directly targeting EF prior to CPT via cognitive training would strengthen executive networks and likely boost treatment effectiveness, allowing Veterans to fully engage in and benefit more from components of CPT (e.g., cognitive restructuring). Evidence suggests that computerized cognitive training improves EF and functioning in EF-related brain regions, increases mental health treatment completion rates, and goal of the proposed study is to examine whether administering computerized EF training (CEFT) immediately prior to CPT will improve executive functioning and enhance treatment adherence, completion rates, and psychological and functional outcomes in OEF/OIF Veterans with PTSD.
Objective (neuropsychological) and subjective (self- report) measures of EF will be collected to determine if CEFT enhances EF and if this in turn mediates the relationship between treatment condition and PTSD symptom improvement. Functional neuroimaging during EF tasks will also be collected at baseline to determine whether functioning within an EF network predicts treatment response, above and beyond traditional paper-and-pencil measures of EF. Veterans will be randomized to either 12 weeks of CEFT-CPT or a placebo word training condition plus CPT.
Assessments will be administered at baseline, immediately after CEFT or word training (prior to CPT), and after CPT completion. The proposed research aims to reduce barriers to treatment engagement and has potential to significantly enhance current treatments for PTSD by combining cognitive and psychotherapeutic approaches. Targeting EF directly and independently represents a logical, innovative, and empirically-informed method for augmenting existing treatments for PTSD in order to optimize outcomes. Findings from the proposed study will not only directly inform clinical practice, but also have the potential to significantly improve the quality of Veterans' lives, reduce societal costs and burden, improve access to care, and reveal ways to better match individuals with treatments they are most likely to benefit from.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEFT-CPT | Experimental | Behavioral: Computerized executive function training plus CPT (CEFT-CPT)Computerized executive function training plus Cognitive Processing Therapy for PTSD |
| WT-CPT | Active comparator | Behavioral: Word game training plus CPT (WT-CPT)Word game training plus Cognitive Processing Therapy for PTSD |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans enrolled at Veterans Affairs San Diego Healthcare System (VASDHS)
- aged 18-55
- current posttraumatic stress disorder (PTSD) diagnosis
- endorsement of cognitive complaints
- no pending medication changes
Key exclusion criteria (9 listed)
- active substance use disorder in the last month
- suicidal intent or attempt within the last month
- schizophrenia, psychotic disorder and/or bipolar disorder
- dementia
- premorbid IQ < 70
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 executive function training plus CPT (CEFT-CPT)Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions) | Behavioural | CEFT-CPT |
| Word game training plus CPT (WT-CPT)Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions) | Behavioural | WT-CPT |
Primary outcome
Wisconsin Card Sorting Test (WCST)
Time frame: change from baseline to completion of computerized cognitive training (6 weeks)
Wisconsin Card Sorting Test (WCST) is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -22 to 15, higher scores mean a worse outcome
Paced Auditory Serial Addition Test (PASAT)
Time frame: change from baseline to completion of computerized cognitive training (6 weeks)
Paced Auditory Serial Addition Test (PASAT) is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -22 to 47, higher scores mean a better outcome
Delis Kaplan Executive Function System (D-KEFS)
Time frame: change from baseline to completion of computerized cognitive training (6 weeks)
Delis Kaplan Executive Function System (D-KEFS) is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -39 to 27, higher scores mean a worse outcome
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: change in subjective executive functioning from baseline to completion of computerized cognitive training (6 weeks)
Behavior Rating Inventory of Executive Function (BRIEF) is a self-report measure of executive functioning, items are summed to create a total score, range: -32 to 30, higher scores mean a worse outcome
WAIS-IV Digit Span Sequencing Subtest
Time frame: change from baseline to completion of computerized cognitive training (6 weeks)
Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) Digit Span Sequencing subtest is a neuropsychological measure of executive functioning, will be examined separately as well as in a composite with the other neuropsychological measures of executive functioning, range: -3 to 3, higher scores mean a better outcome
N-Back Task Performance
Time frame: change from baseline to completion of computerized cognitive training (6 weeks)
N-Back is a task that tests executive functioning, range: -.25 to .28, higher scores means a better outcome
Go/No-Go Task Performance
Time frame: change from baseline to completion of computerized cognitive training (6 weeks)
Go/No-Go is a task that tests executive functioning, range: -.04 to .02, higher scores mean a worse outcome
5 secondary outcomes
Clinician-Administered PTSD Scale for DSM 5 (CAPS-5)
Time frame: change in PTSD symptoms from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment
PTSD Checklist for DSM-5 (PCL-5)
Time frame: change in PTSD symptoms from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment
World Health Organization Quality of Life - BREF
Time frame: change in quality of life from baseline to completion of Cognitive Processing Therapy (12 sessions completed after cognitive training), approximately 12 weeks after baseline assessment
Time (in Minutes) Spent Completing Cognitive Processing Therapy Homework
Time frame: time (in minutes) spent completing homework from CPT session 1 to CPT session 12 (across approximately 6 weeks, weeks 7-12 after baseline)
Number of CPT Sessions Completed
Time frame: CPT sessions completed (out of a possible 12) after completing the cognitive training (across approximately 6 weeks, weeks 7-12 after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset will be created and shared. Requests for access must be made in writing signed by a requestor from the United States and include an email address for delivery and an assurance that the recipient will not attempt to identify or re-identify any individual. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. If the investigator leaves the VA San Diego Healthcare System, the requests may be sent to the Associate Chief of Staff for Research.
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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.
Laura D. Crocker, PhD principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized executive function training plus CPT (CEFT-CPT) and Word game training plus CPT (WT-CPT) in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
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 6 inclusion and 9 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 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 Apr 2024). 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?
Wisconsin Card Sorting Test (WCST) (time frame: change from baseline to completion of computerized cognitive training (6 weeks)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2024.