Posttraumatic Stress DisorderNCT02766296
Emotional Working Memory Training for Veterans With PTSD Symptoms
A study testing Active Emotional Working Memory Training in people with Posttraumatic Stress Disorder, run by Milwaukee VA Medical Center at 1 site in United States.
Trial summary
PTSD is characterized by recurrent intrusion of trauma-related memories and images that cause significant distress and impairment to the affected individuals. The current project aims to examine whether computerized emotional working memory training (eWMT) can help improve working memory capabilities and reduce… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Active Emotional Working Memory Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 2 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fluently speaks English
- The PTSD Checklist (PCL-5) total score >= 38
Who cannot join
- No access to a private computer with high-speed Internet that can be used privately.
- Elevated suicidality
- History of psychotic disorders (e.g., schizophrenia)
- Severe substance use disorder (as per DSM-5 criteria)
- History of severe brain injury or organic mental syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Clement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, 53295
About this study
Official title: Emotional Working Memory Training for Veterans With Elevated Trauma-related Symptoms
PTSD is characterized by recurrent intrusion of trauma-related memories and images that cause significant distress and impairment to the affected individuals. The current project aims to examine whether computerized emotional working memory training (eWMT) can help improve working memory capabilities and reduce trauma-related emotional symptoms among individuals with elevated trauma-related symptoms. Participants will be randomly assigned to one of the two computerized training programs. At baseline, post-training, and 1-month follow-up, participants will be assessed with respect to their emotional symptoms and working memory-related cognitive performance. Pending successful outcomes, this study will provide important knowledge that will guide the future efforts to develop an effective, accessible, and cost-efficient intervention program.
Read the detailed description
PTSD is characterized by recurrent intrusion of trauma-related memories and images that cause significant distress and impairment to the affected individuals. The long-term objective is to develop an effective cognitive treatment program that can reduce such intrusive cognitions observed among individuals who have been exposed to a significant trauma. The specific objective is to examine whether computerized emotional working memory training (eWMT) can help improve working memory capabilities and reduce trauma-related emotional symptoms among individuals with elevated trauma-related symptoms. eWMT is designed to improve the individual's ability to stay focused on the target and filter out irrelevant information from their working memory, which is expected to improve trauma-related emotional symptoms via the improvement of working memory functioning.
Individuals who display elevated trauma symptoms will be randomly assigned to one of two eWMT conditions: (a) adjustable n-back training (i.e., potent working memory training program), and (b) fixed 1-back training (i.e., training that delivers a limited dose). Participants will be blinded to ensure objective assessment of the intervention effects. Before and after the eWMT intervention, all participants will undergo an assessment session that aims to assess each individual's emotional symptoms and working memory-related cognitive performance. Further, following completion of procedure, participants will be invited for a follow-up assessment to assess the long-term effect of training.
The eWMT intervention will be delivered via Internet. Thus, the current intervention is a home-based Internet intervention, which provides an important context for testing and developing a cost-efficient, accessible, and effective intervention program for many individuals suffering from exposure to traumas. Each training session will take about 20 minutes, and all participants in both conditions will receive a total of 15 training sessions. Participants will be guided to complete an average of 3 training sessions every week for a total duration of approximately 5 weeks.
Investigators hypothesize that individuals who undergo the active eWMT will display a greater improvement in overall working memory performance and a greater reduction in trauma-related symptoms, compared to individuals who undergo the less effective control training program. Pending successful outcomes, this study will provide important knowledge that will guide the future efforts to develop an effective, accessible, and cost-efficient intervention program that can reach out to many individuals who suffer from exposure to traumas.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Active Emotional Working Memory Training, Control Working Memory Training
- Keywords
- PTSD, trauma, working memory, working memory training
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Emotional Working Memory TrainingBehavioural
This training regimen has adapted the existing n-back paradigm, which has been widely used in the field. Training requires participants to shift between visual and auditory information while continually updating their working memory.
Control Working Memory TrainingBehavioural
This training utilized a fixed dual 1-back training paradigm.
| Study group | Role | What they receive |
|---|---|---|
| Active Emotional Working Memory Training | Experimental | Each participant will receive 15 sessions (each lasting 20 minutes) over a 5 week. This will be Internet-based cognitive training based on the adaptive dual n-back paradigm. Receives: Behavioral: Active Emotional Working Memory Training |
| Control Working Memory Training | Placebo comparator | Participants in this condition will receive 15 sessions (each lasting 20 minutes) over a 5-week period. This will also be home-based training over the Internet. This training will be based on a fixed 1-back training program. Receives: Behavioral: Control Working Memory Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Severity of trauma-related symptoms from baseline to post-training and 1-month follow-up
PTSD Checklist (PCL-5)
Measured: At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)
Secondary outcomes (1)
Change in working memory performance from baseline to post-training and 1-month follow-up
Automated Complex Span Tasks (Oswald et al., 2014). This is a well-validated computerized measure of working memory capacity, including three sub-domains: (1) Operation span, (2) Reading span, and (3) Symmetry span.
Measured: At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startMay 2016
- Primary completion2 May 2018
- Study completion2 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milwaukee VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Sadie Larsen, Milwaukee VA Medical Center
- Investigators
- Sadie Larsen, Ph.D., Principal investigator, Clement J. Zablocki VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766296
- Sponsor's protocol ID
- 5134-03
- Status last verified
- Jun 2018
- First submitted
- 4 May 2016
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Working Memory Training for Veterans With Elevated Trauma-related Symptoms
- ClinicalTrials.gov ID
- NCT02766296
- Acronym / sponsor ID
- 5134-03
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, trauma, working memory, working memory training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Milwaukee VA Medical CenterUS federal agency
- Study start
- May 2016 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 9 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PTSD is characterized by recurrent intrusion of trauma-related memories and images that cause significant distress and impairment to the affected individuals. The current project aims to examine whether computerized emotional working memory training (eWMT) can help improve working memory capabilities and reduce trauma-related emotional symptoms among individuals with elevated trauma-related symptoms. Participants will be randomly assigned to one of the two computerized training programs. At baseline, post-training, and 1-month follow-up, participants will be assessed with respect to their emotional symptoms and working memory-related cognitive performance. Pending successful outcomes, this study will provide important knowledge that will guide the future efforts to develop an effective, accessible, and cost-efficient intervention program.
Detailed description
PTSD is characterized by recurrent intrusion of trauma-related memories and images that cause significant distress and impairment to the affected individuals. The long-term objective is to develop an effective cognitive treatment program that can reduce such intrusive cognitions observed among individuals who have been exposed to a significant trauma. The specific objective is to examine whether computerized emotional working memory training (eWMT) can help improve working memory capabilities and reduce trauma-related emotional symptoms among individuals with elevated trauma-related symptoms. eWMT is designed to improve the individual's ability to stay focused on the target and filter out irrelevant information from their working memory, which is expected to improve trauma-related emotional symptoms via the improvement of working memory functioning.
Individuals who display elevated trauma symptoms will be randomly assigned to one of two eWMT conditions: (a) adjustable n-back training (i.e., potent working memory training program), and (b) fixed 1-back training (i.e., training that delivers a limited dose). Participants will be blinded to ensure objective assessment of the intervention effects. Before and after the eWMT intervention, all participants will undergo an assessment session that aims to assess each individual's emotional symptoms and working memory-related cognitive performance. Further, following completion of procedure, participants will be invited for a follow-up assessment to assess the long-term effect of training.
The eWMT intervention will be delivered via Internet. Thus, the current intervention is a home-based Internet intervention, which provides an important context for testing and developing a cost-efficient, accessible, and effective intervention program for many individuals suffering from exposure to traumas. Each training session will take about 20 minutes, and all participants in both conditions will receive a total of 15 training sessions. Participants will be guided to complete an average of 3 training sessions every week for a total duration of approximately 5 weeks.
Investigators hypothesize that individuals who undergo the active eWMT will display a greater improvement in overall working memory performance and a greater reduction in trauma-related symptoms, compared to individuals who undergo the less effective control training program. Pending successful outcomes, this study will provide important knowledge that will guide the future efforts to develop an effective, accessible, and cost-efficient intervention program that can reach out to many individuals who suffer from exposure to traumas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Emotional Working Memory Training | Experimental | Behavioral: Active Emotional Working Memory TrainingEach participant will receive 15 sessions (each lasting 20 minutes) over a 5 week. This will be Internet-based cognitive training based on the adaptive dual n-back paradigm. |
| Control Working Memory Training | Placebo comparator | Behavioral: Control Working Memory TrainingParticipants in this condition will receive 15 sessions (each lasting 20 minutes) over a 5-week period. This will also be home-based training over the Internet. This training will be based on a fixed 1-back training program. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Fluently speaks English
- The PTSD Checklist (PCL-5) total score >= 38
Key exclusion criteria (5 listed)
- No access to a private computer with high-speed Internet that can be used privately.
- Elevated suicidality
- History of psychotic disorders (e.g., schizophrenia)
- Severe substance use disorder (as per DSM-5 criteria)
- History of severe brain injury or organic mental syndrome
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 |
|---|---|---|
| Active Emotional Working Memory TrainingThis training regimen has adapted the existing n-back paradigm, which has been widely used in the field. Training requires participants to shift between visual and auditory information while continually updating their working memory. | Behavioural | Active Emotional Working Memory Training |
| Control Working Memory TrainingThis training utilized a fixed dual 1-back training paradigm. | Behavioural | Control Working Memory Training |
Primary outcome
Change in Severity of trauma-related symptoms from baseline to post-training and 1-month follow-up
Time frame: At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)
PTSD Checklist (PCL-5)
1 secondary outcome
Change in working memory performance from baseline to post-training and 1-month follow-up
Time frame: At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
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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.
Sadie Larsen, Ph.D. principal investigator
Clement J. Zablocki VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Emotional Working Memory Training in people with Posttraumatic Stress Disorder, run by Milwaukee VA Medical Center 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 2 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 21 Jun 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Severity of trauma-related symptoms from baseline to post-training and 1-month follow-up (time frame: At baseline, at post-training (after 5 weeks), and at follow-up (1 month from the completion of training)). 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 21 Jun 2018.