Working Memory Training for PTSD

Recruiting in Palo Alto (17 mi)

Overseen by Daniel M Stout, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Must not be taking: Benzodiazepines, Anticholinergics

Disqualifiers: Psychotic disorders, Bipolar, Severe substance use, others

Stay on Your Current Meds

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The proposed study will test whether a working memory training (WMT) program improves fear extinction learning and its underlying neural circuitry in Veterans with posttraumatic stress disorder (PTSD). WMT is designed to improves the ability to maintain task-relevant information in mind. The project will further validate the relationship between working memory and fear extinction using novel computational and multivariate analyses that link to specific PTSD symptoms. If WMT can enhance fear extinction learning, then WMT may be a powerful adjunctive treatment that can enhance exposure therapy outcomes or be leveraged as a stand-alone treatment. This project supports the Department of Veteran Affairs mission of developing viable targets of treatment for Veterans with PTSD.

Will I have to stop taking my current medications?

The trial requires that you have been stable on your current medications for at least 4 weeks before starting. However, if you are taking benzodiazepines or medications with anticholinergic effects, you may need to stop those, as they can affect the study's measures.

What data supports the effectiveness of the treatment Working Memory Training for PTSD?

Research shows that Cogmed Working Memory Training can improve working memory and inhibitory control in various conditions, such as ADHD and among individuals on sick leave due to complex symptoms. However, its effects on general memory capacity and daily life performance are less clear. ^{1 2 3 4 5}

Is Working Memory Training safe for humans?

Research on working memory training, including studies with veterans and individuals with PTSD, suggests it is generally safe. Participants have found the training challenging but beneficial, with no significant safety concerns reported. ^{6 7 8 9 10}

How does Working Memory Training differ from other treatments for PTSD?

Working Memory Training is unique because it is a computer-based program that focuses on improving cognitive functions like working memory and inhibitory control, rather than directly targeting PTSD symptoms. This approach is novel as it aims to enhance mental processes that may indirectly alleviate PTSD symptoms, and it can be accessed online, making it more accessible compared to traditional therapies. ^{2 4 8 11 12}

Research Team

Daniel M Stout, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

This trial is for Veterans with PTSD who can participate in a program designed to improve their memory and ability to focus. It's not suitable for individuals who might have other conditions that could interfere with the training or its assessment.

Inclusion Criteria

Fluent in English

I am willing to do 8 memory training sessions online over 4 weeks.

I have been diagnosed with PTSD according to the DSM-5.

Exclusion Criteria

Inability to safely complete fMRI session (i.e., metal in body, medical implants)

Acute suicidality requiring immediate clinical intervention

Lifetime history of psychotic disorders

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 sessions of working memory training (WMT) or sham-training (ST) over a four-week period

4 weeks

8 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of behavioral and neural changes

5-6 weeks

Treatment Details

Interventions

• Working Memory Training (Behavioural Intervention)

Trial Overview The study is testing a working memory training (WMT) program against sham training to see if it helps Veterans with PTSD learn how to better manage fear responses. The effectiveness of WMT will be measured through changes in brain function and PTSD symptoms.

Participant Groups

Group I: Working Memory Training Experimental Treatment 1 Intervention

Computer-administered working memory training program. WMT is a modified working memory capacity task designed to train working memory functioning. WMT is designed to contain high interference across trials and is adaptive to performance. As participants improve working memory, the task becomes more difficult.

Group II: Sham Training Placebo Group 1 Intervention

The Sham condition requires participants to complete a similar computer task for the same length of time. The Sham Training is a modified working memory capacity task designed to place less demands on working memory.

Working Memory Training is already approved in Canada for the following indications:

Approved in Canada as Cogmed Working Memory Training for:

• ADHD
• Learning Disabilities
• Cognitive Impairment

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

Cogmed Working Memory Training (CWMT) has shown statistically significant improvements in working memory and executive functions among over 280 child and adolescent trainees based on pre- and post-training assessments.

Feedback from families indicates positive changes experienced by trainees, although the study's one-group pre-test post-test design has limitations that should be considered when interpreting the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental Perceptions of the Efficacy of Cogmed Working Memory Training. Graham, AR., Benninger, WB.[2018]

Adaptive working memory training (Cogmed QM) significantly improved inhibitory control in patients on sick leave, indicating that this aspect of cognitive function can be modified through targeted training.

However, the training did not lead to improvements in overall working memory capacity or self-perceived memory functioning, suggesting that while specific cognitive skills can be enhanced, general memory capacity may not be affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Working Memory Training among Subjects Currently on Sick Leave Due to Complex Symptoms. Aasvik, JK., Woodhouse, A., Stiles, TC., et al.[2023]

Cogmed training significantly improved working memory in adults with ADHD, with participants showing lasting benefits in both verbal and visuospatial memory capacities even 6 months after the training ended.

Despite these improvements in working memory, the study found that the benefits did not extend to enhancing nonverbal reasoning, executive function in daily life, or reducing ADHD symptoms, questioning the overall effectiveness of the program for broader ADHD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working Memory Training for Adults With ADHD. Dentz, A., Guay, MC., Parent, V., et al.[2022]

Cogmed working-memory training (CWMT) has been shown to significantly improve both visuospatial and verbal working memory, with strong evidence from multiple studies indicating these effects can last for up to 6 months.

In addition to enhancing working memory, CWMT also appears to improve attention, suggesting that it could have valuable applications in everyday functioning, although further controlled studies are needed to solidify these claims.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cogmed WM training: reviewing the reviews. Shinaver, CS., Entwistle, PC., Söderqvist, S.[2018]

In a study involving 164 participants with acute and chronic PTSD, cognitive and affective computerized training showed significant improvement in identifying fearful faces and a trend towards reducing PTSD symptoms, particularly in re-experiencing symptoms.

The training was more effective for individuals with better cognitive performance at baseline, suggesting that cognitive capacity may influence the effectiveness of such interventions in treating PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered computerized cognitive & affective remediation training for the treatment of acute and chronic posttraumatic stress disorder: Two randomized clinical trials. Fonzo, GA., Fine, NB., Wright, RN., et al.[2020]

Playing the TraumaGameplay (TGP) app, either with or without memory retrieval tasks, did not significantly reduce the frequency of trauma-related intrusions in healthy university students after exposure to a trauma film, based on two experiments involving a total of 212 participants.

These results challenge previous studies suggesting that engaging in a visuospatial video game like Tetris can effectively reduce intrusive memories, highlighting potential differences in methodology and the complexities of replicating psychological research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and testing of TraumaGameplay: an iterative experimental approach using the trauma film paradigm. Asselbergs, J., Sijbrandij, M., Hoogendoorn, E., et al.[2020]

In a pilot study involving Veterans with elevated PTSD symptoms, both adaptive (n-back) and less potent (1-back) online working memory training led to significant decreases in PTSD symptoms, indicating potential efficacy of such interventions.

The n-back training group showed a trend towards better improvement in reexperiencing symptoms, suggesting that more challenging working memory tasks may be particularly beneficial for individuals with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized trial of a dual n-back emotional working memory training program for veterans with elevated PTSD symptoms. Larsen, SE., Lotfi, S., Bennett, KP., et al.[2020]

The randomized controlled trial aimed to assess the impact of a cognitive task intervention on intrusive memories after trauma but was prematurely terminated due to the COVID-19 pandemic, with only 16 participants recruited out of the planned 148.

The study highlights the challenges of conducting clinical research during a pandemic, including the need for face-to-face interactions and the impact of reduced patient flow in emergency departments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simple cognitive task intervention to prevent intrusive memories after trauma in patients in the Emergency Department: A randomized controlled trial terminated due to COVID-19. Kanstrup, M., Singh, L., Göransson, KE., et al.[2021]

The EPIREMED study aims to assess the long-term effects of the Cogmed cognitive training program on visuospatial processing in very preterm children, involving 166 participants aged 5½ to 6 years over an 18-month period.

The study seeks to demonstrate that early cognitive training can improve working memory and overall neuropsychological development, potentially leading to better learning outcomes and reduced behavioral issues in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized EPIREMED protocol study on the long-term visuo spatial effects of very preterm children with a working memory deficit. Gire, C., Beltran Anzola, A., Kaminski, M., et al.[2021]

CogMed Working Memory Training (CWMT) was found to be safe and acceptable for adult patients with glioma, with an 80% retention rate and no adverse events related to the study.

While CWMT led to medium to large improvements in objectively assessed working memory, participants reported only moderate perceived benefits, suggesting that the intensity and time commitment of the program may have affected their overall satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Working memory training for adult glioma patients: a proof-of-concept study. Braun, SE., Aslanzadeh, FJ., Lanoye, A., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Parental Perceptions of the Efficacy of Cogmed Working Memory Training. [2018]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Working Memory Training among Subjects Currently on Sick Leave Due to Complex Symptoms. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Working Memory Training for Adults With ADHD. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cogmed WM training: reviewing the reviews. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

The Feasibility of Web-Based Working Memory Training in Patients With Cancer Attending Inpatient Rehabilitation. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Internet-delivered computerized cognitive & affective remediation training for the treatment of acute and chronic posttraumatic stress disorder: Two randomized clinical trials. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Development and testing of TraumaGameplay: an iterative experimental approach using the trauma film paradigm. [2020]

8. Ireland pubmed.ncbi.nlm.nih.gov

A pilot randomized trial of a dual n-back emotional working memory training program for veterans with elevated PTSD symptoms. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Memory Skills Classes to Address Cognitive Concerns in Older Veterans With a History of Posttraumatic Stress Disorder. [2020]

10. England pubmed.ncbi.nlm.nih.gov

A simple cognitive task intervention to prevent intrusive memories after trauma in patients in the Emergency Department: A randomized controlled trial terminated due to COVID-19. [2021]

11. England pubmed.ncbi.nlm.nih.gov

A randomized EPIREMED protocol study on the long-term visuo spatial effects of very preterm children with a working memory deficit. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Working memory training for adult glioma patients: a proof-of-concept study. [2022]