Cognitive Training for PTSD

(CCTPTSD Trial)

Overseen By Emily R Sano, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Traumatic brain injury, Bipolar, Psychotic disorder, Substance dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3-6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Compensatory Cognitive Training (CCT) to assist Veterans with PTSD who struggle with memory, attention, and other cognitive skills. The goal is to determine if CCT can improve these common cognitive issues in PTSD by teaching strategies to manage them. Veterans treated for PTSD in the last two years who still experience these difficulties might be suitable candidates. Participants will either try CCT or continue their usual PTSD treatments (such as methadone, buprenorphine, naltrexone, Suboxone, Zubsolv, or Vivitrol) to compare effectiveness. As an unphased trial, this study offers Veterans a unique opportunity to explore new strategies for managing cognitive difficulties associated with PTSD.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that Compensatory Cognitive Training (CCT) is safe for Veterans with PTSD?

Research has shown that Compensatory Cognitive Training (CCT) is generally safe for individuals with cognitive difficulties. Studies have found that CCT can enhance learning, memory, and attention without causing major side effects. In previous trials, CCT was used safely for individuals with traumatic brain injuries, with no serious problems reported. Although CCT hasn't been specifically tested for PTSD without prior brain injuries, its safe use in similar groups suggests it is likely safe for this new group as well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Compensatory Cognitive Training (CCT) for PTSD because it offers a fresh approach by focusing on teaching practical strategies to manage cognitive challenges. Unlike traditional therapies that primarily address emotional and psychological symptoms, CCT equips individuals with problem-solving skills and tools like calendar systems and assistive devices to tackle daily tasks. This unique focus on compensatory strategies helps people work around cognitive deficits, potentially improving day-to-day functioning and quality of life for those with PTSD.

What evidence suggests that Compensatory Cognitive Training (CCT) might be an effective treatment for PTSD-related cognitive functioning deficits?

Research has shown that Compensatory Cognitive Training (CCT), which participants in this trial may receive, can improve thinking skills in veterans. Studies have found that CCT enhances memory, focus, and problem-solving abilities. Veterans who participated in CCT noticed clear improvements in their thinking skills, even when facing mental health issues. CCT has proven effective for veterans with traumatic brain injury (TBI) and PTSD, suggesting it might also benefit those with PTSD alone. ^{4 6 7 8 9}

Who Is on the Research Team?

Maya E O'Neil, PhD MS

Principal Investigator

VA Portland Health Care System, Portland, OR

Are You a Good Fit for This Trial?

This trial is for English-speaking Veterans with PTSD who've had treatment in the last 2 years and still struggle with cognitive issues like memory, attention, or decision-making. They must have a mental health provider and not suffer from severe psychiatric disorders, substance dependence (recent), major brain injuries, or conditions affecting cognition.

Inclusion Criteria

Able to read and write and provide informed consent

I have a mental health provider or case manager for my care.

I experience issues with memory, focus, or decision-making.

Exclusion Criteria

Do not have a diagnosis of a substance dependence disorder within the past 30 days

Do not meet criteria for bipolar disorder or a psychotic disorder

I have no history of severe brain injuries or diseases affecting my brain function.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Compensatory Cognitive Training (CCT) or Treatment as Usual (TAU) for cognitive functioning deficits

3-6 months

Weekly sessions

Follow-up

Participants are monitored for changes in cognitive functioning and quality of life

6 months

Assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Compensatory Cognitive Training (CCT)
• Treatment as Usual (TAU)

Trial Overview

The study tests Compensatory Cognitive Training (CCT) against usual care to see if CCT can help veterans with PTSD improve their cognitive skills such as concentration and memory. It's a pilot randomized controlled trial preparing for a larger future study.

How Is the Trial Designed?

Group I: Compensatory Cognitive Training (CCT) Experimental Treatment 1 Intervention

Compensatory Cognitive Training draws from the theoretical literature on compensatory strategy training for other cognitively impaired populations (e.g., Huckans et al., 2013; Twamley et al., 2010; Storzbach et al., 2016). It is a rehabilitation model that aims to teach individuals strategies that allow them to work around cognitive deficits. Consistent with this model and the expert recommendations for civilians and Service members with TBI (Cicerone, 2011), manualized CCT treatment provides training in compensatory attention and learning/memory skills, formal problem-solving strategies applied to daily problems, and the use of external aids such as calendar systems and assistive devices to promote completion of daily tasks (Storzbach et al., 2016).

Group II: Treatment as Usual (TAU) Active Control 1 Intervention

All TAU participants have an ongoing VA mental health provider and received ongoing mental health care during the course of the study (generally weekly individual or group sessions focusing on evidence-based PTSD treatment).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

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]

The CPTPTSD study will investigate how cognitive functioning affects the response to Cognitive Processing Therapy (CPT) in 105 veterans with PTSD, focusing on memory and cognitive abilities before treatment begins.

By identifying the relationship between cognitive deficits and treatment outcomes, this research aims to develop more personalized and effective PTSD therapies, potentially improving the efficacy of existing psychotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocognitive Predictors of Treatment Outcomes in Cognitive Processing Therapy for Post-traumatic Stress Disorder: Study Protocol. Cenkner, DP., Asnaani, A., DiChiara, C., et al.[2022]

Cognitive Processing Therapy (CPT) significantly improved PTSD and depression symptoms in 19 sexual assault survivors after 12 weekly group sessions, with benefits maintained for 6 months post-treatment.

In contrast, a comparison group of 20 individuals who waited for therapy showed no improvement, highlighting the efficacy of CPT in treating PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for sexual assault victims. Resick, PA., Schnicke, MK.[2022]

The study outlines a design for a web-based cognitive remediation training aimed at enhancing neurocognitive functions that may help prevent the development of PTSD in trauma survivors.

By focusing on early intervention shortly after trauma exposure, the study aims to address the challenges of administering targeted training to improve emotional reactivity and regulation, potentially reducing PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating web-based cognitive-affective remediation in recent trauma survivors: study rationale and protocol. Fine, NB., Achituv, M., Etkin, A., et al.[2020]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28483653/

Mental Health Does Not Moderate Compensatory ...

Results: Baseline mental health symptoms did not moderate CCT efficacy: veterans who received CCT reported significantly greater improvement in cognitive ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07055633

Improving Cognitive Rehabilitation Outcomes

The investigators aim to compare CCT+MBLT with CCT+ION for improving cognition, functioning, and secondary outcomes in Veterans with mTBI+PTSD.

3.

academic.oup.com

academic.oup.com/milmed/article/189/5-6/e1263/7422391

Neuropsychological Correlates of PTSD and Depressive ...

Compensatory Cognitive Training (CCT) is associated with improvements in prospective memory, attention, and executive functioning and has also ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12098106/

SMART accelerates rate of cognitive gains in service ...

A second finding was that CR effectively enhanced cognitive capacity in ADSMs with mTBI, irrespective of comorbid PTSD symptom severity. This ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1077722922001377

Clinician Concerns About Cognitive Processing Therapy

Dozens of clinical trials have demonstrated CPT's efficacy reducing PTSD and related symptoms (e.g., Asmundson et al., 2019, Monson et al., 2006, Resick et al., ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26147236/

Psychiatric comorbidity effects on compensatory cognitive ...

Of all participants, 74% met diagnostic criteria for PTSD. All participants received supported employment and half of the sample also received Cognitive Symptom ...

7.

academic.oup.com

academic.oup.com/milmed/article-abstract/189/5-6/e1263/7422391

Neuropsychological Correlates of PTSD and Depressive ...

Our results suggest that cognitive training may bolster skills that are helpful for PTSD and depressive symptom reduction.

8.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/25/NCT03696225/Prot_SAP_000.pdf

Sample Research Protocol

Compared to treatment as usual. (TAU), CCT significantly improves learning, memory, executive functioning, and attention/working memory, as well ...

9.

researchgate.net

researchgate.net/publication/377779364_Compensatory_cognitive_training_for_people_with_traumatic_brain_injury_A_systematic_review_of_randomized_controlled_trial

Compensatory cognitive training for people with traumatic ...

The effects of compensatory cognitive training on cognitive outcomes showed inconsistency. In conclusion, the evidence for the effects of ...