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

21 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Approximately half a million Veterans receiving services at the VA have Posttraumatic Stress Disorder (PTSD). PTSD is strongly associated with cognitive functioning deficits in areas of concentration, attention, memory, learning, verbal abilities, processing speed, and multitasking. Compensatory Cognitive Training (CCT) is an evidence-based intervention for cognitive problems that is effective in other Veteran populations such as those with a history of traumatic brain injury (TBI), but CCT has not yet been tested in Veterans with PTSD who don't have a history of TBI. The investigators will conduct a pilot randomized controlled trial (RCT) of CCT in Veterans who have been treated for PTSD but continue to have cognitive functioning deficits. The investigators will examine feasibility, acceptability, participant characteristics, and effect size estimates in preparation for a fully-powered RCT of CCT for PTSD-related cognitive functioning deficits.

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.

Is Compensatory Cognitive Training (CCT) safe for humans?

Compensatory Cognitive Training (CCT) has been associated with improvements in memory, attention, and executive functioning in veterans with mild traumatic brain injury and PTSD, suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

How is Compensatory Cognitive Training (CCT) different from other treatments for PTSD?

Compensatory Cognitive Training (CCT) is unique because it focuses on improving cognitive functions like memory, attention, and problem-solving, which are often affected in PTSD, especially when combined with traumatic brain injury (TBI). Unlike standard therapies, CCT specifically addresses these cognitive deficits, which can enhance overall treatment outcomes for PTSD. ^{1 3 5 6 7}

What data supports the effectiveness of the treatment Compensatory Cognitive Training (CCT) for PTSD?

Research shows that Compensatory Cognitive Training (CCT) can improve memory, attention, and executive functioning (mental skills used in managing tasks) in veterans with mild traumatic brain injury, and it has small-to-medium effects on reducing PTSD and depressive symptoms. ^{1 3 5 6 8}

Who Is on the Research Team?

Maya Elin 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

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]

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]

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]

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]

Citations

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

Evaluation of a hybrid treatment for Veterans with comorbid traumatic brain injury and posttraumatic stress disorder: Study protocol for a randomized controlled trial. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Neuropsychological Correlates of PTSD and Depressive Symptom Improvement in Compensatory Cognitive Training for Veterans With a History of Mild Traumatic Brain Injury. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Worse baseline executive functioning is associated with dropout and poorer response to trauma-focused treatment for veterans with PTSD and comorbid traumatic brain injury. [2019]

4. England pubmed.ncbi.nlm.nih.gov

SMART-CPT for veterans with comorbid post-traumatic stress disorder and history of traumatic brain injury: a randomised controlled trial. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Neurocognitive Predictors of Treatment Outcomes in Cognitive Processing Therapy for Post-traumatic Stress Disorder: Study Protocol. [2022]

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

Evaluating web-based cognitive-affective remediation in recent trauma survivors: study rationale and protocol. [2020]

7. 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]

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

Cognitive processing therapy for sexual assault victims. [2022]