CPT + Memory Enhancement for PTSD

Overseen By Richard A Moore

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Benzodiazepines

Disqualifiers: Bipolar, Psychotic disorders, Suicidal ideation, Substance use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12-16 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve therapy for older adults with PTSD (posttraumatic stress disorder), a condition affecting feelings after traumatic events. It focuses on Cognitive Processing Therapy (CPT) and examines whether adding memory support can help participants remember and learn from therapy sessions more effectively. The trial seeks veterans over 59 diagnosed with PTSD who are not using certain medications or have other specific conditions. By enhancing memory during therapy, the trial aims to boost the effectiveness of PTSD treatment. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance PTSD therapy for older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use benzodiazepines daily.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Processing Therapy (CPT) effectively treats PTSD. Participants often experience significant relief from PTSD symptoms, as well as from depression and anxiety, suggesting that the therapy is generally manageable.

The added memory support aims to enhance patients' recall and understanding of the therapy. While this aspect is still under investigation, CPT alone has demonstrated positive results across different settings and groups. Specific information on side effects from the memory support addition is not yet available, but CPT itself is known to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining Cognitive Processing Therapy (CPT) with Memory Enhancement for PTSD because it introduces strategies specifically designed to boost learning and memory of therapeutic content. Unlike standard CPT, which focuses on processing trauma-related thoughts and feelings, this enhanced version aims to solidify the therapy's impact by improving how patients retain and apply what they learn. This dual approach could lead to more effective and lasting relief from PTSD symptoms, offering hope for improved recovery outcomes.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research shows that Cognitive Processing Therapy (CPT), one of the treatments in this trial, effectively reduces PTSD symptoms. Studies indicate that CPT not only helps with PTSD but also improves depression, anxiety, and overall quality of life. In this trial, some participants will receive CPT with Memory Support. Early findings suggest this addition might enhance CPT's effectiveness by helping patients better remember and learn from therapy sessions. This could be especially beneficial for older adults who may experience memory difficulties. Overall, CPT with Memory Support aims to address memory issues that can sometimes limit therapy's success. ^{5 6 7 8 9}

Who Is on the Research Team?

James C. Scott, PhD

Principal Investigator

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Are You a Good Fit for This Trial?

This trial is for veterans over the age of 59 with PTSD diagnosed by a specific scale (CAPS-5). It's not suitable for those with severe brain injury, dementia signs, daily benzodiazepine use, bipolar or psychotic disorders, current serious suicidal thoughts, active substance abuse issues not in remission for at least a month, or other limiting conditions.

Inclusion Criteria

I am 60 years old or older.

Veterans with DSM-5 diagnoses of PTSD via the Clinician Administered PTSD Scale (CAPS-5)

Exclusion Criteria

I use benzodiazepines daily.

I have had a severe brain injury.

Current suicidal ideation with plan or intent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Processing Therapy (CPT) with or without Memory Support to enhance learning and memory of therapy content

12-16 weeks

Weekly therapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Processing Therapy
• Cognitive Processing Therapy (CPT) + Memory Support

Trial Overview The study tests whether adding Memory Support to Cognitive Processing Therapy (CPT) can help older adults with PTSD learn and remember therapy content better. The goal is to improve how well they respond to treatment.

How Is the Trial Designed?

Group I: Cognitive Processing Therapy (CPT) + Memory Support Experimental Treatment 2 Interventions

CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content.

Group II: Cognitive Processing Therapy (CPT) Active Control 1 Intervention

Standard CPT as described in the treatment manual

Cognitive Processing Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Approved in European Union as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

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 of 268 active-duty servicemembers, individual cognitive processing therapy (CPT) was found to be more effective than group CPT in reducing PTSD severity, with significant improvements noted immediately after treatment.

Both individual and group formats of CPT led to reductions in depression and suicidal ideation, but about 50% of participants still experienced PTSD symptoms after treatment, highlighting the need for improved or new therapeutic options in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial. Resick, PA., Wachen, JS., Dondanville, KA., et al.[2022]

Cognitive processing therapy (CPT) effectively reduced PTSD symptoms in a 74-year-old woman veteran, indicating its potential utility for older adults with PTSD.

The case study suggests that CPT can be applied to older adults without significant modifications, highlighting its adaptability as a first-line treatment for PTSD in this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivered as Described: A Successful Case of Cognitive Processing Therapy With an Older Woman Veteran With PTSD. Reuman, L., Davison, EH.[2023]

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]

A 12-week course of modified Cognitive Processing Therapy (CPT-C) effectively improved PTSD symptoms and reduced alcohol dependence in a combat veteran, showing promise for treating co-occurring conditions.

The veteran maintained significant improvements in both PTSD and alcohol-related issues 12 weeks after completing the treatment, suggesting the long-term efficacy of this enhanced therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report on the use of cognitive processing therapy-cognitive, enhanced to address heavy alcohol use. McCarthy, E., Petrakis, I.[2022]

Cognitive Processing Therapy (CPT) is an effective evidence-based treatment for PTSD, particularly for individuals who have experienced combat, assault, or interpersonal violence, as supported by randomized controlled trials.

The Department of Veterans Affairs has successfully implemented CPT across its healthcare system, with trained clinicians showing good adoption of the therapy and significant improvements in patients' PTSD and depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. Chard, KM., Ricksecker, EG., Healy, ET., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589979124000027

Effectiveness of Cognitive Processing Therapy for PTSD in ... This study provides promising data on the outcomes associated with a modified CPT protocol for treating PTSD in a high need but under-treated SMI population.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05310097?term=AREA%5BBasicSearch%5D(PTSD%20OR%20post%20traumatic%20stress%20disorder%20OR%20post%20traumatic%20neuroses%20OR%20traumatic%20stress%20disorders%20OR%20combat%20disorders%20OR%20combat%20fatigue%20OR%20disaster%20survivor%20OR%20emotional%20trauma%20OR%20psychological%20shock)%20AND%20AREA%5BOverallStatus%5D(RECRUITING%20OR%20NOT_YET_RECRUITING%20OR%20AVAILABLE)%20AND%20AREA%5BFunderTypeSearch%5D(NIH)&rank=9

Cognitive Processing Therapy (CPT) Memory Support (MS) ... Study Overview. The efficacy of psychological interventions for posttraumatic stress disorder ( PTSD ) is likely limited by the difficulty participants have ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK362339/

Executive Summary - Cognitive Processing Therapy for ... - NCBI Most studies found that CPT was better than WL/UC for improving PTSD symptoms, depression, anxiety, quality of life (QoL), and remission rates. The proportion ...

4. ptsd.va.gov ptsd.va.gov/professional/articles/article-pdf/id1634266.pdf

State of the Science of Cognitive Processing Therapy Results showed a high rate of treatment completion and significant reduc- tions in PTSD symptoms with very large effect sizes (Yamokoski et al., 2023).

5. bu.trialstoday.org bu.trialstoday.org/trial/NCT05310097

Cognitive Processing Therapy (CPT) Memory Support (MS) ... Accordingly, the present study will examine the utility of integrating a Memory Support (MS) intervention into Cognitive Processing Therapy (CPT) ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1077722922001377

Clinician Concerns About Cognitive Processing Therapy The research literature indicates that CPT is effective without preparatory treatment across a range of outcomes, settings, and populations.

7. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/cpt_for_ptsd_pro.asp

Cognitive Processing Therapy for PTSD Those participants who received CPT demonstrated significantly more improvement in PTSD symptoms, depression, anxiety, guilt and social adjustment. Forty ...

8. bmjopen.bmj.com bmjopen.bmj.com/content/7/6/e014292

Study protocol for a randomised controlled trial of cognitive ... The aim of the present trial is to investigate the efficacy of CPT (individual format) as a treatment for PTSD in a population of Japanese patients.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3467002/

Cognitive and Affective Predictors of Treatment Outcome in ... This study examined potential predictors of treatment outcome in two evidence-based treatments for PTSD: CPT and PE. We hypothesized that several cognitive and ...