Cognitive Processing Therapy + Memory Support for PTSD

Overseen By Joseph Carpenter, PhD MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston University

Disqualifiers: Unstable bipolar, Psychosis, Severe SUD, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that any psychiatric medication dose be stable for the past four weeks before participating.

What data supports the effectiveness of the treatment Cognitive Processing Therapy + Memory Support for PTSD?

Cognitive Processing Therapy (CPT) is a well-researched treatment that has been shown to effectively reduce PTSD symptoms in various groups, including combat veterans and sexual assault survivors. Studies have demonstrated significant improvements in PTSD and depression symptoms, with benefits maintained over time. Additionally, CPT has been adapted to address co-occurring issues like alcohol dependence, showing promise in improving both PTSD and related problems. ^{1 2 3 4 5}

Is Cognitive Processing Therapy (CPT) safe for humans?

Cognitive Processing Therapy (CPT) is widely regarded as a safe treatment for post-traumatic stress disorder (PTSD) and has been effectively used in various settings, including among military veterans and within the Department of Veterans Affairs healthcare system. ^{2 4 6 7 8}

How is Cognitive Processing Therapy (CPT) unique in treating PTSD?

Cognitive Processing Therapy (CPT) is unique because it focuses on changing the way individuals process traumatic events by addressing their thoughts and beliefs, which can lead to behavioral changes and symptom improvement. It is particularly effective for PTSD and can be adapted for group or individual settings, and even modified to address co-occurring issues like heavy alcohol use. ^{1 2 3 4 9}

What is the purpose of this trial?

The efficacy of psychological interventions for posttraumatic stress disorder (PTSD) is likely limited by the difficulty participants have learning and remembering important therapy content. Accordingly, the present study will examine the utility of integrating a Memory Support (MS) intervention into Cognitive Processing Therapy (CPT), an empirically supported and widely disseminated treatment for PTSD. MS was designed to integrate techniques aimed at facilitating encoding, consolidation, and retrieval of new learning into existing treatments, and has been shown to improve outcomes when integrated into cognitive therapy for depression. A pilot randomized controlled trial (n=52) comparing CPT with Memory Support (CPT+MS) to CPT-alone will be conducted. Study participants will be adults diagnosed with PTSD. The primary aim of the trial will be to determine if CPT+MS will lead to greater memory and learning of therapy content relative to CPT-alone, and to establish the acceptability and feasibility of integrating MS into CPT. Secondary aims include a preliminary examination of treatment efficacy, as indicated by the magnitude of changes in PTSD symptoms between conditions, and target validation, as indicated by associations between memory and learning of therapy content and treatment response. Exploratory analyses will examine several indicators of baseline memory-related cognitive functioning as predictors of memory and learning of therapy content, providing preliminary data to inform future research on personalized application of MS. Results of the trial will advance scientific knowledge about methods for optimizing memory and learning as a mechanism for improving PTSD treatment outcomes.

Research Team

Joseph Carpenter, PhD MA

Principal Investigator

VA Boston Healthcare System, BUSM Psychiatry Dept.

Eligibility Criteria

Adults with PTSD can join this study. They must have a stable dose of psychiatric meds for the last month if they're taking any, and veterans are specifically welcomed. People with unstable bipolar disorder, psychosis, severe substance abuse, or past severe brain injury cannot participate. Also excluded are those with high verbal memory skills or significant cognitive impairment.

Inclusion Criteria

Veteran status

My psychiatric medication dose has been the same for the last month.

I have been diagnosed with PTSD by a professional.

Exclusion Criteria

Current DSM-5 diagnoses of unstable bipolar disorder, past or present psychosis, or organic mental disorder

Significant cognitive impairment as indicated by a score <10th percentile on the Montreal Cognitive Assessment

History of moderate or severe traumatic brain injury (TBI) based on the Ohio State University TBI Identification Method and Veterans Administration/ Department of Defense (VA/DOD) guidelines

Timeline

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 (MS) for PTSD

12 weeks

Weekly therapy sessions

Mid-treatment

Assessment of memory of therapy content and client satisfaction

6 weeks

1 assessment visit

Post-treatment

Evaluation of changes in PTSD symptoms, depression, and cognitive functioning

12 weeks

1 assessment visit

Follow-up

Participants are monitored for long-term changes in PTSD symptoms and memory of therapy content

6 months

1 follow-up visit

Treatment Details

Interventions

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

Trial Overview The trial is testing whether adding Memory Support (MS) to Cognitive Processing Therapy (CPT) helps people remember therapy content better than CPT alone. It's a small-scale test involving 52 adults to see if it's feasible and acceptable to combine these treatments for PTSD.

Participant Groups

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

CPT + MS will involve the same treatment strategies as CPT while incorporating deliberate and frequent use of memory and learning support strategies. MS strategies are designed to enhance the memory of specific treatment points, defined as any insight, skill or strategy determined to be important for the patient to remember and/or implement. MS is not designed to enhance memory functioning generally, but rather improve the encoding, consolidation and retrieval of specific components of therapeutic learning.

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

CPT is a manualized, trauma-focused therapy for PTSD. Treatment consists of psychoeducation on the cognitive model of PTSD, identification of trauma-related stuck points (i.e. dysfunctional beliefs), and cognitive challenging techniques to help participants identify more realistic and adaptive ways of viewing their trauma, themselves, and the world.

Cognitive Processing Therapy (CPT) 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?

Boston University

Lead Sponsor

Trials

494

Recruited

9,998,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

VA Boston Healthcare System

Collaborator

Trials

73

Recruited

971,000+

Findings from Research

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]

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) 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]

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]

Cognitive Processing Therapy (CPT) effectively reduced PTSD symptoms in a study of 18 patients, with 15 participants showing statistically significant improvements in their symptom scores.

The study highlights the successful adaptation of the CPT protocol to address specific barriers faced by trauma survivors, demonstrating its potential for broader implementation in similar treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive processing therapy for posttraumatic stress disorder in a residential treatment setting. Zappert, LN., Westrup, D.[2019]

In a study of 107 adults with PTSD undergoing 12 sessions of cognitive processing therapy (CPT), feelings of detachment and being upset by trauma reminders were identified as central symptoms at the start of treatment, indicating their significance in the PTSD symptom network.

By midtreatment, these symptoms became less central, suggesting that CPT effectively reduces their impact, while strong negative emotions emerged as key symptoms at the end of treatment, highlighting their role in influencing overall PTSD symptom improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examination of PTSD symptom networks over the course of cognitive processing therapy. Graziano, RC., LoSavio, ST., White, MA., et al.[2023]

This study aims to evaluate the efficacy of Cognitive Processing Therapy (CPT) for treating PTSD in Japanese patients through a 16-week trial involving 58 participants, comparing CPT combined with usual treatment against usual treatment alone.

The primary outcome will be measured using the Clinician-Administered PTSD Scale, with an expected effect size of 1.4, indicating that CPT may significantly improve PTSD symptoms in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study. Ito, M., Horikoshi, M., Resick, PA., et al.[2019]

Cognitive processing therapy (CPT) is an effective treatment for PTSD in veterans, but many do not complete the full program, often receiving only four sessions instead of the full 12, highlighting the need for a more efficient treatment format.

A study involving 270 veterans used a fractional factorial design to identify the most effective components of CPT, aiming to create a shorter version that could reduce dropout rates and improve treatment accessibility for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the multiphase optimization strategy to adapt cognitive processing therapy (CPT MOST): study protocol for a randomized controlled factorial experiment. Sripada, RK., Peterson, CL., Dziak, JJ., et al.[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]

References

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

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

2. United States 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. [2022]

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

Cognitive processing therapy for sexual assault victims. [2022]

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

Dissemination and experience with cognitive processing therapy. [2022]

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

Cognitive processing therapy for posttraumatic stress disorder in a residential treatment setting. [2019]

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

Examination of PTSD symptom networks over the course of cognitive processing therapy. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial of cognitive processing therapy for post-traumatic stress disorder among Japanese patients: the Safety, Power, Intimacy, Esteem, Trust (SPINET) study. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Using the multiphase optimization strategy to adapt cognitive processing therapy (CPT MOST): study protocol for a randomized controlled factorial experiment. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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