Adapted Cognitive Processing Therapy for PTSD

(CPT MOST Trial)

Recruiting at 2 trial locations

Overseen By Rebecca K Sripada, PhD MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Psychotropic

Disqualifiers: Active suicidality, Need for detoxification, Severe cognitive impairment, Psychosis, Unmanaged bipolar, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 15

Duration: 6 weeks

270 Participants Needed

Trial Summary

What is the purpose of this trial?

Cognitive Processing Therapy (CPT) consists of discrete therapeutic components that are delivered across 12 sessions, but most Veterans never reach session 12, and those who drop out receive only 4 sessions on average. Veterans drop out because of time constraints, logistics, and lack of perceived benefit. Unfortunately, Veterans who drop out prematurely may never receive the most effective components of CPT and continue to experience symptom-related distress and numerous other negative outcomes, including lost productivity, substance use, later-life physical disability, reduced quality of life, and increased risk of suicide. The overall objective of this study is to adapt CPT into a brief, effective format. The rationale is that identifying the most effective intervention components and delivering only those components will make CPT deliverable in a shorter timeframe, thus improving efficiency, reducing drop-out related to poor treatment response, and ensuring that Veterans receive the most beneficial components of treatment, which will significantly improve their quality of life.

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 you have been on a stable dose of any psychotropic medication for at least 4 weeks before joining.

What data supports the effectiveness of the treatment Cognitive Processing Therapy (CPT) for PTSD?

Research shows that Cognitive Processing Therapy (CPT) is effective in reducing PTSD symptoms, especially in veterans and trauma survivors, with many studies indicating significant improvements in patients' conditions. The therapy has been widely adopted by the Department of Veterans Affairs and has shown positive outcomes in both fixed and variable-length formats, with many patients experiencing a reduction in PTSD symptoms. ^{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 implemented in various settings, including the Department of Veterans Affairs, without significant safety concerns reported. ^{1 2 4 6 7}

How is Cognitive Processing Therapy (CPT) different from other PTSD treatments?

Cognitive Processing Therapy (CPT) is unique because it focuses on changing faulty beliefs and interpretations related to trauma through a structured protocol of education, exposure, and cognitive components, typically delivered in 12 sessions. It is effective for various groups, including sexual assault survivors and military veterans, and can be adapted for different settings and populations. ^{2 4 7 8 9}

Research Team

Rebecca Kaufman Sripada, PhD MS

Principal Investigator

VA Ann Arbor Healthcare System, Ann Arbor, MI

Eligibility Criteria

This trial is for Veterans over 18 with PTSD treated in PCTs, stable on psychotropic meds for at least 8 weeks, and scoring above 33 on the PCL-5. It's not for those with severe cognitive issues, psychosis or unmanaged bipolar disorder, recent CPT treatment, current detox needs, ongoing trauma-focused therapy, or acute suicide risk.

Inclusion Criteria

Score of 33 or above on the PCL-5

I am over 18 years old.

I have been on the same dose of my mental health medication for at least 8 weeks.

Exclusion Criteria

Need for detoxification

I am currently in therapy for trauma (PE or CPT).

Psychosis or unmanaged bipolar disorder

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Cognitive Processing Therapy (CPT) components in a brief format to improve efficiency and reduce dropout rates.

6 weeks

12 sessions (in-person or virtual)

Follow-up

Participants are monitored for PTSD symptom reduction and overall effectiveness of the adapted CPT intervention.

6 months

3 visits (in-person or virtual) at 6-week, 3-month, and 6-month intervals

Treatment Details

Interventions

• Cognitive Processing Therapy

Trial Overview The study aims to adapt Cognitive Processing Therapy (CPT) into a shorter format by identifying and delivering only its most effective components. This could reduce dropouts due to time constraints or lack of benefit and ensure that Veterans receive the best parts of CPT more efficiently.

Participant Groups

Group I: 10 Active Control 3 Interventions

Core Session 1, Core Session 2, Modified A-B-C , Challenging Beliefs, Module Choice, Final Session

Group II: 4 Active Control 3 Interventions

Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Module Choice, Final Session

Group III: 11 Active Control 3 Interventions

Core Session 1, Core Session 2, Challenging Questions, Challenging Beliefs, Module Choice, Final Session

Group IV: 14 Active Control 3 Interventions

Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Challenging Beliefs, Final Session

Group V: 13 Active Control 3 Interventions

Core Session 1, Core Session 2, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session

Group VI: 16 Active Control 5 Interventions

Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Challenging Beliefs, Module Choice, Final Session

Group VII: 7 Active Control 3 Interventions

Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Module Choice, Final Session

Group VIII: 2 Active Control 1 Intervention

Core Session 1, Core Session 2, Modified A-B-C, Final Session

Group IX: 3 Active Control 1 Intervention

Core Session 1, Core Session 2, Challenging Questions, Final Session

Group X: 5 Active Control 1 Intervention

Core Session 1, Core Session 2, Problematic Patterns, Final Session

Group XI: 6 Active Control 3 Interventions

Core Session 1, Core Session 2, Modified A-B-C, Problematic Patterns, Module Choice, Final Session

Group XII: 8 Active Control 3 Interventions

Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Problematic Patterns, Final Session

Group XIII: 9 Active Control 1 Intervention

Core Session 1, Core Session 2, Challenging Beliefs, Final Session

Group XIV: 12 Active Control 3 Interventions

Core Session 1, Core Session 2, Modified A-B-C, Challenging Questions, Challenging Beliefs, Final Session

Group XV: 15 Active Control 3 Interventions

Core Session 1, Core Session 2, Challenging Questions, Problematic Patterns, Challenging Beliefs, Final Session

Group XVI: 1 Active Control 1 Intervention

Core Session 1, Core Session 2, Module Choice, Final Session

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+

Findings from Research

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]

A clinical trial involving 127 active duty service members showed that using a variable-length Cognitive Processing Therapy (CPT) approach led to more patients achieving significant improvement in PTSD symptoms compared to the traditional fixed 12-session model.

Key factors predicting the need for longer treatment included higher levels of pretreatment depression and PTSD severity, internalizing personality traits, and being in the precontemplation stage of readiness for change, particularly among African American participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variable-length Cognitive Processing Therapy for posttraumatic stress disorder in active duty military: Outcomes and predictors. Resick, PA., Wachen, JS., Dondanville, KA., et al.[2021]

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]

Cognitive processing therapy (CPT) was found to be effective for treating PTSD in a diverse group of 259 veterans, with 76.1% of those who completed the therapy reporting significant improvement in their symptoms.

The study indicated that while CPT is broadly applicable across different demographics and trauma types, individual characteristics largely influenced treatment outcomes, and no specific predictors were identified for varying responses to the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting response to cognitive processing therapy: Does trauma history matter? Roberge, EM., Weinstein, HR., Bryan, CJ.[2022]

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]

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]

In a study involving 38 adolescents and young adults with PTSD, therapeutic adherence and competence in Developmentally Adapted Cognitive Processing Therapy (D-CPT) did not show a significant relationship with treatment outcomes, suggesting that these factors may not be as crucial for symptom reduction as previously thought.

However, a strong therapeutic alliance between the therapist and patient was linked to lower PTSD symptom severity at 12 months post-treatment, highlighting the importance of the relationship in effective therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of therapeutic competence, adherence, and alliance on treatment outcome in youth with PTSD treated with developmentally adapted cognitive processing therapy. Steil, R., Weiss, J., Renneberg, B., et al.[2023]

References

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

Dissemination and experience with cognitive processing therapy. [2022]

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

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

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

Variable-length Cognitive Processing Therapy for posttraumatic stress disorder in active duty military: Outcomes and predictors. [2021]

4. 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]

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

Predicting response to cognitive processing therapy: Does trauma history matter? [2022]

6. 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]

7. 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]

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

Cognitive processing therapy for sexual assault victims. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Effect of therapeutic competence, adherence, and alliance on treatment outcome in youth with PTSD treated with developmentally adapted cognitive processing therapy. [2023]