Adapted Cognitive Processing Therapy for PTSD

(CPT MOST Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance the effectiveness and accessibility of Cognitive Processing Therapy (CPT) for PTSD among Veterans. Researchers seek to identify the therapy's most essential components, allowing it to be delivered in fewer sessions without compromising effectiveness. This study could benefit Veterans who struggle to complete the full therapy due to time constraints or other barriers. Veterans with PTSD who receive care from PTSD Clinical Teams and are not currently in trauma-focused therapy may be suitable candidates. As an unphased trial, this study offers Veterans the chance to help make therapy more accessible and effective for others.

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 prior data suggests that this adapted Cognitive Processing Therapy is safe for Veterans with PTSD?

Research shows that Cognitive Processing Therapy (CPT) is generally well-received by patients. Studies have found it to be a safe and effective treatment for people with posttraumatic stress disorder (PTSD). For instance, one study found that patients who underwent CPT experienced significant improvements in their PTSD symptoms and depression, with no major side effects.

Another study examined CPT combined with suicide risk management for individuals with PTSD and borderline personality disorder (BPD). This research also found CPT effective, with no serious negative effects reported.

Overall, CPT is considered safe for treating PTSD. The therapy involves discussing trauma and changing negative thoughts, which has helped many people. Previous research has not raised any major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores an adapted form of Cognitive Processing Therapy (CPT) for treating PTSD. Unlike standard therapy options, which often follow a fixed protocol, this adapted CPT offers flexibility by incorporating modules like "Challenging Beliefs" and "Problematic Patterns" tailored to individual needs. This personalized approach might enhance effectiveness by addressing specific cognitive barriers faced by PTSD patients. By investigating various combinations of therapeutic modules, researchers aim to identify the most effective configurations, potentially leading to more efficient and targeted PTSD interventions.

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

Research has shown that Cognitive Processing Therapy (CPT) effectively treats PTSD. One study found that participants experienced fewer PTSD symptoms and most remained in the program. These improvements persisted, offering long-term benefits. Another review found that CPT also alleviates depression symptoms. This trial will explore various adapted methods of CPT, each tested in different treatment arms, to assess their effectiveness for individuals with high needs who have limited access to treatment. Overall, CPT has proven effective in reducing PTSD symptoms and improving quality of life. ^{2 3 4 6 7}

Who Is on the Research Team?

Rebecca Kaufman Sripada, PhD MS

Principal Investigator

VA Ann Arbor Healthcare System, Ann Arbor, MI

Are You a Good Fit for This Trial?

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 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) 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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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) 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39908018/

Cognitive Processing Therapy for Posttraumatic Stress ... The CPT-TAU group showed a mean (SE) reduction in CAPS-5 scores of 14.00 (1.92) points, with a low dropout rate (2 of 29 [6.9%]). Patients in ...

2. 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.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829857

Cognitive Processing Therapy for Posttraumatic Stress ... The CPT-TAU group maintained improvements in all outcomes from 17 to 34 weeks. Sensitivity analyses controlling for the types of traumatic ...

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

Cognitive Processing Therapy for PTSD Participants in the active treatment conditions (both CPT and PE) demonstrated significant improvement in PTSD and depression over the course of treatment as ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30332919/

A meta-analytic review of cognitive processing therapy for ... These meta-analytic findings indicate that CPT is an effective PTSD treatment with lasting benefits across a range of outcomes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04230668

NCT04230668 | Cognitive Processing Therapy (CPT) for ... A pilot effectiveness trial of cognitive processing therapy augmented with suicide risk management for individuals with comorbid PTSD and BPD conditions.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11800015/

Cognitive Processing Therapy for Posttraumatic Stress ... Cognitive processing therapy (CPT) is an evidence-based treatment for posttraumatic stress disorder (PTSD). However, there is little evidence on ...