Therapy Methods for Post-Traumatic Stress Disorder

(STEER Trial)

Recruiting at 3 trial locations

Overseen By Donald Lemon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: United States Department of Defense

Disqualifiers: Severe cognitive impairment, Suicidal intent, Psychotic symptoms, others

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

Compensation: Varies

Number of Visits: 15

Duration: 16 weeks

280 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 you cannot have had a psychiatric medication change in the past month to participate.

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

Cognitive Processing Therapy (CPT) is an effective treatment for PTSD, as shown in studies where it significantly reduced PTSD and depression symptoms in sexual assault survivors and veterans. The therapy has been widely adopted by the Department of Veterans Affairs and has demonstrated solid improvements in patients' PTSD symptoms in various settings. ^{1 2 3 4 5}

Is Cognitive Processing Therapy safe for humans?

Cognitive Processing Therapy (CPT) is generally considered safe for humans, as it is an evidence-based treatment widely used for post-traumatic stress disorder (PTSD) in various settings, including the Department of Veterans Affairs. While the focus is on its effectiveness, no significant safety concerns have been reported in the available research. ^{3 4 5 6 7}

How does cognitive processing therapy differ from other treatments for PTSD?

Cognitive Processing Therapy (CPT) is unique because it focuses on changing the way trauma survivors think about their experiences, using education, exposure, and cognitive components. It can be delivered in both individual and group settings, and is effective in-person or via telehealth, making it adaptable to various circumstances. ^{2 3 5 6 8}

What is the purpose of this trial?

Investigators' overall objective is to compare methods of identifying individuals who may be experiencing challenges in Cognitive Processing Therapy (CPT) and compare methods of intervening to optimize treatment retention and outcomes. Investigators' specific aims are: 1. to determine whether the use of CPT skills versus collaboratively considering switching to Present Centered Therapy (PCT) is more effective in improving outcomes for individuals experiencing challenges with CPT. Outcomes include post-traumatic stress disorder (PTSD) severity \[primary\], depression, functioning, and treatment retention; 2. to compare two approaches to identifying individuals in CPT in need of additional support during treatment; 3. to study the barriers and facilitators of implementing these intervention strategies. Finally, exploratory aims will examine the stability of differences between treatment conditions, compare combinations of interventions tested, and examine moderators of intervention effects.

Research Team

Princess Ackland, PhD

Principal Investigator

University of Minnesota

Laura Meis, PhD

Principal Investigator

Women's Health Sciences Division of the National Center for PTSD; University of Minnesota

Eligibility Criteria

This trial is for individuals with Post-Traumatic Stress Disorder (PTSD) who are currently undergoing or about to start Cognitive Processing Therapy (CPT). Participants should be willing to potentially switch therapies if challenges arise. Specific eligibility criteria details were not provided.

Inclusion Criteria

Meets DSM-5 criteria for PTSD

Be able to provide informed consent

I agree not to undergo non-study PTSD therapy during the trial, except for case management or group support.

Exclusion Criteria

Current suicidal or homicidal intent with a specific plan

Uncontrolled psychotic or manic symptoms

A severe SUD as diagnosed by the DSM-5

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Cognitive Processing Therapy (CPT) with potential intervention strategies, including switching to Present Centered Therapy (PCT) if needed

16 weeks

12 sessions (in-person or virtual)

Follow-up

Participants are monitored for PTSD severity, depression, and psychosocial functioning post-treatment

24 weeks

Assessments at 3 and 6 months post-treatment

Treatment Details

Interventions

• Cognitive Processing Therapy
• Present Centered Therapy

Trial Overview The study compares two methods: continuing CPT while learning additional skills, versus considering a switch to Present Centered Therapy (PCT) when facing difficulties in CPT. It aims to see which approach helps more with PTSD severity, depression, functioning, and staying in treatment.

Participant Groups

Group I: Catchall Active Control 2 Interventions

The Catchall approach to identifying individuals in need of intervention is intended to provide a generous, all-inclusive approach to identifying anyone who might have some concerns about their experiences with Cognitive Processing Therapy (CPT) and may benefit from discussing these concerns. The goal of this approach is to err on the side of intervening within anyone who may be experiencing challenges with the therapy. This approach assumes that spending a session talking about any concerns or struggles patients are having will help with patient-provider communication, improve attitudes about treatment, and improve treatment retention and outcomes.

Group II: Targeted Active Control 2 Interventions

The Targeted approach to identifying individuals is intended to capture a narrower band of participants with clearer concerns about Cognitive Processing Therapy (e.g., at least one of their self-report scale scores is similar to or worse than patients who ultimately dropped out of CPT treatment in investigators' pilot data). Providers are more likely to miss some participants who may benefit from intervention through this approach but are less likely to unintentionally undermine CPT for participants who did not need intervention.

Group III: CPT Skills Active Control 2 Interventions

Cognitive Processing Therapy is a 12-session, cognitive-behavioral treatment for PTSD that focuses on challenging and modifying maladaptive beliefs related to prior trauma. The goal is to build a new understanding of prior trauma in order to limit the negative influence trauma and it's reminders have on individuals' daily lives. CPT has built in strategies to address any challenges patients participating in the therapy. The degree to which these strategies are more effective than other approaches to addressing treatment challenges (e.g., switching to another therapy) are unknown.

Group IV: Consider Switching Active Control 3 Interventions

When patients are experiencing challenges with PTSD therapy, providers and their patients will consider switching from CPT to Present Centered Therapy. While PCT is somewhat less effective than CPT, it has solid evidence that it improves symptoms of PTSD. There is also no reflection on past trauma, homework demands are modest, and it has superior completion rates to CPT. Starting with a CPT and then considering switching to PCT, is a promising pathway to ensure individuals struggling in CPT complete an effective treatment. Given the efficacy differences between CPT and PCT, switching will be done collaboratively between patients and providers using shared decision making (versus requiring all patients to switch to PCT). This ensures the choice to switch is patient-centered and relevant to how these decisions would be made in real-world care.

Who Is Running the Clinical Trial?

United States Department of Defense

Lead Sponsor

Trials

940

Recruited

339,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Lowcountry Center for Veterans Research

Collaborator

Trials

1

Recruited

300+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Louisiana Veterans Research and Education Corporation

Collaborator

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

New Orleans VA Medical Center

Collaborator

Trials

1

Recruited

2,700+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Veterans Education and Research Association of Michigan

Collaborator

Center for Veterans Research and Education

Collaborator

Trials

13

Recruited

1,700+

Findings from Research

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]

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) has been shown to be an effective treatment for PTSD in active duty military personnel, as demonstrated in a case study of a service member who underwent 13 therapy sessions.

The case study highlights significant progress in reducing PTSD symptoms and achieving treatment goals, showcasing the practical application of CPT in an outpatient setting and addressing clinical challenges faced during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case Study of Cognitive Processing Therapy for a Military Medic With Posttraumatic Stress Disorder. Wiley, RE.[2020]

Cognitive processing therapy (CPT) is an effective treatment for posttraumatic stress disorder (PTSD) that can be successfully delivered through telehealth, making it adaptable during the COVID-19 pandemic.

The article provides guidelines for implementing CPT via telehealth, focusing on maintaining treatment quality and conducting assessments, which are crucial for effective mental health care in challenging circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Processing Therapy for Posttraumatic Stress Disorder via Telehealth: Practical Considerations During the COVID-19 Pandemic. Moring, JC., Dondanville, KA., Fina, BA., et al.[2022]

References

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

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

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

Cognitive processing therapy for sexual assault victims. [2022]

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

Dissemination and experience with cognitive processing therapy. [2022]

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

Predictors of change in cognitive processing therapy for veterans in a residential PTSD treatment program. [2020]

6. 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]

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

A Case Study of Cognitive Processing Therapy for a Military Medic With Posttraumatic Stress Disorder. [2020]

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

Cognitive Processing Therapy for Posttraumatic Stress Disorder via Telehealth: Practical Considerations During the COVID-19 Pandemic. [2022]