Shared Decision Making for Post-Traumatic Stress Disorder

Recruiting at 1 trial location

Overseen By Vanessa Jacoby, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Acute suicidality, Severe brain injury, Severe alcohol, Active psychosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 to 7 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how Shared Decision Making (SHARE) can enhance therapy outcomes for military personnel with PTSD. Participants will collaborate with therapists to select from three therapy types: Prolonged Exposure, Cognitive Processing, or Written Exposure Therapy. These therapies will be administered either daily or weekly. Active duty service members diagnosed with PTSD, without severe brain injuries or substance abuse issues, may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative PTSD treatment approaches.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

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

Research shows that the therapies in this study—Prolonged Exposure (PE) therapy, Cognitive Processing Therapy (CPT), and Written Exposure Therapy (WET)—are generally safe and well-tolerated for treating PTSD.

Prolonged Exposure therapy significantly reduces PTSD symptoms. Studies report that 65% to 80% of people respond positively to this treatment, with no major safety issues noted.

Written Exposure Therapy is also considered safe. Research suggests it works well even for individuals with additional mood or substance use disorders. This simpler treatment requires less time with a therapist, which may appeal to those concerned about time commitment.

Cognitive Processing Therapy effectively reduces symptoms of PTSD and depression. Low dropout rates suggest that most people find the therapy manageable and continue with it.

Overall, various studies have tested these therapies, proving them to be safe options for managing PTSD symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effectiveness of shared decision-making in treating PTSD, potentially offering a more personalized approach to therapy. Unlike traditional methods that may follow a one-size-fits-all path, this method involves patients in choosing between different therapy types, like Prolonged Exposure (PE) or Cognitive Processing Therapy (CPT), which can be delivered in either massed (daily) or spaced (weekly) sessions. This personalized approach could lead to better engagement and outcomes, as patients have a say in how their treatment is structured. By empowering patients in their treatment decisions, researchers hope to improve adherence and satisfaction, ultimately leading to more successful management of PTSD symptoms.

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

This trial will compare different therapies for PTSD, including Prolonged Exposure (PE) Therapy, Written Exposure Therapy (WET), and Cognitive Processing Therapy (CPT). Research has shown that all three therapies effectively reduce PTSD symptoms.

Participants may receive Prolonged Exposure Therapy, which studies indicate helps many people, with success rates between 65% and 80%. Others may receive Written Exposure Therapy, which research shows significantly reduces PTSD symptoms and has fewer dropouts compared to other treatments. Cognitive Processing Therapy is another option in this trial and has been found to provide lasting benefits in reducing PTSD symptoms across different groups.

Each therapy has strong evidence supporting its effectiveness, making them promising options for treating PTSD. ^{1 2 3 4 6}

Who Is on the Research Team?

Vanessa Jacoby, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Alan L Peterson, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for active duty military personnel who are seeking treatment for PTSD. Participants will be involved in Shared Decision Making to choose from three types of therapy: Prolonged Exposure, Cognitive Processing, or Written Exposure, with sessions either daily or weekly.

Inclusion Criteria

I am an adult active duty military member over 18.

Meets diagnostic criteria for PTSD based on the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders-5 (CAPS-5)

Exclusion Criteria

Acute suicidality or homicidality requiring immediate intervention, such as hospitalization

Moderate to severe brain injury as assessed by the History of Head Injury Form

Severe alcohol consumption patterns as assessed using the Alcohol Use Disorders Identification Test and warranting immediate intervention as determined by clinical judgement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Shared Decision Making Pre-Intervention

Participants engage in Shared Decision Making to match with one of three PTSD therapies

1 week

Treatment

Participants receive one of three therapies: Prolonged Exposure, Cognitive Processing Therapy, or Written Exposure Therapy, in either massed (daily) or spaced (weekly) sessions

2 to 7 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Shared Decision Making (SHARE)

Trial Overview The study tests the impact of Shared Decision Making on engagement and outcomes in PTSD treatments among service members. It compares how different therapies (Prolonged Exposure, Cognitive Processing Therapy, Written Exposure) and session frequencies affect recovery.

How Is the Trial Designed?

Group I: Written Exposure Therapy (WET) Spaced Experimental Treatment 2 Interventions

Weekly treatment formula for up to 24 sessions

Group II: Written Exposure Therapy (WET) Massed Experimental Treatment 2 Interventions

Daily treatment sessions Monday-Friday for up to 24 sessions

Group III: Prolonged Exposure (PE) Therapy Massed Experimental Treatment 2 Interventions

Daily treatment sessions Monday-Friday for up to 24 sessions

Group IV: Prolonged Exposure (PE) Spaced Experimental Treatment 2 Interventions

Weekly treatment formula for up to 24 sessions

Group V: Cognitive Processing Therapy (CPT) spaced Experimental Treatment 2 Interventions

Weekly treatment formula for up to 24 sessions

Group VI: Cognitive Processing Therapy (CPT) Massed Experimental Treatment 2 Interventions

Daily treatment sessions Monday-Friday for up to 24 sessions

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

The pilot Patient Safety Presentation process, implemented in a psychiatry residency program, significantly improved residents' knowledge and engagement in patient safety practices, as evidenced by pre- and post-presentation surveys involving 32 residents.

All participating residents expressed satisfaction with the presentation, highlighting its effectiveness as a model for enhancing patient safety education in residency programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Pilot of a Process for Regularly Sharing Summary Patient Safety Data. Kim, B., Grech, SM., Rembisz, AE., et al.[2023]

Patients prefer complete and transparent disclosure of medical errors, including details about the incident, its causes, and sincere apologies, regardless of their background.

Healthcare professionals often struggle to disclose adverse events due to fear of legal repercussions and lack of support, which can lead to emotional distress and increased risk of mental health issues, highlighting the need for better communication and support systems in healthcare organizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[In the aftermath of medical error: caring for patients, family, and the healthcare workers involved]. Schwappach, DL.[2016]

Adverse events (AEs) in healthcare are common, occurring in about 10% of cases, and can have significant emotional impacts not only on patients but also on the healthcare professionals involved, who may experience trauma as 'second victims'.

Implementing Critical Incident Stress Debriefing (CISD) for healthcare staff after AEs could be a valuable strategy to support their resilience and recovery, similar to its use in other high-stress professions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical incident stress debriefing after adverse patient safety events. Harrison, R., Wu, A.[2018]

The study successfully translated and validated the 'Global Trigger Tool-Psychiatry' (GTT-P) for identifying iatrogenic adverse events in psychiatric care in Norway, incorporating insights from both health professionals and service users to enhance its effectiveness.

Implementing the GTT-P can help mental health nurses in Norway and Sweden to better identify potential triggers for adverse events, ultimately improving patient safety and reducing the risk of harm in psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. Okkenhaug, A., Tritter, JQ., Landstad, BJ.[2023]

Citations

1. 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.

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3336190/

Long-Term Outcomes of Cognitive–Behavioral Treatments ... CPT and PE resulted in lasting changes in PTSD and related symptoms over an extended period of time for female rape victims with extensive histories of trauma.

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.