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

Trial Summary

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.

What data supports the effectiveness of the treatment Shared Decision Making (SHARE) for PTSD?

Research shows that using shared decision-making helps more veterans choose and start effective PTSD treatments sooner, and they feel more involved in their care, which can lead to better engagement in therapy. ^{1 2 3 4 5}

Is Shared Decision Making (SHARE) generally safe for humans?

The research articles provided do not contain specific safety data for Shared Decision Making (SHARE) as a treatment for PTSD or other conditions. ^{6 7 8 9 10}

How does the Shared Decision Making treatment for PTSD differ from other treatments?

The Shared Decision Making (SHARE) treatment for PTSD is unique because it involves patients actively in their treatment planning, allowing them to choose evidence-based therapies that best fit their needs and preferences. This approach aims to increase patient engagement and adherence to therapy, which can lead to better treatment outcomes. ^{1 2 3 5 11}

What is the purpose of this trial?

The purpose of this research study is to learn about how Shared Decision Making, when used to decide treatment, impacts treatment engagement, retention, and outcomes for active duty military personnel seeking treatment for posttraumatic stress disorder (PTSD). Shared Decision Making between the service member and the therapists will be used to match patients to 1 of 3 different types of therapy for PTSD: (1) Prolonged Exposure (PE) therapy, (2) Cognitive Processing Therapy (CPT), or (3) Written Exposure Therapy (WET) in 1 of 2 different frequencies: (1) massed (daily) or (2) spaced (weekly).

Research Team

Alan L Peterson, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Vanessa Jacoby, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Increasing engagement in evidence-based PTSD treatment through shared decision-making: a pilot study. [2022]

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

Evaluation of a shared decision-making intervention on the utilization of evidence-based psychotherapy in a VA outpatient PTSD clinic. [2019]

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

Training providers in shared decision making for trauma treatment planning. [2022]

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

Provider Perspectives on Implementing Shared Decision Making for PTSD Treatment in VA Primary Care. [2023]

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

Desired Involvement in Treatment Decisions Among Adults with PTSD Symptoms. [2018]

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

Development and Pilot of a Process for Regularly Sharing Summary Patient Safety Data. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

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

8. England 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. [2023]

9. Italy pubmed.ncbi.nlm.nih.gov

[Second victims of medical errors: a systematic review of the literature]. [2018]

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

Critical incident stress debriefing after adverse patient safety events. [2018]

11. England pubmed.ncbi.nlm.nih.gov

An Exploratory Pilot Study to Describe Shared Decision-Making for PTSD Treatment Planning: The Provider Perspective. [2019]