POST Facilitation for Post-Traumatic Stress Disorder

(POST-RCT Trial)

Recruiting at 2 trial locations

Overseen By Alexia M Torke, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

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

Compensation: Varies

Number of Visits: 1

778 Participants Needed

Trial Summary

What is the purpose of this trial?

We propose to study the effects of Physician Orders for Scope of Treatment (POST) Facilitation in a randomized controlled trial in a population of community dwelling older adults who qualify for POLST facilitation, including those with normal cognition and those with Alzheimer's Disease and Related Disorders.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Home Safety Evaluation, POST Facilitation for PTSD?

The research suggests that psychological interventions, like cognitive processing therapy, are effective for PTSD, with significant symptom reductions reported. Additionally, early interventions targeting the mechanisms of PTSD can be beneficial, as indicated by studies on web-based cognitive-affective remediation. ^{1 2 3 4 5}

Is POST Facilitation for PTSD safe for humans?

There is a need for more comprehensive monitoring and reporting of adverse events (unintended negative effects) in psychological interventions, including those for PTSD, to ensure safety. Current practices often overlook less severe side effects, which means safety data may be incomplete. ^{6 7 8 9 10}

How is POST Facilitation treatment different from other PTSD treatments?

POST Facilitation is unique because it focuses on psychophysiological interventions, which address the body's physical responses to stress, unlike traditional therapies that primarily focus on psychological aspects. This approach may include techniques like self-hypnosis and clinical hypnosis, which are not commonly used in standard PTSD treatments. ^{3 11 12 13 14}

Research Team

Alexia M Torke, MD

Principal Investigator

Regenstrief Institute, Indiana University

Eligibility Criteria

This trial is for community-dwelling older adults aged 65 or above with certain serious health conditions like metastatic cancer, heart failure, kidney disease, COPD, or advanced Alzheimer's. They must have a high risk of mortality within a year and either be able to make decisions themselves or have a surrogate decision maker. Those already in hospice care or with an existing POST form are excluded.

Inclusion Criteria

I am 65 years old or older.

Patients must be able to pass consent verification

Patients must not have a POST form on file

Exclusion Criteria

Lack of a patient or surrogate decision maker who can participate in POLST facilitation (for non-decisional patients a health care representative (HCR) or designated power of attorney for health care (DPOA-HC) must enroll with them)

Patients who are not community-dwelling

Patients who are already enrolled in hospice

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive POST Facilitation or Home Safety Evaluation

1 visit

1 home visit

Follow-up

Participants are monitored for outcomes such as decision conflict, psychological well-being, and POST form completion

12 months

Outcome Assessment

Assessment of primary and secondary outcomes including discordance between treatment preferences and treatment received

12 months

Treatment Details

Interventions

• Home Safety Evaluation
• POST Facilitation

Trial Overview The study is testing the effectiveness of Physician Orders for Scope of Treatment (POST) Facilitation compared to usual care in improving outcomes for older adults. It involves home safety evaluations and discussions about treatment preferences in case of severe illness.

Participant Groups

Group I: Intervention (POST Facilitation) Experimental Treatment 1 Intervention

A nurse will complete a home visit with the patient and their surrogate decision maker or other family (if they've designated one), in which he or she will provide education about the POST form. The POST facilitators will be nurses trained using the Respecting Choices Advanced Steps model.

Group II: Attention Control (Home Safety Evaluation) Experimental Treatment 1 Intervention

A nurse will complete a home visit with the patient and their surrogate decision maker or other family member (if they've designated one), in which he or she will provide suggestions on how to improve the safety of the patient's home.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Regenstrief Institute, Inc.

Collaborator

Trials

27

Recruited

98,500+

Indiana University Health

Collaborator

Trials

35

Recruited

18,500+

Eskenazi Health

Collaborator

Trials

14

Recruited

3,700+

Respecting Choices

Collaborator

Trials

2

Recruited

830+

Findings from Research

A systematic review of 66 trials involving 4190 patients with PTSD found that specific psychological interventions, such as cognitive behavioral therapy and exposure therapy, have large effect sizes, indicating they are effective in reducing PTSD symptoms.

No single psychological intervention was found to be consistently superior to others, but adherence to PTSD diagnostic criteria and trial quality were linked to larger effect sizes, suggesting that the effectiveness of these interventions can vary based on how well the trials are conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating fragmented evidence by network meta-analysis: relative effectiveness of psychological interventions for adults with post-traumatic stress disorder. Gerger, H., Munder, T., Gemperli, A., et al.[2014]

The study outlines a design for a web-based cognitive remediation training aimed at enhancing neurocognitive functions that may help prevent the development of PTSD in trauma survivors.

By focusing on early intervention shortly after trauma exposure, the study aims to address the challenges of administering targeted training to improve emotional reactivity and regulation, potentially reducing PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating web-based cognitive-affective remediation in recent trauma survivors: study rationale and protocol. Fine, NB., Achituv, M., Etkin, A., et al.[2020]

A systematic review of 126 randomized controlled trials found that certain factors, like having a comorbid diagnosis of depression and higher baseline PTSD severity, are linked to less effective treatment outcomes for PTSD.

Conversely, factors such as higher education, adherence to treatment homework, and experiencing a more recent trauma were associated with better treatment outcomes, highlighting the need for personalized approaches in PTSD therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of factors associated with outcome of psychological treatments for post-traumatic stress disorder. Barawi, KS., Lewis, C., Simon, N., et al.[2022]

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

A significant 79% of pediatricians reported experiencing adverse events, with 'missing a diagnosis' being the most emotionally impactful and 'aggressive behavior' the most common, leading to higher rates of mental health issues compared to the general population.

Only 26.3% of pediatricians had access to a peer support protocol for emotional support after adverse events, highlighting the need for structured support systems and education on coping strategies to improve their mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational well-being in pediatricians-a survey about work-related posttraumatic stress, depression, and anxiety. van Steijn, ME., Scheepstra, KWF., Yasar, G., et al.[2020]

A second victim support intervention was implemented in a 500-bed University Hospital in Granada, Spain, providing structured emotional support to healthcare workers involved in serious adverse events (SAEs) over two years, with 135 workers receiving second-level support.

The intervention led to increased notification rates of SAEs and high acceptance among professionals, enhancing the visibility of support actions and contributing to a stronger culture of patient safety within the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second Victim Support at the Core of Severe Adverse Event Investigation. Cobos-Vargas, A., Pérez-Pérez, P., Núñez-Núñez, M., et al.[2023]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

References

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

Integrating fragmented evidence by network meta-analysis: relative effectiveness of psychological interventions for adults with post-traumatic stress disorder. [2014]

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

Evaluating web-based cognitive-affective remediation in recent trauma survivors: study rationale and protocol. [2020]

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

Using a Learning Collaborative Model to Disseminate Cognitive Processing Therapy to Community-Based Agencies. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Metacognitive therapy for PTSD: a preliminary investigation of a new brief treatment. [2018]

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

A systematic review of factors associated with outcome of psychological treatments for post-traumatic stress disorder. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]

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

Occupational well-being in pediatricians-a survey about work-related posttraumatic stress, depression, and anxiety. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Second Victim Support at the Core of Severe Adverse Event Investigation. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

[Patients and doctors experiences of iatrogenic injury]. [2008]

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

The need for expanded monitoring of adverse events in behavioral health clinical trials. [2012]

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

New insights into secondary prevention in post-traumatic stress disorder. [2022]

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

An Evidence-Based Review of Early Intervention and Prevention of Posttraumatic Stress Disorder. [2018]

13. England pubmed.ncbi.nlm.nih.gov

The Frustrated and Helpless Healer: Pathways Approaches to Posttraumatic Stress Disorders. [2018]

14. England pubmed.ncbi.nlm.nih.gov

Post-traumatic stress disorder. [2018]