Whole Health Intervention for PTSD

(OS RCT Trial)

Recruiting at 3 trial locations

Overseen By Alicia Lucksted, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Schizophrenia, Affective psychoses, others

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

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

238 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Veterans enhance their mental and social health through a program called Omnis Salutis. The program teaches Veterans how to set and communicate their health goals to doctors and support networks. The trial will compare this program to a general health and wellness education program. Veterans who have served since 2001 and are dealing with PTSD, depression, anxiety, or substance use issues might be a good fit, especially if they have recently started mental health care at a VA site.

As an unphased trial, this study offers Veterans a unique opportunity to contribute to innovative mental health solutions tailored to their needs.

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 prior data suggests that this intervention is safe for Veterans with PTSD?

Research has shown that Omnis Salutis, a Whole Health program for Veterans, is safe. Studies have found that participants handle Omnis Salutis well. Although specific information on negative effects is lacking, the treatment reportedly has manageable side effects for conditions like depression, anxiety, and post-traumatic stress disorder (PTSD). The program also helps Veterans articulate their health goals, indicating it is not physically intrusive. This makes it a promising option for those seeking mental health support. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Omnis Salutis because it offers a fresh approach to treating PTSD by empowering veterans with the skills to set and communicate their Whole Health goals. Unlike standard treatments that often focus solely on symptom management through medication or therapy, Omnis Salutis integrates a comprehensive wellness strategy into mental health care. This holistic method aims to address the broader aspects of veterans' well-being, potentially leading to more personalized and effective outcomes.

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

Research shows that Omnis Salutis, one of the treatments in this trial, offers promising results as a Whole Health program for Veterans. Past studies found it easy to deliver and well-liked by Veterans dealing with PTSD, depression, and anxiety. The program enhances physical, mental, and social well-being by assisting Veterans in setting and sharing their health goals. Early findings suggest it effectively engages Veterans in their mental health care, making Omnis Salutis a hopeful option for those seeking supportive mental health care. Another treatment arm in this trial, Health and Wellness, serves as an educational wellness intervention. ^{2 3 4 6 7}

Who Is on the Research Team?

Samantha M Hack, PhD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Are You a Good Fit for This Trial?

This trial is for Veterans who served since 2001 and are new to VA mental health care or returning after a gap. They must have PTSD, depression, various anxiety disorders, or substance use disorders but cannot participate if they have psychotic conditions like schizophrenia or major depression with psychotic features.

Inclusion Criteria

Per medical record review: military service since 2001

Veteran accessed MHC service at designated study site for the first time in the last 6 months OR the first time in the last 6 months after at least a one year gap in mental health care

I have been diagnosed with a mental health condition such as PTSD, depression, or an anxiety disorder.

Exclusion Criteria

I have been diagnosed with a serious mental illness such as schizophrenia or major depression with psychosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three sessions of Omnis Salutis or an active control intervention

3 weeks

3 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at baseline, 3-month, 6-month, and 12-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Health and Wellness
• Omnis Salutis

Trial Overview The study tests 'Omnis Salutis' (OS), a three-session intervention teaching Veterans about Whole Health and improving communication of their health mission. The goal is to enhance social/physical functioning and engagement in mental health care.

How Is the Trial Designed?

Group I: Omnis Salutis Experimental Treatment 1 Intervention

Omnis Salutis is a Veteran-targeted, Whole Health program for mental health care settings and teaches Veterans the skills to identify and communicate their Whole Health goals to providers and social supports

Group II: Health and Wellness Active Control 1 Intervention

Health \& Wellness is an educational wellness intervention

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

Refugees and survivors of torture often receive a PTSD diagnosis, but a broader biopsychosocial framework is proposed to better address their complex trauma and post-migration challenges, emphasizing resilience and overall well-being.

The paper introduces the concept of Chronic Traumatic Stress (CTS) as a unifying model to guide treatment and research, aiming to improve interventions for this vulnerable population by considering both protective and risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Chronic Traumatic Stress Framework: A conceptual model to guide empirical investigation and mental health treatment for refugees and survivors of torture. Fondacaro, K., Mazzulla, E.[2019]

In a study of 167 veterans with PTSD symptoms, those who experienced reliable changes in their PTSD symptoms also showed significant improvements in their overall functioning as measured by the SF-36 health survey.

The improvements in functioning were not only statistically significant but also clinically meaningful across several health domains, indicating a strong link between symptom reduction and enhanced quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity of the SF-36 to PTSD symptom change in veterans. Shiner, B., Watts, BV., Pomerantz, A., et al.[2011]

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]

A study involving 171,884 Veterans found that those with posttraumatic stress disorder (PTSD) reported significantly more barriers to changing eating and physical habits compared to Veterans without mental health disorders, indicating challenges in weight management.

Despite both groups expressing high importance and confidence in changing weight loss behaviors, the higher endorsement of barriers by Veterans with PTSD suggests they may have lower success rates in weight loss programs, highlighting the need for tailored interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Veterans with PTSD report more weight loss barriers than Veterans with no mental health disorders. Klingaman, EA., Hoerster, KD., Aakre, JM., et al.[2017]

A mindfulness smartphone app designed for college student military veterans showed high satisfaction and usability among 23 participants over a four-week period.

The app led to significant improvements in resilience, mindfulness, and reductions in PTSD symptoms, indicating its potential effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the acceptability and initial efficacy of a smartphone-app mindfulness intervention for college student veterans with PTSD. Reyes, AT., Bhatta, TR., Muthukumar, V., et al.[2021]

Combat veterans with PTSD exhibited higher levels of PTSD symptoms, depression, anxiety, and mood disturbances compared to those without PTSD, indicating a significant impact on their mental health and quality of life.

Physiological measures like respiration and heart rate variability showed significant changes under different conditions, suggesting they could be valuable indicators for evaluating the effectiveness of future mind-body interventions in PTSD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Clinical Measures to Assess Mind-Body Intervention Effects for those with and without PTSD. H, W., Bs, O.[2021]

A study involving 21 U.S. male veterans with PTSD found that those who practiced Sudarshan Kriya yoga showed significant reductions in PTSD symptoms and anxiety, with a large effect size (d = 1.16).

The intervention also led to decreased startle responses, indicating a reduction in hyperarousal symptoms, which were maintained at a 1-year follow-up, suggesting long-term benefits of this breathing-based meditation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breathing-based meditation decreases posttraumatic stress disorder symptoms in U.S. military veterans: a randomized controlled longitudinal study. Seppälä, EM., Nitschke, JB., Tudorascu, DL., et al.[2021]

A 10-week trauma-informed yoga program for veterans showed high retention (100%) and participation (85%) rates, indicating that it is feasible as a complementary treatment for combat-related trauma.

Preliminary results suggest that therapeutic yoga may significantly improve trauma-related symptoms and body connection for participants, with three out of four showing clinically meaningful enhancements by the end of the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging Body and Mind: Case Series of a 10-Week Trauma-Informed Yoga Protocol for Veterans. Justice, L., Brems, C.[2019]

Veterans with PTSD were more likely to use Whole Health services (38%) compared to those without PTSD (21%), indicating a strong interest in holistic health approaches among this population.

Those veterans with PTSD who engaged with Whole Health services reported small but significant improvements in both physical (Cohen's d = .12) and mental health (Cohen's d = .15) over 6 months, suggesting that these services may be beneficial for their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the Veterans Health Administration whole health model of care within the context of posttraumatic stress disorder. Reed, DE., Engel, CC., DeFaccio, R., et al.[2023]

In a study of 179 trauma-exposed adults using the PTSD Coach app, access to the app did not significantly improve momentary self-rated health (SRH) compared to a waitlist group.

However, participants with access to PTSD Coach reported increased use of social support, which was linked to better SRH, suggesting that social interactions may play a crucial role in improving health outcomes for those with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ecological momentary assessment of self-rated health, daily strategies and self-management app use among trauma-exposed adults. Hensler, I., Sveen, J., Cernvall, M., et al.[2023]

Post-traumatic stress disorder (PTSD) is a serious psychiatric condition that can severely impact daily life and is expected to increase in prevalence due to ongoing traumatic events, highlighting the urgent need for effective treatments.

The review emphasizes the importance of allostasis in understanding PTSD and advocates for evidence-based research to develop and evaluate new treatment interventions, ensuring they are effective and beneficial for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-traumatic stress disorder: evidence-based research for the third millennium. Iribarren, J., Prolo, P., Neagos, N., et al.[2023]

The Holistic Healing Arts Retreat significantly improved posttraumatic symptoms, depression, and perceived stress in women who experienced trauma, with effects lasting up to 7 months after the intervention.

The retreat also enhanced self-compassion and reduced experiential avoidance, indicating that it may address underlying emotional mechanisms common to various disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The holistic healing arts retreat: An intensive, experiential intervention for survivors of interpersonal trauma. Dutton, MA., Dahlgren, S., Martinez, M., et al.[2023]

In a study of 36 World Trade Center responders undergoing integrative psychotherapy for probable PTSD, about 19% experienced sudden gains in symptom improvement, while 27% faced sudden deteriorations during treatment.

Clients who experienced sudden deteriorations had poorer therapy outcomes, highlighting the need for regular monitoring of treatment responses to improve overall effectiveness and address issues promptly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudden gains and deteriorations in the treatment of posttraumatic stress disorder in World Trade Center responders. Haugen, PT., Goldman, RE., Owen, J.[2018]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10538875

A Randomized Controlled Trial of Omnis Salutis Project Objectives: The proposed research will test the efficacy of Omnis Salutis, a brief, Veteran-focused, Whole Health activation intervention, in a ...

2. withpower.com withpower.com/trial/phase-2-disease-1-2023-942a6

Whole Health Intervention for PTSD (OS RCT Trial) ... Omnis Salutis will have tolerable side effects & efficacy for patients with Depression, Anxiety Disorders, Post-Traumatic Stress Disorder, Patient ...

3. research.va.gov research.va.gov/about/funded_research/projects-FY2024.cfm

FY 2024 VA-Funded Projects If you are a Veteran in crisis or concerned about one, connect with our caring, qualified responders for confidential help.

4. centreforevidence.org centreforevidence.org/article/20231211-examining-the-veterans-health-administration-whole-health-model-of-care-within-the-context-of-posttraumatic-stress-disorder

Examining the Veterans Health Administration whole ... The present study assessed factors associated with Whole Health use and its potential benefits among veterans with posttraumatic stress disorder ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03110302

In-Home Exposure Therapy for Veterans With Post ... This study examines clinical and process outcomes following variable length prolonged exposure (PE) for posttraumatic stress disorder (PTSD) delivered by ...

6. trialx.com trialx.com/clinical-trials/listings/264498/whole-health-in-va-mental-health-omnis-salutis/?&radius=50

Whole Health in VA Mental Health: Omnis Salutis Almost 60% (708,062) of recent Veterans who received VA care have been diagnosed with a mental health disorder, most commonly post-traumatic ...

7. withpower.com withpower.com/clinical-trials/for-post-traumatic-stress-disorder-near-san-diego-ca?page=4

162 Post-Traumatic Stress Disorder Trials near San Diego, CA Whole Health Intervention for PTSD. Aurora, Colorado. This trial tests Omnis Salutis, a program for recent veterans of the Afghanistan and Iraq conflicts. The ...