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

Trial Summary

What is the purpose of this trial?

This trial tests Omnis Salutis, a program for recent veterans of the Afghanistan and Iraq conflicts. The program helps veterans set and share their health goals with doctors and support systems to improve their well-being.

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 Health and Wellness, Whole Health, Omnis Salutis, Omnis Salutis, Omnis Salutis, OS for PTSD?

The Holistic Healing Arts Retreat study suggests that intensive, experiential interventions can help improve symptoms of trauma, depression, and stress, which may be relevant to the Whole Health approach. Additionally, the use of social support, as seen in the PTSD Coach study, was linked to better self-rated health, indicating that social elements of Whole Health could be beneficial. ^{1 2 3 4 5}

Is the Whole Health Intervention for PTSD safe for humans?

The Whole Health system of care, used by veterans with PTSD, showed small improvements in health without reported safety issues. In a related study, a trauma-informed yoga protocol for veterans reported no adverse events, suggesting these holistic approaches are generally safe. ^{2 6 7 8 9}

How is the treatment Omnis Salutis different from other PTSD treatments?

Omnis Salutis is unique because it is a whole health intervention, which likely incorporates a mind-body approach, focusing on overall well-being rather than just symptom reduction, similar to holistic or integrative therapies that emphasize resilience and physical and mental well-being. ^{1 10 11 12 13}

Research Team

Samantha M Hack, PhD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

The holistic healing arts retreat: An intensive, experiential intervention for survivors of interpersonal trauma. [2023]

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

Ecological momentary assessment of self-rated health, daily strategies and self-management app use among trauma-exposed adults. [2023]

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

Sudden gains and deteriorations in the treatment of posttraumatic stress disorder in World Trade Center responders. [2018]

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

Sensitivity of the SF-36 to PTSD symptom change in veterans. [2011]

5. 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]

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

Examining the Veterans Health Administration whole health model of care within the context of posttraumatic stress disorder. [2023]

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

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

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

Veterans with PTSD report more weight loss barriers than Veterans with no mental health disorders. [2017]

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

Testing the acceptability and initial efficacy of a smartphone-app mindfulness intervention for college student veterans with PTSD. [2021]

10. Denmark 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. [2019]

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

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

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

Breathing-based meditation decreases posttraumatic stress disorder symptoms in U.S. military veterans: a randomized controlled longitudinal study. [2021]

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

Post-traumatic stress disorder: evidence-based research for the third millennium. [2023]