Whole Health Intervention for PTSD (OS RCT Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen BySamantha M Hack, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VA Office of Research and Development
No Placebo Group
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.
12345Is 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.
26789How 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.
110111213Eligibility 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
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.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Omnis SalutisExperimental Treatment1 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 WellnessActive Control1 Intervention
Health \& Wellness is an educational wellness intervention
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Martinsburg VA Medical Center, Martinsburg, WVMartinsburg, WV
Washington DC VA Medical Center, Washington, DCWashington, United States
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MDBaltimore, CO
Rocky Mountain Regional VA Medical Center, Aurora, COAurora, CO
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
References
The holistic healing arts retreat: An intensive, experiential intervention for survivors of interpersonal trauma. [2023]This study examined the effectiveness of an intensive, experiential intervention, the Holistic Healing Arts Retreat, for improving posttraumatic symptoms (primary) and comorbid depression and perceived stress (secondary).
Ecological momentary assessment of self-rated health, daily strategies and self-management app use among trauma-exposed adults. [2023]Background: The process whereby trauma-exposed people benefit from self-management apps to increase health is poorly understood. Objective: We investigated whether access to a self-management smartphone app for posttraumatic stress (PTSD Coach) improved momentary self-rated health (SRH) and if use of a self-management app or specific strategies related to SRH. Method: Participants were 179 adults in Sweden with trauma exposure in the past 2 years who were enrolled in a randomized trial of PTSD Coach versus waitlist. Ecological momentary assessments (EMA) were collected twice daily during 21 consecutive days from participants in both groups, with questions about momentary SRH as well as self-management app use and use of strategies (social support, distress management, monitoring of discomfort and seeking information) in the preceding 12 hours. Results: Overall, neither access to PTSD Coach nor reported use of an app in the preceding hours was related to SRH. Even so, people with access to PTSD Coach reported using more social support over time. Socializing and use of social support predicted greater SRH. Use of other strategies was associated with worse short-term SRH. Conclusions: Momentarily improved health relates to utilization of social support. However, the directionality of the day-to-day associations is unclear; uncertainty remains around the timing for assessing these relationships.
Sudden gains and deteriorations in the treatment of posttraumatic stress disorder in World Trade Center responders. [2018]This study sought to examine the prevalence of sudden gains and deteriorations (i.e., symptom reduction/improvement during treatment) and their influence on treatment outcomes among World Trade Center responders with probable posttraumatic stress disorder. Thirty-six outpatient clients received at least three sessions of integrative psychotherapy, which included elements of psychodynamic and cognitive-behavioral therapy approaches, under routine clinical conditions. Approximately 19% of clients experienced a sudden gain and 27% of clients experienced a sudden deterioration. Those who experienced deteriorations had worse therapy outcomes compared with those who did not. Clinical implications are discussed, including the importance of routine monitoring of client treatment response for sudden deteriorations to enhance positive treatment outcomes. Future research with larger samples is needed to further evaluate the mechanisms of sudden gains and sudden deteriorations in this population.
Sensitivity of the SF-36 to PTSD symptom change in veterans. [2011]The authors examined the relationship between changes in symptoms of posttraumatic stress disorder (PTSD) and functioning as measured by the Medical Outcomes Study Short Form-36 (SF-36) among 167 veterans in a primary care clinic. Those who reported at least moderate baseline symptoms were categorized as better, unchanged, or worse at reassessment. The SF-36 was used to examine concordance between change in functioning and symptoms. Veterans with reliable changes in symptoms of PTSD showed corresponding statistically significant changes in functioning across health domains. Moreover, these changes in functioning were clinically significant on several SF-36 subscales and on one summary scale.
Integrating fragmented evidence by network meta-analysis: relative effectiveness of psychological interventions for adults with post-traumatic stress disorder. [2014]To summarize the available evidence on the effectiveness of psychological interventions for patients with post-traumatic stress disorder (PTSD).
Examining the Veterans Health Administration whole health model of care within the context of posttraumatic stress disorder. [2023]The Veterans Health Administration's Whole Health system of care focuses on offering veterans holistic health approaches and tailoring health care to individual's goals and preferences. The present study assessed factors associated with Whole Health use and its potential benefits among veterans with posttraumatic stress disorder (PTSD) receiving Veterans Health Administration care. This cohort study used retrospective electronic health records combined with survey data (baseline, 6 months) from 18 Veterans Affairs Whole Health pilot implementation sites and compared patient-reported outcomes between veterans who used Whole Health services versus those who did not, among veterans with (n = 1,326) and without (n = 3,243) PTSD. Patient-reported outcomes assessed were pain (PEG), patient-reported outcomes measurement information system physical and mental health functioning, and a one-item global meaning and purpose assessment. Veterans with PTSD were more likely to have used Whole Health (38% vs. 21%) than those without PTSD. Veterans with PTSD who used Whole Health services experienced small improvements over 6 months in physical (Cohen's d = .12) and mental (Cohen's d = .15) health functioning. Veterans without PTSD who used Whole Health services experienced small improvements in physical health (Cohen's d = .09) but not mental health (Cohen's d = .04). Veterans with PTSD were frequently connected with Whole Health services even though implementation efforts were not explicitly focused on reaching this population. Results suggest Whole Health may play an important role in how veterans with PTSD engage with health care. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
Bridging Body and Mind: Case Series of a 10-Week Trauma-Informed Yoga Protocol for Veterans. [2019]This case series explored the feasibility and preliminary efficacy of therapeutic yoga as a complementary form of treatment for combat-related trauma. The series recruited for and implemented a 10-week Trauma-Informed Yoga protocol for veterans in an interprofessional community health treatment setting. Participants were enrolled in a series of 90-minute therapeutic yoga classes adapted to be trauma-informed. Feasibility was measured by recruitment, retention, and level of participation in the study. Preliminary efficacy was explored via the Posttraumatic Stress Disorder Checklist, Scale of Body Connection, PROMIS-29, PROMIS Alcohol Use, PROMIS Substance Use, Difficulties in Emotional Regulation Scale, and Self-Compassion Scale-Short Form. All measures were administered at baseline, week 5, week 10, and at a 5-week follow-up. A qualitative Feasibility Questionnaire was administered weekly and at the 5-week follow-up to assess barriers and motivators for home practice and to collect feedback about session content. Recruitment challenges resulted in only seven interested individuals. Four participants (three males, one female) were successfully enrolled in the study after seven phone screenings and five in-person interviews. The four enrolled clients had a 100% follow-up retention rate, reported no adverse events, and on average participated in 85% of classes. Clinically significant enhancements were observed on trauma- and body connection-related scales for three participants from baseline to follow-up. Qualitative data revealed that motivators to practice include in-session philosophical discussions based on psychological themes; breathwork; mindfulness; and physical, social, work/academic, and mental health impact. Barriers included motivation, time, and location. Important themes emerged related to cultural considerations for veterans. Although this 10-week trauma-informed protocol faced challenges to recruitment, retention and participation were high. Efficacy measures yielded promising results for reducing trauma-related symptoms.
Veterans with PTSD report more weight loss barriers than Veterans with no mental health disorders. [2017]This study characterized and compared Veterans of the United States Armed Forces with posttraumatic stress disorder (PTSD) to Veterans with no mental health disorders on self-reported measures of factors that influence success in weight management programs.
Testing the acceptability and initial efficacy of a smartphone-app mindfulness intervention for college student veterans with PTSD. [2021]This single-arm, pre-post feasibility study evaluated the acceptability and initial efficacy of a mindfulness smartphone-app intervention intended to promote resilience and improve posttraumatic stress disorder (PTSD) symptoms among college student military veterans. The app contained mindfulness exercises and meditations based on the acceptance and commitment therapy. Twenty-three student veterans used the app for four weeks. The results showed high levels of perceived satisfaction and usability of the app. Significant changes in resilience, mindfulness, PTSD, experiential avoidance, and rumination were observed. Future research is needed to test the intervention in a randomized controlled trial.
The Chronic Traumatic Stress Framework: A conceptual model to guide empirical investigation and mental health treatment for refugees and survivors of torture. [2019]An increasing number of refugees and survivors of torture resettled in the United States are presenting to clinics for treatment related to trauma and postmigration difficulties. Although clinicians experienced in treating trauma with diverse populations may recognize the limitations of a PTSD diagnosis, one of the primary diagnoses received by refugees and survivors of torture remains post-traumatic stress disorder (PTSD). A variety of interventions exist (e.g., supportive, trauma specific, interdisciplinary including physical, social and psychological) for survivors of torture and trauma that move beyond this diagnosis, however, a unifying conceptual model is needed to guide treatment and further the empirical investigation and evidence base in this growing field. In this paper, we propose a broader biopsychosocial framework of the impact of traumatic war events including the measurement of stress related to post migration living difficulties, and daily hassles while highlighting the importance of protective and risk factors. Intervention outcomes emphasize resilience, physical well-being, and mental well-being, along with traumatic stress symptoms. We describe Chronic Traumatic Stress (CTS) as an integrated and unifying framework which provides guidance for the growing number of providers conducting assessment and intervention with refugees and survivors of torture. We also highlight that this model is specifically designed for empirical testing.
A Pilot Study of Clinical Measures to Assess Mind-Body Intervention Effects for those with and without PTSD. [2021]Assess measures for future mind-body interventions in those with and without PTSD.
Breathing-based meditation decreases posttraumatic stress disorder symptoms in U.S. military veterans: a randomized controlled longitudinal study. [2021]Given the limited success of conventional treatments for veterans with posttraumatic stress disorder (PTSD), investigations of alternative approaches are warranted. We examined the effects of a breathing-based meditation intervention, Sudarshan Kriya yoga, on PTSD outcome variables in U.S. male veterans of the Iraq or Afghanistan war. We randomly assigned 21 veterans to an active (n = 11) or waitlist control (n = 10) group. Laboratory measures of eye-blink startle and respiration rate were obtained before and after the intervention, as were self-report symptom measures; the latter were also obtained 1 month and 1 year later. The active group showed reductions in PTSD scores, d = 1.16, 95% CI [0.20, 2.04], anxiety symptoms, and respiration rate, but the control group did not. Reductions in startle correlated with reductions in hyperarousal symptoms immediately postintervention (r = .93, p
Post-traumatic stress disorder: evidence-based research for the third millennium. [2023]The stress that results from traumatic events precipitates a spectrum of psycho-emotional and physiopathological outcomes. Post-traumatic stress disorder (PTSD) is a psychiatric disorder that results from the experience or witnessing of traumatic or life-threatening events. PTSD has profound psychobiological correlates, which can impair the person's daily life and be life threatening. In light of current events (e.g. extended combat, terrorism, exposure to certain environmental toxins), a sharp rise in patients with PTSD diagnosis is expected in the next decade. PTSD is a serious public health concern, which compels the search for novel paradigms and theoretical models to deepen the understanding of the condition and to develop new and improved modes of treatment intervention. We review the current knowledge of PTSD and introduce the role of allostasis as a new perspective in fundamental PTSD research. We discuss the domain of evidence-based research in medicine, particularly in the context of complementary medical intervention for patients with PTSD. We present arguments in support of the notion that the future of clinical and translational research in PTSD lies in the systematic evaluation of the research evidence in treatment intervention in order to insure the most effective and efficacious treatment for the benefit of the patient.