What is the mechanism of action of this treatment?

Common treatments for Substance Use Disorders include Cognitive Behavioral Therapy (CBT), Motivational Interviewing (MI), and Contingency Management (CM). CBT helps patients recognize and change maladaptive behaviors and thought patterns, MI enhances motivation to change by resolving ambivalence, and CM uses positive reinforcement to encourage abstinence and treatment adherence. Education and communication skills training, as seen in the Omnis Salutis trial, empower patients by improving their understanding of health and enhancing their ability to communicate effectively with healthcare providers and social supports. These mechanisms are crucial as they address both the psychological and social aspects of SUD, promoting long-term recovery and better integration into society.

What side effects are associated with this type of intervention?

The Omnis Salutis trial involves education and communication skills training for treating Substance Use Disorders (SUDs). Common side effects of psychosocial interventions, such as cognitive-behavioral therapy (CBT) and other educational programs, are generally minimal but can include emotional discomfort as patients confront and discuss their substance use and related behaviors. Some individuals may experience increased anxiety or distress during sessions, but these effects are typically temporary and manageable with proper therapeutic support.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for the treatment of Substance Use Disorders, including medications like naltrexone, buprenorphine, and methadone for opioid use disorder, and acamprosate and disulfiram for alcohol use disorder. While these pharmacological treatments are well-documented, educational and communication skills training approaches, such as those studied in the Omnis Salutis trial, focus on improving patient engagement and functional outcomes through non-pharmacological means. These approaches are complementary to medication and aim to enhance overall treatment efficacy by addressing behavioral and psychosocial aspects of SUDs.

What other types of research exist?

Promising novel alternatives to Omnis Salutis for SUD patients include: 1) Assertive Community Treatment (ACT), which provides comprehensive, community-based psychiatric treatment, rehabilitation, and support to patients with severe mental illness and co-occurring substance use disorders. 2) Reinforcement-Based Therapy (RBT), which uses positive reinforcement to encourage abstinence and engagement in treatment. 3) Contingency Management (CM), which provides tangible rewards for positive behaviors such as maintaining sobriety. 4) Community Reinforcement and Family Training (CRAFT), which involves family members in the treatment process to improve patient outcomes. These approaches have shown efficacy in improving treatment retention and reducing substance use.

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Whole Health Intervention for PTSD (OS RCT Trial)

N/A

Recruiting

Led By Samantha Hack, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a current diagnosis of: PTSD (309.81), major depressive disorder (296.20-296.23, 296.30-296.33), social anxiety disorder (300.23), panic disorder (300.01), generalized anxiety disorder (300.02), other specified or unspecified anxiety disorder (300.09, 300.00), substance use disorders (303.90, 304.00, 304.10, 304.30)

Be older than 18 years old

Must not have

Per medical record review, current diagnosis of a psychotic disorder meeting criteria established by the VA Serious Mental Illness Treatment, Research, and Evaluation Center (SMITREC): schizophrenic disorders (295.0-295.9), affective psychoses (296.0-296.1, 296.4-296.8), major depression with psychotic features (296.24, 296.34)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since OS involves educational sessions rather than medication, typical drug side effects aren't expected. However, discussing sensitive topics might cause temporary discomfort or emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Veterans RAND 36-Item Health Survey - Physical Component Summary

Veterans RAND 36-Item Health Survey - Social Functioning Scale

Secondary study objectives

Altarum Consumer Engagement - Commitment and Navigation subscales

VA service use

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Substance Use Disorders include Cognitive Behavioral Therapy (CBT), Motivational Interviewing (MI), and Contingency Management (CM). CBT helps patients recognize and change maladaptive behaviors and thought patterns, MI enhances motivation to change by resolving ambivalence, and CM uses positive reinforcement to encourage abstinence and treatment adherence. Education and communication skills training, as seen in the Omnis Salutis trial, empower patients by improving their understanding of health and enhancing their ability to communicate effectively with healthcare providers and social supports. These mechanisms are crucial as they address both the psychological and social aspects of SUD, promoting long-term recovery and better integration into society.

Curative factors in alcohol and drug treatment: behavioral and disease model perspectives.Delineating mechanisms of change in child and adolescent therapy: methodological issues and research recommendations.Rediscovering fire: small interventions, large effects.