Integrated Health Care for Post-Traumatic Stress Disorder

Not yet recruiting at 4 trial locations
AJ
HS
Overseen ByHaley Suit, MA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Veterans Medical Research Foundation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different integrative care approaches can help Veterans with post-traumatic stress disorder (PTSD) improve daily functioning. Participants will receive 12 weeks of care, which may include usual care, yoga and meditation, wellness classes, or classes to boost positive feelings and social support. The goal is to determine which type of care works best and how these treatments can be effectively used in the VA Healthcare System. Veterans diagnosed with PTSD and eligible for Cognitive Processing Therapy (CPT) at a participating VA site might be a good fit for this trial. As an unphased trial, this study offers Veterans the chance to explore innovative care approaches that could enhance 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 prior data suggests that these integrative care approaches are safe for Veterans with PTSD?

Research shows that the treatments tested in this trial are generally safe for people. Each type of treatment offers specific benefits:

1. **Yoga and Meditation**: Studies have found that yoga and meditation are safe and can alleviate PTSD symptoms. They lower stress and improve mood without causing serious side effects.

2. **Wellness (Exercise and Nutrition)**: Exercise is safe and beneficial for people with PTSD, reducing anxiety and aiding sleep. Research indicates that exercise and nutrition programs are well-received and can enhance overall mental health.

3. **Positive Affect (Increasing Positive Feelings)**: Focusing on positive feelings and building social connections is safe and helpful. Studies suggest that strong social ties boost mental health and help manage PTSD symptoms.

Overall, these treatments have been well-received in other studies, with few reports of negative effects. They aim to support mental health and improve daily life for those with PTSD.12345

Why are researchers excited about this trial?

Researchers are excited about the Integrated Health Care for PTSD trial because it explores alternative approaches to managing PTSD that go beyond traditional therapies like medication and talk therapy. This trial investigates the potential benefits of yoga and meditation, which use Hatha yoga classes and the Mantram Repetition Program to promote mental well-being through relaxation and mindfulness. Additionally, the wellness arm focuses on lifestyle changes with exercise and nutrition classes, aiming to support overall health. The positive affect arm seeks to enhance emotional well-being and social support, providing a holistic approach to mental health. These methods could offer new, non-pharmacological options for individuals with PTSD, potentially enhancing their quality of life in ways that standard treatments may not.

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

This trial will compare various treatment approaches for PTSD. Participants in the "Yoga and meditation" arm will engage in Hatha yoga classes via videoconferencing and self-learn the Mantram Repetition Program. Studies have shown that yoga and meditation can reduce symptoms like depression, anger, and trouble sleeping.

The "Wellness" arm will involve weekly exercise and nutrition classes to support lifestyle changes. Research suggests that regular exercise and a healthy diet can improve mental health and sleep for those with PTSD.

The "Positive affect" arm will focus on weekly classes aimed at increasing positive feelings and social support. Certain psychological techniques that boost positive feelings and social support have been found effective in managing PTSD symptoms. These combined approaches show promise for helping veterans with PTSD.678910

Are You a Good Fit for This Trial?

This trial is for Veterans with PTSD who are seeking treatment. Participants will be assessed at the start, and again at 12 and 24 weeks after starting a randomly assigned integrated care approach, which includes psychotherapy combined with mind-body interventions.

Inclusion Criteria

Able to consent to study activities
I have been diagnosed by a doctor.
I am eligible for Cognitive Processing Therapy at a VA site.

Exclusion Criteria

Current, active engagement in one of the included approaches (per clinician judgment)
I don't have any health issues that prevent me from participating in experimental treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 12 weeks of integrated care, with the type being randomly assigned

12 weeks
Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks
Assessments at 12 and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Integrated Health Care for PTSD
Trial Overview The study tests different integrative care approaches to improve functioning in Veterans with PTSD. These approaches include wellness education, positive affect training, informational support, as well as yoga and meditation practices.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: Yoga and meditationExperimental Treatment2 Interventions
Group II: WellnessExperimental Treatment2 Interventions
Group III: Positive affectExperimental Treatment2 Interventions
Group IV: Usual careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Veterans Medical Research Foundation

Lead Sponsor

Trials
46
Recruited
5,100+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

Positive Affect Processes and Posttraumatic Stress ...One purported outcome of and mechanism underlying PPMT's effects on PTSD is improved positive affect processes.
The efficacy of psychological interventions for adult post ...This meta-analysis reports strong evidence for the notion that psychological interventions are highly effective in treating not just patients with PTSD caused ...
Examining Functioning and Well-Being Outcomes in PTSD ...This study investigates the relationship between the effectiveness on depression/anxiety symptoms and positive mental health of. Acceptance and Commitment ...
Social support and treatment utilization for posttraumatic ...The findings revealed that low social support promoted subsequent treatment utilization, but such treatment did not lead to changes in social ...
Clinical Efficacy of Psychotherapeutic Interventions for Post ...Conclusions: A significant outcome of this study is the short-term effectiveness of CBT in reducing PTSD symptoms in children and adolescents. The findings ...
Social Bonds and Posttraumatic Stress Disorder - PMCThe study data in their totality suggest that negative and positive social support have different patterns of influence.
Social support and posttraumatic stress disorder: A meta ...Social support has long been associated with posttraumatic stress disorder (PTSD), but there is no consistent evidence on the strength and direction of this ...
Social support utilization's effect on post-traumatic stress ...This study aims to assess if number of used social support types predicts PTSS for ambulance personnel.
Effects of social supports on posttraumatic stress disorder ...The purpose of the study was to examine the moderating role of perceived safety on the relationship between social support and posttraumatic stress disorder ...
The Role of Social Support in Coping with Psychological ...Social support has demonstrated numerous protective effects, from buffering risk for negative psychological outcomes (e.g., post-traumatic ...
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