What is the mechanism of action of this treatment?

Common treatments for improving Quality of Life (QoL) that are similar to the SMART trial include cognitive-behavioral therapy (CBT), mindfulness-based stress reduction (MBSR), and other mind-body therapies. These interventions work by teaching patients skills to manage stress, enhance emotional regulation, and improve coping mechanisms. CBT focuses on changing negative thought patterns and behaviors, while MBSR emphasizes present-moment awareness and acceptance. These mechanisms are crucial for QoL patients as they help reduce stress, anxiety, and depression, leading to improved mental and physical well-being, better sleep, and enhanced overall life satisfaction.

What side effects are associated with this type of intervention?

Behavioral interventions like mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) are generally considered safe with minimal side effects. However, some individuals may experience temporary increases in anxiety, emotional discomfort, or distress as they confront and process difficult thoughts and feelings. Additionally, some participants might find the time commitment and regular practice requirements challenging. Overall, these side effects are typically mild and transient, making these interventions a favorable option for improving quality of life.

What prior FDA approvals exist?

There are no specific FDA approvals for treatments solely aimed at improving Quality of Life (QoL) through behavioral interventions like the Stress Management and Resilience Training (SMART). However, various behavioral therapies such as Cognitive Behavioral Therapy (CBT) and mindfulness-based interventions have been widely studied and recommended for their effectiveness in reducing stress and improving overall mental health. These therapies are often used in clinical practice to enhance resilience and QoL, although they do not have specific FDA approval for this indication.

What other types of research exist?

Promising alternatives to SMART for increasing resilience and reducing stress include: 1) Cognitive Behavioral Therapy (CBT), which has shown efficacy in reducing stress and improving quality of life; 2) Mindfulness-Based Stress Reduction (MBSR), which combines mindfulness meditation and yoga to reduce stress and enhance well-being; 3) Hypnotic Relaxation Therapy for Well-Being (HRT-WB), which has demonstrated improvements in well-being and reductions in psychological distress; 4) Mobile phone-based interventions, such as well-being apps, which provide accessible and tailored support for stress management and resilience training.

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Stress Management and Resilience Training for Stress in Air Force Personnel

N/A

Recruiting

Led By Stephen Hernandez, PhD

Research Sponsored by University of New Mexico

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes in self-reported pss from baseline at 12, 24, and 36 weeks post-smart completion

Awards & highlights

No Placebo-Only Group

Summary

This trial examines the effectiveness of the SMART program in helping U.S. Air Force personnel manage stress and build resilience. The program includes practices like gratitude and mindfulness and can be delivered in-person, via video calls, or through computer-based training. The study aims to find out which delivery method is most effective. The SMART program has been previously tested in various settings, including healthcare workers and employees at a medical center, showing significant improvements in stress, resilience, and mindfulness.

Who is the study for?

This trial is for active U.S. Air Force personnel at specific bases who are over 18 years old and can give informed consent. It's not open to those on temporary duty, civilians at the base, trainees in basic military training, prisoners, or anyone under 18.

What is being tested?

The trial tests Stress Management and Resilience Training (SMART) delivered either in-person/video-teleconference or via Computer-Based Training to see if it boosts resilience and reduces stress among participants over time up to 36 weeks post-training.

What are the potential side effects?

Since this intervention involves non-medical stress management techniques, traditional physical side effects are not expected; however, participants may experience varying psychological responses to the training.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes in self-reported cd-10 from baseline at 12, 24, and 36 weeks post-smart completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes in self-reported cd-10 from baseline at 12, 24, and 36 weeks post-smart completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes in self-reported cd-10 from baseline at 12, 24, and 36 weeks post-smart completion for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in Connor-Davidson 10-Item Scale (CD-10)

Secondary study objectives

Changes in Generalized Anxiety Disorder Scale (GAD-7)

Changes in Perceived Stress Scale (PSS)

Changes in Quality of Life (QOL)

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: RandomizationExperimental Treatment1 Intervention

At two study sites, we will randomly assign participants to the VTC/in-person group or CBT group using a ratio of 2:1 to assign participants to the VTC/in-person or CBT training modalities. We anticipate 84 participants (42 per site) will be assigned to the CBT modality and 168 (84 per site) will be assigned to the VTC/in-person modality.

Group II: Self-selectionActive Control1 Intervention

At two study sites, participants will be able to self-select which SMART training modality they will complete (VTC/in-person or CBT).We aim to recruit 250 participants in the self-selection arm.

Do I qualify?Apply below to find out

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 improving Quality of Life (QoL) that are similar to the SMART trial include cognitive-behavioral therapy (CBT), mindfulness-based stress reduction (MBSR), and other mind-body therapies. These interventions work by teaching patients skills to manage stress, enhance emotional regulation, and improve coping mechanisms. CBT focuses on changing negative thought patterns and behaviors, while MBSR emphasizes present-moment awareness and acceptance. These mechanisms are crucial for QoL patients as they help reduce stress, anxiety, and depression, leading to improved mental and physical well-being, better sleep, and enhanced overall life satisfaction.