Clinical trial NCT01725854: Relaxation Response Training for PTSD Prevention in US Military Personnel
Official title: Relaxation Response (RR) Training for PTSD Prevention in Soldiers a.k.a. "SPIRIT SMART" (Stemming PTSD, Increasing Resilience and Impeding Trauma in Service Members: Assessing Relaxation Response Training)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Lead sponsor: William Beaumont Army Medical Center
Sponsor class: FED
First posted: 2012-11-14
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purposes of this study are to evaluate the acceptability and utility of a mind-body intervention on a convenience sample of Soldiers (n=120) who have screened positive through RESPECT-MIL for symptoms that may lead to post-traumatic stress and to test the effectiveness of this Relaxation Response (RR) intervention designed to decrease the physiological and psychosocial effects of stress and trauma. The study aims to enhance the psychological health of Soldiers with a RR intervention designed to promote self-awareness of physiological responses to stress and the ability to increase relaxation responses.

Detailed description: Specific Aims:

1. Demonstrate that trainers can be trained effectively to deliver the intervention, a mind-body skills training program based on the Benson-Henry Institute's standard RR training curriculum and tailored to a military population.
2. Evaluate feasibility, acceptability, and compliance to the training program in an active duty military population.
3. Compare outcomes on sleep disturbance, PTSD, stress-related symptoms, quality of life, and psychosocial variables related to resilience of Soldiers who receive the 6-week training program to promote the Relaxation Response to those Soldiers who do not receive the intervention.

Eligibility criteria: Inclusion Criteria:

* 18 years or older, male and female volunteer individual military Service Members, DoD civilians or approved contractors working for DoD, primarily from multidisciplinary healthcare providers.
* Willingness to participate in the research project.
* Committed to the entire period of time of the research project.
* Currently working or stationed at Ft Bliss, Texas.
* No impending orders for deployment/ TDY/ PCS/ ETS or retirement for at least 8 weeks from the day of study enrollment.
* Able to read and speak English.
* Capable to consent.

Exclusion Criteria:

• Diagnosed with severe PTSD or other mental health issues disclosed as self-reported

Primary outcomes:
measure: Sleep
timeFrame: 6 weeks
Secondary outcomes:
measure: Anger
timeFrame: 6 Weeks
measure: Health Status
timeFrame: 6 Weeks
measure: Resilience
timeFrame: 6 Weeks
measure: Stress
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: El Paso
country: United States
facility: William Beaumont Army Medical Center, Ft Bliss
state: Texas
Study officials:
affiliation: William Beaumont Army Medical Center
name: Richard P Petri, MD
role: PRINCIPAL_INVESTIGATOR
References: