Relaxation Response Training for PTSD Prevention in US Military Personnel

Posttraumatic Stress Disorder Clinical Trial

— RR  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01725854
• Other study ID #: W81XWH-10-1-1011/ 367294
• Status: Terminated
• Phase: N/A
• First received: November 9, 2012
• Last updated: October 31, 2016
• Start date: July 2012
• Est. completion date: May 2015

Study information

• Verified date: October 2016
• Source: William Beaumont Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Relaxation Response training
Behavioral Relaxation Response Training (Benson-Henry Institute Relaxation Response Training) Participants randomized to the intervention group will participate in the six weekly RR sessions. Examples of in-group skill building exercises are mini relaxations, diaphragmatic breathing, introduction to imagery, and eliciting RR through Yoga. Presentations topics include Introduction to Mind/Body Medicine, Introduction to the RR, Experiential RR Sessions, and Introduction to Cognitive Restructuring. Home skill building assignments include relaxation focus practice, an appreciation journal, self-monitoring with Biodots (biosensor technology that helps participants to monitor and regulate their psycho-emotional state), physical activity, balanced nutrition, and progress notes.

Locations

Country	Name	City	State
United States	William Beaumont Army Medical Center, Ft Bliss	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep	Sleep will be measured pre and post intervention. Sleep will be measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI assesses sleep quality and disturbances during the past month based on seven component scores for sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction that sum to a global score. A Sleep Diary will also be used to measure sleep and related factors.	6 weeks	No
Secondary	Anger	Anger, measured with the Spielberger State-Trait Anger Expression Inventory-2 (STAXI-2)	6 Weeks	No
Secondary	Health Status	Health Status as measured with the Veterans RAND 12-item Health Survey Short Form (VR-12 or SF-12) and the Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being 12 (Non-Illness)	6 Weeks	No
Secondary	Resilience	Resilience will be measured with the Post Traumatic Growth Inventory	6 Weeks	No
Secondary	Stress	Stress as measured with physiological measurements of blood pressure and heart rate (pulse) and subjective measurement using the Perceived Stress Scale	6 Weeks	No