Relaxation Response Training for PTSD Prevention in US Military Personnel (RR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01725854
Recruitment Status : Terminated (Loss of staff for completion)
First Posted : November 14, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
William Beaumont Army Medical Center

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Relaxation Response training Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : July 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: Relaxation Response Training
The Military tailored RR training program will consist of six weekly small group sessions which involve group presentations, in-group skill building exercises, and at-home assignments. Groups will contain 5-8 participants who are active-duty Soldiers enrolled in either Respect-MIL or the Interdisciplinary Pain Management Center (IPMC).
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.
Other Name: Benson-Henry Institute Relaxation response training
No Intervention: Standard of Care
Participants randomized to the control group will receive standard care through their providers at Respect-MIL or at the IPMC. Participants randomized to the control group will remain on the wait list for further standard care. After the collection of the final data point, these participants will also have the option to participate in an abbreviated, two-hour version of the RR training.

Primary Outcome Measures :
  1. Sleep [ Time Frame: 6 weeks ]
    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.

Secondary Outcome Measures :
  1. Anger [ Time Frame: 6 Weeks ]
    Anger, measured with the Spielberger State-Trait Anger Expression Inventory-2 (STAXI-2)

  2. Health Status [ Time Frame: 6 Weeks ]
    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)

  3. Resilience [ Time Frame: 6 Weeks ]
    Resilience will be measured with the Post Traumatic Growth Inventory

  4. Stress [ Time Frame: 6 Weeks ]
    Stress as measured with physiological measurements of blood pressure and heart rate (pulse) and subjective measurement using the Perceived Stress Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01725854

United States, Texas
William Beaumont Army Medical Center, Ft Bliss
El Paso, Texas, United States, 79920
Sponsors and Collaborators
William Beaumont Army Medical Center
Principal Investigator: Richard P Petri, MD William Beaumont Army Medical Center

Responsible Party: William Beaumont Army Medical Center Identifier: NCT01725854     History of Changes
Other Study ID Numbers: W81XWH-10-1-1011/ 367294
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study terminated

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders