Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Samueli Institute for Information Biology
Sponsor:
Collaborator:
William Beaumont Army Medical Center
Information provided by (Responsible Party):
Samueli Institute for Information Biology
ClinicalTrials.gov Identifier:
NCT01725854
First received: November 9, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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 Intervention
Posttraumatic Stress Disorder
Behavioral: Relaxation Response training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Further study details as provided by Samueli Institute for Information Biology:

Primary Outcome Measures:
  • Sleep [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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:
  • Anger [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    Anger, measured with the Spielberger State-Trait Anger Expression Inventory-2 (STAXI-2)

  • Health Status [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    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)

  • Resilience [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    Resilience will be measured with the Post Traumatic Growth Inventory

  • Stress [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    Stress as measured with physiological measurements of blood pressure and heart rate (pulse) and subjective measurement using the Perceived Stress Scale


Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01725854

Contacts
Contact: Roxana E Delgado, MS 703-408-6234 rdelgado@siib.org
Contact: COL Richard P Petri, MD 915-742-3245 richard.petri@amedd.army.mil

Locations
United States, Texas
William Beaumont Army Medical Center, Ft Bliss Recruiting
El Paso, Texas, United States, 79920
Contact: Roxana E Delgado, PhD    915-742-3245    rdelgado@siib.org   
Contact: Richard P Petri, MD    915-742-3245    richard.p.petri@amedd.army.mil   
Principal Investigator: Richard P Petri, MD         
Sub-Investigator: Roxana E Delgado, MS         
Sub-Investigator: Joan Walter, JD, PA         
Sub-Investigator: Salvatore Libretto, PhD         
Sponsors and Collaborators
Samueli Institute for Information Biology
William Beaumont Army Medical Center
Investigators
Principal Investigator: Richard P Petri, MD William Beaumont Army Medical Center
  More Information

No publications provided

Responsible Party: Samueli Institute for Information Biology
ClinicalTrials.gov Identifier: NCT01725854     History of Changes
Other Study ID Numbers: W81XWH-10-1-1011/ 367294
Study First Received: November 9, 2012
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 24, 2014