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

Primary Purpose

Posttraumatic Stress Disorder

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation Response training
Sponsored by
William Beaumont Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Posttraumatic Stress Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • William Beaumont Army Medical Center, Ft Bliss

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Relaxation Response Training

Standard of Care

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Anger
Anger, measured with the Spielberger State-Trait Anger Expression Inventory-2 (STAXI-2)
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)
Resilience
Resilience will be measured with the Post Traumatic Growth Inventory
Stress
Stress as measured with physiological measurements of blood pressure and heart rate (pulse) and subjective measurement using the Perceived Stress Scale

Full Information

First Posted
November 9, 2012
Last Updated
October 31, 2016
Sponsor
William Beaumont Army Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01725854
Brief Title
Relaxation Response Training for PTSD Prevention in US Military Personnel
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Loss of staff for completion
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
William Beaumont Army Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. Evaluate feasibility, acceptability, and compliance to the training program in an active duty military population. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation Response Training
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Response training
Other Intervention Name(s)
Benson-Henry Institute Relaxation response training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Anger
Description
Anger, measured with the Spielberger State-Trait Anger Expression Inventory-2 (STAXI-2)
Time Frame
6 Weeks
Title
Health Status
Description
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)
Time Frame
6 Weeks
Title
Resilience
Description
Resilience will be measured with the Post Traumatic Growth Inventory
Time Frame
6 Weeks
Title
Stress
Description
Stress as measured with physiological measurements of blood pressure and heart rate (pulse) and subjective measurement using the Perceived Stress Scale
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard P Petri, MD
Organizational Affiliation
William Beaumont Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Army Medical Center, Ft Bliss
City
El Paso
State/Province
Texas
ZIP/Postal Code
79920
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Study terminated

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Relaxation Response Training for PTSD Prevention in US Military Personnel

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