Relaxation Response Training for PTSD Prevention in US Military Personnel

NCT01725854 | Terminated DMC

• 1 other identifier: W81XWH-10-1-1011/ 367294
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Anger

  6 Weeks

• Health Status

  6 Weeks

• Resilience

  6 Weeks

• Stress

  6 Weeks

Study Arms (2)

Relaxation Response Training

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

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.

Interventions

Relaxation Response training BEHAVIORAL

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.

Also known as: Benson-Henry Institute Relaxation response training

Relaxation Response Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• William Beaumont Army Medical Center: lead

Study Sites (1)

William Beaumont Army Medical Center, Ft Bliss

El Paso, Texas, 79920, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Richard P Petri, MD

  William Beaumont Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2012
• First Posted: November 14, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 2, 2016

Record last verified: 2016-10

Locations

US (1)