Relaxation Response Training for PTSD Prevention in Soldiers
This is a six-week experimental, repeated-measures clinical trial that will use a two arm parallel design to compare the Relaxation Response (RR) training program to usual care through the RESPECT-MIL program in Soldiers at Fort Bliss, El Paso, Texas.
This design has some important advantages, particularly noting that the proposed pilot study represents the first study of RR training in the military. The most pragmatic and cost-effective initial research approach for multicomponent psychosocial interventions is to test the whole therapeutic package at once rather than to test only a single component of the package. In the event the “bundled” therapeutic package is effective, then subsequent and more expensive studies can be designed to “dismantle” the effects of various therapeutic components. If, however, study findings are negative with adequate numbers to detect statistical differences, then the need and scientific desire for subsequent expensive studies is reduced or even eliminated. We have used this same rationale to develop a pilot study design with adequate power to maximize the likelihood to detect statistical significance within resource constraints.
This prospective intervention study will collect data from different groups to measure outcomes of the intervention, fidelity and acceptability of the modified curriculum for a military population, and feasibility of the program’s use for other military populations. A mixed-model method will be applied to evaluate the outcomes of the RR approach for Service Members and the attitudes, barriers, challenges, feasibility, and benefits of implementing this for other military groups. Quantitative data from self-report instruments will be collected from participants and trainers, and qualitative data utilizing focus groups and interviews will be collected from key informants including professional experts, trainers, participants and staff.
Randomization procedures:
After obtaining informed consent, Soldiers will be randomized to the RR training intervention or control group. Soldiers who are eligible and consent to participate will be enrolled and randomly assigned to one of the two study groups, in a ratio of 1:1. Randomization will be done through a central assignment process, after eligibility is determined, participants have consented, and baseline measures have been taken to assure that treatment assignments are done independent. We will use a computer generated adaptive randomization algorithm to assign participants to the experimental group, to further ensure equal distribution of demographic and potentially confounding variables, as well as of co-morbidities. An intention to treat analysis will be done on all subjects who have been randomized.
Study Methodology/Procedures
Intervention group:
Following a “train the trainer” model, volunteer military personnel will be trained to conduct this specialized military tailored version adapted from the evidence-based successful Benson-Henry Institute’s (BHI) RR-based mind-body resiliency enhancement training program. The BHI program focuses on using RR skills, learning to maximize performance under stress, building psychophysical resiliency and using mind/body techniques for cognitive restructuring. The structure of the training, topics included and languaging has been tailored to a military population and adapted in an effort to make the training more relevant and acceptable to the Soldiers who will receive it.
The military tailored RR training program will consist of six small group sessions (approximately 20 participants) that involve group presentations, in-group skill building exercises, and at-home assignments. Examples of in-group skill building exercises are mini relaxations, diaphragmatic breathing, introduction to imagery, and eliciting the RR through Hatha Yoga. Presentation topics include Introduction to Mind/Body Medicine, Introduction to the RR, Experiential RR Sessions, and Introduction to Cognitive Restructuring: Thinking Positively. Home skill building assignments include relaxation/mind focus practice (10-20 minutes, once or twice a day, using CDs provided); an appreciation journal; self-monitoring through use of Biodots (biosensor technology that helps participants to monitor and regulate their psycho-emotional state); physical activity; balanced nutrition; and progress notes.
Control group (RESPECT-Mil):
Participants in the control group will receive standard care through RESPECT-MIL program. These participants who have been randomized to the control group, remain on the wait list for further RESPECT-MIL program (standard care) and will also be offered a condensed, two-hour version of the RR training program (including home exercises that can help them learn and build these skills) following completion of data collection. We believe even this small training program will provide benefit for control subjects and valuable skills that would not otherwise be available for these Soldiers.