Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05094115 |
| Other study ID # |
HSC20210486H |
| Secondary ID |
W81XWH-19-1-0628 |
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 4, 2021 |
| Est. completion date |
August 2025 |
Study information
| Verified date |
September 2023 |
| Source |
The University of Texas Health Science Center at San Antonio |
| Contact |
Alan Peterson, PhD |
| Phone |
210-562-6700 |
| Email |
petersona3[@]uthscsa.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Security Force Assistance Brigades (SFABs) are specialized United States Army units formed to
train, advise, assist, enable and accompany operations with allied and partner nations.
Security Force Assistance Brigades are composed of roughly 800 senior military personnel,
primarily commissioned and non-commissioned officers selected from regular Army units across
a wide range of military specialties. Because of the high operational tempo (OPTEMPO) of
these units, individual resiliency is of utmost importance in maintaining readiness to
successfully execute critical, high-stress missions. Acceptance and Commitment Training (ACT)
is an evidence-based intervention with strong potential to enhance resiliency by bolstering
psychological flexibility along with other factors which have been demonstrated to optimize
individual and group performance. This project will compare an Acceptance and Commitment
Training-based resiliency-enhancement training program as compared to training as usual in
600 3rd Security Force Assistance Brigades soldiers stationed at Fort Hood in Killeen, Texas.
Assessment measures related to resilience will be administered before and after training as
well as before and after deployment. Assessments will be conducted at baseline, and every 4
months thereafter for a total of 16-months.
Description:
Over the past decade, the Department of Defense has also had a significant interest in the
development and evaluation of evidence-based programs for enhancing resiliency in military
personnel to help optimize operational readiness and prevent deployment-related psychological
health causalities (Peterson, Cigrang, & Isler, 2009). Maintaining health, optimizing
performance, and boosting resiliency to stressors in harsh combat environments is a momentous
challenge. Conducting research aimed at enhancing health, performance, and resiliency is
similarly challenging. As a result, few studies have documented evidence-based interventions
to maintain or boost performance under such harsh conditions. Thus, compared to the major
scientific and clinical advancements in the assessment and treatment of deployment-related
psychological health conditions in active duty military personnel, little research has been
conducted on the enhancement of resiliency in military personnel. A major challenge in the
development and evaluation of evidence-based resiliency-enhancement programs for military
personnel is the design of scientifically valid and methodologically sound research designs.
Most of the resiliency-enhancement programs developed to date-such as the Comprehensive
Soldier Fitness Program-have been evidenced-informed programs that were universally
implemented in ways that prevented rigorous scientific validation of their efficacy
(Steenkamp, Nash, & Litz, 2013). Consequently, prospective efficacy research is desperately
needed to evaluate potential approaches to enhance resiliency and optimize readiness in
military personnel.
Ideally, a resiliency enhancement training for military personnel would demonstrate not only
improvements in self-reported resiliency and other related constructs but also demonstrate
positive adaptation in the face of significant stress or adversity as a result of the
training (Britt, Sinclair, & McFadden, 2013). Adler and colleagues have conducted a series of
studies to evaluate the efficacy of resiliency training in active duty military populations
(Adler, et al., 2015; Adler et al., 2015; Cacioppo et al., 2015).
An excellent summary of the science of resiliency was completed as part of a systematic
review by Macedo et al., (2014) of interventions for building resilience in non-clinical
samples of adults. The summary of this review highlighted that to date, no prospective study
has evaluated the efficacy of resiliency-enhancement trainings and investigated the actual
occurrence of adverse situations after the training to document that the training improved
positive adaptation in the face of significant adversity. A Cochrane Report titled
Psychological Interventions for Resilience Enhancement in Adults (Helmreich et al., 2017) is
currently conducting a comprehensive review of the scientific literature on psychological
interventions to enhance resiliency in adults. The currently published protocol for this
Cochrane study indicates that Acceptance and Commitment Therapy is one of the most promising
psychological approaches for resilience enhancement in adults. The study team believe that
Acceptance and Commitment Therapy has some of the strongest scientific support for potential
adaptation for use in military training to enhance resiliency and optimize readiness.
Acceptance and Commitment Therapy, which is pronounced as one word ("act"), is a
contemporary, evidence-based, cognitive-behavioral approach to improving functioning and
performance (Hayes, 2004; Hayes et al., 2006). In Acceptance and Commitment Therapy, the
broad goal is to help individuals identify and act consistently with their values and goals
and to align their actions with those values even if they are experiencing pain or discomfort
(Hayes, 2004; Hayes et al., 2006). Acceptance and Commitment Therapy is rooted in a
well-established theory of human language and cognition (Relational Frame Theory), which
describes how internal experiences (e.g., thoughts, emotions, physiological sensations, and
urges) are viewed as behaviors that can be predicted and influenced. In Acceptance and
Commitment Therapy, trainees practice identifying these internal events for what they are
(i.e., transient phenomena) rather than as permanent experiences. Trainees learn to take a
stance characterized by active acceptance of and willingness to remain in contact with these
experiences rather than allocating attention and energy to attempts to control, reduce, or
eliminate negatively evaluated internal experiences. Examples of such negatively evaluated
internal experiences include physiological sensations such as pain or sensations associated
with lack of oxygen, emotions such as fear, and thoughts such as "I can't stand it" or "It's
not worth it." Under harsh conditions, it is highly unlikely if not impossible that attempts
to control, suppress, or eliminate such experiences will be successful. Thus, a behavioral
stance characterized by active acceptance and willingness is more adaptive, as it increases
the availability of personal resources for optimizing volitional control over one's behavior.
This volitional control may then be optimally applied toward goal attainment. Taking an
accepting, willing stance ultimately gives rise to greater psychological flexibility, which
is the primary target or mechanism in Acceptance and Commitment Therapy. As with elite
athletics, taking an adaptive, flexible stance is a core element of preparation for
successful performance.
There are over 250 published or in press randomized controlled trials (RCTs) using Acceptance
and Commitment Therapy to optimize functional outcomes in diverse domains including improving
workplace performance under stressful conditions, completing physical exercise regimens,
improving parenting skills, and adhering to dietary restrictions (Moran, 2015). Moreover,
Acceptance and Commitment Therapy has been studied extensively and demonstrated to improve
functioning among people living with a wide range of psychological and physical conditions,
syndromes, and injuries. Such randomized controlled trials span applications of Acceptance
and Commitment Therapy for depression, anxiety disorders, substance use disorder, psychosis,
personality disorders, tobacco use, eating disorders, and a range of medical health issues
(e.g., cancer, diabetes, chronic pain). Thus, Acceptance and Commitment Therapy has a proven
track record of improving performance and functioning across a range of conditions, including
those involving intense physical and emotional distress.
According to the Acceptance and Commitment Therapy model, suffering and impairment are
primarily the consequence of psychological inflexibility (i.e., inability to persist in or
change behavior according to situational or contextual factors and personally chosen values
due to problematic, inflexible reactions to negatively evaluated internal experiences).
Psychological inflexibility may be particularly detrimental when an individual is confronted
with stress or adversity (Hayes, 2004; Hayes et al., 2006). Thus, interventions targeting
increased psychological flexibility-Acceptance and Commitment Therapy being the foremost in
this field-are recommended not only for facilitating recovery after stressors but also for
enhancing resilience (e.g., Meyer, Frankfurt, et al., 2018; Meyer, Szabo, et al., 2019).
Highly relevant to the current proposal is a series of randomized experiments in which brief
interventions based on core components of the Acceptance and Commitment Therapy model were
shown to increase pain tolerance. In these studies, pain tolerance was operationalized as
increasing the amount of time spent on the task before quitting, which is an analogue for
greater persistence in an intense military training program. A brief acceptance-based
intervention led to large increases in pain tolerance compared to a control group (Masedo &
Rosa Esteve, 2007). Recently, a brief values-based intervention led to a 55% increase in pain
tolerance, whereas the control condition reported a 12% decrease in pain tolerance at
follow-up (Smith et al., 2018).
Additional empirical support for the Acceptance and Commitment Therapy model comes from a
study led by Co-PI Meyer demonstrating that psychological flexibility predicted lower overall
disability and greater quality of life in combat-exposed veterans, even after accounting for
Post Traumatic Stress Disorder symptom severity (Meyer, Frankfurt, et al., 2018). Acceptance
and Commitment Therapy includes mindfulness training to support the development of
psychological flexibility. This same study also found that mindfulness predicted lower
disability and greater quality of life in combat veterans over and above Post Traumatic
Stress Disorder severity. In Acceptance and Commitment Therapy, these modifiable factors are
targeted in order to promote trainees' ability to commit to engaging in goal- or
values-consistent behavior.
Consistent with the Acceptance and Commitment Therapy model, the recent report by the
Cochrane Collaboration that identified Acceptance and Commitment Therapy as an evidence-based
intervention for enhancing resilience listed psychological flexibility, the central target of
Acceptance and Commitment Therapy, as having the highest tier of evidence support for
promoting resilience (Helmreich et al., 2017). They also rated this relationship as having
the highest tier of empirical support. Specifically, more systematic reviews and
meta-analyses were included in the report for psychological flexibility than any other single
factor. The report delineated how Acceptance and Commitment Therapy is likely to enhance
resilience by bolstering psychological flexibility specifically through teaching mindfulness
and acceptance skills (e.g., maintaining contact with the present moment, cognitive
de-fusion, acceptance of or willingness to experience emotional distress) along with
behavior-change skills (e.g., committed action). In this way, the report authors posit
several resilience factors will be fostered in Acceptance and Commitment Therapy-based
resilience interventions (e.g., cognitive flexibility, purpose in life). In particular, based
on the available evidence, the report emphasized that acceptance of the full range of
emotions, particularly those that are uncomfortable and that is often associated with
behavioral avoidance, likely promotes successful adaptation to stressful conditions (i.e.,
resilience; Helmreich et al., 2017).
Security Force Assistance Brigades are specialized United States Army units formed to train,
advise, assist, enable and accompany operations with allied and partner nations. SFABs are
intended to reduce the burden of such operations on conventionally organized Brigade Combat
Teams (BCTs), allowing Brigade Combat Teams to focus on fighting near-peer threats. Designed
on the model of a standard infantry Brigade Combat Teams, Security Force Assistance Brigades
is composed of roughly 800 senior personnel, primarily commissioned and non-commissioned
officers selected from regular Army units and given additional training at the Military
Advisor Training Academy at Fort Benning, Georgia. The first such unit, the 1st Security
Force Assistance Brigades, began operations in February 2018. The 3rd Security Force
Assistance Brigades began operations at Fort Hood less than a year later in January 2019.
As with other highly trained and specialized military units deployed to hostile and uncertain
areas, the 3rd Security Force Assistance Brigades has been and will continue to be exposed to
physical and psychological stressors as part of their military service.
