Mind-Body Intervention for Veterans With PTSD



Status:Terminated
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 75
Updated:5/9/2018
Start Date:April 2015
End Date:December 31, 2017

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A Pilot Feasibility Study of a Novel Mind-body Intervention Program for Veterans With PTSD

This pilot project evaluates the efficacy of a mind-body awareness training intervention,
Mind-Body Bridging (MBB), in veteran patients with PTSD and comorbid symptoms. Evidence for
relative therapeutic benefit will be indicated by the difference in outcomes from pre- to
post-intervention for PTSD as the primary outcome.

PTSD is a difficult illness to treat and there is a lack of interventions that effectively
reduce it. In recent years, attention has focused on treating PTSD patients by including a
sleep-focused intervention since those with PTSD, such as military personnel, almost always
report some form of sleep disturbance (Neylan et al. 1998; Lewis et al. 2009). In fact, since
sleep disturbance is so prevalent in PTSD, it is considered a hallmark of PTSD diagnosis
(Ross et al. 1989). Two classical PTSD symptoms, hyperarousal and re-experiencing the
traumatic event, comprise sleep difficulty and nightmares, respectively (Lamarche and De
Koninck 2007). Preliminary evidence suggests that interventions targeting sleep may be
beneficial in the treatment of PTSD (Germain et al. 2007; Swanson et al. 2009; Nakamura et
al. 2011).

This study will evaluate the effectiveness of mind-body bridging (MBB) as a primary group
psychotherapy treatment for reduction of PTSD symptoms among veterans. MBB is an awareness
training program,(Block and Block 2007) which has been recently developed into a workbook
specifically for PTSD (Block and Block 2010). MBB has been used successfully at the George E.
Wahlen Veterans Affairs Medical Center (VAMC) for more than 5 years as an adjunctive
treatment. MBB is well accepted by veterans and anecdotally has been reported to improve mood
as well as PTSD and other anxiety symptoms. Furthermore, published pilot studies have
provided preliminary evidence of its benefits.(Tollefson et al. 2009; Nakamura et al. 2011).
In particular, Nakamura et al.(2011) tested a brief sleep-focused MBB intervention program in
a randomized controlled trial, which demonstrated improved sleep and decreased PTSD symptoms.
Our clinical experience and these preliminary studies indicate that a pilot feasibility study
of MBB as a specific treatment for PTSD is warranted.

The proposed, non-randomized single-group study of MBB will serve as a pilot feasibility
study investigating a 10-week MBB program offered to veterans who are clinically diagnosed to
suffer from PTSD. In this pilot study, we determine whether MBB is a beneficial intervention
program for PTSD and co-morbidities, including insomnia, depression, etc., based on
self-report measures and clinical evaluations.

Inclusion Criteria:

- Inclusion of subjects will be based on: pre-screening score of 50 or greater on the
PTSD Checklist for Military (PCL-M). Since we are also interested in the effects of
MBB on co-morbid illnesses besides PTSD, we will include subjects who present with
other behavioral health conditions, including sleep disturbance, depression, anxiety,
pain, and any general medical conditions, except as defined as exclusion criteria.
Subjects using anti-anxiety, anti-depressants, sleep and pain medications, and other
medications for any condition that is not under exclusion criteria will be admitted to
the study. Participants must be willing to commit to the 10-week course and complete
all outcome measures, be literate in English and able to provide informed consent.

Participants will be asked to refrain from engaging in other PTSD treatment programs for
the duration of the proposed study, but can remain on their medications and continue with
their usual medical or mental health care. They will also be allowed to continue with other
activities (such as physical exercise, meditation, yoga, etc.), which they may have already
incorporated into their life.

Exclusion Criteria:

- A patient will be excluded from the study under the following conditions:

1. currently enrolled in active PTSD treatment program.

2. identifying with major psychopathology (i.e., schizophrenia, mania, or poorly
controlled bipolar disorder, borderline or antisocial personality disorder) and
was psychiatrically hospitalized within the past 90 days.

3. cognitive impairment or dementia.

4. severe medical disease such as uncontrolled hypertension or diabetes, or terminal
illness, e.g., cancer.

5. active substance abuse disorder

6. suicidal ideation with intent
We found this trial at
1
site
Salt Lake City, Utah 84148
Phone: 801-585-7697
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Salt Lake City, UT
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