Big Mind for Veterans With PTSD



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:August 2015
End Date:July 2016
Contact:Daniela Solzbacher, MD
Email:daniela.solzbacher@hsc.utah.edu
Phone:801-413-9010

Use our guide to learn which trials are right for you!

A Pilot Study of Big Mind for Veterans With PTSD

A variety of mindfulness-based interventions, such as Mindfulness-Based Stress Reduction and
Mindfulness-Based Cognitive Therapy have been shown to be beneficial for individuals
experiencing mood and anxiety symptoms. The aim of this pilot study is to test the
feasibility of using a similar intervention, known as Big Mind, for veterans with PTSD and
other psychological symptoms.

Big Mind is a method of self-exploration that utilizes a voice dialog technique to help
individuals see the world and themselves from a variety of perspectives. The investigators
hypothesize that this process will increase mindfulness and decrease self-referential
thinking, which is associated with negative affect.

To test the feasibility of using this method, veterans with PTSD will complete a four-week
group Big Mind class with a total of four sessions. The investigators will use a single
group design with pre and post-intervention measures to assess tolerability and acceptance
of the intervention. Secondary outcome measures will evaluate symptom improvement and
increased mindfulness.

If this project demonstrates that using this intervention for veterans with PTSD is
feasible, then more rigorous clinical trials will be warranted.

In recent years, interventions involving mindfulness have become increasingly popular as
complementary mind-body therapeutic strategies for a variety of medical and psychiatric
conditions.

Mindfulness has been described as a practice of focusing attention on moment-by-moment
experience with an attitude of curiosity, openness and acceptance. In other words,
practicing mindfulness is simply experiencing the present moment. During mindfulness,
awareness is focused on external sensory inputs, internal sensations, such as proprioception
and pain, as well as awareness of the internal workings of the mind.

Mindfulness originated in Buddhist spiritual practices. One of these is Zen, a traditional
Buddhist approach that primarily involves the practice of developing mindfulness by way of
seated meditation. Two secular mindfulness-based interventions that have been extensively
studied are Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive
Therapy (MBCT). MBSR was developed by Dr. Jon Kabat-Zinn at the University of Massachusetts
Medical Center as secular method to utilize Buddhist mindfulness in mainstream psychology
and medicine. MBSR includes education about stress as well as training on coping strategies
and assertiveness in addition to mindfulness. MBCT was developed by Zindel Segal, Mark
Williams and John Teasdale. MBCT is based upon MBSR and combines the principles of cognitive
therapy with those of mindfulness to prevent relapse of depression. MBCT, like MBSR,
utilizes secular mindfulness techniques including seated meditation.

A very large literature now supports the effectiveness of MBSR for social anxiety disorder,
generalized anxiety disorder, improved psychological functioning among individuals with
medical disorders and pain. Evidence indicates that MBCT is beneficial for unipolar
depression relapse prevention, generalized anxiety disorder, panic disorder, hypochondriasis
and social phobia. The strongest evidence is for relapse prevention in unipolar illness.
Finally, a recent review and meta-analysis specifically addressed the effectiveness of MBSR
and MBCT (and similar interventions) for reducing symptoms of anxiety and depression. The
authors concluded that mindfulness based therapy improves symptoms of anxiety and depression
across a wide range of severity and even when these symptoms are associated with other
disorders.

The mechanisms underlying the effectiveness of mindfulness interventions are incompletely
understood. However, considerable evidence suggests these approaches decrease depression and
anxiety, at least in part, by altering self-referential thinking. For example, increased
self-focused thinking is associated with affective symptoms. Furthermore, there is strong
evidence that a particular type of thinking about self contributes to dysphoria in general
and unipolar depression. Specifically, analytical self-focused rumination (thinking
analytically about self and symptoms) is maladaptive. This cognitive style is associated
with overgeneral autobiographical memory, global negative self-judgments, greater negative
future thinking and dysphoria. Furthermore, there is compelling evidence that ruminative
self-focus is associated with both the severity and duration of depressive symptoms as well
as relapse of illness. In contrast to analytic self-focus, mindfulness (or experiential
self-focus) is adaptive. Therefore, interventions that increase mindfulness and/or decrease
analytical self-referential ruminations may be effective for depressive and anxiety
symptoms. In fact, studies indicate that mindfulness approaches do in fact exert benefit as
a result of both increasing mindfulness and decreasing self-focused rumination. These
interventions also promote additional cognitive changes that may help ameliorate symptoms.
One of these is enhancing compassion specifically including patience and kindness directed
toward the self. Self-compassion is a predictor of psychological health and increases in
caring for one's self appear to contribute to the effectiveness of these interventions.

There is considerable evidence that MBSR and MBCT have broad spectrum antianxiety and
antidepressant effects as well as generally enhance psychological functioning and pain
tolerance. Nonetheless, these approaches are unlikely to be effective for all patients.
Thus, there is a need to evaluate the potential effectiveness of other mindfulness
interventions. Further, the effectiveness of MBSR and MBCT suggests that other mindfulness
interventions may also be beneficial and that studies of alternative approaches are
warranted. Finally, there is a compelling need to evaluate the use of mindfulness approaches
as adjunctive interventions for veterans with posttraumatic stress disorder (PTSD). The
purpose of this study is to pilot test the feasibility of using an alternative mindfulness
approach, Big Mind for veterans with PTSD seeking complementary and alternative treatment at
the George E. Wahlen VAMC.

Big Mind (BM), developed by Zen Master Dennis Genpo Merzel is a secular mindfulness and
self-discovery intervention that integrates aspects of Zen practice with a voice-dialogue
method. Voice-dialog is sometimes used as a therapeutic tool in western psychology. The BM
process guides individuals to shift their perspective, particularly in regard to
self-perception.

BM facilitates self-discovery by teaching participants to become aware of different aspects
of their sense of self by giving voice to these separate components. In other words, BM
facilitates becoming "mindful" or more aware of one's own cognitions and emotions. Aspects
of self may be cognitive constructs, such as the "Controller," the "Skeptic," the
"Self-Critic," the "Cheater" and "Doubt" or emotional states, such as "Fear," "Anger," "Joy"
or "Compassion" or sensations, such as "Pain." During a BM session, participants develop
self-awareness by speaking as specific component, or "voice" of self, such as "the voice of
Fear." Temporarily assuming the identity of an aspect in principle allows in depth
exploration of the cognitions and emotions associated with that particular construct. The
investigators hypothesize that his process can be therapeutically useful because facets
associated with negative traits (e.g. the Cheater) or unpleasant affect (Fear) may be
partially repressed and unacknowledged by the self. Bringing disowned voices to light
facilitates working with cognitions and emotions in a more constructive way. For example,
when one experiences chronic symptoms of anxiety (fear), the tendency is to try to avoid or
prevent the unpleasant emotion. However, "fear of the fear" actually increases the
discomfort and may result in the adoption of maladaptive strategies, such as excessive
substance use or avoidance. Further, "fear of fear" likely exacerbates anxiety by increasing
the baseline level of fear and perpetuating a vicious cycle of fear leading to even greater
fear. BM offers a unique approach by giving active voice to the fear. Thus, one is able to
examine the fear closely and come to recognize that it is transient and not harmful. When
one both allows and actively encourages the experience of fear, the "fear of fear"
dissipates and more adaptive behavior strategies can be adopted.

The BM process teaches how to shift perspective, therefore providing a means to escape the
cycle of repetitive self-criticism and unconscious behavioral patterns and emotional
responses. This is accomplished by viewing one's thoughts and behaviors from a neutral
standpoint rather than from an ego based or self-focused perspective. Becoming "mindful" of
these patterns facilitates taking conscious control of cognitive and emotional responses
rather than being controlled by them.

In addition to decreasing negative cognitions and emotions, the investigators also
hypothesize that BM increases mindfulness and decreases the analytic self-referential
thinking associated with depression and PTSD. One can become less attached one's
self-concept as well as the overall importance of self. This change in perception decreases
the need to think about self analytically and increases one's ability to experience life in
the here and now (mindfully).

BM has been used extensively over the last decade as a method of spiritual self-discovery.
However, it has not been used as a clinical intervention. Scientific studies have not been
conducted with the exception of one published study which suggested effectiveness as a rapid
spiritual intervention tool. This study also provided preliminary evidence that the BM
process increases mindfulness and decreases depression and anxiety. Based on the evidence
for other mindfulness interventions discussed above, the investigators hypothesize that an
adjunctive BM group intervention will decrease PTSD, mood and anxiety symptoms as well as
increase physical pain tolerance among veterans with PTSD.

The Big Mind intervention will be presented in a group format. There will be four group
sessions (90 minutes per group) and sessions will occur once weekly. Groups will be held in
a classroom or group room at the George E. Wahlen VAMC. The number of subjects per
intervention will be 5 - 10. The intervention will be repeated until a maximum of 30
subjects have been enrolled. Subjects will be given homework assignments to complete between
group sessions. Each session will include BM group practice and review of homework
assignments.

Study participants will complete six instruments at three time points of assessment: 1)
baseline assessment prior to session one; 2) mid-point assessment during the intervention
(end of week 2) and 3) post-intervention (end of week 4).

Attendance and reports of adverse events will be collected throughout the intervention.

Subject feedback will be obtained post-intervention (end of week 4).

Inclusion Criteria:

- male and female veterans with PTSD

- age 18 - 65

- ability to provide informed consent

Exclusion Criteria:

- diagnosis of any psychotic disorder

- psychotic symptoms secondary to a mood disorder or other condition

- diagnosis of cognitive impairment or dementia

- currently on facility suicide high-risk list

- pregnancy

- impaired decision-making capacity
We found this trial at
1
site
Salt Lake City, Utah 84108
Phone: 801-582-1565
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials