Clinical trial NCT02224989: Mind-Body Intervention for Veterans With PTSD
Official title: A Pilot Feasibility Study of a Novel Mind-body Intervention Program for Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the self-report measure of PTSD using the PTSD Checklist for Military (PCLM), from baseline to 3 month follow-up.
timeFrame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3 month follow-up
Secondary outcomes:
measure: Change in subjective measure of sleep using the Medical Outcomes Study - Sleep Scale (MOS-SS), from baseline to 3-month follow-up.
timeFrame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
measure: Change in subjective measure of resilience using the Response to Stressful Experience Scale (RSES), from baseline to 3-month follow-up.
timeFrame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
measure: Change in subjective measure of Health Related Quality of Life using the Medical Outcomes Study SF-36 for Veterans (VR-36), from baseline to 3-month follow-up.
timeFrame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
measure: Change in subjective measure of depression using the Center for Epidemiologic Studies Depression Scale (CES-D), from baseline to 3-month follow-up.
timeFrame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
measure: Change in subjective measure of mindfulness using the Five-facet Mindfulness Questionnaire (FFMQ), from baseline to 3-month follow-up.
timeFrame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
measure: Change in subjective measure of well-being using the Well-Being Index (WBI), from baseline to 3-month follow-up.
timeFrame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
measure: Change in subjective measure of health-related quality of life using the Medical Outcomes Study Short Form - 12 (SF-12), from baseline to 3-month follow-up.
timeFrame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
measure: Change in subjective measure of quality of life using the Mind-Body Bridging Quality of Life scale (MBB QOL), from baseline to 3-month follow-up.
timeFrame: Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Salt Lake City Veterans Affairs Health Care System
state: Utah
Study officials:
affiliation: University of Utah
name: Yoshio Nakamura, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: