Mind-Body Intervention for Veterans With PTSD

NCT ID: NCT02224989

Last Updated: 2018-05-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-12-31

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.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mind-Body Bridging

An awareness training program using mindfulness-based techniques.

Group Type: EXPERIMENTAL

Mind-Body Bridging

Intervention Type: BEHAVIORAL

An awareness training program. One 2 hr class per week for 10 weeks.

Interventions

Mind-Body Bridging

An awareness training program. One 2 hr class per week for 10 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Yoshio Nakamura

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoshio Nakamura, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Salt Lake City Veterans Affairs Health Care System

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

IRB_00052611

Identifier Type: -

Identifier Source: org_study_id