Clinical Trials Directory

Trials / Terminated

TerminatedNCT02224989

Mind-Body Intervention for Veterans With PTSD

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
47 (actual)
Sponsor
University of Utah · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALMind-Body BridgingAn awareness training program. One 2 hr class per week for 10 weeks.

Timeline

Start date
2015-04-01
Primary completion
2017-12-31
Completion
2017-12-31
First posted
2014-08-25
Last updated
2018-05-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02224989. Inclusion in this directory is not an endorsement.