NCT02224989

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

2.8 years

First QC Date

August 21, 2014

Last Update Submit

May 1, 2018

Conditions

Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (1)

  • Change in the self-report measure of PTSD using the PTSD Checklist for Military (PCLM), from baseline to 3 month follow-up.

    The PCL-M is a well-validated 17-item self-report measure to assess PTSD severity among military personnel; both male and female, to assess military-related PTSD. Reliability evidence is very good. Items are based on the Diagnostic and Statistical Manual-IV (DSM-IV) criteria, and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score.

    Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3 month follow-up

Secondary Outcomes (8)

  • Change in subjective measure of sleep using the Medical Outcomes Study - Sleep Scale (MOS-SS), from baseline to 3-month follow-up.

    Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up

  • Change in subjective measure of resilience using the Response to Stressful Experience Scale (RSES), from baseline to 3-month follow-up.

    Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up

  • 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.

    Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up

  • Change in subjective measure of depression using the Center for Epidemiologic Studies Depression Scale (CES-D), from baseline to 3-month follow-up.

    Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up

  • Change in subjective measure of mindfulness using the Five-facet Mindfulness Questionnaire (FFMQ), from baseline to 3-month follow-up.

    Baseline, 5 weeks (mid-treatment), 10 weeks (post-treatment), 3-month follow-up

  • +3 more secondary outcomes

Study Arms (1)

Mind-Body Bridging

EXPERIMENTAL

An awareness training program using mindfulness-based techniques.

Behavioral: Mind-Body Bridging

Interventions

Mind-Body BridgingBEHAVIORAL

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

Mind-Body Bridging

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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:
  • currently enrolled in active PTSD treatment program.
  • 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.
  • cognitive impairment or dementia.
  • severe medical disease such as uncontrolled hypertension or diabetes, or terminal illness, e.g., cancer.
  • active substance abuse disorder
  • suicidal ideation with intent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salt Lake City Veterans Affairs Health Care System

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Yoshio Nakamura, Ph.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 25, 2014

Study Start

April 1, 2015

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

May 7, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)