NCT01619384

Brief Summary

This proposed study aims to determine whether decreasing stress levels in persons with posttraumatic stress disorder (PTSD) can lead to a change in the intestinal microbiota, assessed 8 weeks after enrollment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

3.4 years

First QC Date

June 11, 2012

Last Update Submit

November 17, 2014

Conditions

Posttraumatic Stress DisorderIrritable Bowel Syndrome

Keywords

posttraumatic stressirritable bowel

Outcome Measures

Primary Outcomes (1)

  • Change in intestinal microbiome

    characterization of the intestinal microbiome is a primary endpoint

    baseline, 8 weeks, 4-month follow-up

Study Arms (2)

Treatment as Usual

NO INTERVENTION

Usual VA care

MBSR

EXPERIMENTAL

participation in an 8-week stress reduction course (mindfulness-based stress reduction)

Behavioral: Mindfulness-Based Stress Reduction

Interventions

Mindfulness-Based Stress ReductionBEHAVIORAL

An 8-week validated stress reduction program, designed to teach mindfulness.

MBSR

Eligibility Criteria

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

You may qualify if:

  • posttraumatic stress disorder

You may not qualify if:

  • psychosis
  • suicidal ideation with intent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticIrritable Bowel Syndrome

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • David Kearney, MD

    Seattle Institute for Biomedical and Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 14, 2012

Study Start

July 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

US(1)