NCT01093053

Brief Summary

The purpose of this study is to determine whether participation in mind-body skills groups by veterans who have experienced a stressful war-related situation and have symptoms of posttraumatic stress disorder (PTSD), will improve symptoms of PTSD, depression and anxiety, reduce anger, improve quality of life, quality of sleep and result in posttraumatic growth (a positive change that people can experience when they have been in a traumatic situation).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

3 years

First QC Date

March 24, 2010

Last Update Submit

January 27, 2014

Conditions

Stress Disorders, Post TraumaticBrain InjuriesDepressive DisorderAnxiety DisordersAnger

Keywords

Mind-Body Therapies

Outcome Measures

Primary Outcomes (1)

  • PTSD checklist - military version

    The PTSD checklist contains 17 items corresponding to the DSM-IV criteria for PTSD. Past month symptom severity is indicated using a 5 point scale.

    Baseline; 12 weeks; 20 weeks

Secondary Outcomes (7)

  • State-Trait Anger Expression Inventory-2

    Baseline;12 weeks; 20 weeks

  • The Pittsburgh Sleep Quality Index

    Baseline;12 weeks; 20 weeks

  • The Patient Health Questionnaire-9

    Baseline;12 weeks; 20 weeks

  • State-Trait Anxiety Inventory

    Baseline; 12 weeks; 20 weeks

  • The Posttraumatic Growth Inventory

    Baseline;12 weeks; 20 weeks

  • +2 more secondary outcomes

Study Arms (2)

Mind-Body Skills Groups

EXPERIMENTAL
Behavioral: Mind-Body Skills Groups

Standard Treatment

ACTIVE COMPARATOR
Other: Standard Treatment

Interventions

Mind-Body Skills GroupsBEHAVIORAL

The mind-body skills group program teaches participants how to do meditation, guided imagery, breathing techniques, and biofeedback. These mind-body techniques are taught and practiced in small groups of 8 to 10 people and also contain an element of social support.

Mind-Body Skills Groups
Standard TreatmentOTHER

May include individual or group psychotherapy consisting of cognitive behavioral therapy or present-centered (i.e. unrelated to mindfulness) psychotherapy as well as medication management. Medications for depression, anxiety, and sleep disorders are the most commonly used in standard treatment.

Standard Treatment

Eligibility Criteria

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

You may qualify if:

  • having experienced a deployment-related criterion A stressor and reporting post deployment stress symptoms which include: clinically diagnosed posttraumatic stress disorder (PTSD), or subthreshold PTSD symptoms
  • comorbid conditions may also include mild traumatic brain injury, or clinically significant levels of depression or anxiety.

You may not qualify if:

  • current uncontrolled psychotic or bipolar disorder
  • significant cognitive impairment
  • moderate or severe TBI
  • substance dependence
  • suicidal or homicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southeast Louisiana Veterans Healthcare System

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Combat DisordersBrain InjuriesDepressive DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesMood Disorders

Study Officials

  • James S Gordon, MD

    The Center for Mind-Body Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Founder and Director

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 25, 2010

Study Start

September 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

January 29, 2014

Record last verified: 2014-01

Locations

US(1)