Use of Mindfulness Meditation With Iraqi/Afghanistan War Veterans
Primary Purpose
PTSD, Stress
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Meditation (MfM)
Sponsored by
About this trial
This is an interventional treatment trial for PTSD focused on measuring Post Traumatic Stress Disorder, Mindfulness Meditation
Eligibility Criteria
INCLUSION CRITERIA:
- Iraqi War veterans who have returned from deployment for at least 3 months
- The veterans must be willing to practice MfM for 45 minutes each day and agree to follow all treatment protocols.
EXCLUSION CRITERIA:
Patients with a documented diagnosis of:
- a thought disorder
- a bipolar disorder
- a borderline personality disorder
- active substance abuse/dependence,
Patients that are:
- homeless
- have pending legal dispositions
- are unable to hear, read, visualize, and/or comprehend the assessment
Sites / Locations
- Philadelphia VAMC
Outcomes
Primary Outcome Measures
Sleep & PTSD SYMPTOM SEVERITY -- (measured by) Actigraphy, PTSD Checklist (PCL), Functional Outcomes of Sleep Questionnaire (FOSQ),Pittsburgh Sleep Quality Index (PSQI) -- Self-report measures and actigraphy readings will be
collected at baseline, 8 weeks, and 12 weeks in
both groups.
Secondary Outcome Measures
PSYCHOLOGICAL WELLNESS ASSESSMENTS -- (measured by) Life Orientation Test (LOT), Perceived Wellness Survey (PWS), Spirituality Assessment Scale (SAS)
Full Information
NCT ID
NCT00375531
First Posted
September 12, 2006
Last Updated
January 25, 2018
Sponsor
Corporal Michael J. Crescenz VA Medical Center
Collaborators
Samueli Institute for Information Biology, University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT00375531
Brief Title
Use of Mindfulness Meditation With Iraqi/Afghanistan War Veterans
Official Title
Use of Mindfulness Meditation With Iraqi/Afghanistan War Veterans With Post Traumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Withdrawn
Why Stopped
protocol revisions were deemed unable to be completed by 8/2007
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Corporal Michael J. Crescenz VA Medical Center
Collaborators
Samueli Institute for Information Biology, University of Pennsylvania
4. Oversight
5. Study Description
Brief Summary
Objectives: The primary objective of this study is to conduct a randomized pilot study on the efficacy of Mindfulness Meditation (MfM) on sleep in post war Iraqi/Afghanistan veterans with PTSD. It is hypothesized that the change in sleep (measured by actigraphy), sleep self report measures, and PTSD symptoms (measured by the PTSD Checklist) from baseline, 8 weeks and 12 weeks will be greater for veterans with PTSD who are treated with MfM, controlling for pretreatment values and other clinical and demographic factors.
A secondary objective will investigate whether there is an improvement in psychological wellness (measured by optimism, perceived wellness, and spirituality) following MfM treatments.
It is hypothesized that change in optimism, perceived wellness, and spirituality from baseline, 8 weeks and 12 weeks will improve in veterans with PTSD who are treated with MfM, controlling for pretreatment values and other clinical and demographic factors. Physiological measures of actigraphy in the home will be done at baseline, eight weeks, and twelve weeks. Subjective measure of sleep include measurements of sleep and quality of life(FOSQ) and subjective sleep quality (PSQI). Other self-report measures that will examine psychological wellness include the Life Orientation Test (LOT), the Perceived Wellness Survey (PWS) and the Spirituality Assessment Scale (SAS).
Detailed Description
Research Design: This exploratory study is a randomized, controlled, repeated measures trial to estimate the effectiveness of mindfulness meditation (MfM) to improve the severity of PTSD symptoms, specifically sleep and anxiety, and to improve the psychological wellbeing in Iraqi veterans with PTSD. The study is a repeated measures, comparative study using a parallel design. Both groups will receive routine treatment for PTSD; in addition, the treatment group will receive 8 weeks (1.5 hours/week) of mindfulness meditation from a trained psychologist, (Co-PI, N Chychula) who has been conducting these mindfulness meditation groups with combat veterans for 3 years. Subjects will be asked to commit to practice mindfulness meditation practice for 45 minutes each day. Data will be collected at baseline, eight weeks, and twelve weeks (one month follow-up). An equal number of participants will be randomly assigned to each group with 15 assigned to each group.
Methodology: For purposes of this pilot study, mindfulness meditation will be delivered in the context of a structured manual driven program, developed to enhance awareness of moment-to-moment experience of perceived mental processes. Although rooted in Buddhist traditions, this program is not religious but aims to create a greater awareness of body sensations, feelings and thoughts. This is thought to allow greater perception of one's responses and a gradual reduction in negative affect accompanied by an improvement in vitality and coping and psychological wellbeing (Grossman, 2004).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Stress
Keywords
Post Traumatic Stress Disorder, Mindfulness Meditation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation (MfM)
Primary Outcome Measure Information:
Title
Sleep & PTSD SYMPTOM SEVERITY -- (measured by) Actigraphy, PTSD Checklist (PCL), Functional Outcomes of Sleep Questionnaire (FOSQ),Pittsburgh Sleep Quality Index (PSQI) -- Self-report measures and actigraphy readings will be
Title
collected at baseline, 8 weeks, and 12 weeks in
Title
both groups.
Secondary Outcome Measure Information:
Title
PSYCHOLOGICAL WELLNESS ASSESSMENTS -- (measured by) Life Orientation Test (LOT), Perceived Wellness Survey (PWS), Spirituality Assessment Scale (SAS)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Iraqi War veterans who have returned from deployment for at least 3 months
The veterans must be willing to practice MfM for 45 minutes each day and agree to follow all treatment protocols.
EXCLUSION CRITERIA:
Patients with a documented diagnosis of:
a thought disorder
a bipolar disorder
a borderline personality disorder
active substance abuse/dependence,
Patients that are:
homeless
have pending legal dispositions
are unable to hear, read, visualize, and/or comprehend the assessment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina M Chychula, Ph.D.
Organizational Affiliation
Philadelphia VAMC and University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia VAMC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of Mindfulness Meditation With Iraqi/Afghanistan War Veterans
We'll reach out to this number within 24 hrs