Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375531
Status:
WITHDRAWN
Last Update Posted:
2018-01-29
First Post:
2006-09-12
Brief Title:
Use of Mindfulness Meditation With IraqiAfghanistan War Veterans
Sponsor:
Corporal Michael J Crescenz VA Medical Center
Organization:
Corporal Michael J Crescenz VA Medical Center
Study Overview
Official Title:
Use of Mindfulness Meditation With IraqiAfghanistan War Veterans With Post Traumatic Stress Disorder
Status:
WITHDRAWN
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
protocol revisions were deemed unable to be completed by 82007
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 IraqiAfghanistan 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 lifeFOSQ 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
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 lifeFOSQ 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 15 hoursweek 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 ones responses and a gradual reduction in negative affect accompanied by an improvement in vitality and coping and psychological wellbeing Grossman 2004
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 ones responses and a gradual reduction in negative affect accompanied by an improvement in vitality and coping and psychological wellbeing Grossman 2004
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| USUHS PA181BO-4 | None | None | None |