PTSDNCT00375531
Use of Mindfulness Meditation With Iraqi/Afghanistan War Veterans
A study testing Mindfulness Meditation (MfM) in people with PTSD and Stress, run by Corporal Michael J. Crescenz VA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- Mindfulness Meditation (MfM)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with a documented diagnosis of:
- a thought disorder
- a bipolar disorder
- a borderline personality disorder
- active substance abuse/dependence,
- Patients that are:
Show all 9Show fewer
- homeless
- have pending legal dispositions
- are unable to hear, read, visualize, and/or comprehend the assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Mindfulness Meditation With Iraqi/Afghanistan War Veterans With Post Traumatic Stress Disorder
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).
Read the 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).
- Being tested
- Mindfulness Meditation (MfM)
- Keywords
- Post Traumatic Stress Disorder, Mindfulness Meditation
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Meditation (MfM)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
PSYCHOLOGICAL WELLNESS ASSESSMENTS -- (measured by) Life Orientation Test (LOT), Perceived Wellness Survey (PWS), Spirituality Assessment Scale (SAS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startOct 2006
- Study completionAug 2007 (estimated)
Why it stopped: protocol revisions were deemed unable to be completed by 8/2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Samueli Institute for Information Biology, University of Pennsylvania
- Investigators
- Nina M Chychula, Ph.D., Principal investigator, Philadelphia VAMC and University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375531
- Sponsor's protocol ID
- 00890
- Other IDs
- USUHS #PA181BO-4
- Status last verified
- Oct 2007
- First submitted
- 12 Sep 2006
- Last updated
- 29 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Mindfulness Meditation With Iraqi/Afghanistan War Veterans With Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00375531
- Acronym / sponsor ID
- 00890
- Keywords
- Post Traumatic Stress Disorder, Mindfulness Meditation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: protocol revisions were deemed unable to be completed by 8/2007
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical CenterUS federal agency
- Collaborators
- Samueli Institute for Information Biology, University of Pennsylvania
- Study start
- Oct 2006
- Study completion
- Aug 2007 (estimated)
- First posted
- 13 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- a thought disorder
- a bipolar disorder
- a borderline personality disorder
- active substance abuse/dependence,
- homeless
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Meditation (MfM) | Behavioural | – |
Primary outcome
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.
1 secondary outcome
PSYCHOLOGICAL WELLNESS ASSESSMENTS -- (measured by) Life Orientation Test (LOT), Perceived Wellness Survey (PWS), Spirituality Assessment Scale (SAS)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nina M Chychula, Ph.D. principal investigator
Philadelphia VAMC and University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation (MfM) in people with PTSD and Stress, run by Corporal Michael J. Crescenz VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.