Stress Disorders, Post TraumaticNCT00120627
Mantram Repetition to Manage PTSD in Veterans
A study of Stress Disorders, Post Traumatic, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
With ongoing war in Iraq, the incidence of posttraumatic stress disorder (PTSD) in combat veterans is increasing. Creation, implementation, and testing of new and innovative interventions are needed to provide additional options for enhancing the mental health of those with PTSD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post Traumatic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of PTSD, military related
- Score of greater or equal to 45 on the Clinician Administered PTSD Scale
- Read and write English
- Score of > 50 on PTSD Checklist
- Has a telephone with answering machine or voice mail to receive study messages
- Has a Case Manager assigned for usual care
- Willingness to track medications, relaxation techniques and number of case manager visit
Who cannot join
- Cognitive impairment including active psychosis, untreated bipolar disorder, dementia or personality disorder that interferes with group participation
- Presence of active, serious suicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
VA San Diego Healthcare System, San Diego, CA
San Diego, California, 92161
About this study
Official title: Efficacy of Mantram Repetition on PTSD Symptoms in Veterans
With ongoing war in Iraq, the incidence of posttraumatic stress disorder (PTSD) in combat veterans is increasing. Creation, implementation, and testing of new and innovative interventions are needed to provide additional options for enhancing the mental health of those with PTSD. Surveys indicate that veterans are interested in complementary approaches to health care. The purpose of this study is to determine the efficacy of the Mantram Repetition Program (MRP) delivered as a brief, 6-week, complementary and portable intervention. It includes frequent, silent repetitions of a mantram (mantra), a word or phrase with spiritual associations, to manage PTSD symptoms and improve quality of life military veterans with trauma.
Read the detailed description
The Mantram Repetition Program (MRP) is an innovative, portable meditation-based group intervention. In this study, the MRP was delivered in addition to usual care (defined as case management and medication) in a 6-week (90 minutes/week) group setting. The MRP was compared to usual care only.
This 4-year study employed a mixed-methods, prospective, randomized controlled trial with qualitative phone interviews at 3 months post-intervention to explore ways that the intervention was used. Outpatient Veterans (N=146) with military-related PTSD were recruited from a single VA site and randomly assigned to the experimental arm (n=71) which consisted of usual care and the mantram program versus usual care only control group (n=76).
- Conditions
- Stress Disorders, Post Traumatic
- Being tested
- Mantram Repetition Program (MRP) plus Usual Care, Usual care consisting of medication and case management
- Keywords
- Randomized Controlled Trial, Intervention Study, Mindfulness, Complementary Therapy, Mind-Body Relations (Metaphysics), Spiritual Therapy, Meditation, Qualitative Analysis
- Medical subject headings
- Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mantram Repetition Program (MRP) plus Usual CareBehavioural
The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A "mantram" is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting.
Usual care consisting of medication and case managementOther
Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Mantram + Usual Care | Experimental | Mantram Repetition Program for PTSD delivered in this study as 6-week, 90-minute per week that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management. Receives: Behavioral: Mantram Repetition Program (MRP) plus Usual Care; Other: Usual care consisting of medication and case management |
| Arm 2: Usual Care alone | Active comparator | Usual care alone is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings. Receives: Other: Usual care consisting of medication and case management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR
The Clinician Administered PTSD Scale (CAPS) is used to determine PTSD symptom severity and the presence or absence of a PTSD diagnosis. The total score is obtained by summing the frequency and intensity ratings for 17 items using a 5-point scale. Scores are summed and range from 0-136. The items for frequency are rated from 0="never" to 4="daily or almost everyday." The items for intensity are rated from 0="none" to 4="extreme." Higher scores indicate greater symptom severity. Total scores greater than 45 indicate the presence of a PTSD diagnosis.
The CAPS also has 3 subscales: 1) Criterion B (re-experiencing) has 5 items that are summed and scores range from 0 to 40; 2) Criterion C (avoidance) has 7 items that are summed and scores range from 0 to 56; and 3) Criterion D (hyper-arousal) has 5 items that are summed and scores range from 0 - 40. Higher scores indicate worse symptoms.
Measured: Pre-treatment and post-treatment
PTST Checklist (PCL) Civilian Version
The PTSD Checklist-Civilian is a 17 item self-report measure using a 5-point Likert scale to indicate how much one is bothered by the symptoms of PTSD from trauma. Items are rated from 0="not at all" to 5="extremely". Higher scores indicate greater severity and scores range from 17-85.
Measured: Pre-treatment and Post-treatment
Secondary outcomes (5)
Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)
Short-Form (SF)-12v2 measures health-related quality of life changes in mental and physical health function. The subscale SF12 Norm-Based Mental Component Summary Score rates mental health functioning. Items include "feeling calm and peaceful, having alot of energy, feeling downhearted and blue" -- all rated on a frequency scale from 1= "all of the time" to 6="none of the time." Other items ask if emotional problems such as feeling anxious or depressed interfere with (1) "accomplishing less than you like" and (2) "not doing work or activies as carefully as usual" (yes or no). Items are weighted and summed, and then converted to a 0 to 100 scale with higher scores indicating greater improvements.
Measured: Pre-treatment and post-treatment
Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]
FACIT-SP a measure of existential spiritual well-being. It contains 12 items that assess levels of "feeling peaceful," "having meaning and purpose in life" and "finding comfort in faith or spiritual beliefs." Items are rated on a 5-point Likert scale: 0 = "not at all" and 4 = "very much". Scores can range from 0 to 48. Higher scores reflect greater levels of spiritual well-being.
Measured: Pre- & Post-Intervention
Mindfulness Attention Awareness Scale (MAAS)
The Mindfulness Attention Awareness Scale (MAAS) is a 15-item questionnaire scored from 1 (almost always) to 6 (almost never) assessing individual differences in frequency of mindful states over time. Scores range from 15 to 90. Higher scores indicate greater mindful attention awareness. Mindfulness has been linked to well-being and quality of life. This questionnaire has documented content validity using factor analysis, evidence of convergent and discriminant validity, and test-retest reliability.
Measured: Baseline, Post-Intervention
Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities
Quality of Life Enjoyment \& Satisfaction Questionnaire general activities scale measures quality of life and satisfaction of 14 domains on a 1 (very poor) to 5 (very good) rating scale. Scores are summed and can range from 14 to 70 with higher scores indicating greater quality of life. Domains assessed represent physical health, mood, work/volunteer activity, household activity, social relationships, family relationships, leisure time activities, ability to function in daily life, sexual interest, economic status, living/housing situation, ability to get around physically without being unsafe, ability to do work or hobbies, and overall sense of wellbeing.
Measured: Pre- & Post-Intervention
Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization
The Brief Symptom Inventory 18 (BSI-18) is a self-report questionnaire with three subscales representing depressive symptoms, anxiety, and somatization. Each subscale consists of 6-items rated from 0=no symptoms to 4=great deal of symptoms. Scores for each subscale are summed and each subscale ranges from 0-24 with higher scores meaning worse symptoms.
Measured: Pre-treatment and Post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2005 (estimated)
- Study startNov 2005
- Primary completionFeb 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post TraumaticStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jill E Bormann, PhD RN, Principal investigator, VA San Diego Healthcare System, San Diego, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120627
- Sponsor's protocol ID
- NRI 04-041
- Status last verified
- Aug 2014
- First submitted
- 12 Jul 2005
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bormann JE. Frequent, Silent Mantram Repetition: A Jacuzzi for the Mind. Topics in Emergency Medicine. 2005 Apr 1; 27(2):163-166.
Bormann JE, Thorp S, Wetherell JL, Golshan S. A spiritually based group intervention for combat veterans with posttraumatic stress disorder: feasibility study. J Holist Nurs. 2008 Jun;26(2):109-16. doi: 10.1177/0898010107311276. Epub 2008 Mar 20.
PubMed 18356284Bormann JE, Smith TL, Shively M, Dellefield ME, Gifford AL. Self-monitoring of a stress reduction technique using wrist-worn counters. J Healthc Qual. 2007 Jan-Feb;29(1):45-52. doi: 10.1111/j.1945-1474.2007.tb00175.x.
PubMed 17518033Bormann JE, Smith TL, Becker S, Gershwin M, Pada L, Grudzinski AH, Nurmi EA. Efficacy of frequent mantram repetition on stress, quality of life, and spiritual well-being in veterans: a pilot study. J Holist Nurs. 2005 Dec;23(4):395-414. doi: 10.1177/0898010105278929.
PubMed 16251489Bormann JE, Hurst S, Thorp SR, Glaser D. Spiritually-Based Mantram Repetition to Manage PTSD in Veterans: A Qualitative Analysis of Use and Outcomes. [Abstract]. Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2010 Apr 1; 39(Suppl 1):216.
Bormann JE, Liu L, Thorp SR, Lang AJ. Spiritual wellbeing mediates PTSD change in veterans with military-related PTSD. Int J Behav Med. 2012 Dec;19(4):496-502. doi: 10.1007/s12529-011-9186-1.
PubMed 21874605Bormann JE. Spiritual well-being and PTSD symptoms in veterans: A predictive model. [Abstract]. Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2009 Dec 1; Suppl:114.
Bormann JE, Hurst S, Kelly A. Responses to Mantram Repetition Program from Veterans with posttraumatic stress disorder: a qualitative analysis. J Rehabil Res Dev. 2013;50(6):769-84. doi: 10.1682/JRRD.2012.06.0118.
PubMed 24203540Lang AJ, Strauss JL, Bomyea J, Bormann JE, Hickman SD, Good RC, Essex M. The theoretical and empirical basis for meditation as an intervention for PTSD. Behav Modif. 2012 Nov;36(6):759-86. doi: 10.1177/0145445512441200. Epub 2012 Jun 5.
PubMed 22669968Bormann JE, Thorp SR, Wetherell JL, Golshan S, Lang AJ. Meditation-Based Mantram Intervention for Veterans with Posttraumatic Stress Disorder: A Randomized Trial. Psychological trauma : theory, research, practice and policy. 2013 Jan 1; 5(3):259-267.
Bormann JE, Oman D, Walter KH, Johnson BD. Mindful attention increases and mediates psychological outcomes following mantram repetition practice in veterans with posttraumatic stress disorder. Med Care. 2014 Dec;52(12 Suppl 5):S13-8. doi: 10.1097/MLR.0000000000000200.
PubMed 25397817
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mantram Repetition on PTSD Symptoms in Veterans
- ClinicalTrials.gov ID
- NCT00120627
- Acronym / sponsor ID
- NRI 04-041
- Conditions
- Stress Disorders, Post Traumatic
- Keywords
- Randomized Controlled Trial, Intervention Study, Mindfulness, Complementary Therapy, Mind-Body Relations (Metaphysics), Spiritual Therapy, Meditation, Qualitative Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 18 Jul 2005 (estimated)
- Results
- Posted 27 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With ongoing war in Iraq, the incidence of posttraumatic stress disorder (PTSD) in combat veterans is increasing. Creation, implementation, and testing of new and innovative interventions are needed to provide additional options for enhancing the mental health of those with PTSD. Surveys indicate that veterans are interested in complementary approaches to health care. The purpose of this study is to determine the efficacy of the Mantram Repetition Program (MRP) delivered as a brief, 6-week, complementary and portable intervention. It includes frequent, silent repetitions of a mantram (mantra), a word or phrase with spiritual associations, to manage PTSD symptoms and improve quality of life military veterans with trauma.
Detailed description
The Mantram Repetition Program (MRP) is an innovative, portable meditation-based group intervention. In this study, the MRP was delivered in addition to usual care (defined as case management and medication) in a 6-week (90 minutes/week) group setting. The MRP was compared to usual care only.
This 4-year study employed a mixed-methods, prospective, randomized controlled trial with qualitative phone interviews at 3 months post-intervention to explore ways that the intervention was used. Outpatient Veterans (N=146) with military-related PTSD were recruited from a single VA site and randomly assigned to the experimental arm (n=71) which consisted of usual care and the mantram program versus usual care only control group (n=76).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Mantram + Usual Care | Experimental | Behavioral: Mantram Repetition Program (MRP) plus Usual Care, Other: Usual care consisting of medication and case managementMantram Repetition Program for PTSD delivered in this study as 6-week, 90-minute per week that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management. |
| Arm 2: Usual Care alone | Active comparator | Other: Usual care consisting of medication and case managementUsual care alone is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary diagnosis of PTSD, military related
- Score of greater or equal to 45 on the Clinician Administered PTSD Scale
- Read and write English
- Score of > 50 on PTSD Checklist
- Has a telephone with answering machine or voice mail to receive study messages
Key exclusion criteria (2 listed)
- Cognitive impairment including active psychosis, untreated bipolar disorder, dementia or personality disorder that interferes with group participation
- Presence of active, serious suicidal ideation
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 |
|---|---|---|
| Mantram Repetition Program (MRP) plus Usual CareThe MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A "mantram" is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting. | Behavioural | Arm 1: Mantram + Usual Care |
| Usual care consisting of medication and case managementUsual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed. | Other | Arm 1: Mantram + Usual Care, Arm 2: Usual Care alone |
Primary outcome
Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR
Time frame: Pre-treatment and post-treatment
The Clinician Administered PTSD Scale (CAPS) is used to determine PTSD symptom severity and the presence or absence of a PTSD diagnosis. The total score is obtained by summing the frequency and intensity ratings for 17 items using a 5-point scale. Scores are summed and range from 0-136. The items for frequency are rated from 0="never" to 4="daily or almost everyday." The items for intensity are rated from 0="none" to 4="extreme." Higher scores indicate greater symptom severity. Total scores greater than 45 indicate the presence of a PTSD diagnosis. The CAPS also has 3 subscales: 1) Criterion B (re-experiencing) has 5 items that are summed and scores range from 0 to 40; 2) Criterion C (avoidance) has 7 items that are summed and scores range from 0 to 56; and 3) Criterion D (hyper-arousal) has 5 items that are summed and scores range from 0 - 40. Higher scores indicate worse symptoms.
PTST Checklist (PCL) Civilian Version
Time frame: Pre-treatment and Post-treatment
The PTSD Checklist-Civilian is a 17 item self-report measure using a 5-point Likert scale to indicate how much one is bothered by the symptoms of PTSD from trauma. Items are rated from 0="not at all" to 5="extremely". Higher scores indicate greater severity and scores range from 17-85.
5 secondary outcomes
Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)
Time frame: Pre-treatment and post-treatment
Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]
Time frame: Pre- & Post-Intervention
Mindfulness Attention Awareness Scale (MAAS)
Time frame: Baseline, Post-Intervention
Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities
Time frame: Pre- & Post-Intervention
Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization
Time frame: Pre-treatment and Post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBormann JE. Frequent, Silent Mantram Repetition: A Jacuzzi for the Mind. Topics in Emergency Medicine. 2005 Apr 1; 27(2):163-166.
- Background: PubMed 18356284Bormann JE, Thorp S, Wetherell JL, Golshan S. A spiritually based group intervention for combat veterans with posttraumatic stress disorder: feasibility study. J Holist Nurs. 2008 Jun;26(2):109-16. doi: 10.1177/0898010107311276. Epub 2008 Mar 20.
- Background: PubMed 17518033Bormann JE, Smith TL, Shively M, Dellefield ME, Gifford AL. Self-monitoring of a stress reduction technique using wrist-worn counters. J Healthc Qual. 2007 Jan-Feb;29(1):45-52. doi: 10.1111/j.1945-1474.2007.tb00175.x.
- Background: PubMed 16251489Bormann JE, Smith TL, Becker S, Gershwin M, Pada L, Grudzinski AH, Nurmi EA. Efficacy of frequent mantram repetition on stress, quality of life, and spiritual well-being in veterans: a pilot study. J Holist Nurs. 2005 Dec;23(4):395-414. doi: 10.1177/0898010105278929.
- Results publicationBormann JE, Hurst S, Thorp SR, Glaser D. Spiritually-Based Mantram Repetition to Manage PTSD in Veterans: A Qualitative Analysis of Use and Outcomes. [Abstract]. Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2010 Apr 1; 39(Suppl 1):216.
- Results publication: PubMed 21874605Bormann JE, Liu L, Thorp SR, Lang AJ. Spiritual wellbeing mediates PTSD change in veterans with military-related PTSD. Int J Behav Med. 2012 Dec;19(4):496-502. doi: 10.1007/s12529-011-9186-1.
- Results publicationBormann JE. Spiritual well-being and PTSD symptoms in veterans: A predictive model. [Abstract]. Annals of behavioral medicine : a publication of the Society of Behavioral Medicine. 2009 Dec 1; Suppl:114.
- Results publication: PubMed 24203540Bormann JE, Hurst S, Kelly A. Responses to Mantram Repetition Program from Veterans with posttraumatic stress disorder: a qualitative analysis. J Rehabil Res Dev. 2013;50(6):769-84. doi: 10.1682/JRRD.2012.06.0118.
- Results publication: PubMed 22669968Lang AJ, Strauss JL, Bomyea J, Bormann JE, Hickman SD, Good RC, Essex M. The theoretical and empirical basis for meditation as an intervention for PTSD. Behav Modif. 2012 Nov;36(6):759-86. doi: 10.1177/0145445512441200. Epub 2012 Jun 5.
- Results publicationBormann JE, Thorp SR, Wetherell JL, Golshan S, Lang AJ. Meditation-Based Mantram Intervention for Veterans with Posttraumatic Stress Disorder: A Randomized Trial. Psychological trauma : theory, research, practice and policy. 2013 Jan 1; 5(3):259-267.
- Derived from this study: PubMed 25397817Bormann JE, Oman D, Walter KH, Johnson BD. Mindful attention increases and mediates psychological outcomes following mantram repetition practice in veterans with posttraumatic stress disorder. Med Care. 2014 Dec;52(12 Suppl 5):S13-8. doi: 10.1097/MLR.0000000000000200.
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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.
Jill E Bormann, PhD RN principal investigator
VA San Diego Healthcare System, San Diego, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Stress Disorders, Post Traumatic, run by US Department of Veterans Affairs 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 7 inclusion and 2 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: finished, as of the sponsor's last update on 28 Apr 2015. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR (time frame: Pre-treatment and post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00120627, which also lists 11 linked publications.
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 28 Apr 2015.