- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00120627
Mantram Repetition to Manage PTSD in Veterans
Efficacy of Mantram Repetition on PTSD Symptoms in Veterans
Přehled studie
Postavení
Podmínky
Detailní popis
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).
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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California
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San Diego, California, Spojené státy, 92161
- VA San Diego Healthcare System, San Diego, CA
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- Cognitive impairment including active psychosis, untreated bipolar disorder, dementia or personality disorder that interferes with group participation
- Presence of active, serious suicidal ideation
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Arm 1: Mantram + Usual Care
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.
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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 consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.
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Aktivní komparátor: Arm 2: Usual Care alone
Usual care alone is defined as receiving 6 weeks of medication and case management, as needed by each patient.
No group meetings.
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Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR
Časové okno: Pre-treatment and post-treatment
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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. |
Pre-treatment and post-treatment
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PTST Checklist (PCL) Civilian Version
Časové okno: Pre-treatment and Post-treatment
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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.
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Pre-treatment and Post-treatment
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)
Časové okno: Pre-treatment and post-treatment
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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.
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Pre-treatment and post-treatment
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Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]
Časové okno: Pre- & Post-Intervention
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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.
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Pre- & Post-Intervention
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Mindfulness Attention Awareness Scale (MAAS)
Časové okno: Baseline, Post-Intervention
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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.
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Baseline, Post-Intervention
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Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities
Časové okno: Pre- & Post-Intervention
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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.
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Pre- & Post-Intervention
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Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization
Časové okno: Pre-treatment and Post-treatment
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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.
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Pre-treatment and Post-treatment
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Jill E Bormann, PhD RN, VA San Diego Healthcare System, San Diego, CA
Publikace a užitečné odkazy
Obecné publikace
- 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.
- Bormann 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.
- Bormann 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.
- Bormann 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. Erratum In: Int J Behav Med. 2012 Jun;19(2):241.
- Bormann 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.
- Lang 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.
- Bormann 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- NRI 04-041
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