- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00120627
Mantram Repetition to Manage PTSD in Veterans
Efficacy of Mantram Repetition on PTSD Symptoms in Veterans
Visão geral do estudo
Status
Condições
Descrição detalhada
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).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
California
-
San Diego, California, Estados Unidos, 92161
- VA San Diego Healthcare System, San Diego, CA
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 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.
|
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.
|
Comparador Ativo: 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.
|
Usual care consisted of case management or meeting with Veterans at least once per month and monitoring medications, if prescribed.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) From DSM-IVTR
Prazo: 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. |
Pre-treatment and post-treatment
|
PTST Checklist (PCL) Civilian Version
Prazo: 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.
|
Pre-treatment and Post-treatment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Short-Form (SF)-12v2 Health Quality of Life (Mental Health Component Score)
Prazo: Pre-treatment and post-treatment
|
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.
|
Pre-treatment and post-treatment
|
Spiritual Well-being [Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing (FACIT-Sp)]
Prazo: Pre- & Post-Intervention
|
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.
|
Pre- & Post-Intervention
|
Mindfulness Attention Awareness Scale (MAAS)
Prazo: Baseline, Post-Intervention
|
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.
|
Baseline, Post-Intervention
|
Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LES-Q) General Activities
Prazo: Pre- & Post-Intervention
|
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.
|
Pre- & Post-Intervention
|
Brief Symptom Inventory 18 (BSI-18) With Subscales of Depression, Anxiety, and Somatization
Prazo: Pre-treatment and Post-treatment
|
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.
|
Pre-treatment and Post-treatment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jill E Bormann, PhD RN, VA San Diego Healthcare System, San Diego, CA
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NRI 04-041
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .