Portable Mantram Meditation for Veterans With Military Related PTSD
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 4
- 主要终点
- Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS)
研究概览
简要总结
The aim of this study was to determine the usefulness of a portable, meditation-based intervention called the Mantram Repetition Program (MRP) for Veterans with military-related posttraumatic stress disorder (PTSD). This study compared the individual delivery of the MRP to individual delivery of Present-Centered Therapy (PCT) at two sites in San Diego, California, and Bedford, Massachusetts.
详细描述
The investigators conducted a prospective, parallel group, two-site, randomized clinical trial on the therapeutic treatment efficacy of the Mantram Repetition Program (MRP) by offering it as a stand-alone intervention, compared to an attention control condition of Present Centered Therapy (PCT) in a diverse sample of Veterans with post-traumatic stress disorder (PTSD). Primary outcomes included clinician-assessed and self-reported PTSD symptom severity. Secondary outcomes included insomnia, depression, anger, spiritual well-being, and mindfulness. Veterans were were recruited from a variety of clinics, including primary care, women's health, and specialty clinics in two geographical locations within the Department of Veterans Affairs healthcare system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Read and write English fluently
- •Traumatic event related to military-duty, including combat, military training accidents, and military sexual trauma
- •Transportation to attend meetings and available to complete study protocols
- •Stable dose and type of PTSD medications for at least 6 weeks (per chart review)
- •Willing to track medication changes during study
排除标准
- •Inability to give informed, voluntary consent
- •Cognitive impairment sufficient to cause inability to complete the protocol
- •Psychotic symptoms
- •Dementia or other organic mental disorders that may cause inability to complete the protocol
- •Significant documented alcohol/substance abuse
- •Presence of severe suicidal urges or intent
- •Residence in a geographical area outside of San Diego County or Bedford, Massachusetts area
- •Current daily practice of any skills of any meditation-based program - including, but not limited to:
- •Transcendental Meditation (TM)
- •Vipassana or Insight Meditation
- •Loving-Kindness or Compassion Meditation
- •Mindfulness-Based Stress Reduction (MBSR) or other mindfulness program
- •Guided Imagery
- •Mantram Repetition
- •Passage Meditation
- •Walking Meditation
- •Zen or Buddhist meditation
- •Self-hypnosis, Bio-feedback, etc.
- •Other participant circumstances that, in the opinion of a consensus of the study team, would interfere with the safety of prospective participants or their need for treatment.
研究组 & 干预措施
Mantram Repetition Program (MRP)
A portable meditation-based "Mantram Repetition Program (MRP)" will be delivered individually in 8-weekly 1 hour sessions to teach a set of strategies for training attention to manage symptoms. For this study, the program targets symptoms of posttraumatic stress disorder (PTSD) in Veterans who have experienced military-related trauma.
干预措施: Mantram Repetition Program (MRP) (Behavioral)
Present Centered Therapy (PCT)
Present Centered Therapy (PCT) is a form of individually-delivered 8-weekly, 1 hour sessions that are problem-oriented to improve current coping. For this study, it served as an attention control arm for the non-specific effects of individual therapist interaction.
干预措施: Present Centered Therapy (PCT) (Behavioral)
结局指标
主要结局
Avoidance Subscale (Criterion C) on the Clinician Administered PTSD Scale (CAPS)
时间窗: Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.
This subscale measures the frequency and intensity of persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness as indicated by 3 or more of the following: (1) efforts to avoid thoughts, feelings, or conversations associated with the trauma, (2) efforts to avoid activities, places or people that arouse recollections of the trauma, (3) inability to recall an important aspect of the trauma, (4) markedly diminished interest or participation in significant activities, (5) feelings of detachment or estrangement from others, (6) restricted range of affect, and/or (7) sense of a foreshortened future. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 56 with higher scores indicating greater severity of avoidance.
Clinician-Administered PTSD Scale (CAPS) Diagnostic and Statistical Manual, 4th ed., Text Revision (DSM-IV)
时间窗: Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.
PTSD symptom severity is measured by CAPS to determine PTSD diagnosis. The scale rates 17 items representing the Diagnostic and Statistical Manual IV (DSM-IV) criteria B (re-experiencing), C (avoidance/numbing) and D (hyper-arousal). CAPS has demonstrated high levels of internal consistency, good inter-rater reliability, \& excellent convergent validity. The F1/I2 rule will be applied to establish the diagnosis of PTSD aligned with DSM-IV (e.g. one symptom of Criterion B, three of Criterion C, and two of Criterion D. The CAPS also includes an item to assess duration of PTSD symptoms. CAPS total score ranges from 0-136 with higher scores indicating greater symptom severity.
Hyperarousal (Criterion D) on the Clinician Administered PTSD Scale (CAPS)
时间窗: Baseline to post-treatment (week 8); baseline to 2 months post-treatment.
This subscale measures the frequency and intensity of increased arousal as indicated by two or more of the following: (1) difficulty falling or staying asleep, (2) irritability or outbursts of anger, (3) difficulty concentrating, (4) hypervigilance, and/or (5) exaggerated startle response. Duration of these symptoms is greater than one month and causes clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores range from 0 to 40. Higher scores indicate greater severity of symptoms.
Re-experiencing Subscale (Criterion B) on the Clinician Administered PTSD Scale (CAPS)
时间窗: Baseline to post-treatment (week 8); Baseline to 2 months post-treatment.
This subscale measures the frequency and intensity of (1) recurrent or intrusive recollections of trauma, (2) recurrent, distressing dreams of the trauma, (3) acting as if the traumatic event were recurring like a flashback, (4) intense psychological distress at exposure to internal or external cues that resemble the trauma; and/or (5) physiological reactivity on exposure to internal or external cues that symbolize or resemble an aspect of the trauma. Duration of these symptoms is greater than one month and symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of of functioning. Scores can range from 0 to 40 and higher scores mean greater severity of re-experiencing.
PTSD Checklist-Military Version [Diagnostic and Statistical Manual (DSM) IV-TR Version]
时间窗: Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.
PCL-M: PTSD Checklist-Military version (PCL-M) is a 17-item self-report screening instrument for PTSD symptoms related to military trauma. Items are scored on a 1 (not at all bothersome) to 5 (extremely bothersome) Likert scale. Total scores range from 17 to 85. Higher scores indicate greater symptom bothersomeness. A score of \> 50 can suggest PTSD Test-retest reliability is high (r = 0.96) and validity is adequate, with a Kappa of 0.64 agreement for PTSD diagnosis compared to the Structured Clinical Interview for DSM-IV.
次要结局
- Patient Health Questionnaire (PHQ-9) for Depression(Baseline to post-treatment (week 8); Baseline to 2-months post-treatment.)
- Insomnia Severity Index (ISI)(Baseline to post-treatment (week 8); baseline to 2 months post-treatment.)
- Spielberger State Anger Inventory-Short Form(Baseline to post-treatment (week 8); baseline to 2-months post-treatment.)
- Spielberger Trait Anger Inventory-Short Form(Baseline to post-treatment (week 8); baseline to 2-months post-treatment.)
- Functional Assessment of Chronic Illness Therapy-Spiritual Wellbeing Scale-Expanded (FACIT-SpEx)(Baseline to post-treatment (week 8); baseline to 2-months post-treatment.)
- Five Facet Mindfulness Questionnaire (FFMQ)(Baseline to post-treatment (week 8); baseline to 2-months follow-up.)