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临床试验/NCT02541630
NCT02541630撤回不适用

A Pilot Study of Big Mind for Veterans With PTSD

VA Salt Lake City Health Care System1 个研究点 分布在 1 个国家开始时间: 2015年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Feasibility

研究概览

简要总结

A variety of mindfulness-based interventions, such as Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy have been shown to be beneficial for individuals experiencing mood and anxiety symptoms. The aim of this pilot study is to test the feasibility of using a similar intervention, known as Big Mind, for veterans with PTSD and other psychological symptoms.

Big Mind is a method of self-exploration that utilizes a voice dialog technique to help individuals see the world and themselves from a variety of perspectives. The investigators hypothesize that this process will increase mindfulness and decrease self-referential thinking, which is associated with negative affect.

To test the feasibility of using this method, veterans with PTSD will complete a four-week group Big Mind class with a total of four sessions. The investigators will use a single group design with pre and post-intervention measures to assess tolerability and acceptance of the intervention. Secondary outcome measures will evaluate symptom improvement and increased mindfulness.

If this project demonstrates that using this intervention for veterans with PTSD is feasible, then more rigorous clinical trials will be warranted.

详细描述

In recent years, interventions involving mindfulness have become increasingly popular as complementary mind-body therapeutic strategies for a variety of medical and psychiatric conditions.

Mindfulness has been described as a practice of focusing attention on moment-by-moment experience with an attitude of curiosity, openness and acceptance. In other words, practicing mindfulness is simply experiencing the present moment. During mindfulness, awareness is focused on external sensory inputs, internal sensations, such as proprioception and pain, as well as awareness of the internal workings of the mind.

Mindfulness originated in Buddhist spiritual practices. One of these is Zen, a traditional Buddhist approach that primarily involves the practice of developing mindfulness by way of seated meditation. Two secular mindfulness-based interventions that have been extensively studied are Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT). MBSR was developed by Dr. Jon Kabat-Zinn at the University of Massachusetts Medical Center as secular method to utilize Buddhist mindfulness in mainstream psychology and medicine. MBSR includes education about stress as well as training on coping strategies and assertiveness in addition to mindfulness. MBCT was developed by Zindel Segal, Mark Williams and John Teasdale. MBCT is based upon MBSR and combines the principles of cognitive therapy with those of mindfulness to prevent relapse of depression. MBCT, like MBSR, utilizes secular mindfulness techniques including seated meditation.

A very large literature now supports the effectiveness of MBSR for social anxiety disorder, generalized anxiety disorder, improved psychological functioning among individuals with medical disorders and pain. Evidence indicates that MBCT is beneficial for unipolar depression relapse prevention, generalized anxiety disorder, panic disorder, hypochondriasis and social phobia. The strongest evidence is for relapse prevention in unipolar illness. Finally, a recent review and meta-analysis specifically addressed the effectiveness of MBSR and MBCT (and similar interventions) for reducing symptoms of anxiety and depression. The authors concluded that mindfulness based therapy improves symptoms of anxiety and depression across a wide range of severity and even when these symptoms are associated with other disorders.

The mechanisms underlying the effectiveness of mindfulness interventions are incompletely understood. However, considerable evidence suggests these approaches decrease depression and anxiety, at least in part, by altering self-referential thinking. For example, increased self-focused thinking is associated with affective symptoms. Furthermore, there is strong evidence that a particular type of thinking about self contributes to dysphoria in general and unipolar depression. Specifically, analytical self-focused rumination (thinking analytically about self and symptoms) is maladaptive. This cognitive style is associated with overgeneral autobiographical memory, global negative self-judgments, greater negative future thinking and dysphoria. Furthermore, there is compelling evidence that ruminative self-focus is associated with both the severity and duration of depressive symptoms as well as relapse of illness. In contrast to analytic self-focus, mindfulness (or experiential self-focus) is adaptive. Therefore, interventions that increase mindfulness and/or decrease analytical self-referential ruminations may be effective for depressive and anxiety symptoms. In fact, studies indicate that mindfulness approaches do in fact exert benefit as a result of both increasing mindfulness and decreasing self-focused rumination. These interventions also promote additional cognitive changes that may help ameliorate symptoms. One of these is enhancing compassion specifically including patience and kindness directed toward the self. Self-compassion is a predictor of psychological health and increases in caring for one's self appear to contribute to the effectiveness of these interventions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •male and female veterans with PTSD
  • •age 18 - 65
  • •ability to provide informed consent

排除标准

  • •diagnosis of any psychotic disorder
  • •psychotic symptoms secondary to a mood disorder or other condition
  • •diagnosis of cognitive impairment or dementia
  • •currently on facility suicide high-risk list
  • •pregnancy
  • •impaired decision-making capacity

结局指标

主要结局

Feasibility

时间窗: 4 weeks

The investigators will assess tolerability and acceptance of the intervention via subjective feedback from each participant at the end of week 4, and monitor drop out rates.

次要结局

  • Improvement of anxiety(4 weeks)
  • Increase in mindfulness(4 weeks)
  • Improvement of sleep(4 weeks)
  • Improvement of PTSD symptoms(4 weeks)
  • Improvement of depressive symptoms(4 weeks)

研究者

发起方
VA Salt Lake City Health Care System
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Daniela Solzbacher, MD

Resident Physician

University of Utah

研究点 (1)

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