跳至主要内容
临床试验/NCT01853098
NCT01853098已完成不适用

Effect of a Novel Mindfulness Based Loving Kindness Meditation on Positive and Negative Affect

Boston University Charles River Campus2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
2
主要终点
Change from Baseline in Positive and Negative Affect Scale (PANAS)

研究概览

简要总结

The primary objective of this study is a proof-of-concept study to test whether a novel mindfulness based intervention, Positive Affect Training (PAT), can enhance positive affect and compassion, and decrease negative affect and feelings of depression. PAT involves a combination of practicing mindfulness meditation and loving-kindness meditation in groups. The goal of the research is to test the initial feasibility and efficacy in increasing positive affect and decreasing negative affect in individuals recruited from the general community who experience negative affect. If the training proves to be successful, we will test the intervention, in additional studies, on individuals with dysthymic disorder and other clinical disorders. PAT is a cost-effective, non-invasive intervention. Therefore if effective, it could be an alternative or supplemental intervention option to existing psychotherapy for dysthymic disorder.

详细描述

Loving-kindness meditation (LKM) and mindfulness meditation, in which PAT is rooted, are derived from Buddhist practices that have been empirically shown to have applications in improving mental health. Throughout the 1990s and early 2000s, mindfulness based CBT was shown to decrease stress, negative affect, and chronic pain in both psychiatric and non-psychiatric subjects. Mindfulness-based therapy has since been shown to be effective for treating mood and anxiety disorders. Only recently has LKM been examined as an intervention for affective symptoms. This meditation practice seems to be particularly suited for reducing negative affect while also enhancing positive affect in individuals who show emotional dysregulation, such as people with dysthymic disorder. This notion is supported by experimental studies suggesting that LKM decreases anxiety and stress, positively influences emotional responses to neutral stimuli, and promotes positive emotions such as trust, love, hope, and compassion. Dr. Fredrickson, a prominent researcher and social psychologist who is the foremost expert in LKM will serve as an outside consultant for the development of the protocol. She is not listed as an official collaborator because she will not be in direct contact with the participant data that the investigators will collect.

The intervention the investigators plan to develop, Positive Affect Training (PAT), combines mindfulness and LKM, with a strong emphasis on the latter. The investigators will adopt strategies that have been described in a previous LKM protocol for trauma victims. The investigators contacted Dr. Kearney who shared his manual with us. Given the impressive effect LKM seems to have on generating positive, and attenuating negative affect in experimental studies, the investigators plan to test PAT as a method of improving positive affect. The current study aims to test the initial efficacy of PAT in individuals who report experiencing a low mood. The investigators hypothesize significant improvement in subjects' self-reported ratings of negative and positive affect as a result of the intervention.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be at least 18 years of age
  • Responds positively to the question on the recruitment material (flyer and posting): "Have you been feeling depressed or in a low mood for most of the day, more days than not, nearly every day for 1 year or longer?"
  • Must have a negative affect scale score of the PANAS of at least 21.6 (1 SD above the mean of normative sample)

排除标准

  • Participants with a BDI score of 30 or higher (more than moderate depression) will be excluded.
  • Participants who are at risk of harming themselves will be excluded from participating in the study. Suicidality will be assessed after obtaining consent during the screening visit. In addition, the Beck Depression Inventory will be examined for self-reported suidicality. If a participant is found to have suicidal ideation, the PI will be contacted immediately and appropriate follow-up care will be provided by referring the participant to the ER.
  • Participants will be assessed through a phone screen using questions from the Anxiety Disorders Interview Schedule (ADIS) for disorders that could impose a safety risk for the participants or others (e.g., bipolar disorder, schizophrenia, etc). Subjects who endorse "yes" responses to phone screen items will be excluded.
  • Participants who are receiving any psychiatric or psychological treatment for a mood or anxiety disorder at the time of the assessment will be excluded from the study. Participants who initiate such treatments while being enrolled in the study will be closely monitored. These participants will be allowed to remain in the study, but will later be excluded from the data analyses. They are allowed to remain in the study for ethical reasons and because the present trial is a proof-of-concept study and not a clinical trial.

研究组 & 干预措施

Positive Affect Training (PAT)

Experimental

The intervention will be conducted in groups with 6-8 participants and 2 facilitators/therapists per group. The groups will meet once a week for 12 successive weeks and each session will be approximately 60 minutes long.

干预措施: Positive Affect Training (PAT) (Behavioral)

结局指标

主要结局

Change from Baseline in Positive and Negative Affect Scale (PANAS)

时间窗: 12 weeks

次要结局

  • Change from Baseline in Self-Compassion Scale (SCS)(12 weeks)
  • Change from Baseline in Beck Anxiety and Depression Scale (BDI)(12 weeks)
  • Change from Baseline in Compassionate Love Scale(12 weeks)

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan G. Hofmann

Dr.

Boston University

研究点 (2)

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