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临床试验/NCT03403764
NCT03403764已完成不适用

Consciousness Field Project: Intention Host Device-mediated Distant Intentionality

Merraki Institute2 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230
试验地点
2
主要终点
Neff Self-Compassion Scale - Short Form

研究概览

简要总结

This study evaluates the potential for a new kind of wellness improvement intervention, utilizing the cutting edge model of William Tiller, PhD, material scientist and Stanford Professor Emeritus. The Tiller model suggests that through the use of focused human intentionality, the investigators can impact many things, one of which is the wellness of a population. Prof. Tiller's research found that intention in the form of information can be imprinted on a simple electric device, called an Intention-Host Device, or IHD. This device then energetically broadcasts (or transmits) this information to the study participants. This present study examines what effect an intention broadcasted from an IHD has on well defined outcome variables in adult subjects, namely self-compassion, wellness, and awakening in adults.

详细描述

Aim of this study is to examine whether intention broadcasted from an Intention Host Device (a device which stores and transmits an intention) will affect self-compassion, general wellness, and awakening. Approximately 300 trial participants will be randomly allocated to equal groups of 1/3 in control and 2/3 in the experimental IHD group, respectively. Differences in outcomes between control and experimental groups are expected. Moreover, investigators and study participants will be blinded as to the allocation of participants.

Participants in the experimental group will receive the information from the intention broadcast for 12 consecutive months, whereas the control condition will receive no treatment for the first 6 months. After the 6-month period, the subjects allocated to the control group will begin to receive treatment in the form of the intention broadcast. To evaluate if treatment gains are sustained past the 12-month intervention period, subjects in the treatment group will provide two follow up assessments at months 15 and 18.

The first six months will enable the investigators to identify any differences in effects between the control and treatment groups. The final six months with the treatment group off the broadcast will enable the study to track the persistence of, or degradation of, any effects. Both groups will have funded 12 months of broadcast, which they will respectively receive, however in a staggered fashion. Participants will not know which group they are in until after the study and will be treated the same throughout.

Random allocation of participants will minimize known and unknown confounding variables between treatment and control group and increase likelihood of one population being studied. Attrition will pose a challenge for this longitudinal design and drop out rate is conservatively estimated to be 25%. The investigators anticipate needing to recruit and enroll approximately 300 subjects in order to attain our goal of 200 - 225 participants with complete data. With 100 subjects in each group, the investigators are expecting to 95% power (2-sided alpha 0.05, effect size d=0.5). The power estimate for this study was based on a prior IHD study by Cindy Reed which was an IRB approved study conducted at Holos University (see references). In that project, of 1784 participants invited to participate in the study nationwide, 452 began the study (took the pre-test) and 303 completed (took the post test), thus an attrition rate of 32%. The investigators anticipate less attrition in this study because of the regular teleconferences that will be offered to both the treatment and control groups.

In addition, to address potential bias, the sub-investigator, Paul Mills, Ph.D., will conduct an analysis comparing the outcomes of those who enter the study but drop out as compared to those who complete the study to gauge potential differences between the two groups, and will report on this potential bias in the published manuscript.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The investigator and participants involved in this clinical trial are prevented from having knowledge which intervention is assigned to individual participants. A second control group has no knowledge of the parallel conducted Consciousness Field Project.

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

  • volunteers over age 18 speaking English

排除标准

  • Subjects who cannot read, anybody with a legally authorized representative (LAR), site/sponsor employees directly involved with the study and their family members, site/sponsor employees NOT directly involved with the study and their family members, statutory minors

结局指标

主要结局

Neff Self-Compassion Scale - Short Form

时间窗: 18 months

The Neff Short Form consists of 12 questions cover Self-Kindness (2, 6), Self-Judgment (11, 12), Common Humanity (5, 10), Isolation (4, 8), Mindfulness (3, 7), Over-Identification (1, 9) and they are rated on a Likert scale from 1 (almost never) to 5 (almost always) with the total score derived by adding the means of each subscale together. The 6 subscales measure an individual's level of self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification. Sub scale scores are calculated as the mean of the sub scale items. The total self-compassion score reverses the negative sub scale items of self-judgment, isolation, over-identification (i.e. 1=5, 2=4, 3=3, 4=2, 1=5) to compute a total mean. Change from baseline for total and subscales are tracked. Higher scores indicate higher self-compassion

NIH PROMIS Global Health Short Form

时间窗: 18 months

PROMIS® Global Health Short Form (10 items). The 10 global health items include ratings of the five core PROMIS domains. It includes the most widely used self-rated health item (global01). PROMIS® includes a single item that provides a pure rating of physical health (global03) and another item for mental health (global04). Also included is an overall quality of life item (global02). The remaining items provide global ratings of physical function (global06), fatigue (global08), pain (global07), emotional distress (global10), and social health (global05 and global09). The 10 PROMIS® Global Health items each have 5 response choices, with the exception of the common 11-point pain intensity item ("How would you rate your pain on average" with 0=No pain and 10=Worst imaginable pain). Global 1-5, 9 range from 5 (Excellent) to 1 (Poor), with higher numbers meaning greater health. Certain items are restored (Global 7 such that 5=0 no pain, and 1=10 worst pain), Global8 (5=None, 1=Very Severe),

次要结局

  • The text analysis Linguistic Inquiry and Word Count (2007)(18 months)
  • Barrett Values Inventory(18 months)

研究者

发起方
Merraki Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Gabriele Hilberg, PhD, MFT

Principal Investigator

Merraki Institute

研究点 (2)

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