Mindfulness Meditation for Subjects With Severe Speech and Physical Impairments
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | January 2013 |
| End Date: | August 2025 |
The purpose of this protocol is to (1) Determine whether a one-on-one mindfulness meditation
intervention or audio training improves performance on an adaptive communication system that
utilizes brain-computer interface (BCI); and (2) Determine whether the intervention reduces
stress in subjects with severe speech and physical impairments (SSPI).
Hypothesis: The group of subjects randomized to the mindfulness meditation training will
improve BCI performance and stress levels more than the audio control group.
intervention or audio training improves performance on an adaptive communication system that
utilizes brain-computer interface (BCI); and (2) Determine whether the intervention reduces
stress in subjects with severe speech and physical impairments (SSPI).
Hypothesis: The group of subjects randomized to the mindfulness meditation training will
improve BCI performance and stress levels more than the audio control group.
Members of the research team will visit subjects' homes for 9 visits that will each last no
longer than 2 hours. During the consenting process, participants may opt out of
photograph/video recordings of their visits, and they will also be able to choose whether or
not they would like their data to be stored in a repository. At the Initial visit, one or
more research assistants will visit participants' homes to go over the consent with them and
answer any questions they may have. Participants will then complete a computer-based
attention task. For this task, they will watch letters flash quickly on a screen, and then
they will be asked a "yes/no" question about each series of letters. The computer task will
take 20-60 minutes, and the entire visit will last no longer than 2 hours.
Researchers will return to participants' homes within two weeks to complete a Baseline
visit. At this time, the investigators will administer the same computer-based attention
task. The investigators will also do an EEG recording during a BCI "mastery task," in which
participants will try to spell words by looking at a series of letters presented on computer
screen. During the "mastery task," the investigators will take a recording called an
electroencephalogram (EEG). Participants will be fitted with a cap (much like a swimming
cap) with electrodes (small metal sensors that measure electricity). The investigators will
place a small amount of electrode gel on the scalp at each electrode site. The "mastery
task" will take no longer than 60 minutes.
After the visit, participants will then be emailed an internet-based survey that takes
approximately one hour to complete. They will be asked questions about self-perceived
stress, feelings and emotions, sleep, how well they think they can pay attention, and their
opinions about meditation. This will take approximately 1 hour to complete.
After completing the online surveys, participants will be randomized to receive either an
audio or meditation training. The first training is approximately 2 hours long. If they have
been randomly selected to receive the audio training, they will listen to and discuss
podcasts with the instructor. If they have been randomly selected to receive the meditation
training, they will learn about mindfulness, do an awareness exercise, listen to a guided
meditation, and receive mindfulness handouts. They will be given an iPod Touch with either
podcasts or guided meditations on it (depending on the group assignment) for the duration of
the class, along with headphones and/or speakers.
Participants will be asked to do approximately 30 minutes of practice each day, or as much
as they are able. They will be asked to record how much they practice. Though this is
optional, many people find it helpful to keep a log of their practice. For others, it may
feel too burdensome or infeasible. Participants will be able to choose whether or not they
want to keep a record of their practice. The iPod Touch will record when and for how long
they listen. At the end of the class, they will be given a CD with all of the guided
meditations on it.
If participants receive meditation trainings, the instructor will give them some questions
to think about before the next visit. They may contemplate and share about the questions via
email to whatever extent they choose. The instructor will respond to their emails if they
have any urgent needs and talk with participants about their responses at the
audio/meditation training visits. Throughout the study, regardless of which group
participants are in, they may choose to communicate however much they like—it could be very
little, or they may wish to spend several hours a week emailing reflections, observations,
and questions about their audio/meditation practice. This is entirely up to individual
participants.
The investigators will go to participants home for five more meditation training sessions.
For the meditation group, participants will be asked to do a meditation right before the
instructor arrives. Each training session is about 90 minutes long.
After the meditation/audio training has been completed, the investigators will conduct the
Endpoint visit, which is the same as the Baseline visit and takes approximately 2 hours. It
includes the "mastery task" and the computer-based attention task. After the visit,
participants will be emailed the same online questionnaire about stress, emotions, sleep,
attention, and meditation. This will take approximately 1 hour to complete. Participants
will also be emailed some questions to get their feedback about how the research study went
for them. Offering thoughtful responses to the questions will likely take approximately 30
minutes.
After the baseline and endpoint, an online questionnaire will be emailed to the
participants. It is a series of several surveys: the Perceived Stress Scale (PSS) is a
10-question instrument that utilizes a likert scale and measures self-perceived stress
during the past week. The Positive and Negative Affect Scale (PANAS) will also be
administered. It is also 10 questions and uses a likert scale. It consists of words that
describe feelings and emotions, and participants are to indicate the extent to which they
generally feel that way. The APT-II Attention Questionnaire gathers information about
participants' self-perceived ability to pay attention. The Pittsburgh Sleep Quality Index
(PSQI) asks questions about sleep. And the Attitudes Toward Study solicits information about
participants' thoughts and feelings on meditation (the wording of the Pre- and Post- tests
vary only slightly).
longer than 2 hours. During the consenting process, participants may opt out of
photograph/video recordings of their visits, and they will also be able to choose whether or
not they would like their data to be stored in a repository. At the Initial visit, one or
more research assistants will visit participants' homes to go over the consent with them and
answer any questions they may have. Participants will then complete a computer-based
attention task. For this task, they will watch letters flash quickly on a screen, and then
they will be asked a "yes/no" question about each series of letters. The computer task will
take 20-60 minutes, and the entire visit will last no longer than 2 hours.
Researchers will return to participants' homes within two weeks to complete a Baseline
visit. At this time, the investigators will administer the same computer-based attention
task. The investigators will also do an EEG recording during a BCI "mastery task," in which
participants will try to spell words by looking at a series of letters presented on computer
screen. During the "mastery task," the investigators will take a recording called an
electroencephalogram (EEG). Participants will be fitted with a cap (much like a swimming
cap) with electrodes (small metal sensors that measure electricity). The investigators will
place a small amount of electrode gel on the scalp at each electrode site. The "mastery
task" will take no longer than 60 minutes.
After the visit, participants will then be emailed an internet-based survey that takes
approximately one hour to complete. They will be asked questions about self-perceived
stress, feelings and emotions, sleep, how well they think they can pay attention, and their
opinions about meditation. This will take approximately 1 hour to complete.
After completing the online surveys, participants will be randomized to receive either an
audio or meditation training. The first training is approximately 2 hours long. If they have
been randomly selected to receive the audio training, they will listen to and discuss
podcasts with the instructor. If they have been randomly selected to receive the meditation
training, they will learn about mindfulness, do an awareness exercise, listen to a guided
meditation, and receive mindfulness handouts. They will be given an iPod Touch with either
podcasts or guided meditations on it (depending on the group assignment) for the duration of
the class, along with headphones and/or speakers.
Participants will be asked to do approximately 30 minutes of practice each day, or as much
as they are able. They will be asked to record how much they practice. Though this is
optional, many people find it helpful to keep a log of their practice. For others, it may
feel too burdensome or infeasible. Participants will be able to choose whether or not they
want to keep a record of their practice. The iPod Touch will record when and for how long
they listen. At the end of the class, they will be given a CD with all of the guided
meditations on it.
If participants receive meditation trainings, the instructor will give them some questions
to think about before the next visit. They may contemplate and share about the questions via
email to whatever extent they choose. The instructor will respond to their emails if they
have any urgent needs and talk with participants about their responses at the
audio/meditation training visits. Throughout the study, regardless of which group
participants are in, they may choose to communicate however much they like—it could be very
little, or they may wish to spend several hours a week emailing reflections, observations,
and questions about their audio/meditation practice. This is entirely up to individual
participants.
The investigators will go to participants home for five more meditation training sessions.
For the meditation group, participants will be asked to do a meditation right before the
instructor arrives. Each training session is about 90 minutes long.
After the meditation/audio training has been completed, the investigators will conduct the
Endpoint visit, which is the same as the Baseline visit and takes approximately 2 hours. It
includes the "mastery task" and the computer-based attention task. After the visit,
participants will be emailed the same online questionnaire about stress, emotions, sleep,
attention, and meditation. This will take approximately 1 hour to complete. Participants
will also be emailed some questions to get their feedback about how the research study went
for them. Offering thoughtful responses to the questions will likely take approximately 30
minutes.
After the baseline and endpoint, an online questionnaire will be emailed to the
participants. It is a series of several surveys: the Perceived Stress Scale (PSS) is a
10-question instrument that utilizes a likert scale and measures self-perceived stress
during the past week. The Positive and Negative Affect Scale (PANAS) will also be
administered. It is also 10 questions and uses a likert scale. It consists of words that
describe feelings and emotions, and participants are to indicate the extent to which they
generally feel that way. The APT-II Attention Questionnaire gathers information about
participants' self-perceived ability to pay attention. The Pittsburgh Sleep Quality Index
(PSQI) asks questions about sleep. And the Attitudes Toward Study solicits information about
participants' thoughts and feelings on meditation (the wording of the Pre- and Post- tests
vary only slightly).
Inclusion Criteria:
- Have a diagnosis by a neurologist of acquired neuromuscular or neurodevelopmental
disorder
- be capable of participating in 2-hour experimental interactions
- Be literate in English
- Be English speaking but not be able to communicate by voice or sign language
- Have normal or corrected vision and hearing
- Have speech that is understood less than 25% of the time
- Have reduced hand function for writing and typing
Exclusion Criteria:
- Have full ability to communicate verbally and with writing/typing
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