Correlates of Anxiety Associated With a Life-threatening Illness
| Status: | Completed |
|---|---|
| Conditions: | Anxiety |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/15/2018 |
| Start Date: | November 7, 2015 |
| End Date: | September 30, 2017 |
Physiological Correlates of Anxiety Associated With a Life-threatening Illness.
In this study, people will be undergoing brain scans with functional magnetic imaging (fMRI)
while they perform an emotional regulation task that involves observing either neutral images
or images known to induce negative emotions, with instructions either to view passively or
attempt to reduce the negative affect associated with the images. Resting state brain scans
(with no explicit task) will also be acquired. Heart rate variability will be measured during
these resting state scans. While in the scanner, subjects will also listen to prerecorded
audio scripts about life stresses for themselves and for another person with instructions to
practice compassion for themselves or for others. In yet another task, they will respond to
pictures known to produce positive and negative emotions and perform an attention related
task. The scans will take place once before and at least once after undergoing sessions of
methylenedioxymethamphetamine (MDMA) assisted psychotherapy. Brain scans will happen three
times: an initial scan before placebo or MDMA-assisted psychotherapy, a second scan after
either two placebo or two MDMA sessions (depending on whether the subject was in the placebo
or MDMA group), and one final scan after the conclusion of three active MDMA sessions.
while they perform an emotional regulation task that involves observing either neutral images
or images known to induce negative emotions, with instructions either to view passively or
attempt to reduce the negative affect associated with the images. Resting state brain scans
(with no explicit task) will also be acquired. Heart rate variability will be measured during
these resting state scans. While in the scanner, subjects will also listen to prerecorded
audio scripts about life stresses for themselves and for another person with instructions to
practice compassion for themselves or for others. In yet another task, they will respond to
pictures known to produce positive and negative emotions and perform an attention related
task. The scans will take place once before and at least once after undergoing sessions of
methylenedioxymethamphetamine (MDMA) assisted psychotherapy. Brain scans will happen three
times: an initial scan before placebo or MDMA-assisted psychotherapy, a second scan after
either two placebo or two MDMA sessions (depending on whether the subject was in the placebo
or MDMA group), and one final scan after the conclusion of three active MDMA sessions.
Diagnosis of, and living with a life-threatening illness can result in symptoms similar to
those seen in Posttraumatic Stress Disorder (PTSD), and these symptoms may persist even if
the individual recovers, or their illness goes into remission. These symptoms may include
emotional avoidance and numbing, difficulty relating to or connecting with friends or loved
ones, difficulty sleeping, a sense of foreshortened future, and intrusive thoughts or
memories related to the illness. These symptoms are an additional burden for the individual
experiencing them and for their caretakers, and reduces quality of life.
Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy is an experimental treatment for
anxiety disorders, and initial findings suggest that it holds promise for treatment of PTSD.
This study will examine brain activity in participants enrolled in an investigation of the
safety and efficacy of MDMA-assisted psychotherapy in people with anxiety stemming from
diagnosis with a life-threatening illness to see whether MDMA-assisted psychotherapy alters
emotional reactivity to anxiety-provoking material, including positive and negative images.
The study will also examine brain activity related to the experience of
self-compassion/empathy in response to personalized audio scripts, and whether that response
is altered by MDMA-assisted psychotherapy. Brain imaging may offer a measure of neural
markers of anxiety and self-compassion that do not rely on self-report.
A subset of participants in the study "Randomized, Double-Blind, Placebo-Controlled Phase 2
Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening
Illness" (NCT02427568) without any contraindicating factors for brain imaging will undergo
three fMRI scans as part of this observational study. The first scan will occur prior to
experimental sessions and a second scan will occur after two experimental sessions of MDMA or
placebo-assisted psychotherapy. Participants will then be scanned a third time after they
have completed a total of three sessions of MDMA-assisted psychotherapy (this includes both
subjects that are originally in the MDMA-assisted psychotherapy group, as well as the
subjects in the placebo group who will cross over and complete three active MDMA-assisted
psychotherapy sessions subsequent to their placebo-assisted psychotherapy. The primary
endpoint will be the scan after the second session of MDMA-assisted psychotherapy.
During each scanning session, participants will be undergoing brain scans with functional
magnetic imaging (fMRI) while they perform an emotional regulation task that involves
observing images possessing negative emotional valence. These images are drawn from, and have
their emotional valence validated by, the International Affective Picture System (IAPS).
Participants are instructed either to view passively or attempt to reduce the negative affect
associated with the images. In addition, resting state brain scans will also be acquired
while subjects fixate on a central cross with no explicit task. Heart rate variability will
be measured during these resting state scans. The comparison of changes in brain activity
during execution of the emotional regulation task (as compared to baseline scans) after
receiving psychotherapy with MDMA or placebo, as well as comparison of changes in resting
state functional connectivity, are the primary outcome measures. Study observations are
intended to assess changes in response to emotion-provoking material at several levels, most
notably brain activity in response to anxiety producing images.
While in the scanner, subjects will also listen to prerecorded audio scripts about life
stresses for themselves and for another person with instructions to practice compassion for
themselves or for others. In yet another task, subjects will perform an attentional bias task
where they respond to a dot-probe that appears following a brief presentation of paired
images known to produce positive and negative emotions as their brain activity is measured
and their reaction times are recorded
those seen in Posttraumatic Stress Disorder (PTSD), and these symptoms may persist even if
the individual recovers, or their illness goes into remission. These symptoms may include
emotional avoidance and numbing, difficulty relating to or connecting with friends or loved
ones, difficulty sleeping, a sense of foreshortened future, and intrusive thoughts or
memories related to the illness. These symptoms are an additional burden for the individual
experiencing them and for their caretakers, and reduces quality of life.
Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy is an experimental treatment for
anxiety disorders, and initial findings suggest that it holds promise for treatment of PTSD.
This study will examine brain activity in participants enrolled in an investigation of the
safety and efficacy of MDMA-assisted psychotherapy in people with anxiety stemming from
diagnosis with a life-threatening illness to see whether MDMA-assisted psychotherapy alters
emotional reactivity to anxiety-provoking material, including positive and negative images.
The study will also examine brain activity related to the experience of
self-compassion/empathy in response to personalized audio scripts, and whether that response
is altered by MDMA-assisted psychotherapy. Brain imaging may offer a measure of neural
markers of anxiety and self-compassion that do not rely on self-report.
A subset of participants in the study "Randomized, Double-Blind, Placebo-Controlled Phase 2
Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a Life-Threatening
Illness" (NCT02427568) without any contraindicating factors for brain imaging will undergo
three fMRI scans as part of this observational study. The first scan will occur prior to
experimental sessions and a second scan will occur after two experimental sessions of MDMA or
placebo-assisted psychotherapy. Participants will then be scanned a third time after they
have completed a total of three sessions of MDMA-assisted psychotherapy (this includes both
subjects that are originally in the MDMA-assisted psychotherapy group, as well as the
subjects in the placebo group who will cross over and complete three active MDMA-assisted
psychotherapy sessions subsequent to their placebo-assisted psychotherapy. The primary
endpoint will be the scan after the second session of MDMA-assisted psychotherapy.
During each scanning session, participants will be undergoing brain scans with functional
magnetic imaging (fMRI) while they perform an emotional regulation task that involves
observing images possessing negative emotional valence. These images are drawn from, and have
their emotional valence validated by, the International Affective Picture System (IAPS).
Participants are instructed either to view passively or attempt to reduce the negative affect
associated with the images. In addition, resting state brain scans will also be acquired
while subjects fixate on a central cross with no explicit task. Heart rate variability will
be measured during these resting state scans. The comparison of changes in brain activity
during execution of the emotional regulation task (as compared to baseline scans) after
receiving psychotherapy with MDMA or placebo, as well as comparison of changes in resting
state functional connectivity, are the primary outcome measures. Study observations are
intended to assess changes in response to emotion-provoking material at several levels, most
notably brain activity in response to anxiety producing images.
While in the scanner, subjects will also listen to prerecorded audio scripts about life
stresses for themselves and for another person with instructions to practice compassion for
themselves or for others. In yet another task, subjects will perform an attentional bias task
where they respond to a dot-probe that appears following a brief presentation of paired
images known to produce positive and negative emotions as their brain activity is measured
and their reaction times are recorded
Inclusion Criteria:
- Enrolled in the parent study, "A randomized, Double-Blind, Placebo-Controlled Phase 2
Pilot Study of MDMA-Assisted Psychotherapy for Anxiety Associated with a
Life-Threatening Illness" (NCT02427568)"
Exclusion Criteria:
- Have a brain mass or lesion
- Have metal in their skulls,
- Having brain or heart pacemakers
- History of major head trauma
- Have past or present panic or extreme discomfort with being in small enclosed spaces
(claustrophobia)
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