Ann Berger, MD, MSN. May 2024

May 20, 2024

Information

Title: “National Institutes of Health Healing Experience of All Life Stressors (NIH-HEALS): A measure of psycho-social-spiritual healing and its use in psilocybin studies”

Description: While psychedelics have been shown to improve psycho-spiritual well-being, the underlying elements of this change are not well-characterized. The NIH-HEALS posits that psycho-social-spiritual change occurs through the factors of Connection, Reflection & Introspection, and Trust & Acceptance. This presentation will review the development of The NIH HEALS. There will be discussion of its use in a trial using psilocybin for patients with cancer and depression.

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00:00So we have a small group here,
00:01I expect a few more we'll join
00:03and we're and we are recording.
00:04So I know often these are very
00:06popular downloads for people who
00:07aren't able to make it at this time.
00:09So let's go ahead and get started.
00:13So it's a real pleasure to welcome
00:16Doctor Berger today to give what
00:18will be our last seminar in the
00:20Psychedelic Seminar series for the year.
00:22We'll start up again in September,
00:24and we're very interested in
00:26everyone's suggestions as to who
00:28we should invite for this series.
00:30I think it's been a lot of fun.
00:31I've certainly learned a lot,
00:34and I know that today will be no exception.
00:36I'm grateful to Julian Uruti for making
00:38the connection with Doctor Berger.
00:40She has a long history of working in
00:44the areas of pain and palliative care.
00:46She completed fellowship in medical
00:48oncology at Yale and was on the
00:51faculty here for many years,
00:52but then has gone to found the the
00:54pain and palliative care unit of
00:56the National Institutes of Health
00:58where she continues to work.
01:00And there she does patient care,
01:01education,
01:02administrative and research responsibilities.
01:04So you probably how your schedule
01:06probably looks something like mine.
01:10Doctor Burgers, published extensively in
01:12the field of pain and palliative care,
01:14Wellness, and ways to measure
01:17psychosocial spiritual healing.
01:18He's currently a consultant in
01:20helping organizations transform from
01:21the culture to improve resilience,
01:23Wellness, compassion, empathy,
01:24and human relationships.
01:26And she's going to discuss with us today
01:28the development of the NIH Heals study,
01:31which is a major trans institute
01:33endeavour at the National Institutes
01:36of Health to focus on on Wellness,
01:39pain, addiction and various
01:43other aspects of of healing.
01:46And I'm looking forward to hearing
01:48what you have to share with us.
01:50Thank you for being here.
01:51OK,
01:52Well, thank you for having me.
01:54Actually, I have retired from
01:56NIH as of the end of January.
02:00So congratulations and administrative
02:03responsibilities have gone away.
02:04I'm still doing a lot of teaching.
02:06I'm, I'm jealous, you know,
02:08as a volunteer, a special volunteer,
02:10and I do a lot of teaching I'm doing.
02:12I'm continuing my research.
02:14I'm doing scholarly work with the fellows
02:17you know. And then and then I'm part
02:20of this JQ consulting where we're
02:23changing systems in terms of things like,
02:25you know, using mindfulness and
02:28other integrated modalities.
02:30So I'm still very, very busy.
02:33As I told Jessica,
02:34I will not be playing mahjong or
02:37whatever else people do or supposed
02:39to do. It won't be me.
02:44The other thing is just to clarify
02:46the NIH heels that we developed
02:49this tool is not out of NIH
02:52from the Heel initiative.
02:53Yes, I'm actually
02:55part of the Heel initiative and I'm still,
02:57that's still something they have
02:58me roped into to give grants
03:02and intramurally for that.
03:04But this is actually different.
03:06And when we named this,
03:08we'd already named it before the NHL
03:11when we first published the tool.
03:14I actually even sent it up to
03:15Doctor Collins just to make sure
03:16that wouldn't be a problem and
03:18he was fine with it. So well.
03:22So I've I've already proved the
03:23truth of my own words, which is
03:25that I have a lot to learn today.
03:27Exactly. But that's OK.
03:31So how do I go to next?
03:33What did we do here?
03:35Previous. Oh, here.
03:36Next. OK, no disclosures.
03:38As you can well imagine,
03:40when you work for NIH,
03:42you don't you don't own stock or anything.
03:44Or now this is my mentor,
03:47Dame Sicily Saunders,
03:49who was also a doctor or nurse like myself.
03:53She was also actually a social worker
03:56and started Hospice a long time ago
03:59in UK but actually was the one who
04:03started Branford Hospice in Connecticut.
04:06So the biopsychosocial spiritual model,
04:10just to go over that a little bit,
04:14is the bio is clearly the illness,
04:17the injury of the genetics,
04:19the psychologic, anxiety,
04:20fear, guilt, anger,
04:22social response of significant other
04:25support systems, and spiritual.
04:27Now, the spiritual piece is a piece that
04:31I've been most interested in my research in,
04:35because it is the piece that clearly
04:39helps lead people towards healing,
04:42and we'll talk about what healing is.
04:44But spiritual is a whole
04:46lot more than religion.
04:47I know people hear the word spiritual
04:49and much like palliative care seems
04:51to be a term that people think
04:53is just the end of life care.
04:55And it's not.
04:56Well, spiritual is much more than religion.
05:00For some people,
05:02it is their religion,
05:04but for many others it's not.
05:06And so it has to do with transcendence,
05:09increased sense of connections,
05:11relationships, meaning and purpose,
05:14values and beliefs.
05:17And so we'll talk a little bit
05:19more about this in the tool itself.
05:21So in today the objectives are to
05:24understand the concept of what healing is,
05:27describe the NIH heals and its development,
05:30define the three factors and describe
05:32how it's been used in a study with
05:36patients receiving psilocybin.
05:37And you know,
05:38I'll I'll go over much of the studies,
05:41how we got there and even what
05:43we're doing now like a sneak peek
05:46so NIH heals is a psychosocial
05:51spiritual measure of healing that
05:53assesses positive transformation in
05:55response to challenging life events.
05:58It's a 35 item self report form that
06:02is scored on a 5 point likelihood
06:04scale from strongly disagree to
06:06strongly agree and then there are four
06:09items that have reversed scoring.
06:14Now for a palliative care doctor this is
06:19not a hard lead to go to some patients.
06:22What we've you know,
06:24what I've seen is some patients with
06:26life threatening or chronic illness
06:28report positive psychological,
06:30social and spiritual change during the
06:33course of their treatment or their disease
06:36even in the face of unfavorable prognosis.
06:39So I was interested to know and
06:43identify factors that contribute to
06:46this positive transformation known as
06:49healing in the world of palliative care.
06:51You can call it life transforming events,
06:54whatever and has far reaching
06:58implications for improving well-being,
07:00quality of life, mind,
07:02body and spiritual Wellness in
07:04the face of life's challenges.
07:07You know and even at Yale I was a
07:11oncology fellow and then stayed
07:13on as faculty with a joint faculty
07:16and anesthesia and oncology.
07:19And I did a lot of not only
07:23supportive oncology but a lot of
07:25chronic pain people with failed back,
07:28people with fibromyalgia.
07:29And what you would see was that there
07:33would be patients with life threatening
07:36illness who would feel healed and
07:39those with diseases like fibromyalgia
07:41that could get out of the bed.
07:43So I was interested what is going on here?
07:47And then how can we measure this
07:50psychosocial spiritual healing.
07:56So what I'm talking about here is that
08:01in terms of level of functioning,
08:03it's, you know, before the event and
08:05then you can either succumb to it,
08:08survive with impairment, recover from it,
08:11which implies more resilience,
08:14or thrive from it better than before.
08:18And the next few slides will go over a
08:20patient that you know you'll hear her voice.
08:23Because the first,
08:25the first thing we did was to
08:29discover what was this healing
08:32experience was interview patients.
08:35In order to develop a tool,
08:38I felt like you needed to actually start
08:40from the qualitative and the information
08:43you get from qualitative is tremendous.
08:46So we interviewed,
08:47viewed patients who had cancer,
08:49who had survived cancer,
08:50we interviewed patients who had
08:52survived cardiac conditions and we
08:54also looked at some HIV patients,
08:57some patients with HIV disease.
09:04So we did initial clinical observations,
09:07lit review,
09:08we did the qualitative interviews.
09:10We then did a review from this.
09:13We came up with a bunch of
09:16questions and streamlined them.
09:17We did an initial pilot study with
09:20100 patients to do an initial factor
09:22analysis and reduce some of the items.
09:25We then did cognitive interviewing and then
09:27we did a study to actually validate the tool.
09:32So the first two studies were with
09:35cancer survivors and with cardiac
09:37survivors at a local hospital near
09:39us and NIH Clinical Center and Smith
09:42Farm Center for Healing,
09:43which is in DC.
09:45So here's a lady who talks
09:47about what healing is.
09:49We didn't use the word healing.
09:51They were included in the trial.
09:53If they said they had positive
09:55life transforming events,
09:56she uses the word healing.
10:16Hearing the audio. I don't know
10:17if it's playing on your end.
10:21Yeah, you can hear it.
10:22No, can't hear the audio. Oh,
10:26oh, it is playing
10:27here. I think there's a
10:29Zoom setting, but you have.
10:32I'm not quite sure how to do it.
10:35Anyone on the call know how to connect it?
10:37So zoom will pick up the audio
10:40from Anne's computer.
10:44All right. So yeah, that's odd,
10:46'cause I am hearing it.
10:52But what she talks about
10:54here is she's 30 years old,
10:58she gets breast cancer and she
11:02had to go through a lot of both
11:05curing the disease because she
11:07was told that she had this life
11:10threatening illness as well as
11:13healing on a lot of different levels.
11:14And so she talks about how she goes
11:18back to the trauma of losing her dad,
11:20who was in his early 40s and had also
11:24died from a cancer of some type,
11:27and says here it was more than
11:30just saving myself from cancer.
11:33It was much saving.
11:34It was going through healing
11:36on a lot of different levels.
11:38And so it was like Technicolor.
11:40It was like my life has been
11:41in black and white and all of
11:43a sudden this diagnosis,
11:44it went to Technicolor
11:49now. And if you want to try to share,
11:51there's a suggestion in the in the chat
11:54about how you can share the audio.
11:56I think it's an option in
11:58your share screen menu.
12:02Oh, why don't I think
12:03you move on, 'cause if if
12:04you're not gonna have a lot more. Yeah,
12:07I'm not. No, no,
12:08it was the only one. All right.
12:11So the initial, the initial study,
12:17you know, was the qualitative.
12:20And then we followed that up
12:22with an initial factor analysis
12:25of preliminary factor analysis.
12:27And what happens when you do qualitative
12:30work is, you know, because frankly,
12:32it took them about, you know,
12:3520 years at NIH to tell me that,
12:39yes, doing qualitative work also
12:41was a true science. I had to have,
12:43I had to have reviewers from the outside,
12:45you know, and some of them were
12:47from the National Academy say,
12:48well, actually, yes,
12:49this is a real science that she's done.
12:52So what happens is you come up,
12:55you come up with themes when
12:57you do qualitative work.
12:59I don't know who if people are
13:01familiar with qualitative work and
13:03you come up with themes and sub
13:05themes and then you can put them
13:08into little baskets or factors.
13:11And so we at that time found
13:13that there were four factors of
13:15these questions that had come out
13:18of the qualitative interviews.
13:20We we called it at that time
13:21and you could call it anything,
13:23but we called it religion,
13:24spirituality, intrapersonal relations
13:26and interpersonal relations.
13:29Now as you see, that's gonna change.
13:33Patients during one of our studies
13:38spoke about what healing meant to them.
13:41They said getting appropriate treatment,
13:43accepting the illness, not blaming myself,
13:45letting go of the past, less pain,
13:49feeling better physically and mentally
13:52and regaining strength to make whole
13:55and to function at a normal ability,
13:58focus on getting well instead
14:00of finding a cure. So again,
14:02it's not always cure driven healing,
14:05it's it's getting well,
14:07it's making whole and in palliative care.
14:11Those are words that we're very familiar,
14:13were very familiar with achieving
14:17a sense of well-being,
14:19free of pain, distress,
14:20to correct my body and rid of my disease,
14:23Expecting what you accepting what you
14:25got to go through and making progress
14:27from one state of health to another.
14:29So all of these type of things
14:31helped us come up with questions.
14:34But again,
14:34as you'll see later,
14:36the tool is a tool of
14:39psychosocial spiritual well-being.
14:43One of my favorite pictures.
14:47Anyone who knows me knows that I've always
14:49liked to bring normality to the patients,
14:52so I would bring tea cards out.
14:55This was a guy we saw before he
14:58had a bone marrow transplant.
15:00We always were consulted on and
15:03still are consulted on patients
15:05from the day they come to the
15:07institution to get their transplant.
15:10And the only symptom he had was anxiety.
15:13And so we asked, well, how are we
15:16going to be able to help your anxiety?
15:17And the answer was not
15:19giving him a medication.
15:20It was, let's get me a magic wand and hat.
15:26So the day of his transplant,
15:28we gave him a magic wand and hat,
15:30and we all wore magic wands and hat.
15:32And this guy was with us,
15:35you know, on and off,
15:36in and out of the hospital
15:37and outpatient for about two
15:39or three years until he died.
15:40But Needless to say,
15:42you know we were his team that he
15:44could totally trust because we had
15:47gotten him his magic wand and hat.
15:49So sometimes that's all it takes.
15:55So the validation, we finally got up to
15:59the validation trial and there we recruited
16:02200 patients at the NIH Clinical Center
16:05with severe and or life threatening
16:07illness from June to December of 2017.
16:10The NIH heels at that time was 42 items.
16:16So we started with like 56 and we
16:18just kept whittling it down going
16:21through all the different studies.
16:24And the way you get,
16:27the way you validate,
16:29you have to validate the tool based on
16:32other tools so you can get convergent
16:36and divergent validity and reliability.
16:40So we use the Facet Spiritual,
16:45which is a very common tool used
16:49in the not only health Care World,
16:51but really the oncology world
16:54developed by David Seller.
16:56He's developed all these tools
16:58for chronic illness.
17:00We use the self and this was
17:03for convergent validity.
17:05Self Integration scale was a very
17:07interesting scale that had questions that
17:10actually were for convergent validity
17:13and those that were for divergent.
17:16We were also interested in mindfulness.
17:19So we use the Mindfulness
17:21Attention Awareness Scale,
17:22but that was not for the actual validation.
17:25We also use the Connor Davidson
17:29Resilience scale and we used a
17:32trauma scale and those are not for
17:36the validation that was for you
17:38know looking at at other things.
17:42Can you since we have a rather
17:43mixed audience at this seminar,
17:44can you define what you mean by
17:46convergent and divergent validity when
17:47you're doing scale development like this
17:52what you're trying to
17:53see is how it it relates.
18:00You know, is it similar to scales
18:01that are asking similar questions?
18:03Is it divergent from scales that or
18:06are questions that have nothing to do
18:09with the thing that you're looking at?
18:11You know, so if you're looking at
18:13psychosocial, spiritual healing
18:14and has nothing to do with those,
18:15then it shouldn't, you know,
18:17they shouldn't line up.
18:21Thanks, sorry.
18:25Oh, and then we did
18:26and then we did a another factor
18:29analysis which you have to kind of do.
18:32So it it demonstrated excellent reliability,
18:35internal consistency was
18:39a Chromebook Alpha .89.
18:42And as we see here from in terms
18:45of the convergent divergent
18:48validity and the different scales
18:51with the convergent validity,
18:53we use the questions from that
18:55CIS scale that I talked about,
18:57the integration scale and it the total
19:02score as you see here was statistically
19:06significant not only in the total
19:09score but in all of the factors.
19:12And we'll talk about the factors.
19:15The factors turned out to
19:17be 3 at the end and not 4.
19:20The facet has different factors also,
19:24much like our scale does.
19:26So the different factors in facet was faith,
19:29was peace and meaning.
19:31And again,
19:32it converged beautifully with our scale
19:36and then DIVERGENT again there it didn't,
19:41you know it,
19:42it was our scale was not similar to it.
19:46So these are the three factors that we found.
19:51And these are important because these are
19:56the factors that when we got involved
20:00in looking at it with psychedelics,
20:02people who were doing psychedelic
20:03research came and said,
20:05Oh my God,
20:06this is what the patients are telling us.
20:08So these are factors of connection,
20:12reflection and introspection
20:13and trust and acceptance.
20:15So connection has to do with connection
20:18with religion and higher power,
20:21but also has to do with support from family
20:25and family becoming a higher priority
20:30and essentially support from a community.
20:33It does not have to be religion,
20:37reflection.
20:37Introspection has to do with things
20:41like difficult circumstances in life has
20:45increased my compassion towards other.
20:48I take more time to be in the moment.
20:50I find meaning in helping others.
20:53I I have an increased sense of gratitude.
20:57Being surrounded by nature is meaningful.
21:00I wanna make the most of my life creative
21:03arts to bring peace to their lives.
21:07Awareness,
21:08so self-awareness,
21:12activities that involve both mind and body.
21:15Working through my own grief brings
21:17meaning to life, more connection in
21:21all relationships and doing something
21:24I'm passionate about gives purpose.
21:26So again, it's about meaning.
21:28It's about purpose,
21:29it's about self-awareness.
21:33And this was between this and the
21:37connection became very important
21:39to those studying psychedelic.
21:42So we can, you know,
21:43talk about how we got there
21:45and then trust and acceptance.
21:49So there's a sense of which
21:50was also a a topic that we had
21:53heard in the psychedelic world.
21:56But this was developed before
21:58the people that started studying
22:00psilocybin had come to me.
22:02So I I have a sense of peace in my mind.
22:04I have a sense of purpose.
22:07I am content with life.
22:10I feel calm.
22:11I accept things that I can't change.
22:16Support for medical
22:18caregivers were important.
22:19And all of these we've written
22:22papers about and also talks about
22:27multiple losses because a lot
22:30of what we've seen with some of
22:33the trauma scale that we use,
22:35trauma absolutely correlates to less healing
22:41and you know many people have trauma.
22:45Now another great picture of
22:50a of a tea party that we had.
22:52We do tea parties and this was
22:55actually the patient was a physician
22:57and he was in the ICU but we did a
22:59tea party for he and his wife and
23:02the wife is wearing the hat and
23:04this is like a whole oncology team.
23:06This happens to be Doctor
23:07Rosenberg and there are O,
23:08TS and PTS and research people
23:11and for 24 years we did tea
23:13parties and people loved it.
23:18So we then looked at the data from our
23:25200 patients on differences between
23:27males and females and there was a
23:30suggestion that there was a difference.
23:33There was no difference in 31 out of
23:3635 items and no difference in males and
23:41females on two of the three factors.
23:44But males and females differ significantly
23:46on the factor of reflection, introspection.
23:49And the items that were different was
23:52compassion towards other gratitude,
23:55desire to be more positive and mind
23:57body practices important a little bit.
23:59We haven't gone back to look at this.
24:02Important to just keep that in
24:05mind 'cause sometimes when we pick
24:09modalities for our patients,
24:11you know they may not be
24:13the same for each patient.
24:14And for males and females.
24:18We looked at, as I said,
24:20trauma and history and severity.
24:24And trauma severity was significantly
24:27correlated with the NIH HIELDS
24:29trust and acceptance factor.
24:31As one would probably guess,
24:34we also looked at the NIH Hields as a
24:38related to resilience and mindfulness
24:40in patients with severe and or
24:43life limiting medical diagnosis.
24:47And again the Conner Davidson Resilience
24:52Scale as I'm sure your group knows
24:55has 10 items and that's the scale use.
24:58It was positively and significantly
25:00cut correlated with our scale,
25:03the NH Hills and each of its factors.
25:08The same you're gonna see is true of
25:11the Mindful Attention Awareness Scale.
25:13It was positively and significantly
25:16correlated with our NIHL total
25:19score and all three factors,
25:24and this is just a diagram of that.
25:34So the results of the current study
25:36indicate a relationship between
25:38psychosocial spiritual well-being,
25:40resilience and mindfulness,
25:42and demonstrated that it possibly
25:45was related to resilience and
25:50psychosocial spiritual
25:51well-being and mindfulness.
25:56So we did another trial.
25:59We've done a few trials in Africa where we
26:03validated our tool there and it's now in
26:06about four different African languages.
26:08And then we get up to the
26:11United Heals psilocybin.
26:12So there was cognitive interviewing
26:14in Africa and that's what where are
26:17you cognitive interviewing of a scale,
26:19You go and ask the patients,
26:23you read the questions of the scale and
26:26ask them how they understand the scale,
26:29how they understand that question.
26:31So it's different than qualitative
26:33interviewing in that that was much more it,
26:37it was more open.
26:39This is actually looking at the squid.
26:42This questions on the scale
26:44that you have 17 were women.
26:4731 of the questions were comprehensible.
26:50Some four of them needed rewording
26:54for another populations in Africa
26:57and the ones that needed rewording,
27:00I want to make the most of my life.
27:01I seek more of a connection
27:03in my relationships.
27:04I take more time to be present in the moment,
27:07and working through my own grief
27:08has brought meaning to my life.
27:10The scale has also been looked at in
27:15populations of elderly and specifically
27:18elderly African Americans in the South.
27:22So we've tried to broaden it out to different
27:26populations and again there in Africa,
27:30the the,
27:31the,
27:34the thing that came back when they were
27:36asked about what is healing to you.
27:38Much like in the United States where I
27:41had talked about developing wholeness,
27:44developing well-being,
27:46they talk about having hope,
27:50surrendering to the supernatural
27:53being and similar type themes.
27:58Now we then got involved in the
28:02psychedelic world because they came to us.
28:06It was a practice not far from NIH.
28:09Everybody had trained at
28:11NIHD oncologist Suncoast.
28:15I assume most in this group had
28:18are aware of Suncoast and they
28:20had come to us saying we you know
28:23came across your tool and the
28:25factors that you're talking about,
28:28the connection, the self reflection,
28:31introspection,
28:31the trust and acceptance are to our
28:35themes that our patients are talking about.
28:38But we've not been able to capture it before.
28:42And so the the first study that was
28:45done was with this group of patients
28:49at Suncoast that Manish Hagarwal had.
28:52I know he has the tool now
28:56in many other of his trials,
28:59Ali Zarabi at Emory said.
29:02His trial I think is completed
29:04and he was going to share the
29:06data with me at some point.
29:07I just need to reach out to
29:09him and see what he has found.
29:11But it is being used in other trials.
29:14But this was our first intervention trial,
29:17so it was kind of exciting for us
29:19because we had developed the tool,
29:20which took about 12 years to develop.
29:23It didn't go from you know one day
29:26and next thing you have a tool.
29:29So this was a study that involved a one
29:31time psilocybin administration to 30
29:34patients with both cancer and depression.
29:37And the NIH heels was administered
29:39at baseline day, one day,
29:40week one, week 3 and week 8.
29:44Improvement was noted in the NIH Heels
29:47total score and its three factors over
29:50time in response to the psilocybin
29:52and at every time point compared to
29:55the baseline consistent with outcomes
29:58of anxiety and depression measures.
30:01So of course we were pretty excited.
30:04The age was
30:0930 to 78 mean of 56.
30:13Females were more representative
30:15in this study as you see here.
30:19Here's the ethnicity and race.
30:21It was a highly Caucasian population.
30:26Marital status was also 66%,
30:30and 83% of these patients were employed.
30:37In terms of number of depressive episodes,
30:43there was 40% that have greater than three.
30:47So there was a lot of
30:50depression in this group.
30:52Baseline depression severity
30:54was also significant.
30:57Prior antidepressant group also 50%
31:00significant and cancer prognosis,
31:0453% were non curable, 46% were curable.
31:08Now I had sat in on some of these when
31:12he was doing it because I actually
31:15wanted to see how it was done and
31:21it was, it was interesting to see both
31:26you know, the curable and the non
31:29curable individuals were equally being,
31:35you know gaining well-being
31:38from the psilocybin treatment.
31:40So as you see here,
31:42the baseline NIH shield score was
31:461/19 and week 1 it was 133 and it went
31:51all the way up to 134 at week eight.
31:53So the the well-being psychosocial,
31:56spiritual well-being scores
31:59remained up even at week 8.
32:03And this is the reflection
32:06and introspection factor.
32:07This is the same true for the
32:10trust and acceptance factor.
32:16So let me go back for one SEC.
32:24So we were excited and you know published
32:28on this show that our NIH site Silas
32:32Simon clearly improved psychosocial
32:34spiritual well-being in cancer patients.
32:36But our tool this was the first tool
32:39that our that was an intervention
32:41trial that there was a difference.
32:44I'm gonna give you a sneak peek of another
32:48one that we just sent for publication.
32:50So again, you know,
32:52we can't be quoting that one, but the
32:56NIH heels is a tool that is very robust.
33:01We're finding now and the world,
33:05the psychedelic world.
33:06I know there are people using
33:08it now and using it in research.
33:10Not all of them have contacted me,
33:12so I don't know them all.
33:13I know Manisha is, I know Ali Zarabbia is,
33:16but this is a robust tool that I
33:19think you know can safely be used,
33:23you know,
33:24and I'd love to hear if you're
33:26using it at some point.
33:30So we
33:35have recently completed a trial,
33:36This is not with psychedelics.
33:38We've recently completed a trial
33:40looking at health care providers who
33:43took care of COVID patients and they
33:46received they were either a control
33:48arm or a nature adventure arm or a
33:52nature adventure plus mindfulness.
33:56And we see here this, in this study,
34:00there were more females.
34:03Again, I don't know if more females
34:06generally sign up for studies.
34:08Age was about 35,
34:13a large percentage of Caucasians,
34:1858% were nurses, 15% were physicians.
34:21And then we have physician assistants,
34:24social workers and others.
34:28So we randomized as you see here
34:33control group and it was a control
34:36wait list group nature only and
34:39nature plus or minus mindfulness. Our
34:47primary endpoint was after the mindfulness.
34:55So everybody you know was looked at then and
34:59then the secondary was eight weeks later.
35:04Now what is interesting here is
35:06that we used a lot of scales,
35:09but we used the PSS or the perceived
35:14stress scale as the primary endpoint.
35:19Other scales we used were the mindfulness
35:23tension scale, burnout scale,
35:25We looked at heads for depression,
35:28we looked at sleep, the ISI for sleep.
35:33We looked at self efficacy and what
35:37we found is that the only thing
35:39that changed in this group of of
35:42healthcare providers was the NIH heels.
35:45None of the other scales,
35:48including the BSPSS which was our
35:52primary endpoint, did not change at all.
35:59Now the NIH Shields, that was the PSS.
36:02The NIH Shields did change over
36:06time and so the control did,
36:11which is the one below did not change.
36:15The intervention groups,
36:17Both the nature and the nature
36:20plus the mindfulness did change
36:22in terms of the NIH Shields.
36:25So again, and this is the
36:27intervention groups combined the
36:29nature and the nature mindfulness.
36:31So we know we have a very robust tool here.
36:35It's not only for patients
36:38with life threatening illness,
36:40it's for healthcare providers
36:41who took care of COVID patients.
36:43Now granted, as I've said,
36:46these are also a fairly stressed
36:49group of individuals,
36:51but it was interesting to us 'cause
36:53we assumed the PSS would change and it
36:56did not and we are going to report,
36:59we were reporting on it because
37:00it's important that that information
37:02get out there.
37:07So the last sneak preview,
37:10this also is submitted for
37:12publication but not out there yet.
37:14We developed a nine question questionnaire
37:19from the scores and we have looked
37:22at it now in after developing it we
37:26that that's in publication as I said
37:30but we also have looked at it in two
37:33of our other studies and the nine
37:37question tool correlates very well
37:40with the 35 item And we partly did
37:43this because those looking at it in
37:46the psychedelic field have said you
37:49know a shorter scale would be good
37:51because you're using so many other scales.
37:54And so the questions that they came
37:55out to be as I have a sense of purpose
37:58working through thoughts about dying
38:00brings meaning to life difficult
38:02circumstances of increased compassion
38:04difficult situation strength and connection.
38:08Religious beliefs help me feel calm.
38:11It takes more time to be present at the
38:13moment I have a sense of peace and I
38:16have an increased sense of gratitude.
38:18So conclusion,
38:19it's a 35 item valid and reliable measure.
38:23We developed a short form history of trauma.
38:27Resilience and mindfulness are
38:29factors in experience of healing.
38:31Preliminary data shows that it's
38:33sensitive in psilocybin and now we find
38:36it sensitive in healthcare providers
38:38who took care of COVID patients.
38:41There's another one that we're
38:43looking at now,
38:44but we actually looked at it in a
38:47group of teachers who got a eight
38:50week mindfulness program and the
38:53NIH Shields has also shown change
38:56but that that data is very,
38:58you know we have we really need a lot
39:01more looking at that and we continue
39:04work nationally and internationally.
39:11Couldn't do this without a big team,
39:13both research, clinical and
39:15just a lot of great people.
39:25Great. Thank you so much.
39:27You've done a lot of work and it's
39:29a really nice example of how we can
39:31do more than just measure symptoms,
39:33symptom improvement,
39:34which is so often the primary focus,
39:36but not necessarily what our
39:37patients care most about.
39:39So it's interest.
39:40And it was interesting in that COVID study.
39:42I mean, we looked in COVID Healthcare,
39:45we've looked at that over and over
39:47again with the symptoms of stress and
39:50depression and this and that and sleep.
39:52And we were like, this is not possible,
39:55How is this not possible?
39:56We made our statistician nuts going back
39:58and forth and headed in all kinds of ways.
40:01But it's really more about
40:05well-being and psychosocial,
40:07spiritual well-being.
40:08And it's actually very powerful.
40:12I mean, I think it's a it's something
40:14in my research that I'm quite proud of,
40:18yeah. I I was wondering you showed
40:22the three factor structure in the
40:23original tool and you they emerged
40:25out if you call it well four,
40:26but then three that emerged out
40:28of the qualitative work and then
40:29that was in the original tool.
40:30Two questions about that.
40:32First, is that three factor
40:33structure captured in the brief
40:35version of the tool or have you
40:37sacrificed that dimensionality in
40:38order to get the more convenient
40:40we we had to sacrifice that but are
40:43there questions from each factor? Yes.
40:46But with 9 questions you're not gonna get,
40:48we're not going to get that.
40:50But it correlates actually,
40:51'cause we, we have looked at it,
40:53We're not reporting on that in
40:55that in the paper that we just
40:58submitted on the COVID study,
41:00but we have the data,
41:01it correlates the nine item,
41:03correlates very well with the 35 items.
41:06So I think it's going to hold up.
41:08We also are looking at it
41:10in the teacher study.
41:11We asked them both the 35
41:13item and the nine item.
41:14So and again that data is still the
41:17statistic she's still working on.
41:20But you know she gave me a sneak
41:22preview and interestingly PSS didn't
41:24change there either for the teachers.
41:28So interesting have you looked at in
41:32either of those in any of the three
41:34studies have you looked at sort of
41:36conventional quality of life measures
41:38to see if this is AI mean I I would
41:41predict that this might be a better
41:44predictor of well depends on what
41:46exactly what's being captured by the
41:47tradition what I call the traditional
41:49quality of life measures exactly
41:50because in every world's different.
41:53So like in our study, you know,
41:56in our validation study,
41:57we compared it to the Facet spiritual,
41:59which is considered an
42:01oncology quality of life.
42:03You know, fool, you know,
42:07known in more of my world.
42:08But I think David Sella is actually,
42:11you know, 'cause he developed all those
42:13tools and he developed all the promise tools.
42:15He's so he's gone well beyond just oncology.
42:21But you know,
42:23I I think that this stands up quite
42:27well 'cause it it it answers,
42:29there are a lot of questions in
42:32there that are not in other tools
42:34about the meaning and purpose and
42:36connection and self reflection
42:38and trust and acceptance.
42:40And so it captures a lot.
42:43I just, I what I was wondering is if these
42:45constructs that you're measuring are better
42:47predictors of a very general question,
42:50like do you feel that life is going well?
42:52Do you feel better than you did before?
42:54If you ask, if you ask very
42:56general questions in a way that
42:59captures what patients or subjects,
43:01what they actually care about,
43:02yes, I feel better than I did.
43:05And I'm wondering if what would
43:06be the best predictor of that?
43:08And it might not be symptom reduction,
43:10it might be meaning as you
43:13as you're suggesting, right.
43:15But I didn't have to, but I suspected is
43:18the meaning and and that's
43:20the spiritual piece that we
43:22don't talk about in medicine.
43:24It's it's the meaning and purpose.
43:26And I mean that's the piece that
43:29is most important to patients
43:33and and to not only to
43:34patients, to people in life.
43:37Sure. You know I did wonder going back to the
43:41factor structure of the original instrument.
43:43It seemed like you said you emphasized
43:45a couple times in a couple of these
43:47studies that the you had a significant
43:50improvement both in the the overall
43:53score and in the factors and they all
43:55and they all correlated with one other.
43:56I'm wondering if you've seen any circumstance
43:59where the different factors dissociate.
44:01No, we didn't from one another.
44:04OK, so they may be they may be
44:07measuring closely related, you know,
44:09different aspects of but of a
44:11closely related unitary construct.
44:13Right. OK.
44:17There's a question in the chat.
44:18I bet you're welcome to speak
44:19up or I can read it out.
44:22Yeah, I I can't see the chat.
44:23It says any correlations or
44:25relationship with or or I will add or
44:28relationship to the placebo effect,
44:33all right. I mean, I don't know.
44:34We haven't looked at it
44:35in the placebo effect. But
44:39again, I'm not sure it matters.
44:43If the placebo effect is what helps you,
44:49you know, feel better from a emotional,
44:52spiritual point of view and makes
44:54you feel more connected and gives you
44:57more self-awareness, that's great.
44:58Then I think it's going to pick it up.
45:04But there may be different like placebo
45:06effect, which is itself a we should have
45:08Jerry Santacora's been thinking a lot about
45:10the placebo effect in this parsed out.
45:12We should have him come and talk.
45:13He's he's got some really
45:15interesting observations on what
45:17people mean by the placebo effect.
45:18But in any case, it seems like
45:20they may be two different things.
45:22Well, you're looking for ways to
45:23measure change in a domain that we use.
45:25That's super important,
45:26but we don't usually pay attention to.
45:28And the placebo effect is asking about
45:31changes that are attributable to quote,
45:34non specific, interpersonal,
45:36environmental.
45:37You know those two things may dissociate,
45:40right? You can have placebo
45:41responses in pain or symptoms.
45:43You could have placebo responses in
45:46hope and meaning and you could have,
45:49you could have treatment specific
45:51responses in pain or symptoms.
45:53You could have treatment specific
45:54responses in hope or meaning.
45:55They may be orthogonal.
45:57So, so I can answer that in
45:59some way in that I came in,
46:02you know, I was brought in, like I said
46:05to Manisha's trial because of the tool.
46:09And so I wanted to see how the how the
46:12psychedelics worked and what was going on.
46:14Because honestly,
46:16I am probably the only one in the
46:19psychedelic world 'cause now, you know,
46:21I've gotten hooked up with the whole
46:23psychedelic research world out there.
46:25I'm probably one of the few who
46:29has never tried psychedelics.
46:33OK, so I have never tried it.
46:35So I came with open eyes with
46:38like, you know, OK, well,
46:39what does this really do?
46:41And you know, how does this work?
46:44So I came to the sessions,
46:47and the sessions say first,
46:48as probably you're aware,
46:50the first session is a group of them,
46:54and there's accounts,
46:55There's a therapist on the side
46:58sitting right next to them,
47:00and they're actually given,
47:03they were given a flower
47:04or something to hold.
47:05They were given something to hold.
47:08And I'm sitting there going,
47:10Oh my God,
47:11what's not being measured
47:12here is intentional healing
47:17when we I'm one
47:18that you know, has done Reiki for patients.
47:21So when we do Reiki or even
47:24teach mindfulness, we ask for
47:27people to set their intentions.
47:30I'm a big believer and have given
47:32lectures on healers need to us.
47:35The health care providers need to
47:38also set healing intentions and what
47:41were they doing there? It was absolutely
47:45setting intentions and that's not,
47:48you know that's not something that
47:50is recorded in the in the research.
47:54It's the psilocybin 25 milligrams
47:58worked but you know and decrease the
48:01depression and increase well-being.
48:03But it's all of that stuff around
48:07that whether you want to call
48:10it placebo effect or whatever,
48:12where people are actually setting intention,
48:14that does make a difference,
48:17A huge difference.
48:21Jordan, I see your hand.
48:26Hey, and thanks so much for
48:29your work. I've done some psilocybin research
48:32here and looked at psychological measures
48:35and correlations with symptom improvements.
48:37So I'm happy to see another scale
48:40looking at this domain that also
48:42goes beyond just mystical experience
48:47questionnaire and is is broadening this.
48:50I had a couple questions about the scale and
48:53the and just the psilocybin study I just
48:56noticed with the in the connection domain.
48:59I thought it was interesting
49:01that like the nature,
49:02there was one piece about nature
49:04connection which has gotten discussed
49:05in the the psychedelic community,
49:07but it wasn't in the connection bucket,
49:10it was in sort of the other bucket.
49:12And also it didn't seem like
49:16interpersonal connectedness was
49:18in the connection domain either.
49:20I was just kind of curious how you
49:22parsed out what was connection like.
49:24It seemed like the connection
49:26was more this religious spiritual
49:28idea rather than interpersonal.
49:30The connection was
49:32the the initial connection questions
49:34were in the 35 item or connection
49:37with religion, higher power,
49:40and connection with family.
49:42The connection with friends and
49:45nature are actually in the factor of
49:49self reflection and introspection.
49:51So what happens when you do a
49:53factor analysis is they load in.
49:56The questions themselves load in
49:58different areas and you can't
50:01force them to load somewhere else.
50:03They loaded together with all the
50:06other questions about compassion and
50:11you know all of those questions
50:13mindful behavior and mind
50:15body in that self reflection
50:20awareness, type self reflection piece it it.
50:24So it wasn't called connection,
50:27it was separate from that connection,
50:30but it's still in the tool because the
50:32loading in the factor analysis is not
50:34you can't take the questions and say,
50:36well I want it to be in this factor.
50:41I didn't go away. Yeah,
50:42I mean I have a lot of slides
50:43on the factor analysis itself,
50:45it's I just have to pick and choose what
50:47I'm doing. But yes, you can't. So that that's
50:50how it ended up there.
50:51Now as you notice it's not in
50:53the nine item one, but nature is
50:56very important and that's why,
50:57I mean they seem to correlate very well.
51:00But you know, my bias is still gonna
51:02be if you could use the 35 item,
51:04use the 35 item and we've now used
51:06it in many trials and you know,
51:09even very seriously ill people
51:10are able to do 35 questions.
51:16But yeah,
51:18thanks. And I was just wondering about
51:21the some of the terminology like
51:23there was one item that talked about
51:26connection or support from a quote
51:29specifically a religious community.
51:30And I was wondering why sort of
51:33emphasize religious community
51:34as opposed to any community.
51:37And then another factor talked
51:40about religious beliefs specifically
51:42as opposed to maybe spiritual
51:44beliefs or something more broad.
51:47So I was just curious about
51:49the specific use of religious.
51:50In both cases,
51:52we got religious,
51:53and that was a question
51:55that has come out a lot.
51:58But we got the word religious from
52:02the initial qualitative work.
52:04Those are the, those are the
52:07words that our our subjects used.
52:11And so, you know, and then I don't know if,
52:15I mean it's interesting,
52:16'cause we studied it then in an HIV,
52:19an African American HIV population.
52:21We studied it in elderly
52:23African Americans in the South,
52:25we studied it in Africa.
52:27I don't know if maybe that's why the
52:30religious peace keeps coming back.
52:33I was actually concerned about
52:35that since we have so many who are
52:38not affiliated in the country.
52:40But it seems to be a word
52:43that continues to draw people.
52:49Do you, when when patients do
52:51fill that out, do you kind of give
52:53them guidance that if they don't,
52:54if they're part of a different community,
52:56they can still score it?
52:57Like I just imagine that would create a
53:00little difficulty for non religious folks.
53:02I I I haven't but
53:04certainly you can say
53:06religious slash spiritual.
53:08I mean I, you know and
53:09and we we went round and
53:11round about this 'cause I was like even
53:14when we did the 9 item I was like I I,
53:16you know I feel uncomfortable
53:18with this because I had actually
53:20shown it to my kid at the time
53:23who was who is a neuroscientist.
53:25He's an MDPHD neuroscientist.
53:27It's a piece on the neurology spectrum.
53:30He does Lewy body dementias
53:34and that you forgive him and so
53:38so and he's at Hopkins
53:39but you know he immediately
53:42was like, you know this,
53:44these religious terms are
53:45not gonna hold together,
53:47but they are even holding together with
53:49this group of COVID healthcare providers.
53:51So I can't, we can't change it.
53:53Can we say religious slash slash spiritual?
53:57Probably yes, because that's
53:58all you see in the literature.
54:01Well, it but in the original
54:03qualitative work you had two religious
54:05and spiritual as different domains.
54:07Like your 4 domains were religious,
54:09spiritual, intrapersonal and interpersonal.
54:10Which implies to me that there's going to be.
54:14I mean there is something different
54:16about having spirituality fused
54:18with a structured institutional you
54:20know that that that is a different
54:22category than a spirituality that's
54:24more individual or or less less.
54:26But I think this I would assume that
54:28you're gonna have other questions
54:30that are gonna pick up the non
54:32religious spiritual components.
54:34So, so the distinct from the factors,
54:36the two other factors, the self
54:38reflection, introspection and the
54:43and the trust and acceptance are
54:45picking up the spiritual piece.
54:48Those are the two factors
54:49picking up that spiritual.
54:51So there may be value,
54:52even if it only resonates with a a portion,
54:54a large portion in this country,
54:56but a portion of your of your respondents,
54:58you may still be picking up something
55:00that's importantly different when you
55:02use the word religious than when you use
55:04the word spiritual as long as you're
55:05getting the spiritual with other items.
55:07So and you might lose that if you
55:09switch to religious slash spiritual
55:11and muddied what may actually
55:12be an important distinction.
55:16Well, we left it
55:17even in the nine questions there are still
55:19like two or three with the religious,
55:21you know because it was just interesting
55:23to me that even in this healthcare
55:26providers who are all young people,
55:28of course everybody's young to me,
55:31but they're all young people and they still
55:35scored the religious as positive. So and
55:40I just had one last quick question.
55:42You said the NIH heals you said
55:45was consistent without the outcomes
55:48of changes in depression and
55:50anxiety in the psilocybin study.
55:51But when you say consistent with
55:53you mean like the IT correlated,
55:55the change correlated with those,
55:58yes. And that was
56:00that was the Suncoast study.
56:02The the primary outcome there
56:04was not the heels of course.
56:06The primary outcome was depression. And do
56:10you know if they collected some of
56:13the other commonly used measures of
56:16subjective experience in the study like
56:19the Mystical Experience Questionnaire or
56:22the Emotional Breakthrough Inventory?
56:24And I'm just curious how the NIH heels
56:27think if that if it the change in heels
56:30correlated with depression and anxiety.
56:32Did did it also correlate with those other
56:35measures that are commonly used in the
56:38psychedelic literature or was there some,
56:40I don't know if they did,
56:42I mean that was Manisha's study.
56:44So I I'm assuming you know Manish,
56:46you could probably reach out to Manisha.
56:49I don't think they studied that.
56:51I'm sorry, what was studied what?
56:53I don't think they looked
56:55at the mystical scale,
56:57you know, but you can ask him.
56:59It was his study.
57:00Manish Agarwal at some
57:03It's Sun Sunstone.
57:04It's Sunstone. Yeah. Yeah.
57:07Manish worked with Hopkins,
57:09with the Hopkins group on their
57:11original cancer study and then
57:13sort of split off to form this
57:15freestanding institute, Sunstone.
57:18And this was the initial
57:19study before this was
57:20the. That's. Yeah. This was the Hopkins
57:23Stage 4 cancer study. Well, Hopkins
57:27and essentially compass.
57:30Mm hmm. You know,
57:31Compass is the one who
57:33funded that initial trial.
57:36Yeah. And then he,
57:39you know, did Sun Sunstone.
57:42I think he's not even
57:44doing oncology anymore.
57:48I mean other than psychedelics
57:49in oncology, but.
57:53Oh, good. Thanks so much.
57:54We are, yeah, we are at time.
57:56This has been great and and broadening.
57:59So thank you for spending this time with us.
58:01Thank you all for joining.
58:03Oh, so we contacted me if you
58:05have any questions.
58:07Great. Take care everyone.
58:09Have a good weekend and we'll be
58:11coordinating whether our our schedule
58:13for the seminars in the fall. OK.
58:17Thank you. Thank you. Thank you.