Journal of Affective Disorders 323 (2023) 592–597
Contents lists available at ScienceDirect
Journal of Affective Disorders
journal homepage: www.elsevier.com/locate/jad
Psilocybin-assisted therapy improves psycho-social-spiritual well-being in
cancer patients
Sarah Shnayder a, Rezvan Ameli a, b, Ninet Sinaii c, Ann Berger b, Manish Agrawal a, *
a
Sunstone Therapies, Rockville, MD, United States of America
Pain and Palliative Care Service, Clinical Center, National Institutes of Health, Bethesda, MD, United States of America
c
Biostatistics and Clinical Epidemiology Service, Clinical Center, National Institutes of Health, Bethesda, MD, United States of America
b
A R T I C L E I N F O
A B S T R A C T
Keywords:
Psilocybin
Cancer
Psycho-spiritual
Healing
NIH-HEALS
Background: While psychedelics have been shown to improve psycho-spiritual well-being, the underlying ele­
ments 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 study aimed to
evaluate the changes in NIH-HEALS scores in a cancer population with major depressive disorder undergoing
psilocybin-assisted therapy.
Methods: In this Phase II, single-center, open label trial, 30 cancer patients with major depressive disorder
received a fixed dose of 25 mg of psilocybin. Participants underwent group preparation sessions, simultaneous
psilocybin treatment administered in adjacent rooms, and group integration sessions, along with individual care.
The NIH-HEALS, a self-administered, 35-item measure of psycho-social spiritual healing was completed at
baseline and post-treatment at day 1, week 1, week 3, and week 8 following psilocybin therapy.
Results: NIH-HEALS scores, representing psycho-social-spiritual wellbeing, improved in response to psilocybin
treatment (p < 0.001). All three factors of the NIH-HEALS (Connection, Reflection & Introspection, and Trust &
Acceptance) demonstrated positive change by 12.7 %, 7.7 %, and 22.4 %, respectively. These effects were
apparent at all study time points and were sustained up to the last study interval at 8 weeks (p < 0.001).
Limitations: The study lacks a control group, relies on a self-report measure, and uses a relatively small sample
size with limited diversity that restricts generalizability.
Conclusions: Findings suggest that psilocybin-assisted therapy facilitates psycho-social-spiritual growth as
measured by the NIH-HEALS and its three factors. This supports the factors of Connection, Reflection & Intro­
spection, and Trust & Acceptance as underlying elements for psycho-social-spiritual healing in cancer patients,
and validates the use of the NIH-HEALS within psychedelic research.
1. Introduction
A cancer diagnosis can have a devastating effect on physical, psy­
chological, and spiritual well-being (Niedzwiedz et al., 2019; Zare et al.,
2019). While extensive focus has been placed on mitigating the physi­
ological impact, recent efforts have aimed to uncover the psychospiritual needs of cancer patients (Hatamipour et al., 2015; Astrow
et al., 2018). Many cancer patients experience clinical depression and
anxiety (Zabora et al., 2001; Mitchell et al., 2011), a debilitating fear of
dying, disconnectedness, lack of control, and loss of hope (Coward and
Kahn, 2004; Moreno and Stanton, 2013). Yet, traditional
pharmacotherapeutics have mixed and limited efficacy in treating
cancer-related distress (Li et al., 2012).
Psychedelic therapies such as psilocybin (Griffiths et al., 2016) are
among novel therapeutic approaches that have found a renewed rele­
vance in recent years. Throughout history, Indigenous tribes have uti­
lized plant-based hallucinogenic substances for their healing properties.
These ceremonies promoted mystical experiences, open-mindedness,
and connection with nature and the divine (Carod-Artal, 2015; Nich­
ols, 2020). During the 1960s–1970s, psychedelic research in the United
States documented profound effects on psychological health, quality of
life, and pain in cancer patients (Kast and Collins, 1964; Kast, 1966;
* Corresponding author at: Sunstone Therapies, 9905 Medical Center Drive, Rockville, MD 20850, United States of America.
E-mail addresses: sarah.shnayder@sunstonetherapies.com (S. Shnayder), amelir@mail.nih.gov (R. Ameli), sinaiin@cc.nih.gov (N. Sinaii), aberger@cc.nih.gov
(A. Berger), manish.agrawal@sunstonetherapies.com (M. Agrawal).
https://doi.org/10.1016/j.jad.2022.11.046
Received 2 July 2022; Received in revised form 15 September 2022; Accepted 18 November 2022
Available online 10 December 2022
0165-0327/© 2022 Elsevier B.V. All rights reserved.
S. Shnayder et al.
Journal of Affective Disorders 323 (2023) 592–597
Pahnke, 1969). However, safety concerns were raised in response to
widespread non-medical use, and clinical research was halted with the
Controlled Substance Act. Since then, conditions for safe administration,
proper set and setting, and a code of ethics for psychedelic use have been
established (Johnson et al., 2008; Mithoefer, 2017). In more recent
clinical trials, psilocybin was found to promote significant and sub­
stantial improvements in cancer-related depression, anxiety, existential
distress, and orientation towards death (Grob et al., 2011; Griffiths et al.,
2016; Ross et al., 2016). While the effects are clear, the mechanistic
underpinnings of psychedelic-mediated psycho-spiritual change in
cancer patients are less understood.
A recently validated measure, the NIH-HEALS, has been developed
based on interviews with patients who experienced positive psycho­
logical, social, and spiritual change after being diagnosed with severe
and/or life-threatening diseases. Two hundred patients, 80 % of whom
had diagnoses of cancer, were recruited from the NIH Clinical Center
and participated in the validation of the NIH-HEALS. Results showed the
measure to have high internal consistency, split-half reliability, and
convergent and divergent validity (Ameli et al., 2018). Factor analysis of
the NIH-HEALS yielded three primary elements instrumental in psychosocial-spiritual healing: (1) Connection: a sense of religious, spiritual
and interpersonal connectedness (2) Reflection & Introspection: a sense
of meaning, purpose, and gratitude, experience of joy in nature, use of
activities that connect mind and body, present moment orientation, and
an awareness about the fragility of life; (3) Trust & Acceptance: the
ability to let go of resistance, to feel resolved and at peace with one's
circumstances, and to trust that caregivers, friends and family will
respond to needs as they arise. These factors are consistent with cancer
literature, as higher well-being in cancer patients has been linked to
one's connectedness with others (Lin and Bauer-Wu, 2003), sense of lifemeaning (Lin and Bauer-Wu, 2003; Sleight et al., 2021), and acceptance
of the diagnosis (Secinti et al., 2019).
The factors of connection, reflection &introspection, and trust
&acceptance are also influenced by psychedelic therapy. Subjective re­
ports indicate that psychedelic therapy can improve one's sense of
connection, as participants have described experiences of reduced selfother boundaries (Smigielski et al., 2020), increased nature related­
ness (Kettner et al., 2019), and a profound sense of oneness with all
(Watts et al., 2017). Psychedelic therapy is also thought to promote
introspection by leading one on an exploration of the unconscious, to
discover all disavowed aspects of the self and begin a process of
attachment repair (Vaid and Walker, 2022). Lastly, psychedelics may
encourage acceptance, as attempts to exert control over a challenging
psychedelic experience typically fail while adopting an allowing attitude
and letting go provides the intended relief (Wolff et al., 2020). This
encounter teaches one to move towards suffering rather than away,
transforming habitual avoidance into a growth-inclined attitude (Watts
et al., 2017).
We hypothesize that the elements of Connection, Reflection &
Introspection, and Trust & Acceptance underlie the psycho-socialspiritual improvements evidenced in psilocybin therapy. Thus, the pre­
sent study aims to evaluate the changes in NIH-HEALS scores in a cancer
population with major depressive disorder following psilocybin-assisted
therapy.
(NCT04593563) took place in a cancer center in Rockville, Maryland. It
was approved by the Advarra Institutional Review Board (IRB), spon­
sored by Maryland Oncology Hematology, PA., and funded by COM­
PASS Pathways Ltd., the psilocybin manufacturer.
2.2. Participants
Thirty (30) participants were recruited during an 8-month period at
the study site and through referrals from specialized psychiatric and
oncology services using convenience sampling. Written consent was
obtained from each participant prior to the study. Inclusion criteria
were: 1) aged ≥18 years, 2) Major Depressive Disorder single episode or
recurrent without psychotic features according to the DSM-5, 3) Ham­
ilton Depression Rating Scale (HAMD) score ≥ 18 at baseline, and 4)
malignant neoplasm based on ICD-10 codes C00-C97. Exclusion criteria
were adapted from current standards for psilocybin safety profiles,
which include current or past history of psychotic disorders, bipolar
disorders borderline personality disorder, or significant suicide risk.
Patients tapered psychiatric medications per standard psychedelic
research practices in order to participate safely (Johnson et al., 2008).
No cancer-related procedures were performed during the study period,
but oral cancer medications were continued.
2.3. Study procedure
Cohorts of 3–4 participants completed screening, baseline assess­
ment, treatment, and follow-ups with a total of 8 visits during the 8week study period (Fig. 1). During Visit 1, participants signed an
informed consent form and were assessed for their eligibility with the
Mini International Neuropsychiatric Interview, Version 7.0.2 (MINI
7.0.2) (Sheehan et al., 1998), the 17-item Hamilton Depression Rating
Scale (HAMD) (Hamilton, 1960), and the Columbia-Suicide Severity
Rating Scale (C-SSRS) (Posner et al., 2011). The following information
was also obtained during Visit 1: medical history, physical examination,
medication use, vital signs, electrocardiogram (ECG), and blood and
urine samples. Eligible participants then entered the screening period
and were further evaluated with the Euro Quality of Life-5 Dimensions
(EQ-5D-5L), the DSM-5 Anxious Distress Specifier (DADSI), the Quick
Inventory of Depressive Symptomatology (QIDS-SR), and the Sheehan
Disability Scale (SDS). Clinicians were all licensed with master's or
doctorate degrees and supervised by an experienced psychedelic therapy
informed senior clinician.
After passing the screening phase, participants met with their
assigned therapist for their first preparatory session (V1a). This 2-hour
visit was designed to impart information regarding the psilocybin
treatment, introduce coping strategies such as breathing exercises, and
establish a therapeutic alliance. Visit 2 (Baseline), occurred one day
prior to the psilocybin treatment. This visit included the administration
of outcome measures and a two-part therapeutic session, with both
group and individual components. The group component was guided by
a lead therapist, who disseminated psychoeducational material and
encouraged interaction among participants. The goal of the group
preparation session was to support the development of a relationship
among the group members, treatment team, and the designated thera­
pists. Participants also met individually with their assigned therapist to
address individual concerns, set intentions for the session, and practice
techniques for managing anxiety and supporting experiential
engagement.
At Visit 3, participants were administered 25 mg of psilocybin
alongside their cohort in adjacent rooms, supported by their assigned
therapist. The therapeutic approach was non-directive and entailed the
use of eyeshades and a music program to promote an inner-directed
experience. The dominant mode of therapy was active listening and
presence. Therapeutic goals were to ensure psychological safety, to
maintain each participants attention on the present moment, and to
encourage processing of potentially challenging emotional states.
2. Methods
2.1. Study design
This was a Phase II, single-center, fixed dose, open label trial of
psilocybin-assisted group therapy in cancer patients with Major
Depressive Disorder (MDD). Psychotherapeutic care was provided
before, during, and after psilocybin administration to cohorts of 3–4
participants. Supportive therapy included individual and group prepa­
ration sessions, simultaneous administration of psilocybin to the cohort,
and individual and group integration sessions. This study
593
S. Shnayder et al.
Journal of Affective Disorders 323 (2023) 592–597
Preparation
Preparation
Psilocybin Integration
Integration
session
2-hour individual
75-min group
session
45-min individual
6-7 hours
75-min group
75-min group
45-min individual
45-min individual
Fig. 1. Study schematic outline.
Following the screening phase, participants went through two preparation sessions, psilocybin therapy, and two integration sessions. Safety, efficacy, and exploratory
measures were administered at V2 (Baseline), V4 (Day 1), V5 (Week 1), V6 (Week 3), and V7 (Week 8).
Abbreviations: EoS = End of Study; V = Visit.
Adverse events (AEs) were recorded during the session.
Visits 4 and 5 occurred in a similar two-part therapeutic approach,
with group and individual components. The aim of these sessions was to
facilitate integration of the psychological material accessed during the
psilocybin therapy by exploring these experiences, their significance and
meaning, and their impact on participants' lives. Consistent with self/
inner-directed inquiry, therapists did not make interpretations, influ­
ence understanding, give advice, or suggest solutions during integration
sessions.
The NIH-HEALS was administered at four time points: baseline (V2),
week 1 (V5), week 3 (V6), and week 8 (V7) post-treatment.
Table 1
Three-factor, 35-item NIH-HEALS measure of psycho-social-spiritual wellbeing.
2.4. NIH-HEALS
National Institute of Health, Healing Experiences in All Life Stressors
(NIH-HEALS), is a psycho-social-spiritual measure of healing when
faced with challenges (Table 1) (Ameli et al., 2018). The NIH-HEALS has
strong convergent (r = 0.64, p < 0.0001) and divergent validity (r =
− 0.34, p < 0.0001). There are 35-items scored using a 5-point Likert
scale, with total scores ranging from 35 to 175. It has three factors,
namely Connection (e.g., “my situation strengthened my connection to a
higher power”), Reflection & Introspection (e.g., “working through
thoughts about the possibility of dying brought meaning to my life”),
and Trust & Acceptance (e.g., “I accept things that I cannot change”)
(Ameli et al., 2018). It is important to note that the NIH-HEALS three
factors are not discrete constructs. Rather, they are related concepts that
delineate psycho-social-spiritual elements that could contribute to the
experience of healing.
Connection
Reflection & introspection
Trust & acceptance
3. Connection with a
higher power is
important to me
12. I survived difficult
circumstances because
of a higher power
13. My situation
strengthened my
connection to a higher
power
14. My religious beliefs
help me feel calm when
faced with difficult
circumstances
4. I gain awareness from
self-reflection
1. I am content with my
life
5. I enjoy activities that
involve both the mind &
body
9. Working through
thoughts about dying
brought meaning to my
life
10. Difficult
circumstances in my life
have increased my
compassion towards
others
11. I want to make the
most out of life
2. I have a sense of
purpose in my life
19. Doing something I am
passionate about gives me
purpose during difficult
times
20. I find meaning in
helping others
23. I am not getting the
support I need
15. My personal religious
practice is important to
me
16. My participation in
religious community is
an important aspect of
my life
17. I get support from my
religious community
18. My religious beliefs
give me hope
21. Connection with family
has become by highest
priority
2.5. Statistical analysis
Data are described using frequency (percentage) for categorical data
and mean (SD) for continuous data and were assessed for distributional
(normality) assumptions. Mixed models for repeated measures were
used to analyze NIH-HEALS scores (outcome, dependent variable,
continuous data) at each visit over time (week 1, week 3, week 8). These
models adjusted for baseline NIH-HEALS score, as is required in
repeated measures analysis. In addition, models were adjusted for po­
tential confounding effects of age (continuous) and gender (categorical).
Post-hoc comparisons adjusted for multiple comparisons by Dunnet's
method with baseline as the referent comparison. Data were analyzed
using SAS v9.4 (SAS Institute, Inc., Cary, NC).
22. Support from family
lifts my spirits, which
gives me hope during
difficult times in my life
26. I seek more of a
connection in my
relationships
27. I take more time to be
in the moment
29. Working through my
own grief brings meaning
to my life
31. I have an increased
sense of gratitude
32. Being surrounded by
nature is meaningful
33. Creative arts brings
peace to my life
35. Life challenges raised
my desire to be positive
594
6. I feel isolated
7. I feel calm even
though I am not in
control of my situation
8. I accept things I
cannot change
24. I am confident that
my medical caregivers
will respond to my
needs
25. My friends provide
the support I need
during difficult times
28. My experience with
multiple losses has
made it hard to be
hopeful during difficult
times
30. I have a sense of
peace in my life
34. Life challenges
interfere with activities
that are important to
me
S. Shnayder et al.
Journal of Affective Disorders 323 (2023) 592–597
3. Results
Table 3
NIH-HEALS factor and cumulative total scores over time.
3.1. Demographics
Visit
Demographic information describing the sample is presented in
Table 2. The mean age of participants was 56 years (SD 12). Participants
did not identify outside of the gender binary, with 30 % identifying as
male and 70 % as female. The sample was predominantly Caucasian (80
%), married (67 %), and employed (83 %). Most participants (70 %) had
undergone >1 line of cancer therapy. At baseline, participants had a
mean HAMD score of 25.4 and mean QIDS score of 12.3, both of which
indicate moderate to severe depression. Half of the sample (50 %) re­
ported previous antidepressant usage. Patients who had undergone
curative treatment for cancer as well as those with advanced metastatic
disease were included. Cancer prognosis varied within the samplenearly half (47 %) were diagnosed with curable cancer, while the other
half (53 %) had non-curable, metastatic cancer.
Connection factor
Baseline
30
Week 1
30
Week 3
30
Week 8
30
3.2. Adverse events (AEs)
The reported adverse events related to psilocybin therapy were
generally mild or expected, and included headache (80 %), nausea (40
%), tearfulness (27 %), anxiety (23 %), euphoria (23 %), fatigue (23 %),
and mild impairment of psychomotor functioning (10 %). These effects
resolved at the conclusion of the psilocybin treatment session prior to
discharge. There were no notable laboratory changes, ECG abnormal­
ities, or suicidality.
Age, in years: mean (SD)
Range 30–78
Gender
Female
Male
African American/Black
Asian, Asian American, Pacific
Islander
Caucasian
Hispanic, Latinx
Married
Divorced/separated
Never married
Employed
Retired
Unemployed
3 or less
>3
Unknown
HAMD
QIDS-SR
Yes
No
Unknown
Non-curable
Curable
56.1
(12.4)
70.0 %
30.0 %
10.0 %
6.7 %
Ethnicity/race
Marital status
Employment status
Number of depressive episodes
Baseline depression severity:
mean
Prior antidepressant use
Cancer prognosis
Pvaluea
3.4 (1.3–5.3)
2.9 (0.7–4.9)
3.9 (1.4–5.9)
0.002
0.012
0.003
Reflection & introspection factor
Baseline
30
55.7 (6.8)
Week 1
30
59.6 (6.8)
Week 3
30
60.4 (6.4)
Week 8
30
60.0 (7.9)
3.9 (2.1–6.2)
4.7 (3.2–7.3)
4.3 (2.5–7.3)
<0.001
<0.001
<0.001
Trust & acceptance factor
Baseline
30
32.6 (8.0)
Week 1
30
39.3 (8.9)
Week 3
30
39.7 (8.7)
Week 8
30
39.9 (10.7)
6.7 (3.9–10.3)
7.1 (4.3–10.9)
7.3 (4.2–11.7)
<0.001
<0.001
<0.001
Total score
Baseline
Week 1
Week 3
Week 8
14.4 (8.5–20.3)
15.5 (8.9–20.9)
16.4 (9.1–23.8)
<0.001
<0.001
<0.001
30
30
30
30
119.1 (19.4)
133.1 (19.9)
133.8 (20.3)
134.6 (23.7)
4. Discussion
Table 2
Demographic and clinical characteristics of study participants with cancer.
% (n =
30)
30.8 (9.4)
34.3 (9.1)
33.8 (89.0)
34.7 (9.3)
Magnitude of effect mean
difference
(95 % CI)a
measuring a sense of meaning, purpose, and gratitude, experience of joy
in nature, use of activities that connect mind and body, present moment
orientation, and an awareness about the fragility of life, rose by 7.7 % by
week 8 (p < 0.001). Similarly, scores on the Trust & Acceptance factor,
measuring the ability to let go of resistance, to feel resolved and at peace
with one's circumstances, and to trust that caregivers, friends, and
family will respond to needs as they arise, increased by 22.4 % by week 8
(p < 0.001). Cumulatively, this totaled to an average of a 16.4-point
increase in the NIH-HEALS total scores (p < 0.001; Table 3).
NIH-HEALS scores, representing the extent to which one experiences
psycho-social-spiritual healing, improved in response to psilocybin
treatment (Table 3). All three factors of the NIH-HEALS (Connection,
Reflection & Introspection, and Trust & Acceptance), demonstrated
positive change. These effects were apparent one day after psilocybin
treatment and were sustained up to the last study interval at 8 weeks.
The Connection factor, measuring connection to a higher power and
to loved ones, increased by 12.7 % on average by week 8 (p = 0.003) the
end of the study. Scores on the Reflection & Introspection factor,
Categories
Score mean
(SD)
a
From a repeated measures mixed model analyses adjusting for baseline, age,
and gender, where follow-up visits were compared to baseline. P-values are
corrected for multiple comparisons.
3.3. Psycho-social-spiritual wellbeing
Characteristic
n
In this study, cancer patients with depression experienced marked
improvements in psycho-social-spiritual wellbeing following psilocybinassisted therapy, as assessed by the NIH-HEALS. These improvements
occurred within the domains of Connection, Reflection & Introspection,
and Trust & Acceptance, and were sustained for up to 8 weeks postdosing. Thus, the results of this study demonstrate that the NIHHEALS was a useful measure in the context of psychedelic research,
and point to a potential mechanism for the psycho-spiritual healing
evidenced in cancer patients undergoing psilocybin-assisted therapy.
The results are corroborated by prior psilocybin research, which
documented similar changes in cancer patients. Griffiths et al. (2016)
utilized the Functional Assessment of Chronic Illness Therapy- Spiritual
Well-being (FACIT-sp) to measure changes in the spiritual dimension of
quality life across the domains of meaning, peace, and faith, and found
improvements up to 6 months post psilocybin treatment. Ross et al.
(2016) also found psilocybin therapy to positively influence spiritual
well-being in a cancer patient population using FACIT-swb, a modified
version with a combined meaning/purpose factor. The NIH-HEALS and
its factors are significantly correlated with FACIT-Sp factors (Ameli
et al., 2018). Further, the NIH-HEALS offers an assessment of Trust &
Acceptance as a component of the healing experience in addition to
faith, meaning, and peace.
With a better understanding of the underlying psycho-social spiritual
changes, psychedelic-assisted therapies can be tailored to strengthen
80.0 %
3.30 %
66.7 %
16.7 %
16.7 %
83.3 %
13.3 %
3.33 %
30.0 %
40.0 %
30.0 %
25.4
12.3
50.0 %
36.7 %
13.3 %
53.3 %
46.7 %
595
S. Shnayder et al.
Journal of Affective Disorders 323 (2023) 592–597
well-being further during the intervention. Because data suggests that
Connection, Reflection & Introspection, and Trust & Acceptance are
important elements for psycho-social-spiritual wellbeing, additional
focus can be placed on enhancing the development of these factors
during therapeutic sessions. For example, therapists leading preparation
and integration sessions can emphasize themes of connection, teach
mindfulness skills, promote acceptance of life's circumstances, and
encourage awareness of the fragility of life (Rodin et al., 2018). This
existential awareness, so called “double awareness” on life and death,
vitalizes people to live more fully, while also preparing them for the
inevitable transition (Rodin et al., 2018; Holland and Breitbart, 1998).
The renewed interest in psilocybin therapy represents a paradigm
shift towards a more holistic approach to treatment. There is an un­
derlying assumption that the psyche holds the tools for its own healing,
with psychedelics acting as its catalyst (Grof, 2003; Grinspoon and
Doblin, 2001; Mithoefer, 2017). This therapy also addresses the
complexity of the whole person, including the mind, body, and spirit
(Benor, 2017). While the mind and body have traditionally been
regarded as important dimensions, it is noteworthy that the medical
field is evolving to incorporate spiritual wellbeing into its definition of
health (WHOQOL, 1995). Spirituality was found to be associated with
quality of life to the same degree as physical well-being (Brady et al.,
1999). Thus, the inclusion of this domain of life in treatment aligns with
the current knowledge base on the factors contributing to wellbeing,
healing, and quality of life.
Addressing psycho-spirituality might be particularly salient in the
cancer patient population, whose diagnoses have radically restructured
their lives. In order to experience meaning in life, humans need to
comprehend the world around them (coherence), find direction for their
actions (purpose), and find worth in their lives (significance) (Park and
Ai, 2006; Martela and Steger, 2016). Diagnosis of severe and/or lifethreatening disease can shatter one's sense of coherence, basic safety,
purpose, and significance (Ameli et al., 2018). However, those who are
able to reformulate the world around them and their place within it can
emerge on a growth trajectory, with a greater sense of wholeness than
before their diagnosis (Tedeschi and Calhoun, 1996; Tedeschi et al.,
2017; Ameli et al., 2018). Psilocybin therapy is one tool that has the
potential to facilitate this transformation in patients by encouraging
acceptance of their disease, increasing trust in caregivers, expanding
their perspective of self, and deepening a sense of connection to self,
others, nature, or a higher power.
The present study was limited by the lack of a control group, a po­
tential for social desirability bias in responding to NIH-HEALS items,
and a smaller sample size. In addition, the participants were predomi­
nantly Caucasian, female, and employed. These limitations should be
considered in terms of the generalizability of the study results. Future
studies may aim to reduce these limitations by including a control arm
and repeating the treatment in a larger, more diverse sample.
In summary, these findings bring a deeper understanding to the
psycho-social-spiritual changes that emerge from psilocybin-assisted
therapy, and will hopefully advance the psychedelic research field.
Conflict of interest
The authors confirm that the article content has no conflict of
interest.
Acknowledgments
Declared none.
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CRediT authorship contribution statement
Manish Agrawal—Contributed to acquisition, analysis, interpreta­
tion of data for the article, design of the article, revised critically.
Ann Berger—Revised article critically for important intellectual
content.
Rezvan Ameli—Contributed to design of the article, interpretation of
the data, revised article for important intellectual content.
Sarah Shnayder- Contributed to design of article, interpretation of
data and drafted the article.
Ninet Sinaii—Contributed to statistical analysis of the article.
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