Developing an Ethics and Policy Framework for Psychedelic Clinical Care: A Consensus Statement.

Importance: As government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice. Objective: To identify key ethics and policy issues related to the eventual integration of psychedelic therapies into clinical practice. Evidence Review: From June 9 to 12, 2023, 27 individuals representing the perspectives of clinicians, researchers, Indigenous groups, industry, philanthropy, veterans, retreat facilitators, training programs, and bioethicists convened at the Banbury Center at Cold Spring Harbor Laboratory. Prior to the meeting, attendees submitted key ethics and policy issues for psychedelic medicine. Responses were categorized into 6 broad topics: research ethics issues; managing expectations and informed consent; therapeutic ethics; training, education, and licensure of practitioners; equity and access; and appropriate role of gatekeeping. Attendees with relevant expertise presented on each topic, followed by group discussion. Meeting organizers (A.L.M., I.G.C., D.S.) drafted a summary of the discussion and recommendations, noting points of consensus and disagreement, which were discussed and revised as a group. Findings: This consensus statement reports 20 points of consensus across 5 ethical issues (reparations and reciprocity, equity, and respect; informed consent; professional boundaries and physical touch; personal experience; and gatekeeping), with corresponding relevant actors who will be responsible for implementation. Areas for further research and deliberation are also identified. Conclusions and Relevance: This consensus statement focuses on the future of government-approved medical use of psychedelic medicines in the US and abroad. This is an incredibly exciting and hopeful moment, but it is critical that policymakers take seriously the challenges ahead.

Racial Stress, Racial Trauma, and Evidence-Based Strategies for Coping and Empowerment.

Racial stress and racial trauma refer to psychological, physiological, and behavioral responses to race-based threats and discriminatory experiences. This article reviews the evidence base regarding techniques for coping with racial stress and trauma. These techniques include self-care, self-compassion, social support, mindfulness, cognitive restructuring, cognitive defusion, identity-affirming practices and development of racial/ethnic identity, expressive writing, social action and activism, and psychedelics. These strategies have shown the potential to mitigate psychological symptoms and foster a sense of empowerment among individuals affected by racial stress and trauma. While the ultimate goal should undoubtedly be to address the root cause of racism, it is imperative to acknowledge that until then, implementing these strategies can effectively provide much-needed support for individuals affected by racism. Expected final online publication date for the Annual Review of Clinical Psychology, Volume 20 is May 2024. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

An Evidence-Based Approach for Treating Stress and Trauma due to Racism.

Racism can be stressful or even traumatizing. Psychological unwellness emerges out of the confluence of historical, cultural, and individual experiences, and resulting syndromes may or may not fit into a DSM-5 PTSD diagnostic framework. Although racial stress and trauma are common presentations in therapy, few therapists have the resources or training to treat these issues. Based on the empirical evidence to date, this article describes the essential components of treatment for racial stress and trauma from a cognitive-behavioral perspective, called the Healing Racial Trauma protocol. Each technique is described with reference to the literature supporting its use for racial stress and trauma, along with guidance for how therapists might implement the method with clients. Also provided is information about sequencing techniques for optimal outcomes. Critical therapist prerequisites for engaging in this work are also discussed, with an emphasis on an anti-racist, empathy-centered approach throughout.

Development of the oppression-based traumatic stress inventory: a novel and intersectional approach to measuring traumatic stress.

There is a growing body of literature demonstrating that experiences of oppression (e.g., racism, sexism, heterosexism, poverty) are associated with posttraumatic stress disorder symptoms. Traditional trauma assessments do not assess experiences of oppression and it is therefore imperative to develop instruments that do. To assess oppression-based traumatic stress broadly, and in an intersectional manner, we have developed the oppression-based traumatic stress inventory (OBTSI). The OBTSI includes two parts. Part A comprises open-ended questions asking participants to describe experiences of oppression as well as a set of questions to determine whether Criterion A for PTSD is met. Part B assesses specific posttraumatic stress symptoms anchored to the previously described experiences of oppression and also asks participants to identify the various types of discrimination they have experienced (e.g., based on racial group, sex/gender, sexual orientation, etc.). Clients from a mental health clinic and an undergraduate sample responded to the OBTSI and other self-report measures of depression, anxiety, and traditional posttraumatic stress (N = 90). Preliminary analyses demonstrate strong internal consistency reliability for the overall symptom inventory (α = 0.97) as well as for the four symptom clusters of posttraumatic stress symptoms in the DSM-5 (α ranging from 0.86 to 0.94). In addition to providing descriptive information, we also assess the convergent validity between the OBTSI and measures of anxiety, depression, and traditional posttraumatic stress and examine the factor structure. This study provides preliminary evidence that the OBTSI is a reliable and valid method of assessing oppression-based traumatic stress symptoms.

The illusion of inclusion: contextual behavioral science and the Black community.

Anti-racism approaches require an honest examination of cause, impact, and committed action to change, despite discomfort and without experiential avoidance. While contextual behavioral science (CBS) and third wave cognitive-behavioral modalities demonstrate efficacy among samples composed of primarily White individuals, data regarding their efficacy with people of color, and Black Americans in particular, is lacking. It is important to consider the possible effects of racial stress and trauma on Black clients, and to tailor approaches and techniques grounded in CBS accordingly. We describe how CBS has not done enough to address the needs of Black American communities, using Acceptance and Commitment Therapy (ACT) and Functional Analytic Psychotherapy (FAP) as examples. We also provide examples at the level of research representation, organizational practices, and personal experiences to illuminate covert racist policy tools that maintain inequities. Towards eradicating existing racism in the field, we conclude with suggestions for researchers and leadership in professional psychological organizations.

The intersection of race and femininity in the classroom.

This vignette told in eight graphic panels illustrates a story about how emotional responses associated with White femininity are used to derail a classroom discussion about racial injustice in a university setting. The panels show how this weaponization of femininity occurs and how it shields those who wield it from external criticism while centering themselves in conversations about race. Women of other races typically cannot access this psychological tactic, thus it constitutes a strategic intersectional use of race, psychology, and privilege to access a power position. In offering suggestions on how to respectfully engage in situations in which racial injustice is a topic of discussion, we unveil how failure of emotional regulation is part of the core psychological framework that leads to these kinds of power dynamics.

Healing Words: Effects of Psychoeducation on Likelihood to Seek and Refer Psychedelic-Assisted Psychotherapy Among BIPOC Individuals.

Psychedelic-assisted psychotherapy (PAP) is gaining renewed interest as a treatment for various mental disorders. However, there has been limited Black, Indigenous, and People of Color (BIPOC) representation in PAP clinical trials, signaling the need for culturally consonant communication about the efficacy and safety of PAP. We randomly assigned 321 BIPOC and 301 non-Hispanic White participants to four different modes of psychoeducation (didactic, visual, narrative, hope-based) and tested effects on likelihood of seeking and referring others to PAP using ANCOVAS. The influences of different psychoeducation components on these likelihoods were also tested using hierarchical regression modeling. Regardless of psychoeducation mode, BIPOC participants were more likely to seek PAP than non-Hispanic White participants after psychoeducation. Further, information on physical safety and success rate of PAP uniquely predicted BIPOC participants' likelihood of seeking and referring others to PAP after psychoeducation. Our findings suggest that once provided psychoeducation, BIPOC participants are receptive to seeking or referring others to PAP. BIPOC participants also appear to prioritize physical safety and rate of success of PAP in these decisions. Stigma against PAP is likely not the primary barrier to recruitment of BIPOC individuals into PAP trials. Instead, researchers should conduct more psychoeducational outreach to diversify future trials.

Racism and censorship in the editorial and peer review process.

Psychology aims to capture the diversity of our human experience, yet racial inequity ensures only specific experiences are studied, peer-reviewed, and eventually published. Despite recent publications on racial bias in research topics, study samples, academic teams, and publication trends, bias in the peer review process remains largely unexamined. Drawing on compelling case study examples from APA and other leading international journals, this article proposes key mechanisms underlying racial bias and censorship in the editorial and peer review process, including bias in reviewer selection, devaluing racialized expertise, censorship of critical perspectives, minimal consideration of harm to racialized people, and the publication of unscientific and racist studies. The field of psychology needs more diverse researchers, perspectives, and topics to reach its full potential and meet the mental health needs of communities of colour. Several recommendations are called for to ensure the APA can centre racial equity throughout the editorial and review process.

The weaponization of medicine: Early psychosis in the Black community and the need for racially informed mental healthcare.

There is a notable disparity between the observed prevalence of schizophrenia-spectrum disorders in racialized persons in the United States and Canada and White individuals in these same countries, with Black people being diagnosed at higher rates than other groups. The consequences thereof bring a progression of lifelong punitive societal implications, including reduced opportunities, substandard care, increased contact with the legal system, and criminalization. Other psychological conditions do not show such a wide racial gap as a schizophrenia-spectrum disorder diagnosis. New data show that the differences are not likely to be genetic, but rather societal in origin. Using real-life examples, we discuss how overdiagnoses are largely rooted in the racial biases of clinicians and compounded by higher rates of traumatizing stressors among Black people due to racism. The forgotten history of psychosis in psychology is highlighted to help explain disparities in light of the relevant historical context. We demonstrate how misunderstanding race confounds attempts to diagnose and treat schizophrenia-spectrum disorders in Black individuals. A lack of culturally informed clinicians exacerbates problems, and implicit biases prevent Black patients from receiving proper treatment from mainly White mental healthcare professionals, which can be observed as a lack of empathy. Finally, we consider the role of law enforcement as stereotypes combined with psychotic symptoms may put these patients in danger of police violence and premature mortality. Improving treatment outcomes requires an understanding of the role of psychology in perpetuating racism in healthcare and pathological stereotypes. Increased awareness and training can improve the plight of Black people with severe mental health disorders. Essential steps necessary at multiple levels to address these issues are discussed.

Anxiety-Related Disorders in the Context of Racism.

PURPOSE OF REVIEW: The literature on racism and anxiety-related disorders, especially social anxiety, specific phobia, and generalized anxiety disorder, is notably lacking. This report aims to review recent evidence demonstrating the link between racial discrimination and various anxiety-related disorders. RECENT FINDINGS: Anxiety-related disorders were the most significant mediator for daily discrimination and suicidal thoughts, above both depression and substance use. Further, studies showed that racial discrimination promotes posttraumatic stress and racial trauma among people of color. Systemic racism puts people of color at a higher risk for anxiety disorders than White people. Clinical case examples provide lived evidence of diverse racial and ethnic individuals suffering from anxiety-related disorders, with the development and worsening of symptoms due to racism and microaggressions. There is a prominent need for recent research on anxiety-related disorders and racism. Recommendations for clinicians and future research directions are provided. These actions are required to address bias and mental health inequities and empower people of color.

Effects of Psychedelic Use on Racial Trauma Symptoms and Ethnic Identity among Asians in North America.

There is a need to understand ways in which Asians in North America attempt to heal from racial trauma, given their well-documented high risk of exposure and associated adverse mental health outcomes. We conducted a secondary analysis of Asians from a survey of people of color in North America who have consumed psychedelics in response to racial discrimination. Ninety-two Asian participants (Mage = 30.25, SD = 6.83) completed online questions assessing demographics, racial discrimination frequency, characteristics and acute effects of their most meaningful psychedelic experience, change in racial trauma symptoms 30 days before and after their psychedelic experience, and current ethnic identity. Participants reported improvements in racial trauma symptoms (d = 0.52). Bootstrapped mediation analyses controlling for racial discrimination frequency and psychedelic dose and duration indicated complete mediation of the link between higher intensity of insightful experiences and stronger ethnic identity, via improvements in racial trauma symptoms (indirect effect = .08, 95% CI = [.004, .19]). There was partial mediation for the independent variable of lower intensity of challenging experiences (indirect effect = -.08, 95% CI = [-.18, -.005]). This study highlights the central role of higher-intensity insightful experiences and both higher- and lower-intensity challenging experiences in alleviating racial trauma symptoms and promoting ethnic identity among Asians in North America who have experienced racial discrimination. Future research should attune to culturally relevant outcomes of psychedelic use in response to racial discrimination among Asians.

Racial justice allyship requires civil courage: A behavioral prescription for moral growth and change.

In racialized societies, race divides people, prioritizes some groups over others, and directly impacts opportunities and outcomes in life. These missed opportunities and altered outcomes can be rectified only through the deliberate dismantling of explicit, implicit, and systemic patterns of injustice. Racial problems cannot be corrected merely by the good wishes of individuals-purposeful actions and interventions are required. To create equitable systems, civil courage is vital. Civil courage differs from other forms of courage, as it is directed at social change. People who demonstrate civil courage are aware of the negative consequences and social costs but choose to persist based on a moral imperative. After defining allyship and providing contemporary and historical examples of civil courage, this paper explains the difficulties and impediments inherent in implementing racial justice. To enable growth and change, we introduce ten practical exercises based on cognitive-behavioral approaches to help individuals increase their awareness and ability to demonstrate racial justice allyship in alignment with valued behaviors. We explain how these exercises can be utilized to change thinking patterns, why the exercises can be difficult, and how psychologists and others might make use of them to expand the capacity for civil courage in the service of racial justice. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

A Systematic Review of Black People Coping With Racism: Approaches, Analysis, and Empowerment.

This article reviews the current research literature concerning Black people in Western societies to better understand how they regulate their emotions when coping with racism, which coping strategies they use, and which strategies are functional for well-being. A systematic review of the literature was conducted, and 26 studies were identified on the basis of a comprehensive search of multiple databases and reference sections of relevant articles. Studies were quantitative and qualitative, and all articles located were from the United States or Canada. Findings demonstrate that Black people tend to cope with racism through social support (friends, family, support groups), religion (prayer, church, spirituality), avoidance (attempting to avoid stressors), and problem-focused coping (confronting the situation directly). Findings suggest gender differences in coping strategies. We also explore the relationship between coping with physical versus emotional pain and contrast functional versus dysfunctional coping approaches, underscoring the importance of encouraging personal empowerment to promote psychological well-being. Findings may help inform mental-health interventions. Limitations include the high number of American-based samples and exclusion of other Black ethnic and national groups, which is an important area for further exploration.

Lifetime Trauma Exposure and Posttraumatic Stress Disorder Among African Americans and Black Caribbeans by Sex and Ethnicity.

Objective: Posttraumatic stress disorder (PTSD) is a debilitating disorder requiring timely diagnosis and treatment, with special attention needed for Black populations in the U.S. Yet, stakeholders often fail to recognize Black communities' heterogeneous ethnic composition, thus not allowing diverse sociocultural realities to inform PTSD interventions. This study aims to characterize sex and ethnic differences in lifetime trauma exposure, lifetime PTSD diagnosis and symptoms, and help-seeking among the African Americans and Black Caribbeans in the U.S. Method: This study relied on data from the National Survey of American Life 2001-2003 (NSAL) to investigate the lifetime exposure to traumatic events and prevalence of a clinical PTSD diagnosis based on the DSM-IV among African American (n = 3,570) and Black Caribbean (n = 1,623) adults. 44.5% of respondents were men and 55.5% were women. Logistic regression was utilized to investigate the impact of traumatic events on PTSD. Results: Several ethnic and sex differences in exposure to potentially traumatic events were identified. African American respondents were more likely to experience spousal abuse and toxin exposure than their Black Caribbean counterparts. Black Caribbeans reported higher lifetime exposure to muggings, natural disasters, harsh parental discipline, being a civilian living in terror and/or being a refugee than African American respondents. Specific to sex, Black men reported more events of combat, a peacekeeper/relief worker, being mugged, toxin exposure, seeing atrocities, and/or injuring someone. Black women were more likely to have been rape/sexual assault and/or intimate partner violence victims. The assaultive violence trauma type was most predictive of lifetime PTSD diagnosis among Black Americans. African American women were more likely to report PTSD symptoms than men, with almost no significant differences in Black Caribbean men and women. Approximately half of Black Americans sought help for their worst traumatic event, commonly engaging family/friends, psychiatrists, and mental health professionals. Further, there were almost no ethnic and sex differences related to professional and non-professional help sought. Conclusion: Future PTSD-related research should aim to characterize the heterogenous experiences of potentially traumatic events within different Black communities. Clinicians working with Black clients should strive to understand the limitations within their tools/interventions in meeting the needs of diverse groups.

Ethnoracial Inclusion in Clinical Trials of Ketamine in the Treatment of Mental Health Disorders.

OBJECTIVE: Despite strong evidence for the safety and efficacy of ketamine in the treatment of mood disorders, the enrollment of Black, Indigenous, and People of Color (BIPOC) has not been a focus of this research. Health disparities in the treatment of mood disorders in BIPOC indicate a strong need to understand the clinical, social, and pharmacological aspects of this novel treatment in people of color. METHOD: A comprehensive methodological search for double-blind, placebo-controlled, randomized ketamine clinical trials published from 1993 to 2020 was conducted across several databases to analyze the demographics of trial participants. Researchers contacted corresponding authors to obtain additional information. RESULTS: Only 10 studies provided sufficient information for quantitative analysis. Among these studies (n = 380 participants), 73.7% of the participants were non-Hispanic White, 9.2% were Black, 5.0% were Hispanic/Latinx, and 0.8% were Asian. Higher BIPOC inclusion was negatively correlated with the number of recruitment methods implemented across sites. The present study may underestimate the participation of BIPOC because of the lack of demographic information collected or published. CONCLUSIONS: BIPOC are greatly underrepresented in ketamine clinical trials despite high rates of mood disorders. Reported treatment outcomes may not generalize to all ethnic and cultural groups and significant disparities in access to such novel treatment paradigms exacerbate health disparities.

MDMA-assisted therapy for posttraumatic stress disorder: A pooled analysis of ethnoracial differences in efficacy and safety from two Phase 2 open-label lead-in trials and a Phase 3 randomized, blinded placebo-controlled trial.

BACKGROUND: Limited ethnoracial diversity in previous ±3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) trials for posttraumatic stress disorder (PTSD) has prompted questions concerning whether Black, Indigenous, and People of Color (BIPOC) also benefit from this treatment. METHODS: Secondary analysis was conducted using a modified intent-to-treat sample pooled from two Phase 2 open-label trials and a Phase 3 randomized, blinded placebo-controlled trial to compare efficacy and safety of MDMA-AT for PTSD between BIPOC and non-Hispanic White participants. Four subgroups were of interest: MDMA-AT, BIPOC (n = 20); MDMA-AT, non-Hispanic White (n = 63); Placebo-assisted therapy (Placebo-AT), BIPOC (n = 17); and Placebo-AT, non-Hispanic White (n = 27). Planned comparisons tested subgroup differences in changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores from baseline to primary endpoint, controlling for study type and baseline scores. Adverse events (AEs) on the day of (day 0) to 2 days post-dosing were reported for each subgroup. RESULTS: In the MDMA-AT group, no significant ethnoracial difference in CAPS-5 change scores was observed. In the Placebo-AT group, BIPOC participants trended toward greater reductions in CAPS-5 scores than non-Hispanic Whites. Among non-Hispanic Whites, MDMA-AT was accompanied by significantly greater reductions in CAPS-5 scores than Placebo-AT. No treatment difference emerged among BIPOC participants. AEs were mostly rated as mild or moderate across subgroups. CONCLUSIONS: These findings provide preliminary support for the efficacy and safety of MDMA-AT for treating PTSD across ethnoracial groups. There was also a trend toward greater efficacy with Placebo-AT among BIPOC participants. There was an imbalance in subgroups, highlighting the need for culturally responsive recruitment strategies to diversify future studies.

Call to Action: Recommendations for Justice-Based Treatment of Obsessive-Compulsive Disorder With Sexual Orientation and Gender Themes.

Gender and sexual minorities are subjected to minority stress in the form of discrimination and violence that leads to vigilance; identity concealment and discomfort; and internalized homophobia, biphobia, and transphobia. These experiences are related to increased susceptibility to mental health concerns in this population. Historically, the behavioral treatment of sexual orientation (SO) and gender-themed obsessive-compulsive disorder (OCD) has inadvertently reinforced anti-lesbian, gay, bisexual, transgender, queer/questioning (LGBTQ+) stigma and contributed to minority stress in clients, treatment providers, and society at large. We present updated recommendations for treatment of SO- and gender-themed OCD through a more equitable, justice-based lens, primarily through eliminating exposures that contribute to minority stress and replacing them with psychoeducation about LGBTQ+ identities, and exposures to neutral and positive stimuli, uncertainty, and core fears. We also present recommendations for equitable research on SO- and gender-themed OCD.