ABSTRACT
BACKGROUND: Psilocybin is being studied for use in treatment-resistant depression. METHODS: In this phase 2 double-blind trial, we randomly assigned adults with treatment-resistant depression to receive a single dose of a proprietary, synthetic formulation of psilocybin at a dose of 25 mg, 10 mg, or 1 mg (control), along with psychological support. The primary end point was the change from baseline to week 3 in the total score on the Montgomery-Åsberg Depression Rating Scale (MADRS; range, 0 to 60, with higher scores indicating more severe depression). Secondary end points included response at week 3 (≥50% decrease from baseline in the MADRS total score), remission at week 3 (MADRS total score ≤10), and sustained response at 12 weeks (meeting response criteria at week 3 and all subsequent visits). RESULTS: A total of 79 participants were in the 25-mg group, 75 in the 10-mg group, and 79 in the 1-mg group. The mean MADRS total score at baseline was 32 or 33 in each group. Least-squares mean changes from baseline to week 3 in the score were -12.0 for 25 mg, -7.9 for 10 mg, and -5.4 for 1 mg; the difference between the 25-mg group and 1-mg group was -6.6 (95% confidence interval [CI], -10.2 to -2.9; P<0.001) and between the 10-mg group and 1-mg group was -2.5 (95% CI, -6.2 to 1.2; P = 0.18). In the 25-mg group, the incidences of response and remission at 3 weeks, but not sustained response at 12 weeks, were generally supportive of the primary results. Adverse events occurred in 179 of 233 participants (77%) and included headache, nausea, and dizziness. Suicidal ideation or behavior or self-injury occurred in all dose groups. CONCLUSIONS: In this phase 2 trial involving participants with treatment-resistant depression, psilocybin at a single dose of 25 mg, but not 10 mg, reduced depression scores significantly more than a 1-mg dose over a period of 3 weeks but was associated with adverse effects. Larger and longer trials, including comparison with existing treatments, are required to determine the efficacy and safety of psilocybin for this disorder. (Funded by COMPASS Pathfinder; EudraCT number, 2017-003288-36; ClinicalTrials.gov number, NCT03775200.).
Subject(s)
Antidepressive Agents , Depressive Disorder, Major , Depressive Disorder, Treatment-Resistant , Psilocybin , Adult , Humans , Antidepressive Agents/adverse effects , Antidepressive Agents/therapeutic use , Depression/drug therapy , Depressive Disorder, Major/drug therapy , Depressive Disorder, Major/psychology , Double-Blind Method , Psilocybin/adverse effects , Psilocybin/therapeutic use , Treatment Outcome , Depressive Disorder, Treatment-Resistant/drug therapy , Depressive Disorder, Treatment-Resistant/psychologyABSTRACT
While inflammatory markers have been implicated in the link between PTSD and poor health outcomes, there is a paucity of research investigating C-reactive protein (CRP) and psychotherapy treatment response for posttraumatic stress disorder (PTSD). The present study utilized a large, well-characterized sample of veterans and service members (N = 493) engaged in intensive psychotherapy to investigate the associations between CRP, trauma exposure, related variables, and PTSD and depression, as well as investigating if CRP was associated with PTSD psychotherapy treatment response. Bivariate correlation results indicate that CRP was significantly associated with BMI (r = 0.48) and severity of experiences of childhood physical and sexual abuse (r = 0.14 and 0.15, respectively) and was not significantly associated with baseline PTSD total symptom severity, PTSD symptom clusters, or depression symptom severity (rs ranging from -0.03 to 0.04). In multivariate regression models investigating if CRP and related variables were associated with PTSD baseline symptom severity, CRP was not a significant predictor (ß = -0.03). Hierarchical linear modeling did not identify CRP as a significant predictor of PTSD psychotherapy outcome. Given that findings indicate that CRP was broadly elevated in this treatment seeking sample but not associated with PTSD and depression symptom severity, results suggest CRP may not be a specific biomarker for PTSD or depression but may be elevated in psychiatric disease more generally.
Subject(s)
Stress Disorders, Post-Traumatic , Veterans , Biomarkers , C-Reactive Protein/metabolism , Depression/psychology , Depression/therapy , Humans , Psychotherapy , Stress Disorders, Post-Traumatic/psychology , Veterans/psychologyABSTRACT
Posttraumatic stress disorder (PTSD) is a debilitating syndrome with substantial morbidity and mortality that occurs in the aftermath of trauma. Symptoms of major depressive disorder (MDD) are also a frequent consequence of trauma exposure. Identifying novel risk markers in the immediate aftermath of trauma is a critical step for the identification of novel biological targets to understand mechanisms of pathophysiology and prevention, as well as the determination of patients most at risk who may benefit from immediate intervention. Our study utilizes a novel approach to computationally integrate blood-based transcriptomics, genomics, and interactomics to understand the development of risk vs. resilience in the months following trauma exposure. In a two-site longitudinal, observational prospective study, we assessed over 10,000 individuals and enrolled >700 subjects in the immediate aftermath of trauma (average 5.3 h post-trauma (range 0.5-12 h)) in the Grady Memorial Hospital (Atlanta) and Jackson Memorial Hospital (Miami) emergency departments. RNA expression data and 6-month follow-up data were available for 366 individuals, while genotype, transcriptome, and phenotype data were available for 297 patients. To maximize our power and understanding of genes and pathways that predict risk vs. resilience, we utilized a set-cover approach to capture fluctuations of gene expression of PTSD or depression-converting patients and non-converting trauma-exposed controls to find representative sets of disease-relevant dysregulated genes. We annotated such genes with their corresponding expression quantitative trait loci and applied a variant of a current flow algorithm to identify genes that potentially were causal for the observed dysregulation of disease genes involved in the development of depression and PTSD symptoms after trauma exposure. We obtained a final list of 11 driver causal genes related to MDD symptoms, 13 genes for PTSD symptoms, and 22 genes in PTSD and/or MDD. We observed that these individual or combined disorders shared ESR1, RUNX1, PPARA, and WWOX as driver causal genes, while other genes appeared to be causal driver in the PTSD only or MDD only cases. A number of these identified causal pathways have been previously implicated in the biology or genetics of PTSD and MDD, as well as in preclinical models of amygdala function and fear regulation. Our work provides a promising set of initial pathways that may underlie causal mechanisms in the development of PTSD or MDD in the aftermath of trauma.
Subject(s)
Depressive Disorder, Major , Stress Disorders, Post-Traumatic , Depression , Depressive Disorder, Major/genetics , Genomics , Humans , Prospective Studies , Stress Disorders, Post-Traumatic/genetics , Transcriptome/geneticsABSTRACT
Posttraumatic stress disorder (PTSD) is prevalent and associated with significant morbidity. Mild traumatic brain injury (mTBI) concurrent with psychiatric trauma may be associated with PTSD. Prior studies of PTSD-related structural brain alterations have focused on military populations. The current study examined correlations between PTSD, acute mTBI, and structural brain alterations longitudinally in civilian patients (N = 504) who experienced a recent Criterion A traumatic event. Participants who reported loss of consciousness (LOC) were characterized as having mTBI; all others were included in the control group. PTSD symptoms were assessed at enrollment and over the following year; a subset of participants (n = 89) underwent volumetric brain MRI (M = 53 days posttrauma). Classes of PTSD symptom trajectories were modeled using latent growth mixture modeling. Associations between PTSD symptom trajectories and cortical thicknesses or subcortical volumes were assessed using a moderator-based regression. mTBI with LOC during trauma was positively correlated with the likelihood of developing a chronic PTSD symptom trajectory. mTBI showed significant interactions with cortical thickness in the rostral anterior cingulate cortex (rACC) in predicting PTSD symptoms, r = .461-.463. Bilateral rACC thickness positively predicted PTSD symptoms but only among participants who endorsed LOC, p < .001. The results demonstrate positive correlations between mTBI with LOC and PTSD symptom trajectories, and findings related to mTBI with LOC and rACC thickness interactions in predicting subsequent chronic PTSD symptoms suggest the importance of further understanding the role of mTBI in the context of PTSD to inform intervention and risk stratification.
Subject(s)
Brain Concussion , Military Personnel , Stress Disorders, Post-Traumatic , Brain/diagnostic imaging , Brain Concussion/complications , Brain Concussion/diagnostic imaging , Brain Concussion/psychology , Humans , Military Personnel/psychology , Stress Disorders, Post-Traumatic/complications , Stress Disorders, Post-Traumatic/diagnostic imaging , Stress Disorders, Post-Traumatic/psychology , Unconsciousness/diagnostic imaging , Unconsciousness/etiology , Unconsciousness/psychologyABSTRACT
In the current study, we used a sample of predominantly African-American women with high rates of trauma exposure (N = 434) to examine psychometric properties of the Personality Inventory for DSM-5-Brief Form (PID-5-BF). We compared model fit between a model with five correlated latent factors and a higher-order model in which the five latent factors were used to estimate a single "general pathology" factor. Additionally, we computed estimates of internal consistency and domain interrelations and examined indices of convergent/discriminant validity of the PID-5-BF domains by examining their relations to relevant criterion variables. The expected five-factor structure demonstrated good fit indices in a confirmatory factor analysis, and the more parsimonious, higher-order model was retained. Within this higher-order model, the first-order factors accounted for more variance in the criterion variables than the general pathology factor in most instances. The PID-5-BF domains were highly interrelated (rs = .38 to .66), and convergent/discriminant validity of the domains varied: Negative Affectivity and Detachment generally showed the hypothesized pattern of relations with external criteria, while Antagonism and Disinhibition displayed less consistent and discriminant relations. Results are discussed in terms of the costs and benefits of using brief pathological trait measures in samples characterized by high levels of psychopathology.
Subject(s)
Black or African American/psychology , Crime Victims/psychology , Personality Disorders/diagnosis , Personality Inventory/standards , Adult , Diagnostic Tests, Routine , Diagnostic and Statistical Manual of Mental Disorders , Female , Humans , Problem Behavior , Psychometrics , Reproducibility of Results , Stress, Psychological/diagnosisABSTRACT
BACKGROUND: Posttraumatic stress disorder (PTSD) is linked to a specific event, providing the opportunity to intervene in the immediate aftermath of trauma to prevent the development of this disorder. A previous trial demonstrated that trauma survivors who received three sessions of modified prolonged exposure therapy demonstrated decreased PTSD and depression prospectively compared to assessment only. The present study investigated the optimal dosing of this early intervention to test one versus three sessions of exposure therapy in the immediate aftermath of trauma. METHODS: Participants (n = 95) recruited from a Level 1 Trauma Center were randomly assigned in a 1.5:1.5:1 ratio in a parallel-group design to the three conditions: one-session exposure therapy, three-session exposure therapy, and assessment only. Follow-up assessments were conducted by study assessors blind to study condition. RESULTS: Mixed-effects model results found no significant differences in PTSD or depression symptoms between the control condition and those who received one or three exposure therapy sessions across 1-12-month follow-up assessment. Results indicate that the intervention did not interfere with natural recovery. Receiver operating characteristic curve analyses on the screening measure used for study inclusion (Predicting PTSD Questionnaire; PPQ) in the larger sample from which the treatment sample was drawn (n = 481) found that the PPQ was a poor predictor of likely PTSD at all follow-up time points (Area under the curve's = 0.55-0.62). CONCLUSIONS: This likely impacted study results as many participants demonstrated natural recovery. Recommendations for future early intervention research are reviewed, including strategies to identify more accurately those at risk for PTSD and oversampling more severe trauma types.
Subject(s)
Implosive Therapy/methods , Stress Disorders, Post-Traumatic/psychology , Stress Disorders, Post-Traumatic/therapy , Adult , Female , Humans , Male , Middle Aged , Survivors , Treatment OutcomeABSTRACT
Food addiction (FA) describes a group of disordered eating behaviors. Childhood trauma has been associated with adult FA and trauma has known effects on the endocrine system, but it is unclear whether FA is associated with insulin resistance. We hypothesized that severity of childhood trauma will be associated with FA and higher insulin resistance (HOMA-IR) in a sample of obese women with type 2 diabetes mellitus (T2DM), and that FA will mediate the association between childhood trauma and HOMA-IR. Women with a diagnosis of T2DM (Nâ¯=â¯73; MBMIâ¯=â¯35.86, SDBMIâ¯=â¯7.72; Mageâ¯=â¯50.59, SDageâ¯=â¯9.72) were recruited from a diabetes clinic at a county hospital. Participants completed the Childhood Trauma Questionnaire and the Yale Food Addiction Scale. Fasting blood samples were obtained from 64 participants to assess plasma hemoglobin A1c (HbA1c), insulin and glucose (used to calculate HOMA-IR); Oral Glucose Tolerance Test (OGTT) was performed to measure change in glucose and insulin secretion. 48% of the sample met diagnostic criteria for FA. Women with FA reported significantly higher HOMA-IR (Fâ¯=â¯25.692, pâ¯<â¯0.001, dfâ¯=â¯1,62), HbA1c (Fâ¯=â¯4.358, pâ¯=â¯0.041, dfâ¯=â¯1,62), and OGGT glucose (Fâ¯=â¯5.539, pâ¯=â¯0.022, dfâ¯=â¯1,62) as well as severity of childhood trauma (Fâ¯=â¯10.453, pâ¯=â¯0.002, dfâ¯=â¯1,71). In a hierarchical linear regression controlling for BMI, income level, and T2DM treatment, the severity of childhood trauma did not contribute to the prediction of HOMA-IR (ßâ¯=â¯-0.011, pâ¯=â¯0.942) whereas FA did (ßâ¯=â¯0.422, pâ¯=â¯0.007). In a bootstrapped mediation analysis, the association between childhood trauma and HOMA-IR was mediated by FA severity (bâ¯=â¯0.596, pâ¯=â¯0.020). Understanding the psychological factors that contribute to HOMA-IR in an underserved population of African American women may lead to more effective diabetes management and prevention strategies.
Subject(s)
Adverse Childhood Experiences , Child Abuse , Diabetes Mellitus, Type 2 , Food Addiction/psychology , Insulin Resistance , Adult , Black or African American , Child , Female , Humans , Middle Aged , ObesityABSTRACT
Background and Introduction: Comprehensive monitoring and follow-up after traumatic injury is important for psychological recovery. However, scalable services to facilitate this are limited. Automated text message-based symptom self-monitoring (SSM) may be a feasible approach. This study examined its implementation and utility in identifying patients at risk for mental health difficulties after traumatic injury.Materials and Methods: Five hundred two patients admitted to a Level I trauma center between June 20, 2016 and July 31, 2017 were offered enrollment in a text message-based SSM service. Patients who enrolled received daily text message prompts over 30 days and most participated in a mental health screening 30 days postbaseline.Results: Approximately 67% of patients enrolled in the service; of these, 58% responded to the text messages, with an average response rate of 53%. Younger patients and those with elevated peritraumatic distress were more likely to enroll. Patients with higher levels of mental health stigma, who were White, or had been in a motor vehicle collision were more likely to enroll and respond to text messages once enrolled. Patients' daily ratings of distress detected clinically elevated 30-day mental health screens with high sensitivity (83%) and specificity (70%).Discussion and Conclusions: Text message-based SSM can be implemented as a clinical service in Level I trauma centers, and patient participation may increase engagement in mental health follow-up. Further, it can inform the use of risk assessments in practice, which can be used to identify patients with poor psychological recovery who require additional screening.
Subject(s)
Depression/psychology , Mass Screening/methods , Risk Assessment , Self Care , Stress Disorders, Post-Traumatic/psychology , Text Messaging , Adult , Female , Humans , Male , Middle Aged , South Carolina , Trauma CentersABSTRACT
Given advantages of freely available and modifiable measures, an increase in the use of measures developed from the International Personality Item Pool (IPIP), including the 300-item representation of the Revised NEO Personality Inventory (NEO PI-R; Costa & McCrae, 1992a ) has occurred. The focus of this study was to use item response theory to develop a 60-item, IPIP-based measure of the Five-Factor Model (FFM) that provides equal representation of the FFM facets and to test the reliability and convergent and criterion validity of this measure compared to the NEO Five Factor Inventory (NEO-FFI). In an undergraduate sample (n = 359), scores from the NEO-FFI and IPIP-NEO-60 demonstrated good reliability and convergent validity with the NEO PI-R and IPIP-NEO-300. Additionally, across criterion variables in the undergraduate sample as well as a community-based sample (n = 757), the NEO-FFI and IPIP-NEO-60 demonstrated similar nomological networks across a wide range of external variables (rICC = .96). Finally, as expected, in an MTurk sample the IPIP-NEO-60 demonstrated advantages over the Big Five Inventory-2 (Soto & John, 2017 ; n = 342) with regard to the Agreeableness domain content. The results suggest strong reliability and validity of the IPIP-NEO-60 scores.
Subject(s)
Personality Assessment/statistics & numerical data , Personality Disorders/diagnosis , Personality Inventory/statistics & numerical data , Personality , Adolescent , Adult , Data Collection , Factor Analysis, Statistical , Female , Humans , Male , Psychometrics , Reproducibility of Results , Students , Young AdultABSTRACT
OBJECTIVE: The goal of the present study was to investigate whether having higher scores on maladaptive personality traits was related to rating these traits as more likable. METHOD: Two studies were conducted, one with personality disorder traits (N = 219; Mage = 19.4; 63.8% female; 76.6% Caucasian) and one with general personality traits (N = 198; Mage = 19.5; 69.7% female; 77.3% Caucasian). In each study, participants self-rated their own personality and separately provided ratings of how "likable" they considered those personality traits. RESULTS: As expected, participants rated maladaptive traits more favorably if they considered themselves to possess those traits as well. Also as expected, individuals with higher Antagonism scores (including self-rated Dark Triad constructs of narcissism, psychopathy, and Machiavellianism) rated Antagonism and its related facets as "tolerable"-not necessarily likable, but as less unlikable than the average participant. CONCLUSIONS: These findings have implications for the ways that individuals with personality pathology perceive the people around them, which may in turn impact their expectations and behaviors.
Subject(s)
Emotions , Personality Disorders/psychology , Personality , Adult , Female , Humans , Male , Narcissism , Psychopathology , Self Report , Southeastern United States , Universities , Young AdultABSTRACT
OBJECTIVE: Increasing attention has been paid to the distinction between the dimensions of narcissistic grandiosity and vulnerability. We examine the degree to which basic traits underlie vulnerable narcissism, with a particular emphasis on the importance of Neuroticism and Agreeableness. METHOD: Across four samples (undergraduate, online community, clinical-community), we conduct dominance analyses to partition the variance predicted in vulnerable narcissism by the Five-Factor Model personality domains, as well as compare the empirical profiles generated by vulnerable narcissism and Neuroticism. RESULTS: These analyses demonstrate that the lion's share of variance is explained by Neuroticism (65%) and Agreeableness (19%). Similarity analyses were also conducted in which the extent to which vulnerable narcissism and Neuroticism share similar empirical networks was tested using an array of criteria, including self-, informant, and thin slice ratings of personality; interview-based ratings of personality disorder and pathological traits; and self-ratings of adverse events and functional outcomes. The empirical correlates of vulnerable narcissism and Neuroticism were nearly identical (MrICC = .94). Partial analyses demonstrated that the variance in vulnerable narcissism not shared with Neuroticism is largely specific to disagreeableness-related traits such as distrustfulness and grandiosity. CONCLUSIONS: These findings demonstrate the parsimony of using basic personality to study personality pathology and have implications for how vulnerable narcissism might be approached clinically.
Subject(s)
Narcissism , Neuroticism , Adolescent , Adult , Aged , Aggression , Female , Humans , Male , Middle Aged , Personality , Psychiatric Status Rating Scales , Students , Surveys and Questionnaires , Universities , Young AdultABSTRACT
BACKGROUND: When a memory is recalled, it may again exist in a labile state and stored information becomes amenable to change, a psychobiological process known as reconsolidation. Exposure therapy for anxiety disorders involves accessing a fear memory and modifying it with less fearful information. A preclinical study reported that providing a reminder of a fear memory 10 min prior to extinction training in humans decreased fear up to 1 year later (Schiller et al., 2010). METHODS: For this pilot clinical study, we used virtual reality exposure therapy (VRE) for fear of flying (FoF) to determine if using a cue to reactivate the memory of the feared stimulus 10 min prior to exposure sessions leads to fewer anxiety-related behaviors and a more durable response compared to a neutral cue. FoF participants (N = 89) received four sessions of anxiety management training followed by four sessions of VRE. Participants were randomly assigned to receive an FoF cue (reactivation group) or a neutral cue (control group) prior to the VRE sessions. Heart rate (HR) and skin conductance levels (SCLs) were collected during posttreatment and 3-month follow-up assessments as objective markers of fear responding. RESULTS: Treatment was effective and all clinical measures improved equally between groups at posttreatment with maintained gains through follow-ups. Significant differences were identified with regard to HR and SCL indices. CONCLUSIONS: These results suggest that memory reactivation prior to exposure therapy did not have an impact on clinical measures but may enhance the effect of exposure therapy at the physiological level.
Subject(s)
Memory Consolidation/physiology , Phobic Disorders/therapy , Virtual Reality Exposure Therapy/methods , Adult , Female , Humans , Male , Middle Aged , Phobic Disorders/prevention & control , Pilot Projects , Treatment OutcomeABSTRACT
A robust literature has emerged on the Dark Triad (DT) of personality-Machiavellianism (MACH), psychopathy, and narcissism. Questions remain as to whether MACH and psychopathy are distinguishable and whether MACH's empirical and theoretical networks are consistent. In Study 1 (N = 393; MTurk research participants), factor analyses were used to compare two-factor (MACH and psychopathy combined + narcissism) and three-factor models, with both fitting the data equally well. In Studies 1 and 2 (N = 341; undergraduate research participants), DT scores were examined in relation to a variety of external criteria, including self- and informant ratings of personality, adverse developmental experiences, and psychopathological symptoms/behaviors. In both studies, MACH and psychopathy manifested nearly identical empirical profiles and both were significantly related to disinhibitory traits thought to be antithetical to MACH. In Study 3 (N = 36; expert raters), expert ratings of the Five-Factor Model traits prototypical of MACH were collected and compared with empirically derived profiles. Measures of MACH yielded profiles that were inconsistent with the prototypical expert-rated profile due to their positive relations with a broad spectrum of impulsivity-related traits. Ultimately, measures of psychopathy and MACH appear to be measuring the same construct, and MACH assessments fail to capture the construct as articulated in theoretical descriptions.
Subject(s)
Antisocial Personality Disorder/physiopathology , Machiavellianism , Narcissism , Personality Disorders/physiopathology , Adult , Antisocial Personality Disorder/classification , Female , Humans , Male , Middle Aged , Personality Disorders/classification , Young AdultABSTRACT
BACKGROUND: Alcohol use and sexual risk behaviors (SRBs) are significant problems on college campuses. College women are at particularly high risk for negative consequences associated with sexually transmitted infections (STIs) and unwanted pregnancy. METHODS: The current study (n = 160) examined the effect of a brief, web-based alcohol intervention (n = 53) for college women on reducing SRBs compared to an assessment only control (n = 107) with a randomized controlled trial. Outcome measures included condom use assertiveness and number of vaginal sex partners and data were collected at baseline and three-month follow-up. RESULTS: Regression analyses revealed that the alcohol intervention was associated with higher levels of condom use assertiveness at a three-month follow-up. Additionally, more alcohol use was associated with less condom use assertiveness for those with more significant sexual assault histories. CONCLUSIONS: These findings suggest that alcohol interventions may impact college women's beliefs but not behavior, and future interventions should more explicitly target both alcohol and sexual risk to decrease risky behaviors.
ABSTRACT
This brief review article will describe treatment approaches for posttraumatic stress disorder (PTSD) based on findings from basic research. The focus of this review will be fear conditioning and extinction models, which provide a translational model of PTSD that can help translate basic research in nonhuman animals through well-controlled trials confirming the efficacy of treatment approaches in humans with PTSD such as prolonged exposure therapy. Specific cognitive aspects of fear extinction processes, including consolidation and reconsolidation, are reviewed along with behavioral and pharmacological treatment strategies based on basic research in these areas including attempts to prevent the development of PTSD as well as the treatment of chronic PTSD. Pharmacological, behavioral, and device-based augmentation strategies of PTSD treatment based in basic science findings are reviewed, including those that disrupt noradrenergic receptor processes, medications that act on NMDA receptors, physical exercise, cannabinoids, estradiol, dexamethasone, yohimbine, losartan, dopamine, and MDMA, along with the evidence for their efficacy in human clinical samples. While fear extinction provides an exciting translational opportunity to improve PTSD based on basic science findings, we review limitations and challenges of the extant literature as well as future directions.
ABSTRACT
3,4-methylenedioxymethamphetamine (MDMA) assisted therapy has been shown to be a safe and effective treatment for PTSD and emerging research suggests a change in personality traits may be a factor in treatment response. Most prior research on MDMA and personality has focused on cross-sectional comparisons of MDMA users and non-users; as such, well-controlled research assessing personality and affective states change following MDMA vs placebo administration is needed. In the current pre-registered study, we investigated the impact of MDMA administration on five-factor model (FFM) traits and affective states before and 48 h after drug administration in a randomized, placebo-controlled study of healthy adults (N = 34). Statistical significance was not observed for the four a priori hypotheses; however, medium effect sizes were found between MDMA administration and trait Openness and Positive Affect 48 h following drug administration, compared to placebo (d = .79 and .51, respectively). This study provides initial results to help guide future well-powered studies with large samples and longer follow-up timepoints to continue to investigate how MDMA impacts personality and emotional experience, which may inform optimization of MDMA treatment approaches.
ABSTRACT
OBJECTIVE: Despite considerable research examining the efficacy of psychedelic-assisted therapies (PATs) for treating psychiatric disorders, assessment of adverse events (AEs) in PAT research has lagged. Current AE reporting standards in PAT trials are poorly calibrated to features of PAT that distinguish it from other treatments, leaving many potential AEs unassessed. METHODS: A multidisciplinary working group of experts involved in PAT pooled formally and informally documented AEs observed through research experience and published literature. This information was integrated with (a) current standards and practices for AE reporting in pharmacotherapy and psychotherapy trials and (b) published findings documenting post-acute dosing impacts of psychedelics on subjective states, meaning, and psychosocial health variables, to produce a set of AE constructs important to evaluate in PAT as well as recommended methods and time frames for their assessment and monitoring. Correspondence between identified potential AEs and current standards for AE assessment was examined, including the extent of coverage of identified AE constructs by 25 existing measures used in relevant research. RESULTS: Fifty-four potential AE terms warranting systematized assessment in PAT were identified, defined, and categorized. Existing measures demonstrated substantial gaps in their coverage of identified AE constructs. Recommendations were developed for how to assess PAT AEs (including patient, clinician, and informant reports), and when to assess over preparation, dosing session, integration, and follow-up. Application of this framework is demonstrated in a preliminary assessment protocol (available in the supplement). CONCLUSIONS: This assessment framework addresses the need to capture post-acute dosing AEs in PAT, accounting for its pharmacotherapy and psychotherapy components, as well as documented impacts of psychedelics on worldviews and spirituality.
Subject(s)
Hallucinogens , Mental Disorders , Humans , Hallucinogens/adverse effects , Hallucinogens/administration & dosage , Mental Disorders/drug therapy , Psychotherapy/methods , Adverse Drug Reaction Reporting Systems/standards , Drug-Related Side Effects and Adverse ReactionsABSTRACT
BACKGROUND: Psychedelic-assisted therapies hold early promise for treating multiple psychiatric conditions. However, absent standards for the care, teams providing psychedelic-assisted therapy pose a major roadblock to safe administration. Psychedelics often produce spiritually and existentially meaningful experiences, and spiritual health practitioners have been involved in administering psychedelic-assisted therapies in multiple settings, suggesting important qualifications for delivering these therapies. However, the roles and competencies of spiritual health practitioners in psychedelic-assisted therapies have not been described in research. METHOD: This study examined interviews with 15 spiritual health practitioners who have facilitated psychedelic-assisted therapy. Thematic analyses focused on their contributions, application of expertise and professional background, and roles in administering these therapies. RESULTS: Seven themes emerged, comprising two domains: unique and general contributions. Unique contributions included: competency to work with spiritual material, awareness of power dynamics, familiarity with non-ordinary states of consciousness, holding space, and offer a counterbalance to biomedical perspectives. General contributions included use of generalizable therapeutic repertoire when conducting PAT, and contributing to interdisciplinary collaboration. IMPLICATIONS: Spiritual health practitioners bring unique and specific expertise to psychedelic-assisted therapy based on their training and professional experience. They are skilled at interprofessional collaboration in a way that complements other clinical team members. Psychedelic-assisted therapy teams may benefit from including spiritual health practitioners. In order to ensure rigorous standards and quality care, further efforts to delineate the roles and necessary qualifications and training of spiritual health clinicians for psychedelic-assisted therapy are needed.
Subject(s)
Hallucinogens , Hallucinogens/therapeutic use , Quality of Health CareABSTRACT
BACKGROUND: The Emory Healthcare Veterans Program (EHVP) is a multidisciplinary intensive outpatient treatment program for post-9/11 veterans and service members with invisible wounds, including posttraumatic stress disorder (PTSD), traumatic brain injury (TBI), substance use disorders (SUD), and other anxiety- and depression-related disorders. OBJECTIVE: This article reviews the EHVP. METHODS: The different treatment tracks that provide integrated and comprehensive treatment are highlighted along with a review of the standard, adjunctive, and auxiliary services that complement individualized treatment plans. RESULTS: This review particularly emphasizes the adjunctive neurorehabilitation service offered to veterans and service members with a TBI history and the EVHP data that indicate large reductions in PTSD and depression symptoms across treatment tracks that are maintained across 12 months follow up. Finally, there is a discussion of possible suboptimal treatment response and the pilot programs related to different treatment augmentation strategies being deploying to ensure optimal treatment response for all. CONCLUSION: Published data indicate that the two-week intensive outpatient program is an effective treatment program for a variety of complex presentations of PTSD, TBI, SUD, and other anxiety- and depression-related disorders in veterans and active duty service members.