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A Field-Wide Review and Analysis of Study Materials Used in Psilocybin Trials: Assessment of Two Decades of Research
Yaden, David B; Graziosi, Marianna; Owen, Alexa M; Agin-Liebes, Gabrielle; Aaronson, Scott T; Allen, Katja Ehrmann; Barrett, Frederick S; Bogenschutz, Michael P; Carhart-Harris, Robin; Ching, Terence H W; Cosimano, Mary P; Danforth, Alicia; Davis, Alan K; Garcia-Romeu, Albert; Griffiths, Roland; Grob, Charles S; Gründer, Gerhard; Gukasyan, Natalie; Heinzerling, Keith G; Hendricks, Peter S; Holze, Friederike; Horton, David M; Johnson, Matthew W; Kelmendi, Benjamin; Knatz Peck, Stephanie; Koslowski, Michael; Liechti, Matthias E; Mertens, Lea J; Moreno, Francisco A; Nayak, Sandeep M; Nicholas, Christopher R; Preller, Katrin H; Rieser, Nathalie M; Ross, Stephen; Sergi, Karina; Sloshower, Jordan; Smigielski, Lukasz; Stenbæk, Dea Siggaard; Vollenweider, Franz X; Weiss, Brandon; Wolff, Max; Yaden, Mary Elizabeth
INTRODUCTION/UNASSIGNED:Serotonergic psychedelics, serotonin 2A receptor agonists such as psilocybin that can result in substantially altered states of consciousness, are used in recreational and research settings. The safety of psychedelic experiences in research settings is supported by controlled physical environments, presence of clinical and medical staff to address emergent issues, screening for personal and family history of potential contraindications, and psychoeducational preparation with psychological support. Research settings typically provide psychoeducation to participants verbally and in writing (e.g., informed consent), and such documents and conversations can provide safety-related information-but may also introduce a wide range of expectancies. Such expectancies might involve the specific character of the acute subjective effects of psychedelics, possible side effects, and anticipated outcomes. METHODS/UNASSIGNED:To better understand the content of this psychoeducation, we gathered study materials from many psilocybin studies conducted in the past two decades in healthy and therapeutic populations. We conducted a reflexive thematic analysis to better understand these documents. RESULTS/UNASSIGNED:While these documents varied substantially between studies, we identified themes intended to lower levels of risk and optimize therapeutic effects from psychedelic treatments. The most frequently coded themes related to (1) biological and physical safety, (2) psychological safety and well-being, (3) aspects of setting, and (4) potential for expectancies. Prioritizing biological and psychological safety was evident in the materials from all sites. Furthermore, we identify potential contributors to expectancy unrelated to safety and suggest that these extrapharmacological elements be studied systematically in future research. CONCLUSIONS/UNASSIGNED:Ideally, future research should strive to maximize safety while attempting to minimize extraneous expectancies.
PMCID:12060849
PMID: 40351554
ISSN: 2831-4433
CID: 5843892
Examining Psychedelic-Induced Changes in Social Functioning and Connectedness in a Naturalistic Online Sample Using the Five-Factor Model of Personality
Weiss, Brandon; Nygart, Victoria; Pommerencke, Lis Marie; Carhart-Harris, Robin L; Erritzoe, David
The present study examines prospective changes in personality traits relevant to social functioning as well as perceived social connectedness in relation to the naturalistic use of psychedelic compounds in an online volunteer sample. The study also examined the degree to which demographic characteristics, social setting, baseline personality, and acute subjective factors (e.g., emotional breakthrough experiences) influenced trajectories of personality and perceived social connectedness. Participants recruited online completed self-report measures of personality and social connectedness at three timepoints (baseline, 2weeks post-experience, 4weeks post-experience). Linear mixed models were used to examine changes in outcomes and the moderation of these outcomes by covariates. The most substantive changes were reductions in the personality domains Neuroticism, and increases in Agreeableness and social connectedness. Notably, reductions in Neuroticism and increases in Agreeableness covaried over time, which may be suggestive of common processes involving emotion regulation. Preliminary evidence was found for a specific effect on a component of Agreeableness involving a critical and quarrelsome interpersonal style. Although moderation by demographic characteristics, social setting, baseline personality, and acute factors generally found limited support, baseline standing on Neuroticism, perspective taking, and social connectedness showed tentative signs of amplifying adaptive effects on each trait, respectively. Our findings hold implications for the potential use of psychedelics for treating interpersonal elements of personality pathology as well as loneliness.
PMCID:8655335
PMID: 34899488
ISSN: 1664-1078
CID: 5304122
A Randomized Controlled Trial of Brief Skills Training in Affective and Interpersonal Regulation (STAIR) for Veterans in Primary Care
Jain, Shaili; Ortigo, Kile; Gimeno, Julia; Baldor, Denine A; Weiss, Brandon J; Cloitre, Marylène
This randomized controlled trial assessed the efficacy of a five-session version of Skills Training in Affective and Interpersonal Regulation (STAIR) among veterans obtaining treatment in primary care. Veterans who screened positive for either posttraumatic stress disorder (PTSD) or depression (N = 26) were enrolled and randomized into either five-session STAIR or treatment as usual (TAU). Assessments of PTSD symptoms (PTSD Checklist for DSM-5; PCL-5), depression (Beck Depression Inventory-II; BDI-II), emotion regulation (Difficulties in Emotion Regulation Scale; DERS), and social engagement difficulties (World Health Organization Disability Assessment 2.0; WHODAS-2) were assessed at pretreatment, posttreatment, and 3-month follow-up assessments. Participants assigned to the five-session STAIR condition reported significant improvements on all measures, whereas those assigned to TAU showed no change. Group × Treatment interactions were significant for all outcomes, and effect sizes for the interactions ranged from moderate to large, Hedge's gs = 0.81 for the PCL-5, 1.15 for the BDI-II, 0.75 for the DERS, and 0.81 for the WHODAS-2. The results indicate that five-session STAIR, a brief, skills-focused treatment, may be effective in reducing a range of symptoms and in improving social functioning among veterans treated in primary care settings.
PMID: 32506563
ISSN: 1573-6598
CID: 4477662
Clinician Perceptions Related to the Use of the CBT-I Coach Mobile App
Miller, Katherine E; Kuhn, Eric; Owen, Jason E; Taylor, Katherine; Yu, Jessica S; Weiss, Brandon J; Crowley, Jill J; Trockel, Mickey
PMID: 29120247
ISSN: 1540-2010
CID: 5304032
STAIR Group Treatment for Veterans with PTSD: Efficacy and Impact of Gender on Outcome
Jackson, Christie; Weiss, Brandon J; Cloitre, Marylene
Introduction/UNASSIGNED:Group Skills Training in Affective and Interpersonal Regulation (STAIR) is an evidence-based, manualized treatment for individuals with post-traumatic stress symptoms, that focuses on improving functioning through mood management (e.g., emotion regulation) and relationship skills development. To date, no study has evaluated the potential benefit of group STAIR among Veterans. Feasibility of delivering STAIR in a mixed-gender group format and the potential impact of gender on outcome were examined. Materials and Methods/UNASSIGNED:Participants (n = 39) were Veterans enrolled in a post-traumatic stress disorder (PTSD) Clinic at a large VA Medical Center. Veterans participated in one of four mixed-gender STAIR groups and completed self-report questionnaires of PTSD symptoms and general psychological distress at pre-treatment and post-treatment. Institutional review board approval was obtained for this study. Results/UNASSIGNED:There was significant pre-treatment to post-treatment improvements in PTSD symptoms as measured by the Post-traumatic Stress Checklist (PCL) (Cohen's d = 0.91), as well as in general psychological distress as measured by the Brief Symptom Inventory (BSI) (Cohen's d = 0.90). Change in PTSD symptoms from pre-treatment to post-treatment did not differ across gender. However, the interaction between gender and time on change in (BSI) was significant, where change in general psychological distress significantly decreased from pre-treatment to post-treatment for male Veterans but not for female Veterans. Conclusion/UNASSIGNED:The results from this study demonstrate the feasibility and initial effectiveness of STAIR delivered in a mixed-gender group format for Veterans with PTSD. It should be noted, however, that male Veterans benefited more from this approach than female Veterans. The findings suggest the value of investigating Veterans' attitudes and beliefs about the benefits and drawbacks of mixed-gender group therapy for trauma-related difficulties.
PMID: 30007286
ISSN: 1930-613x
CID: 3200442
Telemental Health Delivery of Skills Training in Affective and Interpersonal Regulation (STAIR) for Rural Women Veterans Who Have Experienced Military Sexual Trauma
Weiss, Brandon J; Azevedo, Kathryn; Webb, Katie; Gimeno, Julia; Cloitre, Marylene
This pilot study assessed the feasibility, acceptability, and initial efficacy of a skills-focused treatment delivered via video teleconferencing (VTC) to women veterans living in rural areas who had experienced military sexual trauma (MST). The Skills Training in Affective and Interpersonal Regulation (STAIR) program focuses on teaching emotion management and interpersonal skills in 8 to 10 sessions. The STAIR program may be a good fit for individuals in rural areas for whom social isolation and low social support are particularly problematic. Clinic-to-clinic VTC was used to connect a STAIR therapist with veterans for weekly individual therapy sessions. The participants (n = 10) reported high satisfaction with the intervention and would recommend the program to others. There were significant pretreatment to posttreatment improvements in social functioning, Hedge's g = 1.41, as well as in posttraumatic stress disorder symptoms, Hedge's g = 2.35; depression, Hedge's g = 1.81; and emotion regulation, Hedge's g = 2.32. This is the first report of the successful application of a skills-focused treatment via VTC for women veterans.
PMID: 30070399
ISSN: 1573-6598
CID: 3217542
Implementation and Evaluation of the Skills Training in Affective and Interpersonal Regulation (STAIR) in a Community Setting in the Context of Childhood Sexual Abuse
MacIntosh, Heather B.; Cloitre, Marylene; Kortis, Kerrie; Peck, Alison; Weiss, Brandon J.
ISI:000436068100009
ISSN: 1049-7315
CID: 5304152
Depression as a moderator of STAIR Narrative Therapy for women with post-traumatic stress disorder related to childhood abuse
Cloitre, Marylene; Garvert, Donn W; Weiss, Brandon J
Background: Depression among those who have experienced childhood abuse is associated with earlier onset, more persistent and severe symptoms, more frequent relapse, and poorer treatment outcomes across a variety of psychiatric disorders. In addition, individuals with a history of childhood abuse are more likely to develop post-traumatic stress disorder (PTSD) co-occurring with depression. Objective: This study evaluated whether severity of depression moderated the outcome in a PTSD treatment for childhood abuse survivors. Specifically, we assessed whether individuals with significant depression obtained better outcomes when provided with a two-module treatment which included a skills training component with behavioral activation interventions, Skills Training in Affective and Interpersonal Regulation (STAIR) followed by a trauma-focused component, Narrative Therapy, as compared to two control conditions where one component (STAIR or Narrative Therapy) was replaced with Supportive Counseling. Method: Participants were 104 women with PTSD related to childhood abuse. Participants were randomized into three conditions: (1) STAIR plus Narrative Therapy (SNT), (2) STAIR plus Supportive Counseling (SSC), and (3) Supportive Counseling plus Narrative Therapy (SCNT). Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) PTSD symptom severity was assessed at pre-treatment, post-treatment, and 3 and 6Â month follow-up. Results: Participants with severe depression showed superior PTSD symptom reduction following SNT, while those in the other two conditions experienced a loss of improvement after treatment ended. A similar finding was obtained among those with moderate depression, while among those with low levels of depression, outcomes did not differ across the three treatment conditions. Conclusions: Childhood abuse survivors with severe depression obtained superior outcomes in a treatment that combined skills training with trauma-focused work. Skills packages which contain behavioral activation interventions in combination with trauma-focused work may be particularly beneficial for patients with childhood abuse and severe depression.
PMCID:5639421
PMID: 29038682
ISSN: 2000-8066
CID: 3065792
CBT-I Coach: A Description and Clinician Perceptions of a Mobile App for Cognitive Behavioral Therapy for Insomnia
Kuhn, Eric; Weiss, Brandon J; Taylor, Katherine L; Hoffman, Julia E; Ramsey, Kelly M; Manber, Rachel; Gehrman, Philip; Crowley, Jill J; Ruzek, Josef I; Trockel, Mickey
STUDY OBJECTIVES/OBJECTIVE:This paper describes CBT-I Coach, a patient-facing smartphone app designed to enhance cognitive behavioral therapy for insomnia (CBT-I). It presents findings of two surveys of U.S. Department of Veterans Affairs (VA) CBT-I trained clinicians regarding their perceptions of CBT-I Coach before it was released (n = 138) and use of it two years after it was released (n = 176). METHODS:VA-trained CBT-I clinicians completed web-based surveys before and two years after CBT-I Coach was publicly released. RESULTS:Prior to CBT-I Coach release, clinicians reported that it was moderately to very likely that the app could improve care and a majority (87.0%) intended to use it if it were available. Intention to use the app was predicted by smartphone ownership (β = 0.116, p < 0.05) and perceptions of relative advantage to existing CBT-I practices (β = 0.286, p < 0.01), compatibility with their own needs and values (β = 0.307, p < 0.01), and expectations about the complexity of the app (β = 0.245, p < 0.05). Two years after CBT-I Coach became available, 59.9% of participants reported using it with patients and had favorable impressions of its impact on homework adherence and outcomes. CONCLUSIONS:Findings suggest that before release, CBT-I Coach was perceived to have potential to enhance CBT-I and address common adherence issues and clinicians would use it. These results are reinforced by findings two years after it was released suggesting robust uptake and favorable perceptions of its value.
PMCID:4795288
PMID: 26888586
ISSN: 1550-9397
CID: 5304002
Patient characteristics as a moderator of post-traumatic stress disorder treatment outcome: combining symptom burden and strengths
Cloitre, Marylene; Petkova, Eva; Su, Zhe; Weiss, Brandon
BACKGROUND: Post-traumatic stress disorder (PTSD) psychotherapy research has failed to identify patient characteristics that consistently predict differential outcome. AIMS: To identify patient characteristics associated with differential outcome via a statistically generated composite moderator among women with childhood abuse-related PTSD in a randomised controlled trial comparing exposure therapy, skills training and their combination. METHOD: Six baseline patient characteristics were combined in a composite moderator of treatment effects for PTSD symptoms across the three treatment conditions through a 6-month follow-up. RESULTS: The optimal moderator was the combined burden of all symptoms and emotion regulation strength. Those with high moderator scores, reflecting high symptom load relative to emotion regulation, did least well in exposure, moderately well in skills and best in the combination. CONCLUSIONS: A clinically meaningful moderator, which combines patient symptom burden and strengths, was identified. Assessment at follow-up may provide a more accurate indicator of variability in outcome than that obtained immediately post-treatment
PMCID:4995554
PMID: 27703762
ISSN: 2056-4724
CID: 2274092