BackgroundDespite renewed interest in studying the safety and efficacy of psychedelic-assisted psychotherapy for the treatment of psychological disorders, the enrollment of racially diverse participants and the unique presentation of psychopathology in this population has not been a focus of this potentially ground-breaking area of research. In 1993, the United States National Institutes of Health issued a mandate that funded research must include participants of color and proposals must include methods for achieving diverse samples.MethodsA methodological search of psychedelic studies from 1993 to 2017 was conducted to evaluate ethnoracial differences in inclusion and effective methods of recruiting peopple of color.ResultsOf the 18 studies that met full criteria (n = 282 participants), 82.3% of the participants were non-Hispanic White, 2.5% were African-American, 2.1% were of Latino origin, 1.8% were of Asian origin, 4.6% were of indigenous origin, 4.6% were of mixed race, 1.8% identified their race as “other,” and the ethnicity of 8.2% of participants was unknown. There were no significant differences in recruitment methodologies between those studies that had higher (> 20%) rates of inclusion.ConclusionsAs minorities are greatly underrepresented in psychedelic medicine studies, reported treatment outcomes may not generalize to all ethnic and cultural groups. Inclusion of minorities in futures studies and improved recruitment strategies are necessary to better understand the efficacy of psychedelic-assisted psychotherapy in people of color and provide all with equal opportunities for involvement in this potentially promising treatment paradigm.
Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction) is a guided, online couple intervention adapted from Cognitive-Behavioral Conjoint Therapy for posttraumatic stress disorder (PTSD). It was created to overcome a range of barriers to accessing evidence-based treatments for PTSD and the intimate relationship problems associated with it. This manuscript describes initial outcomes of the intervention in a series of 10 couples. Participants were military, veteran and first responders with probable PTSD and their intimate partners. Couples completed the program and measurements of PTSD, relationship satisfaction, and secondary outcomes at pre-, mid-, and post-intervention. Mean satisfaction for the program was high and it was completed by seven of ten couples. Participants with PTSD evidenced significant and large pre- to post-intervention effect size improvements in PTSD symptoms ( g = 0.80) and perceived health ( g = 1.13). They also exhibited non-significant but medium effect size pre- to post-intervention improvements in quality of life ( g = 0.62), and depression ( g = 0.53), and small effect size pre- to post-intervention improvements in argumentativeness ( g = 0.43), anger ( g = 0.31), and anxiety ( g = 0.31). Partners reported significant and moderate pre- to post-intervention effect size improvements in relationship satisfaction (g = 0.68 ), and medium but not significant effect size improvements in accommodation of PTSD ( g = 0.56). Results provide initial support for the feasibility, acceptability, and efficacy of Couple HOPES for improving PTSD and relationship satisfaction. However, more testing in larger samples, including with randomized controlled designs, is needed.
To re-analyse the clinical outcomes and interferon (IFN) activity data from the JOQUER trial, a phase III trial investigating hydroxychloroquine (HCQ) in patients with primary Sjögren’s syndrome (pSS), after stratifying patients into putative pathobiological subgroups utilizing the Newcastle Sjögren’s Stratification Tool (NSST) based on patient-reported symptoms of dryness, pain, fatigue, anxiety and depression. 107 patients were assigned to one of four subgroups using NSST at baseline—the high symptom burden (HSB), pain dominant with fatigue (PDF), dryness dominant with fatigue (DDF) and low symptom burden (LSB). Endpoints were re-analysed after stratification, testing for treatment differences within subgroups and adjusting for baseline differences using a repeated measures covariate model. The HSB subgroup (n = 32) showed a relative improvement in ESSPRI of 1.49 points (95% CI 0.54–2.43; p = 0.002) within 12 weeks in patients taking HCQ compared to placebo, with no further changes after 24 weeks. For the LSB subgroup (n = 14), the ESSPRI worsened in the placebo but not the HCQ arm after 12 weeks (mean difference 1.44, 95% CI 0.05–2.83, p = 0.042). Neither the HSB nor the LSB patients showed significant changes in IFN activity at 24 weeks. There were no significant differences in ESSPRI in the PDF (n = 39) and DDF (n = 22) patients taking HCQ. However, significant reductions in overall IFN score at 24 weeks were seen in both PDF (difference at 24 weeks; 6.41, 95% CI, 2.48–10.34, p = 0.002) and DDF (difference at 24 weeks; 7.23, 95% CI, 1.85–12.6, p = 0.009) without improvement in ESSPRI. Although the JOQUER trial reported no overall benefit from HCQ in pSS patients, stratification suggests that both HSB and LSB subgroups may respond to HCQ. However, these patients may benefit through mechanisms other than the reduction of IFN activities.
Background: Despite renewed interest in studying the safety and efficacy of psychedelic-assisted psychotherapy for the treatment of psychological disorders, the enrollment of racially diverse participants and the unique presentation of psychopathology in this population has not been a focus of this potentially ground-breaking area of research. In 1993, the United States National Institutes of Health issued a mandate that funded research must include participants of color and proposals must include methods for achieving diverse samples. Methods: A methodological search of psychedelic studies from 1993 to 2017 was conducted to evaluate ethnoracial differences in inclusion and effective methods of recruiting peopple of color.Results: Of the 18 studies that met full criteria (n = 282 participants), 82.3% of the participants were non-Hispanic White, 2.5% were African-American, 2.1% were of Latino origin, 1.8% were of Asian origin, 4.6% were of indigenous origin, 4.6% were of mixed race, 1.8% identified their race as "other," and the ethnicity of 8.2% of participants was unknown. There were no significant differences in recruitment methodologies between those studies that had higher (> 20%) rates of inclusion.Conclusions: As minorities are greatly underrepresented in psychedelic medicine studies, reported treatment outcomes may not generalize to all ethnic and cultural groups. Inclusion of minorities in futures studies and improved recruitment strategies are necessary to better understand the efficacy of psychedelic-assisted psychotherapy in people of color and provide all with equal opportunities for involvement in this potentially promising treatment paradigm.
Novel interventions that overcome limited access to empirically supported psychotherapies for posttraumatic stress disorder (PTSD) are sorely needed. Couple helping overcome PTSD and enhance relationships (HOPES), a guided, online couple intervention drawing from cognitive-behavioral conjoint therapy (CBCT) for PTSD (Monson, 2012), was designed to decrease PTSD symptoms and improve relationship satisfaction. The present study is the first uncontrolled trial of 17 couples in which one partner was a military member, veteran, or first responder and had probable PTSD (PTSD+ partner) based on self-report assessment. Intent-to-intervene analyses revealed significant improvements from pre-to postintervention in PTSD+ partners' self-reported PTSD symptoms (g = .72), as well as their intimate partner's relationship satisfaction (g = .34) and behavioral accommodation of PTSD symptoms (g = .84). There were also significant improvements in PTSD+ partners' depression (g = .43) and perceived relationship arguments (g = .62). There were similar results found in the completer sample. There were no adverse events and high satisfaction with the intervention in those who completed the evaluation. These findings provide additional initial data on the safety, feasibility, and efficacy of Couple HOPES. The similarities of intent-to-intervene and completer results, as well as the need for randomized controlled trial designs to test Couple HOPES, are discussed.
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