Depressive DisordersPTSDMDMAMDMAPsilocybin

Beliefs and Perceived Barriers Regarding Psychedelic-assisted Therapy in a Pilot Study of Service Members and Veterans With a History of Traumatic Brain Injury

In a pilot sample of 21 service members and veterans with traumatic brain injury, brief psychoeducation significantly increased positive attitudes and interest in psychedelic-assisted therapy (PAT), and most participants supported PAT availability in medical settings if proven beneficial. Participants nonetheless expressed health concerns (long-term effects, losing their mind, personality changes) and logistical barriers (time, transport, cost), indicating the need for targeted education, command support and practical facilitation to ensure access if PAT is approved.

Authors

  • Carter, S. E.
  • Gray, J. C.
  • Johnson, M. W.

Published

Military Medicine
individual Study

Abstract

ABSTRACT Introduction Posttraumatic stress disorder (PTSD) and depression are common in service members and veterans, and the response to currently available treatments is often modest at best. Recent studies suggest potential benefit with psychedelic-assisted therapies (PATs), particularly 3,4-methylenedioxymethamphetamine-assisted therapy for PTSD and psilocybin-assisted therapy for depression. This study examined beliefs and perceived barriers regarding PAT among service members and veterans to inform the delivery of these treatments if they are approved by the FDA. Materials and Methods Twenty-one service members and veterans (67% male, 81% White, and 43% active duty) with a history of traumatic brain injury and co-occurring cognitive and psychological symptoms completed a measure assessing baseline knowledge and views of PAT, read a brief psychoeducation regarding PAT, and then responded to questions related to their beliefs and perceived barriers to PAT. Results Before psychoeducation, participants reported a neutral view of psychedelic drugs (M = 2.76; range: 1-5), PAT (M = 3.33), and interest in PAT (M = 3.10). After psychoeducation, participants reported a significantly more positive view of psychedelic drugs (M = 3.24, P = .014) and interest in PAT (M = 3.67, P = .016). Overall, participants indicated that they would support PAT availability in medical settings if proven beneficial (M = 4.52; 5 = “agree strongly”) and they would support a loved one engaging in PAT (M = 4.29). The most frequently reported health concerns were concern of long-term effects (43%), fear of losing their mind (33%), fear of personality changes (33%), and fear of traumatic brain injury complications (24%). The most frequently endorsed barriers were time commitment, transportation, financial concerns, work, and childcare (33%-19%), with 48% reporting no barriers. Conclusions This is the first study to explore beliefs and perceived barriers regarding PAT among service members and veterans. These results indicate that military populations may be interested in PAT, particularly if psychoeducation and outreach regarding these treatments occurred. If FDA approved, it will be important to facilitate command support and address logistical barriers to ensure appropriate access within military contexts.

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Research Summary of 'Beliefs and Perceived Barriers Regarding Psychedelic-assisted Therapy in a Pilot Study of Service Members and Veterans With a History of Traumatic Brain Injury'

Introduction

Randomised controlled trials have recently strengthened interest in psychedelic-assisted therapy (PAT), particularly MDMA-assisted therapy for post-traumatic stress disorder (PTSD) and psilocybin-assisted therapy for major depressive disorder. Gray and colleagues note that Phase III data have shown promising efficacy signals (for example, a substantial proportion of MDMA-treated participants no longer met PTSD criteria in a Phase III trial) and that a Phase III programme for psilocybin is planned. Service members and veterans have high rates of PTSD, depression and co-occurring traumatic brain injury (TBI), and standard treatments often yield modest or incomplete responses in these populations; the authors argue that PAT could be a novel option worthy of attention for patients with treatment-resistant presentations. This study sought to characterise beliefs, familiarity, and perceived barriers regarding PAT among service members and veterans with a history of TBI and co-occurring cognitive or psychological symptoms. Using a brief written psychoeducation module and a questionnaire administered at baseline, the investigators aimed to measure participants' baseline knowledge and attitudes toward psychedelic drugs and PAT, to assess changes in those attitudes after reading the psychoeducation, and to identify anticipated logistical, stigma-related, and health concerns that might affect uptake if PAT becomes FDA approved and available in medical settings. Given the exploratory nature of the work, the authors expected a wide range of familiarity and views among participants.

Methods

Participants were recruited from multiple channels including a referral programme for current or former service members and civilians with TBI. Interested individuals completed a phone screening for eligibility. Inclusion criteria were being an active duty service member, veteran, retired service member, TRICARE-eligible reservist, or national guard member aged over 18 with a history of mild or moderate TBI occurring more than 3 months earlier, as determined by the Ohio State University Traumatic Brain Injury Identification Method (OSU-TBI). The authors note that the OSU-TBI criterion was formally added after the first six participants were enrolled. Lack of English fluency sufficient to complete measures was an exclusion criterion. The study received Institutional Review Board approval from the Uniformed Services University. Participants provided informed consent and were compensated US$90 for participation except for active duty individuals who did not receive payment due to Department of Defense restrictions. Study procedures comprised three appointments spaced roughly 4 weeks apart that included self-report assessments, performance-based executive functioning tasks, and interviews about TBI and depression; this paper reports data exclusively from the baseline session. Four participants completed the PAT-related questions after their final appointment because those items were added after study initiation. Trained research staff administered the assessments. Perceptions of PAT were measured with a bespoke Psychedelic Perceptions Survey. Participants rated familiarity with psychedelic drugs and PAT and interest in PAT on 1–5 scales, completed a brief written psychoeducation about psychedelic drugs and PAT, and then re-rated the same items. Additional items probed agreement (1 = disagree strongly to 5 = agree strongly) with statements about PAT (for example, support for availability in medical settings, trust in therapists) and asked participants to endorse barriers and concerns across three domains: logistical barriers (time commitment, transportation, work, childcare, financial concerns), stigma (fear of judgment, fear of legal or workplace consequences), and health concerns (fear of TBI complications, long-term effects, personality changes). Clinical measures completed at baseline included demographics and validated symptom scales: the Montgomery–Åsberg Depression Rating Scale (MADRS) and the Patient Health Questionnaire-9 (PHQ-9) for depression, the Generalized Anxiety Disorder screener (GAD-7) for anxiety, and the PTSD Checklist (PCL-5) for PTSD symptoms. TBI history was assessed with the OSU-TBI semi-structured interview. Analyses were conducted in R (version 3.5.1); descriptive statistics summarised sample characteristics and questionnaire responses, summary scores were computed for symptom measures, and paired-samples t-tests evaluated changes in views of psychedelics and PAT before and after the brief psychoeducation.

Results

Twenty-one participants provided baseline data. The sample ranged in age from 31 to 65 years (mean 46.7), was 67% male and 81% White, and included 43% active duty and 57% veterans. Clinical screening indicated that 12 participants screened positive for depression on the PHQ-9, eight for PTSD on the PCL-5, five for probable generalized anxiety on the GAD-7, and 17 reported a history of mild TBI. Familiarity and baseline views were generally low to neutral. One section of the extracted text reports baseline familiarity with psychedelic drugs as slightly familiar (mean = 2.19 on a 1–5 scale) and with PAT as not familiar at all (mean = 1.48). Elsewhere in the extracted text (the abstract) different baseline means are reported (for example, a neutral view of psychedelic drugs M = 2.76 and PAT M = 3.33). The extracted text does not resolve this discrepancy. Despite generally low familiarity, participants on average agreed that they would support PAT being made available in medical settings if proven beneficial (mean = 4.52 on a 1–5 agreement scale) and that they would support a loved one pursuing PAT (mean = 4.29). Trust in therapists during PAT was rated around neutral-to-positive (mean = 3.86). Participants did not endorse the importance of therapist concordance on race/ethnicity (mean = 1.76) or gender (mean = 2.00). After reading a brief written psychoeducation, participants reported an increase in positivity toward psychedelic drugs and interest in PAT. The abstract reports statistically significant increases: for views of psychedelic drugs (mean increased to 3.24, P = .014) and for interest in PAT (mean increased to 3.67, P = .016), and the investigators analysed these changes with paired-samples t-tests. The extracted text does not fully reconcile the differing baseline scores noted above. Regarding barriers and concerns, the most frequently endorsed logistical barrier was time commitment (33%), followed by transportation, financial concerns, work, and childcare (endorsed by 29%–19% of participants). About 48% of participants reported no logistical barriers. Stigma-related concerns included fear of workplace consequences (29%) and fear of judgement (24%). Health concerns most commonly cited were fear of long-term effects (43%), fear of “losing their mind” (33%), fear of personality changes (33%), and fear of TBI complications (24%). One-third (33%) reported no stigma or health concerns related to engaging in PAT.

Discussion

Gray and colleagues interpret these findings as an initial indication that service members and veterans with a history of TBI and co-occurring cognitive or psychological symptoms are, on average, only slightly familiar with PAT, hold neutral-to-somewhat positive views, and show increased interest after receiving brief psychoeducation. The researchers highlight that participants expressed a mix of enthusiasm and hesitation: there was strong agreement supporting availability of PAT in medical settings if proven beneficial, yet many participants also reported fears about potential long-term effects, loss of mental stability, personality changes and specific concerns about TBI-related complications. The investigators underline logistical and military-specific barriers that may hinder access if PAT becomes available. More than half of participants endorsed at least one logistical barrier, with time commitment, transportation and financial concerns most commonly mentioned. Although few participants reported legal or career concerns, the lowest level of endorsement concerned command support for engaging in PAT; the authors emphasise that how PAT would be integrated into the Military Health System, whether it would affect readiness, and how stigma might play out remain open questions. The paper notes recent policy developments (House-passed amendments in the 2023 National Defense Authorization Act authorising DoD study of PAT) as a sign of growing institutional interest. The discussion also places participant concerns in the context of limited data about safety and efficacy of psychedelics in people with TBI. The authors cite preclinical findings that psychedelics can promote neuroplasticity and mention early clinical research such as a psilocybin trial for migraine showing reduced frequency and intensity without unexpected serious adverse events, and an ongoing study of psilocybin for post-concussive headaches. They conclude that further dedicated investigations of safety and efficacy in TBI populations are warranted. Several limitations are acknowledged. The survey asked conjointly about MDMA- and psilocybin-assisted psychotherapy, preventing substance-specific inferences. The small sample size (pilot study) limited statistical power and representativeness, and four participants completed PAT items later because those questions were added after study start. The volunteer nature of the sample may bias results, and the study was underpowered to compare views between active duty and veteran subgroups. The authors call for larger, more diverse studies including key stakeholders such as Military Health System providers, and for future work to test different informational framings and to examine substance-specific, dosing- and format-specific (for example, group versus individual) beliefs. They emphasise that addressing patient expectations and logistical and military-specific barriers will be important if PAT is approved and implemented, given that expectations can influence treatment effectiveness.

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CONCLUSION

This is the first study to explore beliefs and perceived barriers regarding PAT among service members and veterans. The primary findings were that participants on average were only slightly familiar, had neutral views, and were somewhat interested in PAT. The positivity of their views of PAT, and to a lesser extent their interest, increased after reading a brief description of PAT. They endorsed a wide range of views regarding the potential benefits or downsides of PAT as well as potential fears and barriers related to engaging in the treatment. With regard to barriers to participating, more than half of participants identified at least one barrier to engaging in PAT. The top three barriers were time commitment, transportation, and financial concerns. Participants expressed a diversity of positive and negative views of aspects of PAT. They were on average neutral in their views, but there were some deviations. In particular, there was strong agreement in support of PAT, if proven beneficial, being made available in medical settings to help with mental health problems. The lowest endorsement was of command supporting them in engaging in PAT. On the other hand, participants broadly endorsed very few legal or career concerns from engaging in PAT. Real or perceived career ramifications are an important consideration because it is not yet clear if and how PAT may achieve approval and be integrated in the Military Health System, including the logistics of implementing this resource intensive treatment modality, how it may impact military readiness, and what stigma soldiers may experience in pursuing PAT versus other treatment options. Notably, the 2023 National Defense Authorization Act, in its current form,passed two amendments through the House that specifically authorize the DoD to study PAT for active duty service members, suggesting that there may be increasing interest in the potential of PAT for service members. Many participants endorsed fear regarding perceived effects and risks of PAT. In particular, several participants reported fear of negative long-term effects, losing their mind, and personality change. The concern over negative longterm effects may in part be related to specific concerns over TBI-related issues, as more than a third endorsed a fear of TBI complications. Notably, psilocybin, MDMA, and other psychedelics have been found to promote neuroplasticity in the form of neuritogenesis and synaptogenesis,but it is yet unclear to what extent these findings may translate to outcomes of safety and efficacy in those with TBI. The first study of psilocybin for migraines found that migraine frequency and intensity were significantly reduced compared to placebo after a single dose with no unexpected or serious adverse events.The first study of psilocybin for postconcussive headaches is currently underway (NCT03806985).Altogether, further investigation is warranted to study the safety and efficacy of psychedelics for the treatment of TBI and related conditions. This study has notable limitations. First, this study asked jointly about MDMA-and psilocybin-assisted psychotherapy, and thus it was not possible to parse substance-specific beliefs that patients may have. It will be important for future studies to explore beliefs regarding separate substances and formats of PAT administration (e.g., group versus individual) as well as the impact of reading descriptions of PAT that include different framing and emphases on the potential benefits and side effects. Second, this study was underpowered to explore differences in views between service members and veterans. Third, this study has a small sample size and thus should not be seen as being broadly representative of the views of active duty service members and veterans. Fourth, the reported results in this set of individuals who volunteered to take part in this assessment may not generalize to other groups of veterans and soldiers who may have different sociodemographic or clinical characteristics and who may be more reticent to consider novel therapies. It will be important for future studies to build on this pilot study to comprehensively evaluate beliefs regarding PAT in a large, diverse cohort of patients and key stakeholders (e.g., Military Health System providers). Despite these limitations, this study was the first of its kind to provide a voice to service members and veterans regarding PAT. In conclusion, this study offers important insights into the views on PAT among service members and veterans with a history of head injury and co-occurring cognitive or psychological symptoms. While their familiarity and views were varied, many expressed both interest and hesitation with respect to PAT. The results highlight the need to give careful consideration to patient views of novel treatments for longstanding conditions, particularly given research indicating that treatment expectations impact intervention effectiveness.It is therefore important that expectations and concerns of patients are anticipated and addressed in future psychoeducational materials and PAT treatment protocols. Furthermore, militaryspecific concerns or barriers need to be further evaluated and addressed if these treatments are FDA approved, given the identified concern of command support and logistical barriers.

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