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To explore the cost-effectiveness of midomafetamine-assisted therapy (MDMA-AT) compared to placebo with therapy (PT) in US healthcare settings. A health state-transition model was used to analyze the cost-effectiveness of MDMA-AT for treating patients with chronic PTSD of moderate or higher severity. Both treatment arms consisted of 3 preparation (90-min), 3 interventional (8-h), and 9 integration (90-min) sessions, lasting ~4 months total. All sessions included psychotherapy, with interventional also including MDMA or placebo. After receiving treatment, patients were distributed across health states of No PTSD (not meeting PTSD diagnostic criteria), Non-Severe PTSD (treatment responders), Severe PTSD (treatment non-responders), and death. Each state had unique healthcare costs and utilities sourced from real-world data analysis and patient data from MDMA-AT clinical trials (including long-term follow-up). The base-case analysis considered the payer's perspective with a 5-year horizon, 3.5% annual cost and effect discounts, and an assumed MDMA medication price of $12,000 per session. Trial-derived utilities and US life tables mortality data were used to calculate quality-adjusted life years (QALY). The main outcome was an incremental cost-effectiveness ratio (ICER) with a $150,000 willingness-to-pay (WTP) threshold. The base-case ICER was $83,845 per QALY. Total direct costs were $64,745 in the MDMA-AT and $33,132 in the PT arms ($31,613 increment). The costs of intervention were $48,376 for MDMA-AT and $12,376 for PT. The highest MDMA medication cost to fit under the WTP threshold was $20,314 per session. Costs related to PTSD healthcare visits and other PTSD treatments were lower with MDMA-AT than PT (-$2,511 and -$1,877 increments, respectively). Utility benefits were higher in MDMA-AT than PT, with 3.691 and 3.314 QALYs generated over 5 years, respectively (0.377 QALY increment). These data suggest MDMA-AT may be a cost-effective treatment compared to PT for patients with chronic PTSD of moderate or higher severity.

Severe posttraumatic stress disorder (PTSD) is a prevalent and debilitating condition in the United States. and globally. Using pooled efficacy data from six phase 2 trials, therapy using 3,4-methylenedioxymethamphetamine (MDMA) appeared cost-saving from a payer's perspective. This study updates the cost-effectiveness analysis of this novel therapy using data from a new phase 3 trial, including the incremental cost-effectiveness of the more intensive phase 3 regimen compared with the shorter phase 2 regimen. We adapted a previously-published Markov model to portray the costs and health benefits of providing MDMA-assisted therapy (MDMA-AT) to patients with chronic, severe, or extreme PTSD in a recent phase 3 trial, compared with standard care. Inputs were based on trial results and published literature. The trial treated 90 patients with a clinician administered PTSD scale (CAPS-5) total severity score of 35 or greater at baseline, and duration of PTSD symptoms of 6 months or longer. The primary outcome was assessed 8 weeks after the final experimental session. Patients received three 90-minute preparatory psychotherapy sessions, three 8-hour active MDMA or placebo sessions, and nine 90-minute integrative psychotherapy sessions. Our model calculates the per-patient cost of MDMA-AT, net all-cause medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). We reported results from the U.S. health care payer's perspective for multiple analytic time horizons, (base-case is 30 years), and conducted extensive sensitivity analyses. Costs and QALYs were discounted by 3% annually. Costs were adjusted to 2020 U.S. dollars according to the medical component of the U.S. Bureau of Labor Statistics' Consumer Price Index (CPI). MDMA-AT as conducted in the phase 3 trial costs $11,537 per patient. Compared to standard of care for 1,000 patients, MDMA-AT generates discounted net health care savings of $132.9 million over 30 years, accruing 4,856 QALYs, and averting 61.4 premature deaths. MDMA-AT breaks even on cost at 3.8 years while delivering 887 QALYs. A third MDMA session generates additional medical savings and health benefits compared with a two-session regimen. Hypothetically assuming no savings in health care costs, MDMA-AT has an ICER of $2,384 per QALY gained. MDMA-AT provided to patients with severe or extreme chronic PTSD is cost-saving from a payer's perspective, while delivering substantial clinical benefit.

A recent trial found that Transcendental Meditation (TM) was an effective non-trauma focused treatment for veterans with Post-Traumatic Stress Disorder (PTSD). The objective of this analysis was to examine the cost-effectiveness of TM for PTSD based on the trial results. Between 2013-2017, 203 veterans with PTSD were randomized to either TM, Prolonged Exposure (PE), or to a PTSD health education (HE) control. Each group received 12 treatment sessions over 12 weeks. Results indicated that TM was non-inferior to PE for improving PTSD outcomes and both TM and PE were superior to HE, as hypothesized. The proportion of participants with a clinically significant improvement on the CAPS (≥10 point reduction) were TM = 61%, PE = 42%, and HE = 32%. A Markov model was developed to estimate the cost-effectiveness of TM, using the trial effectiveness data. Intervention costs, health care costs, and health utility values associated with response and non-response were derived from scientific literature. Costs were viewed from an organizational perspective and a 5-year time horizon (20 3-month cycles). One-way and probabilistic sensitivity analyses were conducted. TM was the dominant treatment strategy over both PE and HE in the cost-effectiveness analysis. TM cost an estimated $1504/12 sessions while PE and HE cost $2,822 and $492, respectively. The higher health care costs associated with non-response to therapy offset intervention cost differences. Findings were robust to variability. In summary, using data from a recent RCT, TM was found to both improve health outcomes and reduce total costs in this analysis. Based on these results, further effectiveness trials and wider adoption of TM should be considered.

Childhood maltreatment (CM) significantly increases the risk of developing post-traumatic stress disorder (PTSD) for which the prevalence in Europe is higher than initially assumed. While the high economic burden of PTSD is well-documented, little is known about the health care cost differences between individuals with PTSD-CM and those without PTSD in Germany. This study aimed to determine the excess health care and absenteeism costs associated with PTSD-CM in Germany. Baseline data from a multi-center randomized controlled trial on individuals with PTSD-CM (n = 361) were combined with data from individuals without PTSD (n = 4760). Entropy balancing was used to balance the data sets with regard to sociodemographic characteristics. Six-month excess health care costs from a societal perspective were calculated for 2022, using two-part models with logit specification for the first part and a generalized linear model for the second part. The total six-month excess costs associated with PTSD-CM were €8864 (95% CI: €6855 to €10,873) per person. Of this, the excess health care costs accounted for €4647 (95% CI €3296 to €5997) and the excess costs of absenteeism for €4217 (95% CI: €3121 to €5314). Individuals with mild to moderate PTSD symptoms incurred total excess costs of €6038 (95% CI: €3879 to €8197), while those with severe to extreme symptoms faced €11,433 (95% CI: €8220 to €14,646). Excess health care and absenteeism costs associated with PTSD-CM were substantial, with absenteeism accounting for roughly half of the total excess costs.

IntroductionPost-traumatic stress disorder (PTSD) is a serious disorder that burdens individuals and society. The current standard of first-line treatment for PTSD is spaced trauma-focused treatment (S-TFT), involving weekly sessions. While effective, S-TFT may take relatively long to complete, especially in patients exposed to multiple potentially traumatic events (PTEs). Massed trauma-focused treatment (M-TFT), involving increased session frequency, potentially results in faster symptom reduction and restoration of quality of life, as well as in a reduction of societal costs. However, M-TFT is not recommended as first-line treatment. This paper describes the research protocol of a single-blind, multicentre randomised controlled trial (RCT) aimed at investigating: (1) the clinical and cost-effectiveness of M-TFT versus S-TFT in employed, multiply traumatised patients who seek first-line treatment for PTSD and (2) predictive and moderating factors related to treatment response.Methods and analysis186 participants are recruited from five centres and will be included if they are ≥18 years old, meet criteria for a Diagnostic and Statistical Manual of Mental Disorders Fifth Edition PTSD diagnosis based on ≥two PTEs, seek treatment for the first time and are employed. Patients with specified comorbid disorders and insufficient Dutch language proficiency are excluded. Participants are randomised to 800 min of either M-TFT or S-TFT. M-TFT consists of two once-weekly preparatory sessions, 10 twice-daily sessions of prolonged exposure, eye movement desensitisation and reprocessing therapy for 2 weeks and two once-weekly closing sessions. S-TFT consists of weekly sessions of one of five evidence-based treatment interventions. Outcomes are assessed at baseline and at 7 weeks, 17 weeks, 6 months and 9 months after baseline. Primary outcomes are clinical effectiveness in terms of PTSD symptom severity and cost-effectiveness based on quality of life measures and societal costs. Data will be analysed with linear mixed models.Ethics and disseminationThis study protocol was approved by the Medical Ethics Review Board of the Amsterdam University Medical Center (NL86057.018.24). Participants will provide informed consent before enrolment in the trial. Results will be published in peer-reviewed journals and will be released to clinicians, patient groups and the general community.Trial registration numberThis protocol is registered at Overview of Medical Research in the Netherlands (OMON; trial register number 56960) and ClinicalTrials.gov (NCT06700590).

App interventions show promise as effective interventions for trauma-related distress, but evaluations of their cost-effectiveness are scarce. This study aimed to assess the cost-effectiveness of an app-based intervention for self-management of posttraumatic stress compared to no guided self-management. An economic evaluation from a Swedish public health care perspective was conducted alongside a randomized controlled trial in which participants (N=179) were randomly assigned to either immediate exposure (intervention group; n=89, 49.7%) or delayed exposure at 3 months (waitlist group; n=90, 50.3%). The number of quality-adjusted life years (QALYs) gained or lost, increases or decreases in the use of different types of health care, and the monetary costs (in SEK; 2023 price level) saved or incurred with the intervention versus the comparator at 9 months after exposure were estimated based on functional disability and health care consumption reported by participants via a web-based written questionnaire at baseline and at 3, 6, and 9 months of follow-up. Estimation was done via linear regression with clustering at the participant level. The probability of the intervention being cost-effective was calculated over a range of cost-effectiveness thresholds up to SEK 1 million per QALY (US $94,225 per QALY; 2023 average exchange rate, US $1=SEK 10.61), and value of information analysis was used to interpret statistical uncertainty in the cost-effectiveness results. There was no statistically significant difference between the intervention and comparator at 9 months after exposure when QALYs and all categories of health care consumption were analyzed jointly (P=.46). When analyzed separately, there was a significant increase in the number of consultations made in private mental health care (P=.03). The intervention was associated with 0.0065 (95% CI -0.0219 to 0.0349) QALYs gained per user and an increment in costs of SEK -46,359 (95% CI -111,696 to 18,977; US $-4368, 95% CI -10,525 to 1788) per user compared to no guided self-management. Cost savings were due to fewer consultations and care days per user in public health care (-5.50, 95% CI -14.83 to 3.83). The intervention had a 62% probability of both gaining QALYs and saving costs, and the probability that it would be cost-effective remained constant at 92% over our threshold range. The total expected value of perfect information was SEK 5.4 million (US $510,480) and was largely attributable to statistical uncertainty in incremental costs. The use of a mobile app for self-management of posttraumatic stress was found to be cost-effective in a Swedish setting. A value-of-information analysis suggests that current research is sufficient to support the use of the app in Swedish practice from a cost-effectiveness perspective. However, to support its adoption in other settings or the potential of app-based interventions in general, stronger cost-effectiveness evidence is required. ClinicalTrials.gov NCT04094922; https://clinicaltrials.gov/ct2/show/NCT04094922.

Background In humanitarian settings common mental disorders (depression, anxiety disorders, posttraumatic stress disorder) are highly prevalent. The World Health Organization (WHO) has developed Problem Management Plus (PM+), a 5-session, individual psychological intervention program, delivered by paraprofessionals that addresses common mental disorders in people in communities affected by adversity. The objectives of this study are to test effectiveness and cost-effectiveness of the locally adapted PM+ compared to Treatment as usual (TAU) in Peshawar District, Pakistan. Methods A randomised controlled trial will be conducted in 346 primary care attendees in 3 health care centres in Peshawar District, Pakistan. After informed consent, primary care attendees with high levels of psychological distress according to the General Health Questionnaire-12 (GHQ-12) and functional impairment (WHO Disability Assessment Schedule 2.0 (WHODAS)) will be assigned to PM+ (n = 173) or TAU (n = 173). At baseline, 1 week and 3 months following PM+, independent assessors will assess psychological distress with the Hospital Anxiety and Depression Scale (HADS), and functional disability with the WHODAS. Secondary outcomes are posttraumatic stress disorder (PTSD) symptoms, and client-perceived priority problems. Further, cost-effectiveness will be assessed using the Service Receipt Inventory (SRI). Discussion If proven effective, PM+ will be rolled out to other areas for further adaptation and testing in diverse humanitarian settings. Trial registration ACTRN12614001235695 . Registered 26 November 2014. Australian New Zealand Clinical Trials Registry

Veterans filing claims that service-induced PTSD impairs them worry that claims examiners may attribute their difficulties to conditions other than PTSD, such as substance use. Substance use commonly co-occurs with PTSD and complicates establishing a PTSD diagnosis because symptoms may be explained by PTSD alone, PTSD-induced substance use, or by a substance use condition independent of PTSD. These alternative explanations of symptoms lead to different conclusions about whether a PTSD diagnosis can be made. How substance use impacts an examiner's diagnosis of PTSD in a Veteran's service-connection claim has not been previously studied. In this study, we tested the hypothesis that mention of risky substance use in the Compensation & Pension (C&P) examination would result in a lower likelihood of service-connection award, presumably because substance use reflected an alternative explanation for symptoms. Data were analyzed from 208 Veterans' C&P examinations, medical records, and confidentially-collected research assessments. In this sample, 165/208 (79%) Veterans' claims were approved for a mental health condition; 70/83 (84%) with risky substance use mentioned and 95/125 (76%) without risky use mentioned (p = .02). Contrary to the a priori hypothesis, Veterans with risky substance use were more likely to get a service-connection award, even after controlling for baseline PTSD severity and other potential confounds. They had almost twice the odds of receiving any mental health award and 2.4 times greater odds of receiving an award for PTSD specifically. These data contradict assertions of bias against Veterans with risky substance use when their claims are reviewed. The data are more consistent with substance use often being judged as a symptom of PTSD. The more liberal granting of awards is consistent with literature concerning comorbid PTSD and substance use, and with claims procedures that make it more likely that substance use will be attributed to trauma exposure than to other causes.

ABSTRACT BACKGROUND Although collaborative care is effective for treating depression and other mental disorders in primary care, there have been no randomized trials of collaborative care specifically for patients with Posttraumatic stress disorder (PTSD). OBJECTIVE To compare a collaborative approach, the Three Component Model (3CM), with usual care for treating PTSD in primary care. DESIGN The study was a two-arm, parallel randomized clinical trial. PTSD patients were recruited from five primary care clinics at four Veterans Affairs healthcare facilities and randomized to receive usual care or usual care plus 3CM. Blinded assessors collected data at baseline and 3-month and 6-month follow-up. PARTICIPANTS Participants were 195 Veterans. Their average age was 45 years, 91% were male, 58% were white, 40% served in Iraq or Afghanistan, and 42% served in Vietnam. INTERVENTION All participants received usual care. Participants assigned to 3CM also received telephone care management. Care managers received supervision from a psychiatrist. MAIN MEASURES PTSD symptom severity was the primary outcome. Depression, functioning, perceived quality of care, utilization, and costs were secondary outcomes. KEY RESULTS There were no differences between 3CM and usual care in symptoms or functioning. Participants assigned to 3CM were more likely to have a mental health visit, fill an antidepressant prescription, and have adequate antidepressant refills. 3CM participants also had more mental health visits and higher outpatient pharmacy costs. CONCLUSIONS Results suggest the need for careful examination of the way that collaborative care models are implemented for treating PTSD, and for additional supports to encourage primary care providers to manage PTSD.

The aim of this study was to determine the influence of posttraumatic stress disorder (PTSD) on treatment outcomes in patients with borderline personality disorder (BPD). Participants were 180 individuals diagnosed with BPD enrolled in a randomized controlled trial that compared the clinical and cost effectiveness of dialectical behavior therapy (DBT) and general psychiatric management (GPM). Multilevel linear models and generalized linear models were used to compare clinical outcomes of BPD patients with and without PTSD. BPD patients with comorbid PTSD reported significantly higher levels of global psychological distress at baseline and end of treatment compared to their non-PTSD counterparts. Both groups evidenced comparable rates of change on suicide attempts and non-suicidal self-injury (NSSI), global psychological distress, and BPD symptoms over the course of treatment and post-treatment follow-up. DBT and GPM were effective for BPD patients with and without PTSD across a broad range of outcomes.