Perceptions of voluntary consent among jail diverted veterans with co-occurring disorders.

This study assessed perceptions of voluntary consent among 69 veterans who enrolled in a "jail diversion" program for co-occurring disorders. Perceptions were measured using modified items from the MacArthur Perceived Coercion and Negative Pressure Scales. A majority reported that they "chose to" (88.4%) or "felt free to" (85.5%) enroll. Most reported having "control over" (69.6%) and "more influence than anyone else" regarding (60.9%) their participation. About half reported that enrollment was "their idea" (49.3%). Fewer reported perceptions of negative pressure, including the feeling that someone "talked them into" enrolling (24.6%), "threatened them with the maximum criminal punishment" (13.0%), "offered or promised them something" (5.8%), or "forced" them to enroll (5.8%). Nobody felt "tricked, lied to, or fooled into" participating. Total negative pressure scores were higher in those with combat experience, U = 406.50, p = .016. Although potentially inappropriate pressures were reported, these data suggest that the majority perceived enrollment as voluntary.

SYMPTOM AND FUNCTIONAL TRAITS OF BRIEF MAJOR DEPRESSIVE EPISODES AND DISCRIMINATION OF BEREAVEMENT.

BACKGROUND: Despite the removal of the bereavement exclusion from DSM-5, clinicians may feel uncertain on how to proceed when caring for a patient who presents with depressive symptoms following the death of someone close. The ability to better distinguish, on a symptom and functional level, between patients who experience depression in the context of bereavement and those with nonbereavement-related depression, could help guide clinical decision making. METHOD: Individual and clustered depressive symptom and impairment measures were used for modeling bereavement status within a nationally representative longitudinal cohort. Deviance, linear shrinkage factor, and bias-corrected c-statistic were used for identifying a well-calibrated and discriminating final model. RESULTS: Of the 450 (1.2%) respondents with a single brief major depressive episode, 162 (38.4%) reported the episode as bereavement-related. The bereaved were less likely to endorse worthlessness (P < .001), social conflict (P < .001), distress (P < .001), thoughts of suicide (P = .001), wanting to die (P = .01), self-medicating (P = .01), and being withdrawn (P = .04). In a multivariate model, the bereaved were more likely to have thoughts of their own death (P = .003), guilt coupled with weight or appetite loss (P = .013), and were less likely to report social conflict (P < .001), worthlessness coupled with difficulty making decisions (P < .001), thoughts of suicide (P = .006), distress coupled with weight or appetite gain (P = .022), and self-medicating (P = .045). CONCLUSIONS: Traits and trait combinations differentiate individuals who experience brief depressive episodes following the death of a loved one from other brief episodes. These differences can help guide clinical care of patients who present with depressive symptoms shortly after a loved one's death.

Gender Differences in Civil Commitment Hearing Experience for Persons Who Use Opioids.

OBJECTIVES: Civil commitment has increasingly served as a court-based legal intervention for severe opioid use, but little research has examined the civil commitment (CC) hearing process from the perspective of the person who is committed. Despite documented gender differences in opioid use and experiences within the legal system, past research has also not investigated gender differences in perceptions of the CC process for persons who use opioids. METHODS: Participants were 121 persons (43% female) with opioid use who were interviewed upon arrival at the CC facility about their experience of the CC hearing process in Massachusetts. RESULTS: Two thirds of participants were taken to the commitment hearing by police, and 59.5% shared a cell with others while waiting. Overall, the commitment intake process at the courthouse took over 5 hours. Participants spent, on average, less than 15 minutes with their lawyer before the hearing, and a majority of CC hearings lasted less than 15 minutes. Once transferred to a CC facility, opioid withdrawal management began within 4 hours. Compared with women, men reported longer wait times between the hearing and transfer, as well as longer wait times for withdrawal management at the facility ( P < 0.05). Women perceived worse interactions with the judge and greater dissatisfaction with the commitment process compared with men ( P < 0.05). CONCLUSIONS: There were few gender differences in the experience of CC. However, overall, participants reported a lengthy court process and low levels of perceived procedural justice.

Enrolling in deep brain stimulation research for depression: influences on potential subjects' decision making.

BACKGROUND: Ethical concerns regarding early-phase clinical trials of DBS for treatment-resistant depression (TRD) include the possibility that participants' decisions to enroll might be motivated by unrealistic expectations of personal benefit or minimization of risks. METHODS: Thematic analyses were conducted on a sample of 26 adults considering participation in two DBS trials. Influences on the decision making of these potential DBS trial participants were derived from responses to questions posed in the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a semi-structured interview designed to evaluate decisional capacity to consent to research. RESULTS: Participants cited numerous factors as influential in their enrollment decisions, including perceived lack of other treatment options, desire to take initiative, beliefs about DBS as a novel treatment, possibility of DBS efficacy, hoped-for improvements, potential risks and disadvantages of DBS or clinical trial participation, and altruism. No individual expressed a set of motivations or influencing factors that suggested compromised decision-making capacity or diminished voluntariness of decision making. CONCLUSIONS: These results suggest that individuals make the decision to enroll in early-phase trials of DBS for TRD based on a number of complex and sometimes idiosyncratic considerations, and that the trials that were studied utilized sufficiently robust informed consent processes. These findings offer evidence that the emerging research area of DBS can be advanced in an ethically sound manner, provided that safeguards and processes for discussing trials with participants are carefully and proactively enacted.

Opioid relapse and MOUD outcomes following civil commitment for opioid use.

INTRODUCTION: Opioid use disorder (OUD) continues to present a major public health problem in the United States. Civil commitment for substance use is one mandatory form of treatment for severe opioid use that has become increasingly available in recent years, but empirical data on this approach are lacking. This study examines clinical outcomes of civil commitment in a sample of adults with severe opioid use. METHODS: Participants were 121 persons with opioid use who were interviewed at the point of entry into civil commitment, then followed for 12 weeks after their release. RESULTS: Prior to civil commitment, this sample exhibited serious substance use characteristics (including high rates of illicit opioid use, other substance use, and injection drug use), as well as mental health problems (diagnoses of depression and anxiety disorders). During follow-up, approximately 41 % of the sample reported at least one illicit opioid use day. More than 64 % of the sample reported at least one day of medication for opioid use disorder (MOUD) receipt, and participants were significantly less likely to use illicit opioids on days that they received MOUDs. No participants died during the follow-up period. CONCLUSIONS: In this sample of persons with severe opioid use, clinical outcomes of civil commitment included illicit opioid relapse as well as varying levels of MOUD uptake. Civil commitment may be a viable method for short-term prevention of overdose for a subset of this vulnerable patient population.

Risk behaviors among persons civilly committed for opioid use.

Despite the growth in civil commitment for persons who use opioids, we know little about the kinds of risk behaviors among those committed. This study examined the behaviors that a judge might use to determine if there is sufficient evidence that an individual's opioid use poses a risk for serious harm. The study recruited participants (n = 121) from three Massachusetts Department of Public Health civil commitment facilities in 2018. We used a list of risk behaviors that courts consider supportive of opioid-related civil commitment. Participants averaged 28 years of age, 56% were male, and 91% met criteria for severe opioid use disorder. Participants endorsed an average of 9 of the 27 risk behaviors. On average, participants endorsed three of the six drug use behaviors representing a danger to themselves, four of eleven behaviors representing an inability to care for or protect themselves (home safety, weight loss), and two of ten behaviors representing a danger to others (driving high or drunk). Participants who reported they were "not at all pleased" to have been civilly committed endorsed significantly (p = .009) fewer behaviors representing a danger to themselves than those who said they were at least "a little pleased." We conclude that the majority of individuals civilly committed for opioid use are engaging in multiple high-risk behaviors that pose a serious risk of harm to themselves.

Do prisoners trust the healthcare system?

BACKGROUND: Individuals who are incarcerated have greater healthcare needs than non-justice-involved individuals, yet incarcerated individuals often report substandard care. There are disproportionate numbers of black, indigenous, and people of color (BIPOC) in prison, who, even in general society face greater obstacles to accessing healthcare and have worse health outcomes due to structural racism. Regardless of race, people with criminal justice involvement often report stigma from the non-carceral healthcare system. Providing sufficient healthcare in carceral settings themselves is complicated by lack of privacy and the inherent dialectic of prisons that restrict freedom and providers focusing on healing and health. Based on these adverse experiences, people who are incarcerated may have decreased distrust in the healthcare system, deterring individuals from getting adequate medical care. METHODS: In this exploratory study, health care system distrust was evaluated among 200 people who were incarcerated using the Revised Health Care System Distrust scale, a community-validated, 9-item measure comprised of 2 subscales (values and competence distrust). RESULTS: Distrust was moderately and positively associated with participant age (rs = 0.150, p = 0.034), with the second-oldest quintile (33 to 42-year-olds) reporting the highest level of overall and competence distrust. Participants identifying as Non-Latinx White reported higher competence distrust compared to Latinx and Non-Latinx/Non-White respondents. CONCLUSIONS: These preliminary findings suggest that select groups of prisoners may be less likely to trust the healthcare system, highlighting an impediment to receiving adequate care while incarcerated. Further study of this topic is warranted.

Experiences of Court Clinicians Who Perform Civil Commitment Evaluations for Substance Use Disorders.

Civil commitment for substance use disorders is an increasingly used intervention to mitigate the risks associated with severe substance use. Although court clinicians play a vital role in helping courts determine whether respondents meet statutory requirements for commitment, little is known about their experiences conducting these evaluations. In this pilot study, we surveyed all court clinicians who perform evaluations for civil commitment for substance use disorders in Massachusetts, a state with one of the highest rates of such commitments nationally. Court clinicians reported that these evaluations are most frequently ordered for individuals who use heroin and other opioids, alcohol, and cannabis. They reported a recent suicide attempt or drug overdose, intentional physical harm to another, use of dangerous weapon, and driving while intoxicated as the behaviors most likely to satisfy the statutory requirement of imminent risk. At the same time, many court clinicians consider a much broader range of behaviors as constituting imminent risk, and many reported having endorsed commitment on one or more occasions in the absence of statutory criteria being satisfied. These findings underscore the need for additional research on the performance of civil commitment evaluations for substance use disorder and standards for such evaluations.

Civil Commitment for Substance Use Disorders: A National Survey of Addiction Medicine Physicians.

BACKGROUND: Civil commitment (CC) for substance use disorders (SUDs) is a legal mechanism, initiated by family members, healthcare professionals, or others, that compels individuals with substance use problems into involuntary treatment. With the recent rise of US overdose deaths, more states are considering these laws. Yet little is known about physicians' perspectives regarding CC in treating patients with SUDs. METHODS: We conducted a web-based survey of American Society of Addiction Medicine (ASAM) physician members regarding their awareness of, attitudes towards, and experiences with CC for adults with SUDs. RESULTS: One hundred sixty-five addiction physicians completed the survey; 60.7% favored, 21.5% opposed, and 17.8% were unsure regarding CC for SUDs. More than a third (38.4%) were unfamiliar with these laws and more than a quarter (28.8%) were unsure if CC for SUDs was permitted in their state. Support for CC was strongest for SUDs involving heroin (79.0%), alcohol (74.7%), and nonheroin opioids (74.7%). Those opposing CC were more likely to believe it would jeopardize patient rapport (P < 0.001), would be ineffective for unmotivated individuals (P < 0.001), and should only be permitted for certain substances (P = 0.007). A majority of respondents endorsed the need for more clinician education (91.5%) and research (87.1%) on this topic. CONCLUSIONS: Although most addiction physicians in this study approve of CC for SUDs, enthusiasm for this compulsory intervention is mixed with strongest support for patients with opioid and alcohol use disorders. At the same time, many respondents are unfamiliar with these laws and most believe more education and research are needed.

Psychiatric residents' experience conducting disability evaluations.

OBJECTIVE: The increasing frequency and societal cost of psychiatric disability underscore the need for accuracy in evaluating patients who seek disability benefits. The authors investigated senior psychiatric residents' experiences performing disability evaluations, their self-assessment of competence for this task, and whether they perceived a need for more training. METHODS: Seventy-nine third- and fourth-year psychiatric residents in Massachusetts and Rhode Island training programs were surveyed from May to June in 2008. Participants were asked about the frequency of requests and completion of disability evaluations, the practice patterns followed when performing evaluations, the identification of role and potential conflict of interest in doing evaluations, and their sense of preparedness and need for more training. RESULTS: Residents reported having limited experience performing disability evaluations and followed a variety of practice patterns when performing evaluations. They reported having a limited understanding of what constitutes psychiatric disability and a lack of confidence in their ability to perform evaluations accurately. A significant minority had identified patients as disabled despite believing otherwise. A majority of residents reported receiving no didactics on psychiatric disability and desired more training. CONCLUSION: Residents may be unprepared to perform disability evaluations. Residency programs may need to provide additional training.

Comparing views on civil commitment for drug misuse and for mental illness among persons with opioid use disorder.

Despite the growing use of civil commitment for drug use disorders, little is known about attitudes among individuals who might be subject to civil commitment. This study examined attitudes of persons with opioid use disorder toward civil commitment for drug misuse and for psychiatric illness. Consecutive persons entering a brief, inpatient opioid detoxification (n = 254) were surveyed regarding their attitudes about civil commitment for mental illness and for drug use, and responses were compared by commitment type and by individual history of being civilly committed for opioid misuse. Participants endorsed high support for civil commitment (both psychiatric and drug misuse-related) when used to address risk of harm to self, to others, and of criminal activity. Respondents were more likely to support civil commitment for psychiatric disorders than for drug misuse, expressing higher support for civil commitment in general, higher agreement with the criteria used to justify civil commitment, and greater perceived efficacy of commitment. Individuals previously committed for opioid misuse were less likely to support drug misuse-related commitment on the basis of its perceived efficacy. These results suggest individuals with opioid use disorder hold more favorable views toward civil commitment for mental health disorders than for drug misuse, and reinforce the need for more research on the procedures and outcomes related to civil commitment for drug misuse.

Civil commitment experiences among opioid users.

INTRODUCTION: Civil commitment is an increasingly used policy intervention to combat the opioid epidemic. Yet little is known about persons who get committed and outcomes following commitment for opioid use. In the current cross-sectional study, we compared the characteristics of persons with and without a history of civil commitment, and the correlates of post-commitment abstinence. METHODS: Between October 2017 and May 2018, we surveyed consecutive persons entering a brief, inpatient opioid detoxification (n = 292) regarding their lifetime experiences with civil commitment for opioid use. RESULTS: Participants averaged 34.6 years of age, 27.1% were female, and 78.1% were White. Seventy-eight (26.7%) experienced civil commitment for opioid use at least once in their lifetime. Committed individuals had significantly higher rates of fentanyl, heroin, and injection drug use, drug overdoses, past incarceration, current criminal justice involvement, and past medication treatment for opioid use (p < .05). The average time to relapse following commitment was 72 days, although 33.8% relapsed on the same day of their release. Longer post-commitment abstinence was significantly associated with post-commitment medication treatment, higher perceived procedural justice (i.e., fairness) during the commitment hearing, positive attitude and higher motivation at the end of commitment, and improvement in attitude during commitment (p < .05). CONCLUSION: Opioid users who experience civil commitment constitute an especially high risk group. A positive commitment experience and post-commitment medication treatment are associated with longer post-commitment abstinence.

Consent form readability and educational levels of potential participants in mental health research.

OBJECTIVES: Poor readability of informed consent forms has been a persistent problem in clinical research. The low educational attainments of many patients with mental illness might suggest a still greater problem in mental health settings. To explore this potential disparity, this study sought to determine whether the informed consent forms used in research approved by the Massachusetts Department of Mental Health were written at a grade level that was higher than that achieved by potential study participants. METHODS: The readability (grade level necessary to read text) of informed consent forms for 154 studies was calculated with several standard formulas. Readability scores were stratified on the basis of the risk level of the study from which the consent form was taken. These data were then compared with data on the maximum attained grade level of potential participants aged 19 years or older. RESULTS: The overall mean readability scores for the informed consent forms, as determined by the four methods, ranged from grade levels 12 to 14.5. Furthermore, the mean readability scores increased with higher risk levels of the studies. Approximately 35% of potential participants had not graduated from high school, 37% had graduated from high school or obtained a GED, and 28% had some education beyond the 12th grade. CONCLUSIONS: These data demonstrate poor readability of informed consent forms used in research approved by the Massachusetts Department of Mental Health and highlight a mismatch between consent form readability and the educational level of potential study participants. The findings suggest that methods of reducing the complexity of forms, as part of improving the overall consent process, are much needed.

Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

BACKGROUND: Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials. METHODS: This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50), and willingness to participate in the clinical trial. RESULTS: 154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017). Willingness to participate in the hypothetical trial was not significantly different (p = 0.603) between intervention (52.1%, 95% CI [40.2% to 62.4%]) and control (56.3%, 95% CI [45.3% to 66.6%] groups. CONCLUSIONS: An enhanced educational intervention augmenting traditional informed consent led to a meaningful reduction in therapeutic misconception without a statistically significant change in willingness to enroll in hypothetical clinical trials. Additional study of this intervention is required in real-world clinical trials.

Enrolling in Clinical Research While Incarcerated: What Influences Participants' Decisions?

As a 2006 Institute of Medicine report highlights, surprisingly little empirical attention has been paid to how prisoners arrive at decisions to participate in modern research. With our study, we aimed to fill this gap by identifying a more comprehensive range of factors as reported by prisoners themselves during semistructured interviews. Our participants described a diverse range of motives, both favoring and opposing their eventual decision to join. Many are well-recognized considerations among nonincarcerated clinical research participants, including a desire for various forms of personal benefit, altruism, and concern about study risks and inconveniences. However, a number of influences seem unique to prisoners. Participants did not report that they were not coerced into enrolling, and they have even been under pressure not to enroll. However, many sought to enroll in order to obtain access to better health care, raising a concern about whether they were unfairly exploited.

An exploratory study of therapeutic misconception among incarcerated clinical trial participants.

BACKGROUND: Therapeutic misconception, the misunderstanding of differences between research and clinical care, is widely prevalent among non-incarcerated trial participants. Yet little attention has been paid to its presence among individuals who participate in research while incarcerated. METHODS: This study examined the extent to which seventy-two incarcerated individuals may experience therapeutic misconception about their participation in one of six clinical trials, and its correlation with participant characteristics and potential influences on research participation. RESULTS: On average, participants endorsed 70% of items suggestive of therapeutic misconception. The tendency toward therapeutic misconception was significantly higher among: African Americans and Latinos compared to Whites; older and less educated participants; enrollment in a substance abuse-related trial; and correlated with a belief that the trial was the only way to obtain needed treatment. CONCLUSIONS: Therapeutic misconception may be particularly high among select incarcerated individuals and is associated with a perceived lack of treatment options. Further examination of therapeutic misconception among incarcerated research participants is needed.