BackgroundParticipants 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.MethodsThis 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.Results154 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.ConclusionsAn 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.

Depression, anxiety, and ADHD are common among students referred by college counseling centers for medication evaluation and treatment.

Introduction: Individuals with chronic mental illness and addiction have poorer health outcomes than the general population, largely because of preventable medical conditions. Early onset and heightened incidence of chronic disease—such as type two diabetes, chronic obstructive pulmonary disease, and hypertension—might limit behavioral health consumers’ quality life years and ultimately lead to early mortality. These health risks are exacerbated by coinciding poor health correlates such as low socioeconomic status, disrupted cycles of care, and substance use. Primary and Behavioral Health Care Integration (PBHCI) initiatives address these compounding health disparities by improving access to quality primary care and wellness services inside of behavioral health centers. As opposed to traditional integrated care models in which behavioral health services are co-located in medical settings, reverse integration targets consumers with serious and persistent mental illness who are more likely to frequent behavioral health care settings. Recently, this model of reverse integrated care delivery has been on the rise because of its unique capacity to meet the complex needs of behavioral health consumers... The current study employs semi-structured individual interviews to assess behavioral health consumers’ perceived barriers to and engagement in PBHCI services at an urban community mental health center

With a sample of 125 adults under community supervision (71.20% male, 76.00% White, mean age = 33.17 years), this study evaluated need‐to‐service matching using an evaluation framework from implementation science. Need‐to‐service matching is a case management strategy intended to align service referrals in case plans with justice‐involved persons' criminogenic needs. The results indicated that need‐to‐service matching reached a high percentage of its target population at 81.70%. Within criminogenic need areas, good match frequencies ranged from 80.00% in family/marital problems to 98.29% in alcohol/drug problems. Clinical staff also met the adherence benchmark applied by the current study, which required a 75.00% match between individuals' criminogenic needs and the services they received. Justice‐involved persons had, on average, 90.46% of their criminogenic needs matched with at least one service referral. Over‐prescription of services (i.e., recommendation of services that were not needed) was high, with frequencies in need areas ranging from 60.98% in education/employment to 82.21% in antisocial patterns. Methods from implementation science are useful for structuring evaluations of need‐to‐service matching, understanding implementation success and failure, and generating recommendations for improving implementation practice. The field would benefit greatly from benchmarks for need‐to‐service matching evaluation elements.

Prior research has demonstrated that clinical research trial participants are often unable to differentiate between experimental and conventional care. 3 TM research shows that some research participants consent to participating in a clinical research trial without fully understanding the research process. 4 To protect the rights of participants in clinical research trials, researchers should ensure that participants fully understand what it means to be in a clinical research trial so they can make informed decisions about whether or not to participate. Therapeutic Misconception and Scientific Reframing is a National Institute of Mental Health funded study led by Charles Lidz, Ph.D. The study's goals are to: Research in the Works