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Outcomes of a Metaintervention to Improve Treatment Engagement Among Young Adults With Serious Mental Illnesses: Application of a Pilot Randomized Explanatory Design.

ABSTRACT:

Purpose

The objective of this study was to conduct a preliminary evaluation of a new young adult-centered metaintervention to improve treatment engagement among those with serious mental illness.

Methods

Young adults, clinic staff, and policy makers provided feedback on the intervention, which is a two-module engagement program provided by a clinician and person with lived experience (peer) during intake. A two-group pilot randomized explanatory trial design was conducted, comparing treatment as usual with treatment as usual plus the engagement program, Just Do You. The primary outcomes were treatment engagement and presumed mediators of program effects measured at 3 months after baseline.

Results

The randomized explanatory trial indicated that young adults in Just Do You were more engaged in treatment than treatment as usual and that changes in several mediators of engagement occurred. Mechanisms that demonstrated between-group differences were stigma, perceived expertise of providers, trust in providers, and beliefs about the benefits of treatment. Results also provide diagnostic information on mediators that the program failed to change, such as hope, self-efficacy, and emotional reactions to treatment. These results inform next steps in the development of this promising intervention.

Conclusions

Just Do You illustrated feasibility, acceptability and preliminary impact. It represents an innovative metaintervention that has promise for improving treatment engagement in mental health services among young adults who have a history of poor engagement.

SUBMITTER: Munson MR

PROVIDER: S-EPMC8545849 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundYoung adults have elevated rates of mental health disorders, yet they often do not receive consistent care. The challenge of continuing to engage young adults has been pervasive worldwide. Few engagement interventions have been designed for young adults with serious mental illness. Just Do You is a theoretically guided engagement intervention. It uses innovative modalities (i.e., technology, expressive arts activities, narrative expression, mentoring) to engage participants in conversations about services and how they work, while simultaneously orienting them to treatment.Methods/designThis pilot and feasibility study utilizes a hybrid research design, examining feasibility, acceptability, and preliminary impact, alongside implementation. The study combines qualitative methods, a small pilot randomized trial, and a small cost-benefit analysis. Respondents are clinic staff and young adults who have made initial contact with the Personalized Recovery Oriented Services (PROS) program. Quantitative survey data are collected at baseline, 2 weeks (post-intervention), 1 month, and 3 months. The assessments focus on measuring feasibility, acceptability, engagement, and mental health outcomes. Medical record extraction will be used to triangulate self-report data. We will conduct single degree of freedom contrasts to examine whether Just Do You leads to improved outcomes relative to Treatment-As-Usual using robust regression for each outcome measure. We will examine whether changes in the proposed mediating variables occur across groups using a similar contrast strategy. In addition, we will use structural equation modeling to examine the contribution of mediators to ultimate outcomes. Finally, we will use constant comparison coding techniques for qualitative analyses.DiscussionThe aim of this study is to examine the feasibility of a young adult engagement meta-intervention through an intensive preliminary pilot trial, learning through collaboration with stakeholders. Just Do You has the potential to fill a gap in the service system for young adults with serious mental illnesses, improving the seemingly intractable problem of disengagement. The program uses culturally responsive strategies, is recovery-oriented, and builds upon the best evidence to date. Our efforts align with local and national health care reform efforts embedding people with lived experience.Trial registrationThis trial was registered with ClinicalTrials.gov (Identifier: NCT03423212) on April 18, 2018, as Protocol Record R34 MH111861-01, New York University, as the Just Do You Program for Young Adults with Serious Mental Illness.

Project description:The serious mental illnesses schizophrenia, schizoaffective disorder, and bipolar disorder are complex conditions affecting 1% to 4% of the population. Individuals with serious mental illnesses express interest in genetic counseling, an intervention showing promise for increasing patient knowledge and adaptation. This trial aimed to evaluate the effects of genetic counseling for people with serious mental illnesses as compared to an educational intervention or wait list.A pilot 3-arm (each n = 40; genetic counseling, a control intervention involving an educational booklet, or wait list), parallel-group, randomized clinical trial was conducted from September 2008 through November 2011 in Vancouver, Canada. Participants with schizophrenia, bipolar disorder, or schizoaffective disorder (DSM-IV) completed outcome measures assessing knowledge, risk perception, internalized stigma, and perceived control over illness at baseline and 1-month follow-up. The Brief Symptom Inventory was administered to control for current symptoms. Analyses included linear mixed-effects models and ?(2) tests.Knowledge increased for genetic counseling/educational booklet compared to wait list at follow-up (LRT1 = 19.33, Holm-adjusted P = .0003, R(2)LMM(m) = 0.17). Risk perception accuracy increased at follow-up for genetic counseling compared to wait list (Yates continuity corrected ?(2)1 = 9.1, Bonferroni P = .003) and educational booklet (Yates continuity corrected ?(2)1 = 8.2, Bonferroni P = .004). There were no significant differences between groups for stigma or perceived control scores.Genetic counseling and the educational booklet improved knowledge, and genetic counseling, but not the educational booklet, improved risk perception accuracy for this population. The impact of genetic counseling on internalized stigma and perceived control is worth further investigation. Genetic counseling should be considered for patients with serious mental illnesses.ClinicalTrials.gov identifier: NCT00713804.

Project description:BACKGROUND:Medication used for acute aggression in psychiatry must have rapid onset of effect, low frequency of administration and low levels of adverse effects. Zuclopenthixol acetate is said to have these properties. OBJECTIVES:To estimate the clinical effects of zuclopenthixol acetate for the management of acute aggression or violence thought to be due to serious mental illnesses, in comparison to other drugs used to treat similar conditions. SEARCH METHODS:We searched the Cochrane Schizophrenia's Group Trials Register (July 2011). We supplemented this by citation searching and personal contact with authors and relevant pharmaceutical companies. SELECTION CRITERIA:All randomised clinical trials involving people thought to have serious mental illnesses comparing zuclopenthixol acetate with other drugs. DATA COLLECTION AND ANALYSIS:Two review authors extracted and cross-checked data independently. We calculated fixed-effect relative risks (RR) and 95% confidence intervals (CI) for dichotomous data. We analysed by intention-to-treat. We used mean differences (MD) for continuous variables. MAIN RESULTS:We found no data for the primary outcome, tranquillisation. Compared with haloperidol, zuclopenthixol acetate was no more sedating at two hours (n = 40, 1 RCT, RR 0.60, 95% CI 0.27 to 1.34). People given zuclopenthixol acetate were not at reduced risk of being given supplementary antipsychotics (n = 134, 3 RCTs, RR 1.49, 95% CI 0.97 to 2.30) although additional use of benzodiazepines was less (n = 50, 1 RCT, RR 0.03, 95% CI 0.00 to 0.47). People given zuclopenthixol acetate had fewer injections over seven days compared with those allocated to haloperidol IM (n = 70, 1 RCT, RR 0.39, 95% CI 0.18 to 0.84, NNT 4, CI 3 to 14). We found no data on more episodes of aggression or harm to self or others. One trial (n = 148) reported no significant difference in adverse effects for people receiving zuclopenthixol acetate compared with those allocated haloperidol at one, three and six days (RR 0.74, 95% CI 0.43 to 1.27). Compared with haloperidol or clotiapine, people allocated zuclopenthixol did not seem to be at more risk of a range of movement disorders (< 20%). Three studies found no difference in the proportion of people getting blurred vision/dry mouth (n = 192, 2 RCTs, RR at 24 hours 0.90, 95% CI 0.48 to 1.70). Similarly, dizziness was equally infrequent for those allocated zuclopenthixol acetate compared with haloperidol (n = 192, 2 RCTs, RR at 24 hours 1.15, 95% CI 0.46 to 2.88). There was no difference between treatments for leaving the study before completion (n = 522, RR 0.85, 95% CI 0.31 to 2.31). One study reported no difference in adverse effects and outcome scores, when high dose (50-100 mg/injection) zuclopenthixol acetate was compared with low dose (25-50 mg/injection) zuclopenthixol acetate. AUTHORS' CONCLUSIONS:Recommendations on the use of zuclopenthixol acetate for the management of psychiatric emergencies in preference to 'standard' treatment have to be viewed with caution. Most of the small trials present important methodological flaws and findings are poorly reported. This review did not find any suggestion that zuclopenthixol acetate is more or less effective in controlling aggressive acute psychosis, or in preventing adverse effects than intramuscular haloperidol, and neither seemed to have a rapid onset of action. Use of zuclopenthixol acetate may result in less numerous coercive injections and low doses of the drug may be as effective as higher doses. Well-conducted pragmatic randomised controlled trials are needed.

Project description:BackgroundDigital mental health interventions offer unique advantages, and research indicates that these interventions are effective for a range of mental health concerns. Although these interventions are less established for individuals with serious mental illnesses, they demonstrate significant promise. A central consideration in traditional face-to-face therapies is the therapeutic alliance, whereas the nature of a digital therapeutic alliance and its relationship with outcomes requires further attention, particularly for individuals with serious mental illnesses.ObjectiveThis narrative review aims to encourage further consideration and critical evaluation of the therapeutic alliance in digital mental health, specifically for individuals with serious mental illnesses.MethodsA narrative review was conducted by combining 3 main areas of the literature: the first examining the evidence for digital mental health interventions for serious mental illnesses, the second illuminating the nature and role of the therapeutic alliance in digital interventions, and the third surrounding practical considerations to enhance a digital therapeutic alliance.ResultsResults indicated that a therapeutic alliance can be cultivated in digital interventions for those with serious mental illnesses, but that it may have unique, yet-to-be-confirmed characteristics in digital contexts. In addition, a therapeutic alliance appears to be less directly associated with outcomes in digital interventions than with those in face-to-face therapies. One possibility is that the digital therapeutic alliance is associated with increased engagement and adherence to digital interventions, through which it appears to influence outcomes. A number of design and implementation considerations may enhance the digital therapeutic alliance, including human support and technological features.ConclusionsMore research is required to further understand the nature and specific role of a therapeutic alliance in digital interventions for serious mental illnesses, particularly in informing their design. This review revealed several key research priorities to advance the therapeutic alliance in digital interventions.

Project description:IntroductionPatients with mental and physical health conditions are complex to treat and often use multiple medications. It is unclear how adherence to one medication predicts adherence to others. A predictive relationship could permit less expensive adherence monitoring if overall adherence could be predicted through tracking a single medication.MethodsTo test this hypothesis, we examined whether patients with multiple mental and physical illnesses have similar adherence trajectories across medications. Specifically, we conducted a retrospective cohort analysis using health insurance claims data for enrollees who were diagnosed with a serious mental illness, initiated an atypical antipsychotic, as well as an SSRI (to treat serious mental illness), biguanides (to treat type 2 diabetes), or an ACE inhibitor (to treat hypertension). Using group-based trajectory modeling, we estimated adherence patterns based on monthly estimates of the proportion of days covered with each medication. We measured the predictive value of the atypical antipsychotic trajectories to adherence predictions based on patient characteristics and assessed their relative strength with the R-squared goodness of fit metric.ResultsWithin our sample of 431,591 patients, four trajectory groups were observed: non-adherent, gradual discontinuation, stop-start, and adherent. The accuracy of atypical antipsychotic adherence for predicting adherence to ACE inhibitors, biguanides, and SSRIs was 44.5, 44.5, and 49.6%, respectively (all p < 0.001 vs. random). We also found that information on patient adherence patterns to atypical antipsychotics was a better predictor of patient adherence to these three medications than would be the case using patient demographic and clinical characteristics alone.ConclusionAmong patients with multiple chronic mental and physical illnesses, patterns of atypical antipsychotic adherence were useful predictors of adherence patterns to a patient's adherence to ACE inhibitors, biguanides, and SSRIs.FundingOtsuka Pharmaceutical Development & Commercialization, Inc.