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A pragmatic randomized control trial and realist evaluation on the implementation and effectiveness of an internet application to support self-management among individuals seeking specialized mental health care: a study protocol.

ABSTRACT: Mental illness is a substantial and rising contributor to the global burden of disease. Access to and utilization of mental health care, however, is limited by structural barriers such as specialist availability, time, out-of-pocket costs, and attitudinal barriers including stigma. Innovative solutions like virtual care are rapidly entering the health care domain. The advancement and adoption of virtual care for mental health, however, often occurs in the absence of rigorous evaluation and adequate planning for sustainability and spread.A pragmatic randomized controlled trial with a nested comparative effectiveness arm, and concurrent realist process evaluation to examine acceptability, effectiveness, and cost-effectiveness of the Big White Wall (BWW) online platform for mental health self-management and peer support among individuals aged 16 and older who are accessing mental health services in Ontario, Canada. Participants will be randomized to 3 months of BWW or treatment as usual. At the end of the 3 months, participants in the intervention group will have the opportunity to opt-in to an intervention extension arm. Those who opt-in will be randomized to receive an additional 3 months of BWW or no additional intervention. The primary outcome is recovery at 3 months as measured by the Recovery Assessment Scale-revised (RAS-r). Secondary outcomes include symptoms of depression and anxiety measured with the Personal Health Questionnaire-9 item (PHQ-9) and the Generalized Anxiety Disorder Questionnaire-7 item (GAD-7) respectively, quality of life measured with the EQ-5D-5L, and community integration assessed with the Community Integration Questionnaire. Cost-effectiveness evaluations will account for the cost of the intervention and direct health care costs. Qualitative interviews with participants and stakeholders will be conducted throughout.Understanding the impact of virtual strategies, such as BWW, on patient outcomes and experience, and health system costs is essential for informing whether and how health system decision-makers can support these strategies system-wide. This requires clear evidence of effectiveness and an understanding of how the intervention works, for whom, and under what circumstances. This study will produce such effectiveness data for BWW, while simultaneously exploring the characteristics and experiences of users for whom this and similar online interventions could be helpful.Clinicaltrials.gov NCT02896894 . Registered on 31 August 2016 (retrospectively registered).

SUBMITTER: Hensel JM

PROVIDER: S-EPMC5069942 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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A pragmatic randomized control trial and realist evaluation on the implementation and effectiveness of an internet application to support self-management among individuals seeking specialized mental health care: a study protocol.

Hensel Jennifer M JM Shaw Jay J Jeffs Lianne L Ivers Noah M NM Desveaux Laura L Cohen Ashley A Agarwal Payal P Wodchis Walter P WP Tepper Joshua J Larsen Darren D McGahan Anita A Cram Peter P Mukerji Geetha G Mamdani Muhammad M Yang Rebecca R Wong Ivy I Onabajo Nike N Jamieson Trevor T Bhatia R Sacha RS

BMC psychiatry 20161018 1

<h4>Background</h4>Mental illness is a substantial and rising contributor to the global burden of disease. Access to and utilization of mental health care, however, is limited by structural barriers such as specialist availability, time, out-of-pocket costs, and attitudinal barriers including stigma. Innovative solutions like virtual care are rapidly entering the health care domain. The advancement and adoption of virtual care for mental health, however, often occurs in the absence of rigorous e ...[more]

PMID: 27756281

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Project description:BackgroundWeb-based self-directed mental health applications are rapidly emerging to address health service gaps and unmet needs for information and support.ObjectiveThe aim of this study was to determine if a multicomponent, moderated Web-based mental health application could benefit individuals with mental health symptoms severe enough to warrant specialized mental health care.MethodsA multicenter, pragmatic randomized controlled trial was conducted across several outpatient mental health programs affiliated with 3 hospital programs in Ontario, Canada. Individuals referred to or receiving treatment, aged 16 years or older, with access to the internet and an email address, and having the ability to navigate a Web-based mental health application were eligible. A total of 812 participants were randomized 2:1 to receive immediate (immediate treatment group, ITG) or delayed (delayed treatment group, DTG) access for 3 months to the Big White Wall (BWW), a multicomponent Web-based mental health intervention based in the United Kingdom and New Zealand. The primary outcome was the total score on the Recovery Assessment Scale, revised (RAS-r) which measures mental health recovery. Secondary outcomes were total scores on the Patient Health Questionnaire-9 item (PHQ-9), the Generalized Anxiety Disorder Questionnaire-7 item (GAD-7), the EuroQOL 5-dimension quality of life questionnaire (EQ-5D-5L), and the Community Integration Questionnaire. An exploratory analysis examined the association between actual BWW use (categorized into quartiles) and outcomes among study completers.ResultsIntervention participants achieved small, statistically significant increases in adjusted RAS-r score (4.97 points, 95% CI 2.90 to 7.05), and decreases in PHQ-9 score (-1.83 points, 95% CI -2.85 to -0.82) and GAD-7 score (-1.55 points, 95% CI -2.42 to -0.70). Follow-up was achieved for 55% (446/812) at 3 months, 48% (260/542) of ITG participants and 69% (186/270) of DTG participants. Only 58% (312/542) of ITG participants logged on more than once. Some higher BWW user groups had significantly greater improvements in PHQ-9 and GAD-7 relative to the lowest use group.ConclusionsThe Web-based application may be beneficial; however, many participants did not engage in an ongoing way. This has implications for patient selection and engagement as well as delivery and funding structures for similar Web-based interventions.Trial registrationClinicalTrials.gov NCT02896894; https://clinicaltrials.gov/ct2/show/NCT02896894 (Archived by WebCite at http://www.webcitation.org/78LIpnuRO).

Project description:BackgroundLittle empirical evidence is available to support the effectiveness and cost-effectiveness of internet interventions to increase help-seeking behavior for mental health in young adults.ObjectiveThe aim of this study was to evaluate the cost-effectiveness of a Web-based mental health help-seeking navigation tool (Link) in comparison with usual help-seeking strategies.MethodsA cost-utility analysis alongside the main randomized trial of Link was conducted from the Australian health care sector perspective. Young adults aged 18 to 25 years were randomized to the Link intervention (n=205) or usual care (n=208) with 1- and 3-month follow-ups. The primary outcome of this study was quality-adjusted life years (QALYs) measured by the assessment of quality of life-4D. Costs were calculated based on the self-reported resource use questionnaire and were reported in 2015 Australian dollars. Primary analyses were conducted as intention-to-treat and reported as incremental cost-effectiveness ratios. Completer analyses were conducted in a sensitivity analysis.ResultsSignificantly more QALYs were gained in the intervention group than the control group (0.15 vs 0.14; P<.001). The intervention was associated with significantly lower health professional consultation costs at 1-month follow-up (mean costs Aus $98 vs Aus $162; P<.05). Costs of hospital services were lower at 3 months in the intervention arm (mean costs Aus $47 vs Aus $101); however, there was insufficient sample size to detect a significant difference between the groups. There were no statistically significant differences in the total costs between the 2 arms. Relative to the control group, those who received the intervention experienced 0.01 more QALYs (0.00-0.02) and had lower total health sector costs of Aus -$81 (Aus -$348 to Aus $186) over 3 months. The intervention was found to be more effective and less costly compared with usual help-seeking strategies. The intervention was 100% likely to be cost-effective below a willingness-to-pay value-for-money threshold of Aus $28,033 per QALY. Results were robust in the sensitivity analysis.ConclusionsOur study found that the online youth mental health help-seeking Web service is a cost-effective intervention for young people aged 18 to 25 years compared with usual search strategies. Further research is required to confirm these results.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12614001223628; https://www.anzctr.org.au /Trial/Registration/TrialReview.aspx?id=366731.

Project description:BACKGROUND:Disseminating care guidelines into clinical practice remains challenging, partly due to inadequate evidence on how best to help clinics incorporate new guidelines into routine care. This is particularly true in safety net community health centers (CHCs). METHODS:This pragmatic comparative effectiveness trial used a parallel mixed methods design. Twenty-nine CHC clinics were randomized to receive increasingly intensive implementation support (implementation toolkit (arm 1); toolkit + in-person training + training webinars (arm 2); toolkit + training + webinars + offered practice facilitation (arm 3)) targeting uptake of electronic health record (EHR) tools focused on guideline-concordant cardioprotective prescribing for patients with diabetes. Outcomes were compared across study arms, to test whether increased support yielded additive improvements, and with 137 non-study CHCs that share the same EHR as the study clinics. Quantitative data from the CHCs' EHR were used to compare the magnitude of change in guideline-concordant ACE/ARB and statin prescribing, using adjusted Poisson regressions. Qualitative data collected using diverse methods (e.g., interviews, observations) identified factors influencing the quantitative outcomes. RESULTS:Outcomes at CHCs receiving higher-intensity support did not improve in an additive pattern. ACE/ARB prescribing did not improve in any CHC group. Statin prescribing improved overall and was significantly greater only in the arm 1 and arm 2 CHCs compared with the non-study CHCs. Factors influencing the finding of no additive impact included: aspects of the EHR tools that reduced their utility, barriers to providing the intended implementation support, and study design elements, e.g., inability to adapt the provided support. Factors influencing overall improvements in statin outcomes likely included a secular trend in awareness of statin prescribing guidelines, selection bias where motivated clinics volunteered for the study, and study participation focusing clinic staff on the targeted outcomes. CONCLUSIONS:Efforts to implement care guidelines should: ensure adaptability when providing implementation support and conduct formative evaluations to determine the optimal form of such support for a given clinic; consider how study data collection influences adoption; and consider barriers to clinics' ability to use/accept implementation support as planned. More research is needed on supporting change implementation in under-resourced settings like CHCs. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02325531. Registered 15 December 2014.

Project description:BackgroundComputerized cognitive behavioral therapy (cCBT) can improve mental health outcomes in White populations; however, it is unknown whether racial and ethnic minority populations receive clinical benefits from cCBT.ObjectiveTo study race differences in the impact of cCBT use on mental health outcomes among White and African American primary care patients.DesignSecondary analysis of a three-arm randomized controlled clinical trial.ParticipantsPrimary care physicians (PCPs) referred 2,884 patients aged 18-75; 954 met eligibility criteria (including elevated mood and/or anxiety symptoms indicated as a score ? 10 on Patient Health Questionnaire or Generalized Anxiety Disorder scale); 704 were randomized in 3:3:1 ratio to receive either (1) the cCBT program (cCBT-only), (2) cCBT plus access to an Internet Support Group (cCBT+ISG), or (3) their PCP's usual care (UC). After exclusions, this study analyzed 689 patients: 590 receiving cCBT, in the combined cCBT-only and cCBT+ISG groups (91 African American, 499 White), and 99 receiving UC (22 African American, 77 White).Intervention(s)We used the Beating the Blues cCBT program that consisted of eight 50-min Internet-delivered interactive sessions and "homework" assignments to complete between weekly sessions. College graduate-level care coaches provided six months of remote support.Main measure(s)After prior analyses demonstrated no effect of the ISG program, we combined the cCBT-only and cCBT+ISG groups (cCBT) to compare to UC at 6-month follow-up. Controlling for sociodemographic factors, baseline symptoms, and treatment arm, we examined race differences for impact of cCBT versus UC on the mental health-related quality-of-life (Short-form 12 Health Survey), and Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety, and depression.ResultsCompared to UC, cCBT had no effect on quality of life (d = 0.10; p = 0.40), depression (d = - 0.19; p = 0.10), or anxiety (d = - 0.16; p = 0.18) for Whites. However, for African American patients, cCBT was associated with significant 6-month decrease in depression (d = - 0.47, p < 0.01) and anxiety scores (d = - 0.54, p < 0.01).ConclusionscCBT may be an efficient and scalable first step to eliminating disparities in mental health care.Trial registrationClinicaltrials.gov Identifier: NCT01482806. https://www.clinicaltrials.gov/ct2/show/NCT01482806?term=rollman&rank=4.

Project description:BackgroundMajor depressive disorder is a chronic condition; its prevalence is expected to grow with the aging trend of high-income countries. Internet-based cognitive-behavioral therapy has proven efficacy in treating major depressive disorder.ObjectiveThe objective of this study was to assess the cost-effectiveness of implementing a community internet-based cognitive behavioral therapy intervention (Super@, the Spanish program for the MasterMind project) for treating major depressive disorder.MethodsThe cost-effectiveness of the Super@ program was assessed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, using a 3-state Markov model. Data from the cost and effectiveness of the intervention were prospectively collected from the implementation of the program by a health care provider in Badalona, Spain; the corresponding data for usual care were gathered from the literature. The health states, transition probabilities, and utilities were computed using Patient Health Questionnaire-9 scores.ResultsThe analysis was performed using data from 229 participants using the Super@ program. Results showed that the intervention was more costly than usual care; the discounted (3%) and nondiscounted incremental cost-effectiveness ratios were €29,367 and €26,484 per quality-adjusted life-year, respectively (approximately US $35,299 and $31,833, respectively). The intervention was cost-effective based on the €30,000 willingness-to-pay threshold typically applied in Spain (equivalent to approximately $36,060). According to the deterministic sensitivity analyses, the potential reduction of costs associated with intervention scale-up would reduce the incremental cost-effectiveness ratio of the intervention, although it remained more costly than usual care. A discount in the incremental effects up to 5% exceeded the willingness-to-pay threshold of €30,000.ConclusionsThe Super@ program, an internet-based cognitive behavioral therapy intervention for treating major depressive disorder, cost more than treatment as usual. Nevertheless, its implementation in Spain would be cost-effective from health care and societal perspectives, given the willingness-to-pay threshold of €30,000 compared with treatment as usual.

Project description:BackgroundThe use of technologies has served to reduce gaps in access to treatment, and digital health interventions show promise in the care of mental health problems. However, to understand what and how these interventions work, it is imperative to document the aspects related to their challenging implementation.ObjectiveThe aim of this study was to determine what evidence is available for synchronous digital mental health implementation and to develop a framework, informed by a realist review, to explain what makes digital mental health interventions work for people with mental health problems.MethodsThe SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, and Research type) framework was used to develop the following review question: What makes digital mental health interventions with a synchronous component work on people with mental health problems, including depression, anxiety, or stress, based on implementation, economic, quantitative, qualitative, and mixed methods studies? The MEDLINE, EBM Reviews, PsycINFO, EMBASE, SCOPUS, CINAHL Complete, and Web of Science databases were searched from January 1, 2015, to September 2020 with no language restriction. A Measurement Tool to Assess Systematic Reviews-2 (AMSTAR-2) was used to assess the risk of bias and Confidence in Evidence from Reviews of Qualitative Research (CERQual) was used to assess the confidence in cumulative evidence. Realist synthesis analysis allowed for developing a framework on the implementation of synchronous digital mental health using a grounded-theory approach with an emergent approach.ResultsA total of 21 systematic reviews were included in the study. Among these, 90% (n=19) presented a critically low confidence level as assessed with AMSTAR-2. The realist synthesis allowed for the development of three hypotheses to identify the context and mechanisms in which these interventions achieve these outcomes: (1) these interventions reach populations otherwise unable to have access because they do not require the physical presence of the therapist nor the patient, thereby tackling geographic barriers posed by in-person therapy; (2) these interventions reach populations otherwise unable to have access because they can be successfully delivered by nonspecialists, which makes them more cost-effective to implement in health services; and (3) these interventions are acceptable and show good results in satisfaction because they require less need of disclosure and provide more privacy, comfortability, and participation, enabling the establishment of rapport with the therapist.ConclusionsWe developed a framework with three hypotheses that explain what makes digital mental health interventions with a synchronous component work on people with mental health problems. Each hypothesis represents essential outcomes in the implementation process.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42020203811; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020203811.International registered report identifier (irrid)RR2-10.12688/f1000research.27150.2.

Project description:INTRODUCTION:The use of adequate self-management strategies for people with chronic obstructive pulmonary disease (COPD) reduces healthcare use, improves health-related quality of life (HRQoL) and recovery after acute exacerbations. However, not many people with COPD receive support that promotes the use of such strategies and therefore new methods to facilitate and promote the use of self-management strategies are highly warranted. This pilot trial aims to evaluate the feasibility of the study design and study procedures considering effectiveness of the novel intervention, the COPD-web. METHODS AND ANALYSIS: The overall design is a pragmatic controlled pilot trial with preassessments and postassessments and a parallel process evaluation. Patients with the diagnosis of COPD will be eligible for the study. The intervention group will be recruited when visiting one of the six participating primary care units in Sweden. The control group will be identified from the unit's computerised registers. The intervention, the COPD-web, is an interactive web page with two sections; one directed at people with COPD and one at healthcare professionals. The sections aim to support patients' self-management skills-and to facilitate the provision of support for self-management strategies, respectively. Effectiveness with regard to patients' symptoms, HRQoL, knowledge of and readiness for COPD-related self-management, health literacy, self-efficacy for physical activity and time spent in physical activity and time being sedentary, and further, healthcare professionals' knowledge of and readiness to support COPD-related self-management strategies will be assessed using questionnaires at 3 and 12 months. The process evaluation will include observations and interviews. ETHICS AND DISSEMINATION:Ethical approval has been obtained. Findings will be presented at conferences, submitted for publication in peer-reviewed publications and presented to the involved healthcare professionals, patients and to patient organisations. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov: NCT02696187.

Project description:BackgroundMental disorders are more common in young adults than at any other life stage. Despite this, young people have low rates of seeking professional help for mental health problems. Young elite athletes have less positive attitudes toward seeking help than nonathletes and thus may be particularly unlikely to seek help. Interventions aimed at increasing help-seeking in young elite athletes are warranted.ObjectiveTo test the feasibility and efficacy of three Internet-based interventions designed to increase mental health help-seeking attitudes, intentions, and behavior in young elite athletes compared with a control condition.MethodsWe conducted a randomized controlled trial (RCT) of three brief fully automated Internet-based mental health help-seeking interventions with 59 young elite athletes recruited online in a closed trial in Australia. The interventions consisted of a mental health literacy and destigmatization condition, a feedback condition providing symptom levels, and a minimal content condition comprising a list of help-seeking resources, compared with a control condition (no intervention). We measured help-seeking attitudes, intentions and behavior using self-assessed surveys. Participation was open to elite athletes regardless of their mental health status or risk of mental illness.ResultsOf 120 athletes initially agreeing to participate, 59 (49%) submitted a preintervention or postintervention survey, or both, and were included in the present study. Adherence was satisfactory, with 48 (81%) participants visiting both weeks of assigned intervention material. None of the interventions yielded a significant increase in help-seeking attitudes, intentions, or behavior relative to control. However, at postintervention, there was a trend toward a greater increase in help-seeking behavior from formal sources for the mental health literacy/destigmatization condition compared with control (P = .06). This intervention was also associated with increased depression literacy (P = .003, P = .005) and anxiety literacy (P = .002, P = .001) relative to control at postintervention and 3-month follow-up, respectively, and a reduction in depression stigma relative to control at postintervention (P = .01, P = .12) and anxiety stigma at 3-month follow-up (P = .18, P = .02). The feedback and help-seeking list interventions did not improve depression or anxiety literacy or decrease stigmatizing attitudes to these conditions. However, the study findings should be treated with caution. Due to recruitment challenges, the achieved sample size fell significantly short of the target size and the study was underpowered. Accordingly, the results should be considered as providing preliminary pilot data only.ConclusionsThis is the first RCT of an Internet-based mental health help-seeking intervention for young elite athletes. The results suggest that brief mental health literacy and destigmatization improves knowledge and may decrease stigma but does not increase help-seeking. However, since the trial was underpowered, a larger trial is warranted.Trial registration2009/373 (www.clinicaltrials.gov ID: NCT00940732), cited at http://www.webcitation.org/5ymsRLy9r.

Dataset Information

A pragmatic randomized control trial and realist evaluation on the implementation and effectiveness of an internet application to support self-management among individuals seeking specialized mental health care: a study protocol.

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A pragmatic randomized control trial and realist evaluation on the implementation and effectiveness of an internet application to support self-management among individuals seeking specialized mental health care: a study protocol.

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