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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:BackgroundPeer support has been suggested as an alternative or complement to professional support for mothers with perinatal mental health difficulties. The aim of this realist review was to synthesise the evidence on perinatal mental health peer support programmes outside mental health services, to understand what is it about community-based perinatal mental health peer support that works, for whom, in what circumstances, in what respects, and why.MethodsApplying realist methodology, an initial theoretical model was tested against evidence from empirical studies. 29 empirical studies were included, covering 22 antenatal and postnatal mental health interventions that offered one-to-one or group peer support, in person or by telephone. Data extraction identified the configurations of contexts (C), mechanisms (M) and outcomes (O) relevant to mothers' use of peer support and to the positive and negative effects of using peer support.Results13 C-M-O configurations explained take-up of peer support. These were based on mothers' perceptions that peer support would offer empathetic understanding and non-judgemental acceptance outside their social circle; their relationships with primary health professionals; their cultural background and perspectives on mental health; their desire for professional support; overcoming practical barriers; the format of the support; and the use of volunteers. A further 13 C-M-O configurations explained positive impact on mothers. These were based on receiving empathetic listening, acceptance, affirmation and normalisation; peers sharing ideas about self-care, coping, and services; peers using therapeutic techniques; the opportunity to give support to others; meaningful social relationships with volunteers and other mothers; and other benefits of attending a group. There were 8 C-M-O configurations explaining negative impact. These were based on lack of validation; self-criticism from downward and upward social comparison; a culture of negativity; peers being judgemental or directive; not feeling heard; peer support as a stressful social relationship; and distress at endings.ConclusionsPeer support works in complex ways that are affected by personal and social contexts. Providers, commissioners and evaluators can use this review to understand and maximise the valuable benefits of peer support, to minimise potential risks, and to devise ways of reaching mothers who do not currently engage with it.

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:BackgroundDisseminating 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).MethodsThis 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.ResultsOutcomes 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.ConclusionsEfforts 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 registrationClinicalTrials.gov, NCT02325531. Registered 15 December 2014.

Project description:BackgroundPeer support for mental health is recommended across international policy guidance and provision. Our systematic umbrella review summarises evidence on the effectiveness, implementation, and experiences of paid peer support approaches for mental health.MethodsWe searched MEDLINE, EMBASE, PsycINFO, The Campbell Collaboration, and The Cochrane Database of Systematic Reviews (2012-2022) for reviews of paid peer support interventions for mental health. The AMSTAR2 assessed quality. Results were synthesised narratively, with implementation reported using the CFIR (Consolidated Framework for Implementation Research). The protocol was registered with PROSPERO (registration number: CRD42022362099).ResultsWe included 35 reviews (426 primary studies, n = 95-40,927 participants): systematic reviews with (n = 13) or without (n = 13) meta-analysis, or with qualitative synthesis (n = 3), scoping reviews (n = 6). Most reviews were low or critically low (97%) quality, one review was high quality. Effectiveness was investigated in 23 reviews. Results were mixed; there was some evidence from meta-analyses that peer support may improve depression symptoms (particularly perinatal depression), self-efficacy, and recovery. Factors promoting successful implementation, investigated in 9 reviews, included adequate training and supervision, a recovery-oriented workplace, strong leadership, and a supportive and trusting workplace culture with effective collaboration. Barriers included lack of time, resources and funding, and lack of recognised peer support worker (PSW) certification. Experiences of peer support were explored in 11 reviews, with 3 overarching themes: (i) what the PSW role can bring, including recovery and improved wellbeing for service users and PSWs; (ii) confusion over the PSW role, including role ambiguity and unclear boundaries; and (iii) organisational challenges and impact, including low pay, negative non-peer staff attitudes, and lack of support and training.ConclusionsPeer support may be effective at improving some clinical outcomes, self-efficacy, and recovery. Certain populations, e.g. perinatal populations, may especially benefit from peer support. Potential strategies to successfully implement PSWs include co-production, clearly defined PSW roles, a receptive hierarchical structure and staff, appropriate PSW and staff training with clinical and/or peer supervision alongside safeguarding. Services could benefit from clear, coproduced, setting specific implementation guidelines for PSW. PSW roles tend to be poorly defined and associations between PSW intervention content and impacts need further investigation. Future research should reflect the priorities of providers/service users involved in peer support.

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.

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.

Publications

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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