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

BackgroundMental 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.MethodsA 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.DiscussionUnderstanding 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.Trial registrationClinicaltrials.gov NCT02896894. Registered on 31 August 2016 (retrospectively registered).

Dynamical Relations in the Self-Pattern

“…Thus, for example, Miriam Kyselo (2014) writes: “Once the diversity of self related phenomena is acknowledged [as in PTS], we also need to understand how the elements of a collection of relevant self features interrelate. A pattern approach to the self acknowledges diversity but lacks integration, offering no account of the individual as explanatory whole” (p. 1; also see Beni, 2016 ). Likewise, de Haan et al (2017) suggest that the main weakness of PTS is that “it is just a list; a heaping of aspects, without an account of how they relate.…”

“… The notion of a self-pattern, as developed in the pattern theory of self ( Gallagher, 2013 ), which holds that the self is best explained in terms of the kind of reality that pertains to a dynamical pattern, acknowledges the importance of neural dynamics, but also expands the account of self to extra-neural (embodied and enactive) dynamics. The pattern theory of self, however, has been criticized for failing to explicate the dynamical relations among elements of the self-pattern (e.g., Kyselo, 2014 ; Beni, 2016 ; de Haan et al, 2017 ); as such, it seems to be nothing more than a mere list of elements. We’ll argue that the dynamics of a self-pattern are reflected in three significant and interrelated ways that allow for investigation.…”

“… 8 This may be one way to address a worry raised by Beni (2016 , p. 3731), namely that it can be particularly difficult to account for the relation of the very different kinds of aspects of the self-pattern, across different dimensions, since “the dynamically constituted self-pattern is not woven around a central self that has its own independent existence.” This implies that one acknowledges the diversity of elements that enter into the self-pattern, and at the same time allow for the possibility that in any single organism there may be some degree of integration reflected at the level of neurobiology. …”

Adoption, Acceptability, and Effectiveness of a Mobile Health App for Personalized Prostate Cancer Survivorship Care: Protocol for a Realist Case Study of the Ned App

“…Researchers who engage with this methodology collect data on the contextual features that might affect how and for whom an intervention is expected to work, and then analyze the data to examine the interaction between context and mechanisms of action [ 36 ]. The adoption of this methodology has grown in the health services research community and is now recognized as a powerful approach to designing and analyzing complex evaluations [ 37 ]. Realist evaluations are particularly well suited for evaluating digital health interventions given the complex sociotechnical relationship between users and technology [ 38 ].…”

A web-based mental health platform in individuals seeking specialized mental health care services: multi-centre pragmatic randomized controlled trial (Preprint)

“…Participants seeking services at specialized mental health and addictions programs at the participating sites were randomized 2:1, stratified by site and treatment setting from which they were recruited, to receive immediate access to the BWW for 3 months (immediate treatment group; ITG) or delayed access after a 3-month control period (delayed treatment group; DTG). The trial protocol has been previously published and is available open access at: https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-016-1057-5 [16].…”