This is a mixed methods study that evaluates the effectiveness of the Big White Wall (BWW)
      online community and its implementation in 3 hospital/health system sites across Ontario. The
      6 month study includes 1000 participants that are randomized to an immediate treatment group
      or a delayed treatment group. The primary outcome includes a change in total and subscale
      scores on the Recovery Assessment Scale. Qualitative interviews with various stakeholders
      will explore issues relating to successful implementation.

Evaluate the Value of Telehomecare for Mental Health

Mental Disorders

The study consists of a pragmatic randomized controlled trial (RCT) with a nested comparative
      effectiveness arm to assess the value of intervention extension, with concurrent Realist
      Evaluation. The pragmatic randomized trial will assess whether the intervention (the Big
      White Wall) works when introduced into a public health or clinical setting, i.e., in real
      life conditions. The qualitative realist evaluation will assess the contextual influences and
      strategies by which the Big White Wall is adopted or rejected.

        1. Pragmatic Randomized Control Trial (RCT) with nested comparative effectiveness arm:

           The RCT will include a delayed treatment crossover control. The immediate treatment
           group (ITG) will get access to the BWW at time of enrollment and have continuous access
           for a period of 3 months. The delayed treatment group (DTG) will have no access for the
           first 3 months, then receive access to the BWW for 3 consecutive months. A 2:1
           allocation ratio will be used to randomized participants to ITG or DTG. After 3 months
           of intervention, ITG participants will have the opportunity to opt-in to an intervention
           extension arm. Those who opt-in will be randomized at a 1:1 ratio to receive an
           additional 3 months of BWW or no additional intervention.

           Objective:

           To determine the incremental benefit and cost-effectiveness of the BWW for patients with
           mental health problems who seek care at hospital-based mental health programs.

           Hypothesis:

           The investigators hypothesize that users of the BWW will experience an increase in their
           mental health recovery orientation as evidenced using a standardized recovery assessment
           tool. The investigators also hypothesize that improvements will be observed in symptoms
           of depression and anxiety, along with quality of life and community integration.

           Recruitment/Study Setting:

           A total of 1000 study participants will be recruited from 3 large mental health settings
           in Ontario: Ontario Shores Mental Health Sciences, Lakeridge Health, and Women's College
           Hospital (WCH). Lakeridge Health and Ontario Shores both have inpatient and outpatient
           mental health services that support individuals with mental health issues across the
           lifespan while Women's College Hospital has a large outpatient mental health program.

           Intervention:

           All study participants will be given access to the BWW, free of charge, for 3 months or
           6 months for those randomized to the ITG extension arm. Services on the BWW include peer
           support, self-guided and facilitated self-help resources, psycho-educational material
           and interactive creative activities. All participants will maintain anonymity on the
           site through a unique non-identifiable user identifier (ID). All participants will
           receive a unique access code for the BWW. Use of the BWW is participant dependent, with
           the ability to log in and utilize the services at any frequency.

           Data Collection:

           Baseline socio-demographic data will be collected following consent. Self-report data on
           all outcomes will be collected via questionnaires at baseline, 3 months and 6 months.
           Baseline outcome questionnaires will be completed in 1 of 3 ways: 1) web survey
           (default); 2) by phone; 3) in-person hard copy. All other questionnaires will be
           administered with web-based surveys.

           Data Analysis:

           Data analysis will be done at study completion, after all data has been collected.
           Analysis will be blinded to treatment allocation. Initially, descriptive analysis will
           be conducted for all variables. The primary outcome, The Recovery Assessment
           Scale-Revised (RAS-r) at 3 months, will be analyzed with an intent-to-treat analysis
           using an ANCOVA controlling for baseline RAS-r score as well as treatment group,
           unadjusted and adjusted for baseline Patient Health Questionnaire (PHQ-9), baseline
           Generalized Anxiety Disorder (GAD-7), age, sex, education, relationship status,
           household income, duration of episode, and recruitment setting. In sensitivity analysis,
           the investigators will repeat this using a marginal structural model to account for
           attrition. The same analysis will be repeated for all secondary outcomes at 3 months
           controlling for baseline score and treatment group. In the subset of ITG participants
           who opt in to the nested extension study, the investigators will examine outcomes at 6
           months between treatment groups. Analysis of primary and secondary outcomes will be
           repeated as described above, controlling for scores at both baseline and 3 months. The
           first exploratory analysis will examine a subset of the ITG group who had a PHQ-9 or
           GAD-7 score of at least 10 at baseline. Participants will be categorized as 'responders'
           or 'non-responders' based on whether or not they achieved at least a 50% reduction in
           the PHQ-9 or GAD-7 at 3 months relative to baseline. Second, the investigators will
           examine engagement with the BWW among ITG participants. The number of logins and total
           time on the site will be separately predicted with age, gender, education, relationship
           status, living situation, household income, baseline belief in treatment credibility and
           outcome expectancy, baseline PHQ-9 and GAD-7 scores, duration of current episode,
           recruitment setting and outpatient mental health visits. In terms of economic
           evaluation, the combination of program costs, out-of-pocket costs and costs in the
           health care system will be used to determine the total costs associated with
           participants in the program. Incremental cost-effectiveness will be assessed using an
           incremental cost-effectiveness ratio calculated as the difference in costs between DTG
           and ITG divided by the difference in outcomes between these groups.

        2. Qualitative Realist Evaluation Protocol The Realist Evaluation will occur alongside the
           pragmatic randomized trials described above, and will include two key methods. The first
           is qualitative interviews with key stakeholders involved in the implementation and use
           of BWW, and the second is observations of the introduction and use of the virtual care
           interventions among health care provider participants.

      Objective:

      The objective of the qualitative realist evaluation component of this study is to (a)
      understand perspectives of mental health care providers regarding the appropriateness of BWW
      for their patients, (b) explore participants' perspectives of the usability and acceptability
      of the BWW online community, and (c) examine the key issues associated with scaling BWW up
      across Ontario.

      Recruitment:

      At the time of recruitment into the broader pragmatic randomized trial of which this
      qualitative study is a part, patient participants will be asked if they consent to be
      contacted with further information regarding the qualitative element of the study. The
      qualitative research team will purposefully sample from the pool of interested ITG
      participants who consented to be contacted for an interview at study enrollment. The
      investigators aim to interview 4-6 participants at each site, spanning different age
      categories, for a total of 12-15 patient participants. Qualitative interviews will be
      completed with 5-7 health care providers at each site; 2-4 organizational leaders at each
      site (for example, clinical managers); and 5-7 health system decision makers in Ontario.
      These participants will be identified by clinical site leads using a snowball sampling
      process to identify key informants.

      Data Collection:

      Patient interviews will be conducted via telephone or personal video conferencing. Patients
      will be invited to participate in two interviews 1-2 weeks after gaining access to the BWW
      and again at 8-12 weeks after gaining access. Observation of the educational session in which
      health care providers and other staff are educated regarding the BWW will take place.
      Participants who opt in for the intervention extension arm of the study will again be asked
      whether they are interested in participating in a qualitative interview. Participants who
      identify as willing to be contacted may or may not have participated in a qualitative
      interview in the first phase of the study, and will be purposefully sampled and interviewed
      2-4 weeks after the re-randomization process in the same manner as the initial interviews.
      The investigators will again recruit 2-3 participants at each of the 3 sites for a total of
      12-15 patient participants from the extension arm. Healthcare providers will also be invited
      to participate in an interview 1-2 weeks post-education session on the BWW. Health care
      provider interviews will take place at their location of work or via telephone.
      Organizational leaders will be invited to participate in an interview in person or via
      telephone 3 to 4 months post BWW implementation. Health system decision makers will be
      invited to participate in an interview in person or via telephone 3 to 6 months post BWW
      implementation. Patient interviews will include general questions about how the patient
      manages his or her mental health in the community, their perspectives of the BWW, and how
      they use the BWW. If the patient has not engaged with the BWW, the qualitative interview will
      include questions about why not, and what alternative strategies the patient uses to manage
      mental health in the community. Health care provider interviews will include questions about
      health care providers' perspectives on the BWW community, mental health services in Ontario,
      and the value of virtual care interventions such as the BWW for promoting self-management of
      mental health overall. Interviews with organizational leaders and health system decision
      makers will include questions about the effectiveness of virtual care interventions to
      promote mental health self-management in the community, the context of mental health services
      in Ontario, and the procurement and implementation of virtual care interventions such as the
      BWW.

      Data Analysis:

      Observation and interview data will be analyzed using thematic analysis strategies,
      identifying key themes that demonstrate important contextual influences and practices related
      to the implementation and evaluation of the virtual care technologies in actual contexts of
      health care delivery. The findings of the qualitative data will be used to develop statements
      of the relationships between (a) key contextual factors, (b) the mechanisms by which they
      effect the implementation of the virtual care interventions, and (c) the impact on the
      outcomes of the intervention themselves. These statements will be used to develop
      understanding of (a) the specific mechanisms by which BWW is effective for users, and (b)
      strategies to inform the future implementation of BWW and/or similar interventions on a
      larger scale.

Big White Wall (BWW)

Mental health recovery, outcome is total score.

PHQ-9 assesses symptoms of depression, outcome is total score.

GAD-7 assesses symptoms of generalized anxiety, outcome is total score.

Community integration questionnaires assesses home, social, and work integration. Outcome is total and subscale scores.

Quality of life, outcome is the total score across the five dimensions

Quality of life Visual Analogue Scale (VAS) score.

RAS-r Subscales, total score on 5 subscales: 1) personal confidence and hope, 2) willingness to ask for help, 3) goal and success orientation, 4) reliance on others, and 5) not dominated by symptoms.

The Immediate Treatment Group will receive access to the study intervention - the Big White Wall, immediately after consenting for a total duration of 3 months.

The Delayed Treatment Group will have no access to the study intervention - the Big White Wall for the first 3 months, then receive access to the BWW for 3 consecutive months.

Immediate Treatment Group participants who opt in to the nested study and are randomized to the The Immediate Treatment Group - Extension, will receive access to the Big White Wall for an additional 3 months (months 4-6), immediately after receiving the initial 3 months of access.

Immediate Treatment Group participants who opt in to the nested study and are randomized to The Immediate Treatment Group - No extension, will not receive extended access to the Big White Wall.

Evaluate the Value of Telehomecare for Mental Health

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?