The BEACON study: an update to the protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem-solving therapy in men who present with intentional self-harm to emergency departments in Ontario.

BACKGROUND: Men who present to the emergency department (ED) with self-harm are at high risk of dying by suicide, with 2.7% of men dying in the year following their presentation, more than double the rate for women (1.2%). Despite this, care received after an ED visit is highly variable and many are not assessed for psychological needs. Furthermore, the limited psychological care that is available is often not covered by provincial health insurance. Even when referrals for follow-up care are made, engagement rates are low. Previous recommendations to improve engagement include written discharge plans, caring contacts, and focused interventions targeting middle-aged men at elevated risk of dying by suicide. Blended care, the incorporation of technology into traditional care, has also been proposed as a method to increase engagement in and clinical benefits from psychotherapy. This project aims to determine whether the delivery of an evidence based treatment (problem-solving therapy (PST)) is enhanced by the addition of a custom smartphone application (BEACON) compared to usual care. Due to the impact of the COVID-19 pandemic on site participation and the planned implementation, we have made several changes to the study design, primary outcome, and implementation. METHOD: We originally proposed a cohort study nested within a larger cluster randomized trial wherein intervention sites would deliver the blended care, and control sites, whose personnel were not aware of their participation, would continue delivering usual care. The cohort study evaluated participant level outcomes as previously described by Hatcher et al. (2020). Due to pandemic-related constraints, our number of participating sites dropped to five potential sites which left the cohort study underpowered. As such, we changed the study design to a multi-site, individual randomized controlled trial (RCT) among the five remaining sites. Participants will be randomized to six sessions of therapy (PST) alone, or to the therapy plus BEACON, and followed up for 6 months. Our primary outcome was changed to evaluate feasibility and acceptability with the aim of designing a definitive RCT. Study implementation was reimagined to allow for completely virtual/online conduct to comply with local COVID-19 and institutional restrictions on in-person activities. CONCLUSION: This updated protocol will provide strong results for the planning of a definitive RCT of the blended care intervention in the future, addressing areas of difficulty and concern prior to its implementation. We will evaluate the feasibility of the study intervention, assess recruitment and retention of participants, and address challenges with implementing the protocol. Lastly, we will evaluate the appropriateness of our primary outcome measure and accurately determine a sample size for a definitive RCT. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03473535 . Registered on March 22, 2018.

Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent COVID-19 symptoms.

BACKGROUND: As of May 2022, Ontario has seen more than 1.3 million cases of COVID-19. While the majority of individuals will recover from infection within 4 weeks, a significant subset experience persistent and often debilitating symptoms, known as "post-COVID syndrome" or "Long COVID." Those with Long COVID experience a wide array of symptoms, with variable severity, including fatigue, cognitive impairment, and shortness of breath. Further, the prevalence and duration of Long COVID is not clear, nor is there evidence on the best course of rehabilitation for individuals to return to their desired level of function. Previous work with chronic conditions has suggested that the addition of electronic case management (ECM) may help to improve outcomes. These platforms provide enhanced connection with care providers, detailed symptom tracking and goal setting, and access to relevant resources. In this study, our primary aim is to determine if the addition of ECM with health coaching improves Long COVID outcomes at 3 months compared to health coaching alone. METHODS: The trial is an open-label, single-site, randomized controlled trial of ECM with health coaching (ECM+) compared to health coaching alone (HC). Both groups will continue to receive usual care. Participants will be randomized equally to receive health coaching (± ECM) for a period of 8 weeks and a 12-week follow-up. Our primary outcome is the WHO Disability Assessment Scale (WHODAS), 36-item self-report total score. Participants will also complete measures of cognition, fatigue, breathlessness, and mental health. Participants and care providers will be asked to complete a brief qualitative interview at the end of the study to evaluate acceptability and implementation of the intervention. DISCUSSION: There is currently little evidence about the optimal treatment of Long COVID patients or the use of digital health platforms in this population. The results of this trial could result in rapid, scalable, and personalized care for people with Long COVID which will decrease morbidity after an acute infection. Results from this study will also inform decision making in Long COVID and treatment guidelines at provincial and national levels. TRIAL REGISTRATION: ClinicalTrials.gov NCT05019963. Registered on 25 August 2021.

Feasibility and acceptability of Narrative Exposure Therapy to treat individuals with PTSD who are homeless or vulnerably housed: a pilot randomized controlled trial.

BACKGROUND: Diagnosed PTSD rates in people who are homeless are more than double that of the general population, ranging between 21 and 53%. Complex PTSD (cPTSD) also appears to be more common than PTSD. One treatment option is Narrative Exposure Therapy (NET), a brief trauma-focused psychotherapy which attempts to place trauma within a narrative of the person's life. Our primary aim was to assess the feasibility and acceptability of recruiting people to a randomized controlled trial (RCT) of NET alone compared to NET augmented by a genealogical assessment. We hypothesized that incorporating a genealogical assessment may be more effective than NET alone in a population with predominately complex PTSD. METHODS: This pilot RCT enrolled participants who were 18 years of age or older, currently homeless or vulnerably housed, and with active symptoms of PTSD. Participants were randomized to NET alone or NET plus a genealogical assessment. Rates of referral, consent, and retention were examined as part of feasibility. Demographic and clinical data were collected at baseline. Symptoms of PTSD, drug use, and housing status were re-assessed at follow-up visits. We conducted a thematic analysis of qualitative interviews of service providers involved in the study which explored barriers and facilitators of study participation. RESULTS: Twenty-two potential participants were referred to the study, with 15 consenting to participate. Of these, one was a screen failure and 14 were randomized equally to the treatment arms. One randomized participant was withdrawn for safety. Attrition occurred primarily prior to starting therapy. Once therapy began, retention was high with 80% of participants completing all six sessions. Seven participants completed all follow-up sessions. Service providers identified a clear need for the treatment and emphasized the importance of trauma-informed care, a desire to know more about NET, and more communication about the process of referral. CONCLUSION: Recruiting participants who were vulnerably housed to an RCT of a trauma-based therapy was possible. Once therapy had started, participants were likely to stay engaged. We will incorporate the results of this trial into a conceptual model which we will test in a factorial study as part of the optimization phase of MOST. TRIAL REGISTRATION: ClinicalTrials.gov NCT03781297 . Registered: December 19, 2018.

The Impact of Infectious Disease-Related Public Health Emergencies on Suicide, Suicidal Behavior, and Suicidal Thoughts.

Background: Infectious disease-related public health emergencies (epidemics) may increase suicide risk, and high-quality evidence is needed to guide an international response. Aims: We investigated the potential impacts of epidemics on suicide-related outcomes. Method: We searched MEDLINE, EMBASE, PsycInfo, CINAHL, Scopus, Web of Science, PsyArXiv, medRxiv, and bioRxiv from inception to May 13-16, 2020. Inclusion criteria: primary studies, reviews, and meta-analyses; reporting the impact of epidemics; with a primary outcome of suicide, suicidal behavior, suicidal ideation, and/or self-harm. Exclusion criteria: not concerned with suicide-related outcomes; not suitable for data extraction. PROSPERO registration: #CRD42020187013. Results: Eight primary papers were included, examining the effects of five epidemics on suicide-related outcomes. There was evidence of increased suicide rates among older adults during SARS and in the year following the epidemic (possibly motivated by social disconnectedness, fears of virus infection, and concern about burdening others) and associations between SARS/Ebola exposure and increased suicide attempts. A preprint study reported associations between COVID-19 distress and past-month suicidal ideation. Limitations: Few studies have investigated the topic; these are of relatively low methodological quality. Conclusion: Findings support an association between previous epidemics and increased risk of suicide-related outcomes. Research is needed to investigate the impact of COVID-19 on suicide outcomes.