Apparent Lack of Benefit of Combining Repetitive Transcranial Magnetic Stimulation with Internet-Delivered Cognitive Behavior Therapy for the Treatment of Resistant Depression: Patient-Centered Randomized Controlled Pilot Trial.

Background: Treatment-resistant depression (TRD) is considered one of the major clinical challenges in the field of psychiatry. An estimated 44% of patients with major depressive disorder (MDD) do not respond to two consecutive antidepressant therapies, and 33% do not respond to up to four antidepressants. Over 15% of all patients with MDD remain refractory to any treatment intervention. rTMS is considered a treatment option for patients with TRD. Likewise, iCBT is evidence-based, symptom-focused psychotherapy recommended for the treatment of TRD. Objective: This study aimed to evaluate the initial comparative clinical effectiveness of rTMS treatment with and without iCBT as an innovative intervention for the treatment of participants diagnosed with TRD. Methods: This study is a prospective two-arm randomized controlled trial. Overall, 78 participants diagnosed with TRD were randomized to one of two treatment interventions: rTMS sessions alone and rTMS sessions plus iCBT. Participants in each group were made to complete evaluation measures at baseline, and 6 weeks (discharge) from treatment. The primary outcome measure was baseline to six weeks change in mean score for the 17-item Hamilton depression rating scale (HAMD-17). Secondary outcomes included mean baseline to six-week changes in the Columbia suicide severity rating scale (CSSRS) for the rate of suicidal ideations, the QIDS-SR16 for subjective depression, and the EQ-5D-5L to assess the quality of health in participants. Results: A majority of the participants were females 50 (64.1%), aged ≥ 40 39 (50.0%), and had college/university education 54 (73.0%). After adjusting for the baseline scores, the study failed to find a significant difference in the changes in mean scores for participants from baseline to six weeks between the two interventions under study on the HAMD-17 scale: F (1, 53) = 0.15, p = 0.70, partial eta squared = 0.003, CSSRS; F (1, 56) = 0.04 p = 0.85, partial eta squared = 0.001, QIDS-SR16 scale; F (1, 53) = 0.04 p = 0.61, partial eta squared = 0.005, and EQ-5D-VAS; F (1, 51) = 0.46 p = 0.50, and partial eta squared = 0.009. However, there was a significant reduction in means scores at week six compared to baseline scores for the combined study population on the HAMD-17 scale (42%), CSSRS (41%), QIDS-SR16 scale (35%), and EQ-VAS scale (62%). Conclusion: This study did not find that combined treatment of TRD with rTMS + iCBT (unguided) was superior to treatment with rTMS alone. Our findings do not support the use of combined treatment of rTMS + iCBT for the management of TRD disorders.

Health resource utilization and cost before versus after initiation of second-generation long-acting injectable antipsychotics among adults with schizophrenia in Alberta, Canada: a retrospective, observational single-arm study.

BACKGROUND: Long-acting injectable (LAI) antipsychotics, along with community treatment orders (CTOs), are used to improve treatment effectiveness through adherence among individuals with schizophrenia. Understanding real-world medication adherence, and healthcare resource utilization (HRU) and costs in individuals with schizophrenia overall and by CTO status before and after second generation antipsychotic (SGA)-LAI initiation may guide strategies to optimize treatment among those with schizophrenia. METHODS: This retrospective observational single-arm study utilized administrative health data from Alberta, Canada. Adults (≥ 18 years) with schizophrenia who initiated a SGA-LAI (no use in the previous 2-years) between April 1, 2014 and March 31, 2016, and had ≥ 1 additional dispensation of a SGA-LAI were included; index date was the date of SGA-LAI initiation. Medication possession ratio (MPR) was determined, and paired t-tests were used to examine mean differences in all-cause and mental health-related HRU and costs (Canadian dollars), comprised of hospitalizations, physician visits, emergency department visits, and total visits, over the 2-year post-index and 2-year pre-index periods. Analyses were stratified by presence or absence of an active CTO during the pre-index and/or post-index periods. RESULTS: Among 1,211 adults with schizophrenia who initiated SGA-LAIs, 64% were males with a mean age of 38 (standard deviation [SD] 14) years. The mean overall antipsychotic MPR was 0.39 (95% confidence interval [CI] 0.36, 0.41) greater during the 2-year post-index period (0.84 [SD 0.26]) compared with the 2-year pre-index period (0.45 [SD 0.40]). All-cause and mental health-related HRU and costs were lower post-index versus pre-index (p < 0.001) for hospitalizations, physician visits, emergency department visits, and total visits; mean total all-cause HRU costs were $33,788 (95% CI -$38,993, -$28,583) lower post- versus pre-index ($40,343 [SD $68,887] versus $74,131 [SD $75,941]), and total mental health-related HRU costs were $34,198 (95%CI -$39,098, -$29,297) lower post- versus pre-index ($34,205 [SD $63,428] versus $68,403 [SD $72,088]) per-patient. Forty-three percent had ≥ 1 active CTO during the study period; HRU and costs varied according to CTO status. CONCLUSIONS: SGA-LAIs are associated with greater medication adherence, and lower HRU and costs however the latter vary according to CTO status.

Shared Care Practices in Community Addiction and Mental Health Services: A Qualitative Study on the Experiences and Perspectives of Stakeholders.

Shared care involves collaboration between primary care, secondary and tertiary care that enables the allocation of responsibilities of care according to the treatment needs of patients over the course of a mental illness. This study aims to determine stakeholders' perspectives on the features of an ideal shared care model and barriers to practicing shared care within addiction and mental health programs in Edmonton, Canada. This is a qualitative cross-sectional study with data collected through focus group discussions. Participants included patients, general practitioners, psychiatrists, management, and therapists working in primary and secondary addiction and mental health. Responses were audio-recorded, transcribed, and analyzed thematically. Perceived barriers to the implementation of an ideal shared care model identified by participants include fragmented communication between primary and secondary healthcare providers, patient and family physician discomfort with discussing addiction and mental health, a lack of staff capacity, confidentiality issues, and practitioner buy-in. Participants also identified enablers to include implementing shared electronic medical record systems, improving communication and collaboration, physical co-location, and increasing practitioner awareness of appropriate referrals and services. This original research provides stakeholders' perspectives on the features of an ideal shared care model and barriers to practicing shared care within addiction and mental health programs.

Clinical Outcomes in Routine Evaluation Measures for Patients Discharged from Acute Psychiatric Care: Four-Arm Peer and Text Messaging Support Controlled Observational Study.

Background: Peer support workers (PSW) and text messaging services (TxM) are supportive health services that are frequently examined in the field of mental health. Both interventions have positive outcomes, with TxM demonstrating clinical and economic effectiveness and PSW showing its utility within the recovery-oriented model. Objective: To evaluate the effectiveness of PSW and TxM in reducing psychological distress of recently discharged patients receiving psychiatric care. Methods: This is a prospective, rater-blinded, pilot-controlled observational study consisting of 181 patients discharged from acute psychiatric care. Patients were randomized into one of four conditions: daily supportive text messages only, peer support only, peer support plus daily text messages, or treatment as usual. Clinical Outcomes in Routine Evaluation­Outcome Measure (CORE-OM), a standardized measure of mental distress, was administered at four time points: baseline, six weeks, three months, and six months. MANCOVA was used to assess the impact of the interventions on participants' scores on four CORE-OM subscales across the three follow-up time points. Recovery, clinical change, and reliable change in CORE-OM all-item analysis were examined across the four groups, and the prevalence of risk symptoms was measured. Results: A total of 63 patients completed assessments at each time point. The interaction between PSW and TxM was predictive of differences in scores on the CORE-OM functioning subscale with a medium effect size (F1,63 = 4.19; p = 0.045; ηp2 = 0.07). The PSW + TxM group consistently achieved higher rates of recovery and clinical and reliable improvement compared to the other study groups. Additionally, the text message group and the PSW + TxM group significantly reduced the prevalence of risk of self/other harm symptoms after six months of intervention, with 27.59% (χ2(1) = 4.42, p = 0.04) and 50% (χ2(1) = 9.03, p < 0.01) prevalence reduction, respectively. Conclusions: The combination of peer support and supportive text messaging is an impactful intervention with positive clinical outcomes for acute care patients. Adding the two interventions into routine psychiatric care for patients after discharge is highly recommended.

Reducing readmission rates for individuals discharged from acute psychiatric care in Alberta using peer and text message support: Protocol for an innovative supportive program.

BACKGROUND: Individuals discharged from inpatient psychiatry units have the highest readmission rates of all hospitalized patients. These readmissions are often due to unmet need for mental health care compounded by limited human resources. Reducing the need for hospital admissions by providing alternative effective care will mitigate the strain on the healthcare system and for people with mental illnesses and their relatives. We propose implementation and evaluation of an innovative program which augments Mental Health Peer Support with an evidence-based supportive text messaging program developed using the principles of cognitive behavioral therapy. METHODS: A pragmatic stepped-wedge cluster-randomized trial, where daily supportive text messages (Text4Support) and mental health peer support are the interventions, will be employed. We anticipate recruiting 10,000 participants at the point of their discharge from 9 acute care psychiatry sites and day hospitals across four cities in Alberta. The primary outcome measure will be the number of psychiatric readmissions within 30 days of discharge. We will also evaluate implementation outcomes such as reach, acceptability, fidelity, and sustainability. Our study will be guided by the Consolidated Framework for Implementation Research, and the Reach-Effectiveness-Adoption-Implementation-Maintenance framework. Data will be extracted from administrative data, surveys, and qualitative methods. Quantitative data will be analysed using machine learning. Qualitative interviews will be transcribed and analyzed thematically using both inductive and deductive approaches. CONCLUSIONS: To our knowledge, this will be the first large-scale clinical trial to assess the impact of a daily supportive text message program with and without mental health peer support for individuals discharged from acute psychiatric care. We anticipate that the interventions will generate significant cost-savings by reducing readmissions, while improving access to quality community mental healthcare and reducing demand for acute care. It is envisaged that the results will shed light on the effectiveness, as well as contextual barriers and facilitators to implementation of automated supportive text message and mental health peer support interventions to reduce the psychological treatment and support gap for patients who have been discharged from acute psychiatric care. TRIAL REGISTRATION: clinicaltrials.gov, NCT05133726 . Registered 24 November 2021.

Text4Hope: Receiving Daily Supportive Text Messages for 3 Months During the COVID-19 Pandemic Reduces Stress, Anxiety, and Depression.

BACKGROUND: This study reports on the changes in stress, anxiety, and depressive symptoms of subscribers after 3 months using Text4Hope, a supportive text messaging program designed to provide support during the pandemic. METHODS: Standardized self-report measures were used to evaluate perceived stress (measured with the Perceived Stress Scale-10 [PSS-10]), anxiety (measured with the General Anxiety Disorder Scale 7 [GAD-7]), and depressive symptoms (measured with the Patient Health Questionnaire [PHQ-9]), at baseline and 3rd month (n = 373). RESULTS: After 3 months of using Text4Hope, subscribers' self-reports revealed significant (p< 0.001) mean score reductions compared with baseline on: the GAD-7 by 22.7%, PHQ-9 by 10.3%, and PSS-10 scores by 5.7%. Reductions in inferred prevalence rates for moderate to high symptoms were also observed, with anxiety demonstrating the largest reduction (15.7%). CONCLUSIONS: Observed Text4Hope-related reductions in psychological distress during COVID-19 indicate that Text4Hope is an effective, convenient, and accessible means of implementing a population-level psychological intervention.

Recovery Following Peer and Text Messaging Support After Discharge From Acute Psychiatric Care in Edmonton, Alberta: Controlled Observational Study.

BACKGROUND: Peer support is an emotional, social, and practical help provided by nonprofessionals to assist others in sustaining health behaviors. Peer support is valued in recovery-oriented models of mental health and is becoming increasingly implemented at the organizational level. Text messaging is a relatively low-cost, high-impact, and easily scalable program that uses existing technology, is devoid of geographic barriers, and is easily accessible to end users. OBJECTIVE: This study aims to evaluate the effectiveness of an innovative peer support system plus a supportive text messaging program on the recovery of discharged patients from acute psychiatric care. METHODS: This prospective, rater blinded, controlled observational study included 181 patients who were discharged from acute psychiatric care. Patients were randomized to one of four conditions: treatment as usual (follow-up care), daily supportive text messages only, peer support only, or peer support plus daily supportive text messages. A standardized self-report measure of recovery (Recovery Assessment Scale [RAS]) was completed at baseline, 6 weeks, 3 months, and 6 months. Descriptive analysis, one-way analysis of variance, and repeated measures multivariate analysis of covariance were used to examine the changes in the RAS among the study groups and over the follow-up time points. RESULTS: A total of 65 patients completed the assessments at each time point. For the overall sample, higher scores were found for the peer support plus text message condition compared with the text message only and treatment as usual condition on several scales (ie, willingness to ask for help and personal confidence and hope) and total score on the RAS, after 6 months of intervention. CONCLUSIONS: Peer support plus supportive text messaging seems to result in improved recovery compared with other interventions. It may be advisable to incorporate the two interventions as part of routine practice for patients with psychiatric disorders upon hospital discharge.

Mental Health Outreach via Supportive Text Messages during the COVID-19 Pandemic: Improved Mental Health and Reduced Suicidal Ideation after Six Weeks in Subscribers of Text4Hope Compared to a Control Population.

Background: In March 2020, Alberta Health Services launched Text4Hope, a free mental health text-message service. The service aimed to alleviate pandemic-associated stress, generalized anxiety disorder (GAD), major depressive disorder (MDD), and suicidal propensity. The effectiveness of Text4Hope was evaluated by comparing psychiatric parameters between two subscriber groups. Methods: A comparative cross-sectional study with two arms: Text4Hope subscribers who received daily texts for six weeks, the intervention group (IG); and new Text4Hope subscribers who were yet to receive messages, the control group (CG). Logistic regression models were used in the analysis. Results: Participants in the IG had lower prevalence rates for moderate/high stress (78.8% vs. 88.0%), likely GAD (31.4% vs. 46.5%), and likely MDD (36.8% vs. 52.1%), respectively, compared to respondents in the CG. After controlling for demographic variables, the IG remained less likely to self-report symptoms of moderate/high stress (OR = 0.56; 95% CI = 0.41-0.75), likely GAD (OR = 0.55; 95% CI = 0.44-0.68), and likely MDD (OR = 0.50; 95% CI = 0.47-0.73). The mean Composite Mental Health score, the sum of mean scores on the PSS, GAD-7, and PHQ-9 was 20.9% higher in the CG. Conclusions: Text4Hope is an effective population-level intervention that helps reduce stress, anxiety, depression, and suicidal thoughts during the COVID-19 pandemic. Similar texting services should be implemented during global crises.

Gender Differences in Satisfaction With a Text Messaging Program (Text4Hope) and Anticipated Receptivity to Technology-Based Health Support During the COVID-19 Pandemic: Cross-sectional Survey Study.

BACKGROUND: In March 2020, Text4Hope-a community health service-was provided to Alberta residents. This free service aims to promote psychological resilience and alleviate pandemic-associated stress, anxiety, and depression symptoms during the COVID-19 pandemic. OBJECTIVE: This study aimed to evaluate the feedback, satisfaction, experience, and perceptions of Text4Hope subscribers and to examine any differences based on gender after subscribers received 6 weeks of daily supportive text messages. Additionally, this study examined subscribers' anticipated receptivity to technology-based medical services that could be offered during major crises, emergencies, or pandemics. METHODS: Individuals self-subscribed to Text4Hope to receive daily supportive text messages for 3 months. Subscribers were invited to complete a web-based survey at 6 weeks postintervention to provide service satisfaction-related information. Overall satisfaction was assessed on a scale of 0-10, and satisfaction scores were analyzed using a related-measures t test. Likert scale satisfaction responses were used to assess various aspects of the Text4Hope program. Gender differences were analyzed using one-way analysis of variance (ANOVA) and Chi-square analyses. RESULTS: A total of 2032 subscribers completed the baseline and 6-week surveys; 1788 (88%) were female, 219 (10.8%) were male, and 25 (1.2%) were other gender. The mean age of study participants was 44.58 years (SD 13.45 years). The mean overall satisfaction score was 8.55 (SD 1.78), suggesting high overall satisfaction with Text4Hope. The ANOVA analysis, which was conducted using the Welch test (n=1716), demonstrated that females had significantly higher mean satisfaction scores than males (8.65 vs 8.11, respectively; mean difference=0.546; 95% CI 0.19 to 0.91; P<.001) and nonsignificantly lower satisfaction scores than other gender respondents (mean difference=-0.938; 95% CI -0.37 to 2.25; P=.15). More than 70% of subscribers agreed that Text4Hope helped them cope with stress (1334/1731, 77.1%) and anxiety (1309/1728, 75.8%), feel connected to a support system (1400/1729, 81%), manage COVID-19-related issues (1279/1728, 74%), and improve mental well-being (1308/1731, 75.6%). Similarly, subscribers agreed that messages were positive, affirmative, and succinct. Messages were always or often read by 97.9% (1681/1716) of respondents, and more than 20% (401/1716, 23.4%) always or often returned to messages. The majority of subscribers (1471/1666, 88.3%) read the messages and either reflected upon them or took a positive action. Subscribers welcomed almost all technology-based services as part of their health care during crisis or emergency situations. Text4Hope was perceived to be effective by many female subscribers, who reported higher satisfaction and improved coping after receiving text messages for 6 weeks. CONCLUSIONS: Respondents affirmed the high quality of the text messages with their positive feedback. Technology-based services can provide remotely accessible and population-level interventions that align with the recommended physical distancing practices for pandemics. Text4Hope subscriber feedback revealed high satisfaction and acceptance at 6 weeks postintervention. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19292.

Changes in Stress, Anxiety, and Depression Levels of Subscribers to a Daily Supportive Text Message Program (Text4Hope) During the COVID-19 Pandemic: Cross-Sectional Survey Study.

BACKGROUND: In addition to the obvious physical medical impact of COVID-19, the disease poses evident threats to people's mental health, psychological safety, and well-being. Provision of support for these challenges is complicated by the high number of people requiring support and the need to maintain physical distancing. Text4Hope, a daily supportive SMS text messaging program, was launched in Canada to mitigate the negative mental health impacts of the pandemic among Canadians. OBJECTIVE: This paper describes the changes in the stress, anxiety, and depression levels of subscribers to the Text4Hope program after 6 weeks of exposure to daily supportive SMS text messages. METHODS: We used self-administered, empirically supported web-based questionnaires to assess the demographic and clinical characteristics of Text4Hope subscribers. Perceived stress, anxiety, and depression were measured with the 10-Item Perceived Stress Scale (PSS-10), the Generalized Anxiety Disorder-7 (GAD-7) scale, and the Patient Health Questionnaire-9 (PHQ-9) scale at baseline and sixth week time points. Moderate or high perceived stress, likely generalized anxiety disorder, and likely major depressive disorder were assessed using cutoff scores of ≥14 for the PSS-10, ≥10 for the GAD-7, and ≥10 for the PHQ-9, respectively. At 6 weeks into the program, 766 participants had completed the questionnaires at both time points. RESULTS: At the 6-week time point, there were statistically significant reductions in mean scores on the PSS-10 and GAD-7 scales but not on the PHQ-9 scale. Effect sizes were small overall. There were statistically significant reductions in the prevalence rates of moderate or high stress and likely generalized anxiety disorder but not likely major depressive disorder for the group that completed both the baseline and 6-week assessments. The largest reductions in mean scores and prevalence rates were for anxiety (18.7% and 13.5%, respectively). CONCLUSIONS: Text4Hope is a convenient, cost-effective, and accessible means of implementing a population-level psychological intervention. This service demonstrated significant reductions in anxiety and stress levels during the COVID-19 pandemic and could be used as a population-level mental health intervention during natural disasters and other emergencies. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19292.

Repetitive Transcranial Magnetic Stimulation With and Without Internet-Delivered Cognitive-Behavioral Therapy for the Treatment of Resistant Depression: Protocol for Patient-Centered Randomized Controlled Pilot Trial.

BACKGROUND: Major depression is a severe, disabling, and potentially lethal clinical disorder. Only about half of patients respond to an initial course of antidepressant pharmacotherapy. At least 15% of all patients with major depressive disorder (MDD) remain refractory to any treatment intervention. By the time that a patient has experienced 3 definitive treatment failures, the likelihood of achieving remission with the fourth treatment option offered is below 10%. Repetitive transcranial magnetic stimulation (rTMS) is considered a treatment option for patients with MDD who are refractory to antidepressant treatment. It is not currently known if the addition of internet-delivered cognitive-behavioral therapy (iCBT) enhances patients' responses to rTMS treatments. OBJECTIVE: This study will evaluate the initial comparative clinical effectiveness of rTMS with and without iCBT as an innovative patient-centered intervention for the treatment of participants diagnosed with treatment-resistant depression (TRD). METHODS: This study is a prospective, two-arm randomized controlled trial. In total, 100 participants diagnosed with resistant depression at a psychiatric care clinic in Edmonton, Alberta, Canada, will be randomized to one of two conditions: (1) enrolment in rTMS sessions alone and (2) enrolment in the rTMS sessions plus iCBT. Participants in each group will complete evaluation measures (eg, recovery, general symptomatology, and functional outcomes) at baseline, 1 month, 3 months, and 6 months. The primary outcome measure will be the mean change to scores on the Hamilton Depression Rating Scale. Patient service utilization data and clinician-rated measures will also be used to gauge patient progress. Patient data will be analyzed with descriptive statistics, repeated measures, and correlational analyses. RESULTS: We expect the results of the study to be available in 24 months. We hypothesize that participants enrolled in the study who receive rTMS plus iCBT will achieve superior outcomes in comparison to participants who receive rTMS alone. CONCLUSIONS: The concomitant application of psychotherapy with rTMS has not been investigated previously. We hope that this project will provide us with a concrete base of data to evaluate the practical application and efficacy of using a novel combination of these two treatment modalities (rTMS plus iCBT). TRIAL REGISTRATION: ClinicalTrials.gov NCT0423965; https://clinicaltrials.gov/ct2/show/NCT04239651. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/18843.

Closing the Psychological Treatment Gap During the COVID-19 Pandemic With a Supportive Text Messaging Program: Protocol for Implementation and Evaluation.

BACKGROUND: Coronavirus disease (COVID-19) has spread globally with far-reaching, significant, and unprecedented impacts on health and everyday life. Threats to mental health, psychological safety, and well-being are now emerging, increasing the impact of this virus on world health. Providing support for these challenges is difficult because of the high number of people requiring support in the context of a need to maintain physical distancing. This protocol describes the use of SMS text messaging (Text4Hope) as a convenient, cost-effective, and accessible population-level mental health intervention. This program is evidence-based, with prior research supporting good outcomes and high user satisfaction. OBJECTIVE: The project goal is to implement a program of daily supportive SMS text messaging (Text4Hope) to reduce distress related to the COVID-19 crisis, initially among Canadians. The prevalence of stress, anxiety, and depressive symptoms; the demographic correlates of the same; and the outcomes of the Text4Hope intervention in mitigating distress will be evaluated. METHODS: Self-administered anonymous online questionnaires will be used to assess stress (Perceived Stress Scale), anxiety (Generalized Anxiety Disorder-7 scale [GAD-7]), and depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]). Data will be collected at baseline (onset of SMS text messaging), the program midpoint (6 weeks), and the program endpoint (12 weeks). RESULTS: Data analysis will include parametric and nonparametric techniques, focusing on primary outcomes (ie, stress, anxiety, and depressive symptoms) and metrics of use, including the number of subscribers and user satisfaction. Given the large size of the data set, machine learning and data mining methods will also be used. CONCLUSIONS: This COVID-19 project will provide key information regarding prevalence rates of stress, anxiety, and depressive symptoms during the pandemic; demographic correlates of distress; and outcome data related to this scalable population-level intervention. Information from this study will be valuable for practitioners and useful for informing policy and decision making regarding psychological interventions during the pandemic. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19292.

Effectiveness of Group Cognitive Behavioral Therapy and Exercise in the Management of Major Depressive Disorder: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: Despite evidence in scientific literature indicating the effectiveness of both cognitive behavioral therapy (CBT) and physical exercise in the management of major depressive disorder (MDD), few studies have directly compared them. OBJECTIVE: This study aims to evaluate and compare the effectiveness of group CBT, physical exercise, and only wait-listing to receive treatment-as-usual (TAU) in the management of MDD. The investigators hypothesize that participants with MDD assigned to the group CBT or exercise arms of the study will achieve superior outcomes compared with participants wait-listed to receive TAU only. METHODS: This prospective rater-blinded randomized controlled trial assesses the benefits of group CBT and exercise for participants with MDD. A total of 120 patients with MDD referred to addiction and mental health clinics in Edmonton, Canada, will be randomly assigned to one of the three equal-sized arms of the study to receive either weekly sessions of group CBT plus TAU, group exercise three times a week plus TAU, or only TAU for 14 weeks. Participants will be assessed at enrollment, 3 and 6 months post enrollment, midtreatment, and upon treatment completion for primary (functional and symptom variables) and secondary outcomes (service variables and health care utilization). In addition, participants in the intervention groups would be evaluated weekly with one functional measure. The data will be analyzed using repeated measures and effect size analyses, and correlational analyses will be completed between measures at each time point. RESULTS: The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong amendment) and Good Clinical Practice (Canadian guidelines). Written informed consent will be obtained from each subject. The study received ethical clearance from the Health Ethics Research Board of the University of Alberta on September 7, 2018 (Pro 00080975) and operational approval from the provincial health authority (Alberta Health Services 43638). As of October 13, 2019, we have enrolled 32 participants. The results will be disseminated at several levels, including patients, practitioners, academics, researchers, and health care organizations. CONCLUSIONS: The results of the pilot trial may inform the implementation of a multicenter clinical trial and provide useful information for administrators and clinicians who are interested in incorporating group CBT and group exercise interventions into existing care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03731728; https://clinicaltrials.gov/ct2/show/NCT03731728. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/14309.

Transforming youth mental health services in a large urban centre: ACCESS Open Minds Edmonton.

AIM: This paper outlines the transformation of youth mental health services in Edmonton, Alberta, a large city in Western Canada. We describe the processes and challenges involved in restructuring how services and care are delivered to youth (11-25 years old) with mental health needs based on the objectives of the pan-Canadian ACCESS Open Minds network. METHODS: We provide a narrative review of how youth mental health services have developed since our engagement with the ACCESS Open Minds initiative, based on its five central objectives of early identification, rapid access, appropriate care, continuity of care, and youth and family engagement. RESULTS: Building on an initial community mapping exercise, a service network has been developed; teams that were previously age-oriented have been integrated together to seamlessly cover the age 11 to 25 range; early identification has thus far focused on high-school populations; and an actual drop-in space facilitates rapid access and linkages to appropriate care within the 30-day benchmark. CONCLUSIONS: Initial aspects of the transformation have relied on restructuring and partnerships that have generated early successes. However, further transformation over the longer term will depend on data demonstrating how this has impacted clinical outcomes and service utilization. Ultimately, sustainability in a large urban centre will likely involve scaling up to a network of similar services to cover the entire population of the city.

Enhancing peer support experience for patients discharged from acute psychiatric care: protocol for a randomised controlled pilot trial.

INTRODUCTION: This study will evaluate the effectiveness of an innovative peer support programme. The programme incorporates leadership training, mentorship, recognition and reward systems for peer support workers, and supportive/reminder text messaging for patients discharged from acute (hospital) care. We hypothesise that patients enrolled in the peer support system plus daily supportive/reminder text messages condition will achieve superior outcomes in comparison to other groups. METHODS AND ANALYSIS: This is a prospective, rater-blinded, four-arm randomised controlled trial. 180 patients discharged from acute psychiatric care in Edmonton, Alberta, Canada will be randomised to one of four conditions: (1) enrolment in a peer support system; (2) enrolment in a peer support system plus automated daily supportive/reminder text messages; (3) enrolment in automated daily supportive/reminder text messages alone; or (4) treatment as usual follow-up care. Patients in each group will complete evaluation measures (eg, recovery, general symptomatology and functional outcomes) at baseline, 6 months and 12months. Patient service utilisation data and clinician-rated measures will also be used to gauge patient progress. Patient data will be analysed with descriptive statistics, repeated measures and correlational analyses. The peer support worker experience will be captured using qualitative methods. ETHICS AND DISSEMINATION: The study will be conducted in accordance with the Declaration of Helsinki (Hong Kong Amendment) and Good Clinical Practice (Canadian Guidelines). The study has received ethical clearance from the Health Ethics Research Board of the University of Alberta (Ref # Pro00078427) and operational approval from our regional health authority (AHS- (PRJ) #35293). All participants will provide informed consent prior to study inclusion. The results will be disseminated at several levels, including patients/peer supports, practitioners, academics/researchers, and healthcare organisations. TRIAL REGISTRATION NUMBER: NCT03404882; Pre-results.

Study of natural health product-drug adverse reactions (S.O.N.A.R.) in patients seeking mental health services.

BACKGROUND: Natural health products (N.H.P.s) are frequently used by mental health patients, who are also more likely to be given prescription medications. Few patients report use of N.H.P.s to their health care providers, increasing the challenges of safe N.H.P. use. OBJECTIVE: To determine: (1) the proportion of patients seeking mental health services taking prescription drugs only, N.H.P.s only, prescription drug-N.H.P.s concurrently and neither, (2) which prescription drugs and N.H.P.s are most commonly used by these patients, either alone or in combination, (3) what proportion of patients in each of the above groups report an adverse event (A.E.) using active surveillance, and (4) what type of A.E.s are reported in these patient groups. METHOD: Employing active surveillance, participating clinicians from six mental health clinics in Edmonton, Alberta asked individuals seeking mental health services about (i) prescription drug use, ii) N.H.P. use, and iii) experiences of A.E.s. RESULTS: Of 1466 patients with complete screening data available, 672 (45.8%) patients took prescription drugs only, 79 (5.4%) took N.H.P.s only, 279 (19.0%) took N.H.P.s and drugs concurrently and 436 (29.7%) took neither. In total, 147 patients reported an A.E., representing 10.7%, 2.5%, 25.5% and 0.5% of each population, respectively. Compared with prescription drug use, patients reporting concurrent N.H.P.-drug use were 2.8 times more likely to experience an A.E. (95% C.I.: 2.0-4.1; p < 0.001). A key limitation of the study is the lack of causality assessment of A.E.s reported; additionally, the patient population reflects a population that phones a provincial mental health phone line with or without referral from a mental health professional. CONCLUSION: Nearly one-fifth of patients seeking mental health services take N.H.P.s and prescription drugs concurrently; these patients are also at a greater risk of experiencing an A.E. Active surveillance provides a valuable means of detecting such A.E.s and can be incorporated into the medical histories obtained by clinicians.

Fast and slow processes underlie the selection of both step frequency and walking speed.

People prefer gaits that minimize their energetic cost. Research focused on step frequency selection suggests that a fast predictive process and a slower optimization process underlie this energy optimization. Our purpose in this study was to test whether the mechanisms controlling step frequency selection are used more generally to select one of the most relevant characteristics of walking - preferred speed. To accomplish this, we contrasted the dynamic adjustments in speed following perturbations to step frequency against the dynamic adjustments in step frequency following perturbations to speed. Despite the use of different perturbations and contexts, we found that the responses were very similar. In both experiments, subjects responded to perturbations by first rapidly changing their speed or step frequency towards their preferred pattern, and then slowly adjusting their gait to converge onto their preferred pattern. We measured similar response times for both the fast processes (1.4±0.3 versus 2.7±0.6 s) and the slow processes (74.2±25.4 versus 79.7±20.2 s). We also found that the fast process, although quite variable in amplitude, dominated the adjustments in both speed and step frequency. These distinct but complementary experiments demonstrate that people appear to rely heavily on prediction to rapidly select the most relevant aspects of their preferred gait and then gradually fine-tune that selection, perhaps using direct optimization of energetic cost.

Running perturbations reveal general strategies for step frequency selection.

Recent research has suggested that energy minimization in human walking involves both a fast preprogrammed process and a slow optimization process. Here, we studied human running to test whether these two processes represent control mechanisms specific to walking or a more general strategy for minimizing energetic cost in human locomotion. To accomplish this, we used free response experiments to enforce step frequency with a metronome at values above and below preferred step frequency and then determined the response times for the return to preferred steady-state step frequency when the auditory constraint was suddenly removed. In forced response experiments, we applied rapid changes in treadmill speed and examined response times for the processes involved in the consequent adjustments to step frequency. We then compared the dynamics of step frequency adjustments resulting from the two different perturbations to each other and to previous results found in walking. Despite the distinct perturbations applied in the two experiments, both responses were dominated by a fast process with a response time of 1.47 ± 0.05 s with fine-tuning provided by a slow process with a response time of 34.33 ± 0.50 s. The dynamics of the processes underlying step frequency adjustments in running match those found previously in walking, both in magnitude and relative importance. Our results suggest that the underlying mechanisms are fundamental strategies for minimizing energetic cost in human locomotion.

Distinct fast and slow processes contribute to the selection of preferred step frequency during human walking.

Humans spontaneously select a step frequency that minimizes the energy expenditure of walking. This selection might be embedded within the neural circuits that generate gait so that the optimum is pre-programmed for a given walking speed. Or perhaps step frequency is directly optimized, based on sensed feedback of energy expenditure. Direct optimization is expected to be slow due to the compounded effect of delays and iteration, whereas a pre-programmed mechanism presumably allows for faster step frequency selection, albeit dependent on prior experience. To test for both pre-programmed selection and direct optimization, we applied perturbations to treadmill walking to elicit transient changes in step frequency. We found that human step frequency adjustments (n = 7) occurred with two components, the first dominating the response (66 ± 10% of total amplitude change; mean ± SD) and occurring quite quickly (1.44 ± 1.14 s to complete 95% of total change). The other component was of smaller amplitude (35 ± 10% of total change) and took tens of seconds (27.56 ± 16.18 s for 95% completion). The fast process appeared to be too fast for direct optimization and more indicative of a pre-programmed response. It also persisted even with unusual closed-loop perturbations that conflicted with prior experience and rendered the response energetically suboptimal. The slow process was more consistent with the timing expected for direct optimization. Our interpretation of these results is that humans may rely heavily on pre-programmed gaits to rapidly select their preferred step frequency and then gradually fine-tune that selection with direct optimization.