Efficacy and safety of a 4-week course of repeated subcutaneous ketamine injections for treatment-resistant depression (KADS study): randomised double-blind active-controlled trial.

BACKGROUND: Prior trials suggest that intravenous racemic ketamine is a highly effective for treatment-resistant depression (TRD), but phase 3 trials of racemic ketamine are needed. AIMS: To assess the acute efficacy and safety of a 4-week course of subcutaneous racemic ketamine in participants with TRD. Trial registration: ACTRN12616001096448 at www.anzctr.org.au. METHOD: This phase 3, double-blind, randomised, active-controlled multicentre trial was conducted at seven mood disorders centres in Australia and New Zealand. Participants received twice-weekly subcutaneous racemic ketamine or midazolam for 4 weeks. Initially, the trial tested fixed-dose ketamine 0.5 mg/kg versus midazolam 0.025 mg/kg (cohort 1). Dosing was revised, after a Data Safety Monitoring Board recommendation, to flexible-dose ketamine 0.5-0.9 mg/kg or midazolam 0.025-0.045 mg/kg, with response-guided dosing increments (cohort 2). The primary outcome was remission (Montgomery-Åsberg Rating Scale for Depression score ≤10) at the end of week 4. RESULTS: The final analysis (those who received at least one treatment) comprised 68 in cohort 1 (fixed-dose), 106 in cohort 2 (flexible-dose). Ketamine was more efficacious than midazolam in cohort 2 (remission rate 19.6% v. 2.0%; OR = 12.1, 95% CI 2.1-69.2, P = 0.005), but not different in cohort 1 (remission rate 6.3% v. 8.8%; OR = 1.3, 95% CI 0.2-8.2, P = 0.76). Ketamine was well tolerated. Acute adverse effects (psychotomimetic, blood pressure increases) resolved within 2 h. CONCLUSIONS: Adequately dosed subcutaneous racemic ketamine was efficacious and safe in treating TRD over a 4-week treatment period. The subcutaneous route is practical and feasible.

Testing the effectiveness and acceptability of online supportive supervision for mental health practitioners in humanitarian settings: a study protocol for the caring for carers project.

BACKGROUND: Local humanitarian workers in low and middle-income countries must often contend with potentially morally injurious situations, often with limited resources. This creates barriers to providing sustainable mental health and psychosocial support (MHPSS) to displaced individuals. Clinical supervision is an often neglected part of ensuring high-quality, sustainable care. The Caring for Carers (C4C) project aims to test the effectiveness and acceptability of online group-based supportive supervision on the well-being of MHPSS practitioners, as well as service-user-reported service satisfaction and quality when working with displaced communities in Türkiye, Syria, and Bangladesh. This protocol paper describes the aim, design, and methodology of the C4C project. METHOD: A quasi-experimental, mixed-method, community-based participatory research study will be conducted to test the effectiveness of online group-based supportive clinical supervision provided to 50 Syrian and 50 Bangladeshi MHPSS practitioners working with Syrian and Rohingya displaced communities. Monthly data will be collected from the practitioners and their beneficiaries during the active control (six months) and supervision period (16 months over two terms). Outcomes are psychological distress (Kessler-6), burnout (the Copenhagen Burnout Inventory), compassion fatigue, compassion satisfaction, and secondary traumatic stress (Professional Quality of Life Scale), perceived injustice, clinical self-efficacy (Counseling Activity Self-Efficacy Scale), service satisfaction, and quality (Client Satisfaction Questionnaire and an 18-item measure developed in this project). A realist evaluation framework will be used to elucidate the contextual factors, mechanisms, and outcomes of the supervision intervention. DISCUSSION: There is a scarcity of evidence on the role of clinical supervision in improving the well-being of MHPSS practitioners and the quality of service they provide to displaced people. By combining qualitative and quantitative data collection, the C4C project will address the long-standing question of the effectiveness and acceptability of clinical supervision in humanitarian settings.

Breaching the family walls: Modelling the impact of prolonged visa insecurity on asylum-seeking children.

OBJECTIVE: Children in asylum-seeking families are increasingly subject to deterrent host nation policies that undermine security in the post-migration context, however, little is known on the mental health consequences of such policy. This study examined the impact of prolonged visa insecurity on child mental health, by comparing two cohorts of refugee children entering Australia between 2010 and 2013, distinguished by visa security. METHODS: The insecure visa sample comprised children from Tamil asylum-seeking families, while the secure visa sample was drawn from refugee families participating in the multi-ethnic 'Building a New Life in Australia' cohort study. Children in each sample were assessed for current mental health problems and trauma exposure. Mothers were assessed for trauma exposure, post-migration family stressors and post-traumatic stress disorder (PTSD). The effects of prolonged visa insecurity on child mental health via family-and child-level variables were modelled using multi-level path analysis. RESULTS: Data comprised 361 children, aged 10-18, and 242 mothers across three levels of visa insecurity: permanent protection (n = 293), temporary protection (n = 40) and bridging visa (n = 28). Modelling showed that (1) visa insecurity was associated with poorer child mental health, (2) the association was mediated sequentially by post-migration family stressors and maternal PTSD and (3) the association was moderated by maternal PTSD. CONCLUSION: Our findings suggest that when government policy persistently undermines post-migration security, the capacity of families to protect children from accrued stressors is lowered, leaving a significantly higher proportion of children developing along trajectories of risk rather than resilience.

Modelling self-diagnosed burnout as a categorical syndrome.

OBJECTIVE: There is currently little consensus as to how burnout is best defined and measured, and whether the syndrome should be afforded clinical status. The latter issue would be advanced by determining whether burnout is a singular dimensional construct varying only by severity (and with some level of severity perhaps indicating clinical status), or whether a categorical model is superior, presumably reflecting differing 'sub-clinical' versus 'clinical' or 'burning out' vs 'burnt out' sub-groups. This study sought to determine whether self-diagnosed burnout was best modelled dimensionally or categorically. METHODS: We recently developed a new measure of burnout which includes symptoms of exhaustion, cognitive impairment, social withdrawal, insularity, and other psychological symptoms. Mixture modelling was utilised to determine if scores from 622 participants on the measure were best modelled dimensionally or categorically. RESULTS: A categorical model was supported, with the suggestion of a sub-syndromal class and, after excluding such putative members of that class, two other classes. Analyses indicated that the latter bimodal pattern was not likely related to current working status or differences in depression symptomatology between participants, but reflected subsets of participants with and without a previous diagnosis of a mental health condition. CONCLUSION: Findings indicated that sub-categories of self-identified burnout experienced by the lay population may exist. A previous diagnosis of a mental illness from a mental health professional, and therefore potentially a psychological vulnerability factor, was the most likely determinant of the bimodal data, a finding which has theoretical implications relating to how best to model burnout.

Screening for anxiety disorders in third trimester pregnancy: a comparison of four brief measures.

Evidence regarding the accuracy of existing anxiety screeners used in pregnancy is limited. This study compares the psychometric characteristics of the Generalized Anxiety Disorder 2- and 7-item Scales (GAD-2 and GAD-7), the anxiety subscale of the Edinburgh Postnatal Depression Scale (EPDS-3A) and the two anxiety items of the Antenatal Risk Questionnaire (ANRQ-2A). Nine hundred fifty-four women completed the screening measures and anxiety modules of a diagnostic reference standard (SAGE-SR) in the third trimester. Test performance characteristics of each measure was assessed using Receiver Operator Characteristic (ROC) analysis. We applied four previously recommended criteria to ascertain the value of each measure for widespread clinical use: area under the curve (AUC ≥ 0.8, Youden's index ≥ 0.5, negative predictive value (NPV) ≥ 0.8 and positive likelihood ratio (LR +) ≥ 4.0). Prevalence for any SAGE-SR anxiety disorder was 3%. All measures yielded an acceptable AUC of ≥ 0.8, Youden's index of ≥ 0.5 and NPV of ≥ 0.8. Only the EPDS-3A, at a cut-point ≥ 5, also achieved a LR + of ≥ 4.0 (4.35) but at this cut-point sensitivity was less than 0.75. The ANRQ-2A, at its optimal cut-point of ≥ 6, was the only measure to additionally attain both a sensitivity and specificity of ≥ .75. This study expands the evidence base for brief anxiety screening measures in the maternity setting and provides empirical support for the use of the EPDS-3A and ANRQ-2A in routine screening programmes. Studies assessing the performance of these measures in samples with higher disease prevalence and broader socio-economic status are warranted.

A Single-Blind Randomized Comparison of Lithium and Lamotrigine as Maintenance Treatments for Managing Bipolar II Disorder.

PURPOSE/BACKGROUND: No study to date has compared lithium and lamotrigine as maintenance mood stabilizers for bipolar II disorder. The aim of this study was to evaluate and compare these two medications in terms of their maintenance efficacy and side effect profile, thus evaluating their comparative cost/benefit profile. METHODS/PROCEDURES: Forty-four subjects with a newly diagnosed bipolar II disorder were randomly assigned to receive either lithium or lamotrigine treatment in a 20-week single-blinded study. Subjects received either slow-release lithium progressively up-titrated to achieve a serum level of 0.8 mEq/L, or lamotrigine increased progressively to a maintenance dose of 200 mg/d. Our primary outcome measure examined daily data on hypomanic and depressive symptoms. Secondary measures evaluated hypomanic and depressive symptom severity, global functioning, and global improvement in hypomanic and depressive symptoms. FINDINGS/RESULTS: We terminated the trial principally because of severe ongoing side effects experienced by many of those receiving lithium, and with additional concerns about initial severe side effects (including psychosis) experienced by several assigned to lamotrigine. Analyses of study completer data for 28 participants suggested comparable efficacy of both medications; however, lamotrigine had a distinctly lower rate of severe side effects across the study. We calculated that if study trends on outcome measures were valid, then an extremely large sample would be required to demonstrate superiority of either drug, thus making it unlikely that any such adequately powered study will be mounted in the future. IMPLICATIONS/CONCLUSIONS: The small sample size limits any definitive conclusions, but our data suggest that lithium and lamotrigine are likely to have equal efficacy as mood stabilizers for those with a bipolar II condition but that, as maintenance treatments, lithium has more distinctive side effects.

Prolonged grief in refugees, parenting behaviour and children's mental health.

BACKGROUND: Many refugees experience bereavement, and as a result they suffer elevated rates of prolonged grief disorder. Evidence also indicates that elevated rates of psychological disturbance in refugee children can be associated with parental mental health. This study examined the extent to which prolonged grief disorder in refugees is associated with their parenting behaviour and in turn with their children's mental health. METHODS: This study recruited participants from the Building a New Life in Australia prospective cohort study of refugees admitted to Australia between October 2013 and February 2014. The current data were collected in 2015-2016 and comprised 1799 adults, as well as 411 children of the adult respondents. Adult refugees were assessed for trauma history, post-migration difficulties, harsh and warm parenting, probable prolonged grief disorder and posttraumatic stress disorder. Children were administered the Strengths and Difficulties Questionnaire. The current analyses on bereaved refugees comprise 110 caregivers and 178 children. RESULTS: In this cohort, 37% of bereaved refugees reported probable prolonged grief disorder. Path analysis indicated that caregivers' grief was directly associated with children's emotional difficulties. Caregiver warmth was associated with reduced emotional problems in children of refugees with minimal grief but associated with more emotional problems in caregivers with more severe grief. More harsh parenting was associated with children's conduct problems, and this was more evident in those with less severe grief. CONCLUSION: Severity of prolonged grief disorder is directly linked to refugee children's mental health. The association between parenting style, grief severity and children's mental health highlights that managing grief reactions in refugees can benefit both refugees and their children.

New adolescent grief scales open new research possibilities: A commentary.

In this commentary, we highlight the availability of two newly developed instruments that measure grief in adolescents. We present similarities and differences regarding their content, factor structure, and characteristics of the validated populations. Given the small body of adolescent grief instruments, these two new scales will prove to be useful instruments to enhance our knowledge of grief and effectiveness of grief interventions in this population.

Effects of polygenic risk for suicide attempt and risky behavior on brain structure in young people with familial risk of bipolar disorder.

Bipolar disorder (BD) is associated with a 20-30-fold increased suicide risk compared to the general population. First-degree relatives of BD patients show inflated rates of psychopathology including suicidal behaviors. As reliable biomarkers of suicide attempts (SA) are lacking, we examined associations between suicide-related polygenic risk scores (PRSs)-a quantitative index of genomic risk-and variability in brain structures implicated in SA. Participants (n = 206; aged 12-30 years) were unrelated individuals of European ancestry and comprised three groups: 41 BD cases, 96 BD relatives ("high risk"), and 69 controls. Genotyping employed PsychArray, followed by imputation. Three PRSs were computed using genome-wide association data for SA in BD (SA-in-BD), SA in major depressive disorder (SA-in-MDD) (Mullins et al., 2019, The American Journal of Psychiatry, 176(8), 651-660), and risky behavior (Karlsson Linnér et al., 2019, Nature Genetics, 51(2), 245-257). Structural magnetic resonance imaging processing employed FreeSurfer v5.3.0. General linear models were constructed using 32 regions-of-interest identified from suicide neuroimaging literature, with false-discovery-rate correction. SA-in-MDD and SA-in-BD PRSs negatively predicted parahippocampal thickness, with the latter association modified by group membership. SA-in-BD and Risky Behavior PRSs inversely predicted rostral and caudal anterior cingulate structure, respectively, with the latter effect driven by the "high risk" group. SA-in-MDD and SA-in-BD PRSs positively predicted cuneus structure, irrespective of group. This study demonstrated associations between PRSs for suicide-related phenotypes and structural variability in brain regions implicated in SA. Future exploration of extended PRSs, in conjunction with a range of biological, phenotypic, environmental, and experiential data in high risk populations, may inform predictive models for suicidal behaviors.

Transcranial Random Noise Stimulation for the Acute Treatment of Depression: A Randomized Controlled Trial.

BACKGROUND: Transcranial electrical stimulation has broad potential as a treatment for depression. Transcranial random noise stimulation, which delivers randomly fluctuating current intensities, may have greater cortical excitatory effects compared with other forms of transcranial electrical stimulation. We therefore aimed to investigate the antidepressant efficacy of transcranial random noise stimulation. METHODS: Depressed participants were randomly assigned by computer number generator to receive 20 sessions of either active or sham transcranial random noise stimulation over 4 weeks in a double-blinded, parallel group randomized-controlled trial. Transcranial random noise stimulation was delivered for 30 minutes with a direct current offset of 2 mA and a random noise range of 2 mA. Primary analyses assessed changes in depression severity using the Montgomery-Asperg Depression Rating Scale. Neuroplasticity, neuropsychological, and safety outcomes were analyzed as secondary measures. RESULTS: Sixty-nine participants were randomized, of which 3 discontinued treatment early, leaving 66 (sham n = 34, active n = 32) for per-protocol analysis. Depression severity scores reduced in both groups (Montgomery-Asperg Depression Rating Scale reduction in sham = 7.0 [95% CI = 5.0-8.9]; and active = 5.2 [95% CI = 3.2-7.3]). However, there were no differences between active and sham groups in the reduction of depressive symptoms or the number of participants meeting response (sham = 14.7%; active = 3.1%) and remission criteria (sham = 5.9%; active = 0%). Erythema, paresthesia, fatigue, and dizziness/light-headedness occurred more frequently in the active transcranial random noise stimulation group. Neuroplasticity, neuropsychological, and acute cognitive effects were comparable between groups. CONCLUSION: Our results do not support the use of transcranial random noise stimulation with the current stimulation parameters as a therapeutic intervention for the treatment of depression. CLINICAL TRIAL REGISTRATION AT CLINICALTRIALS: gov/NCT01792414.

Cognitive effects of brief and ultrabrief pulse bitemporal electroconvulsive therapy: a randomised controlled proof-of-concept trial.

BACKGROUND: Reduction of the pulse width has been reported to improve ECT outcomes with unilateral ECT (similar efficacy, fewer cognitive side effects), but has been minimally studied for bitemporal ECT. The only study comparing brief and ultrabrief pulse bitemporal ECT found reduced efficacy for bitemporal ultrabrief compared to bitemporal brief pulse stimulation. This randomised controlled trial (RCT) aimed to test if ultrabrief pulse bitemporal ECT results in fewer cognitive side effects than brief pulse bitemporal ECT, when given at doses adjusted with the aim of achieving comparable efficacy. METHODS: Thirty-six participants were randomly assigned to receive ultrabrief (at 3 times seizure threshold) or brief (at 1.5 times seizure threshold) pulse bitemporal ECT given 3 times a week in a double-blind, controlled proof-of-concept trial. Blinded raters assessed mood and cognitive functioning over the ECT course. RESULTS: Efficacy and cognitive outcomes did not differ significantly between the two treatment groups over the ECT course. The ultrabrief pulse group performed better on a test of visual memory assessed acutely after an ECT treatment. CONCLUSIONS: This study suggests there may be a small cognitive advantage in giving bitemporal ECT with an ultrabrief pulse when dosage is increased to match the efficacy of brief pulse bitemporal ECT, but the study was underpowered to fully examine this issue.Clinical Trials Registration: www.clinicaltrials.gov, NCT00870805.

The well-being of medical students: A biopsychosocial approach.

OBJECTIVE: Mental health problems among medical students have been widely reported, but the predisposing and perpetuating factors and biological concomitants are poorly understood. Adopting a biopsychosocial approach, we studied well-being in a group of Australian medical students, focusing on sleep, autonomic and immune mechanisms, as well as mental, social and physical well-being, health-related behaviours, and daily functioning. METHODS: Fourth-year medical students (N = 151) completed comprehensive assessments, including laboratory-based and nocturnal autonomic monitoring via ambulatory bioharness, a psychiatric diagnostic interview, and questionnaires assessing sleep quality and psychosocial and physical well-being. A blood sample was taken to quantify the inflammatory marker C-reactive protein. Sleep, mood and activity was additionally monitored daily for 7 days. RESULTS: A sizable minority of students reported diminished physical, mental and psychosocial well-being. We also found concerning levels of sleep disturbance and social and occupational impairment in a subset of students. The strong co-occurrence of problems across symptom domains supported a biopsychosocial interdependence of health and well-being states. Maladaptive coping behaviours were apparent, notably hazardous alcohol consumption, which was associated with a clinically significant elevation in C-reactive protein levels (> 3 mg/L). We documented, for the first time, significantly diminished nocturnal heart rate variability in medical students with a mental health diagnosis. Nocturnal heart rate variability was strongly associated with sleep quality, daytime autonomic stress reactivity, as well as occupational and social functioning. CONCLUSION: Well-being is a multifaceted phenomenon firmly interlinked with sleep, autonomic and immune function, health behaviours and functional outcomes. Our novel findings supported a key role for nocturnal autonomic function in promoting sleep quality and mental well-being. Interventions could focus on sleep hygiene and health behaviours as a buffer for well-being and teach more adaptive strategies for coping with the stresses of medical training.

A Web-Based Mental Health Intervention to Improve Social and Occupational Functioning in Adults With Type 2 Diabetes (The Springboard Trial): 12-Month Outcomes of a Randomized Controlled Trial.

BACKGROUND: People with type 2 diabetes mellitus (T2DM) often experience mental health symptoms that exacerbate illness and increase mortality risk. Access to psychological support is low in people with T2DM. Detection of depression is variable in primary care and can be further hampered by mental health stigma. Electronic mental health (eMH) programs may provide an accessible, private, nonstigmatizing mental health solution for this group. OBJECTIVE: This study aims to evaluate the efficacy over 12 months of follow-up of an eMH program (myCompass) for improving social and occupational functioning in a community sample of people with T2DM and self-reported mild-to-moderate depressive symptoms. myCompass is a fully automated and self-guided web-based public health program for people with depression or anxiety. The effects of myCompass on depressive symptoms, diabetes-related distress, anxiety symptoms, and self-care behavior were also examined. METHODS: Adults with T2DM and mild-to-moderate depressive symptoms (N=780) were recruited via online advertisements, community organizations, and general practices. Screening, consent, and self-report questionnaires were administered online. Eligible participants were randomized to receive either myCompass (n=391) or an attention control generic health literacy program (Healthy Lifestyles; n=379) for 8 weeks. At baseline and at 3, 6, and 12 months postintervention, participants completed the Work and Social Adjustment Scale, the Patient Health Questionnaire-9 item, the Diabetes Distress Scale, the Generalized Anxiety Disorder Questionnaire-7 item, and items from the Self-Management Profile for Type 2 Diabetes. Glycosylated hemoglobin measurements were obtained at baseline and 6 and 12 months postintervention. RESULTS: A total of 38.9% (304/780) of the trial participants completed all postintervention assessments. myCompass users logged in on an average of 6 times and completed an average of 0.29 modules. Healthy Lifestyles users logged in on an average of 4 times and completed an average of 1.37 modules. At baseline, the mean scores on several outcome measures, including the primary outcome of work and social functioning, were close to the normal range, despite a varied and extensive recruitment process. Intention-to-treat analyses revealed slightly greater improvement at 12 months in work and social functioning for the Healthy Lifestyles group relative to the myCompass group. All participants reported equivalent improvements in depression anxiety, diabetes distress, diabetes self-management, and glycemic control across the trial. CONCLUSIONS: The Healthy Lifestyles group reported higher ratings of social and occupational functioning than the myCompass group, but no differences were observed for any secondary outcome. Although these findings should be interpreted in light of the near-floor symptom scores at baseline, the trial yields important insights into how people with T2DM might be engaged in eMH programs and the challenges of focusing specifically on mental health. Several avenues emerge for continued investigation into how best to deal with the growing mental health burden in adults with T2DM. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry Number (ACTRN) 12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109&isReview=true.

The influence of personality on trajectories of distress, health and functioning in mild-to-moderately depressed adults with type 2 diabetes.

Identification of mental health risk is important for optimising diabetes care in type 2 diabetes mellitus (T2DM). Personality is linked to diabetes health and may assist detection of individuals with T2DM most at risk of chronic mental health difficulties. This study examined the moderator effect of personality factors on changes in psychological distress and functioning in adults with T2DM and mild-to-moderate depressive symptoms across a 12-month period. Data were obtained from participants in a randomised controlled trial of adults with T2DM.  Participants completed measures of depression (Patient Health Questionnaire-9), anxiety (General Anxiety Disorder-7), general functioning (Work and Social Adjustment Scale), diabetes distress (Diabetes Distress Scale), and diabetes self-management (Self-Management Profile for Type 2 Diabetes) at baseline, 3-, 6- and 12-months. Glycaemic control (HbA1c) was measured at baseline, 6- and 12-months. Two hundred trial completers agreed to complete a personality inventory (Big Five Inventory). Low neuroticism was linked with reduced depression, anxiety, functional impairment and diabetes distress over the year. High extraversion was associated with decreased anxiety and functional impairment. High conscientiousness was linked to increased healthy eating. No personality trait moderated HbA1c levels. Personality screening may help identify mental health risk and guide medical carer approach in T2DM patients.

Longitudinal association between trust, psychological symptoms and community engagement in resettled refugees.

BACKGROUND: The mental health and social functioning of millions of forcibly displaced individuals worldwide represents a key public health priority for host governments. This is the first longitudinal study with a representative sample to examine the impact of interpersonal trust and psychological symptoms on community engagement in refugees. METHODS: Participants were 1894 resettled refugees, assessed within 6 months of receiving a permanent visa in Australia, and again 2-3 years later. Variables measured included post-traumatic stress disorder symptoms, depression/anxiety symptoms, interpersonal trust and engagement with refugees' own and other communities. RESULTS: A multilevel path analysis was conducted, with the final model evidencing good fit (Comparative Fit Index = 0.97, Tucker-Lewis Index = 0.89, Root Mean Square Error of Approximation = 0.05, Standardized Root-Mean-Square-Residual = 0.05). Findings revealed that high levels of depression symptoms were associated with lower subsequent engagement with refugees' own communities. In contrast, low levels of interpersonal trust were associated with lower engagement with the host community over the same timeframe. CONCLUSIONS: Findings point to differential pathways to social engagement in the medium-term post-resettlement. Results indicate that depression symptoms are linked to reduced engagement with one's own community, while interpersonal trust is implicated in engagement with the broader community in the host country. These findings have potentially important implications for policy and clinical practice, suggesting that clinical and support services should target psychological symptoms and interpersonal processes when fostering positive adaptation in resettled refugees.

Identifying distinctive psychological symptom profiles among a nationally representative sample of refugees resettled in Australia.

OBJECTIVE: The number of refugees worldwide is unprecedented in recent history. Little is known, however, about profiles of psychological symptoms following persecution and displacement. METHODS: This study reports on a latent class analysis that identified profiles of posttraumatic stress disorder (PTSD), depression and anxiety symptoms in a nationally representative sample of 1625 refugees in Australia. The association between specific symptom profiles, exposure to potentially traumatic events and post-migration stressors, and overall health and help-seeking was examined. RESULTS: Latent class analysis yielded an optimal five-class solution. These classes comprised the Pervasive Symptom class (19.2%), the High PTSD Symptom class (17.1%), the High Depression/Anxiety Symptom class (16.4%), the Moderate PTSD Symptom class (16.2%) and the Low Symptom class (31.1%). Participants in the symptomatic classes were more likely to be female, older and report greater post-migration stressors than those in the Low Symptom class. In addition, individuals in classes characterized by PTSD symptoms had been exposed to more types of potentially traumatic events. Membership in symptomatic classes was associated with poorer overall heath and greater help-seeking. CONCLUSION: Qualitatively distinct symptom profiles were observed in a nationally representative sample of refugees. In addition to a group of people who reported high symptoms across psychological disorders and may warrant clinical intervention, we identified two subclinical classes who may be missed by existing diagnostic classification systems. Post-migration stressors play an important role in influencing refugee symptom profiles over and above exposure to potentially traumatic events. Clinicians should consider specific symptom profiles and contextual factors when planning interventions with refugees.

A Web-Based Cognitive Behavior Therapy Intervention to Improve Social and Occupational Functioning in Adults With Type 2 Diabetes (The SpringboarD Trial): Randomized Controlled Trial.

BACKGROUND: Depressive symptoms are common in people with type 2 diabetes mellitus (T2DM). Effective depression treatments exist; however, access to psychological support is characteristically low. Web-based cognitive behavioral therapy (CBT) is accessible, nonstigmatizing, and may help address substantial personal and public health impact of comorbid T2DM and depression. OBJECTIVE: The aim of this study was to evaluate the Web-based CBT program, myCompass, for improving social and occupational functioning in adults with T2DM and mild-to-moderate depressive symptoms. myCompass is a fully automated, self-guided public health treatment program for common mental health problems. The impact of treatment on depressive symptoms, diabetes-related distress, anxiety symptoms, and self-care behavior was also examined. METHODS: Participants with T2DM and mild-to-moderate depressive symptoms (N=780) were recruited online via Google and Facebook advertisements targeting adults with T2DM and via community and general practice settings. Screening, consent, and self-report scales were all self-administered online. Participants were randomized using double-blind computerized block randomization to either myCompass (n=391) for 8 weeks plus a 4-week tailing-off period or an active placebo intervention (n=379). At baseline and postintervention (3 months), participants completed the Work and Social Adjustment Scale, the primary outcome measure. Secondary outcome measures included the Patient Health Questionnaire-9 item, Diabetes Distress Scale, Generalized Anxiety Disorder Questionnaire-7 item, and items from the Self-Management Profile for Type 2 Diabetes. RESULTS: myCompass users logged in an average of 6 times and completed an average of .29 modules. Healthy Lifestyles users logged in an average of 4 times and completed an average of 1.37 modules. At baseline, mean scores on several outcome measures, including the primary outcome of work and social functioning, were near to the normal range, despite an extensive recruitment process. Approximately 61.6% (473/780) of participants completed the postintervention assessment. Intention-to-treat analyses revealed improvement in functioning, depression, anxiety, diabetes distress, and healthy eating over time in both groups. Except for blood glucose monitoring and medication adherence, there were no specific between-group effects. Follow-up analyses suggested the outcomes did not depend on age, morbidity, or treatment engagement. CONCLUSIONS: Improvement in social and occupational functioning and the secondary outcomes was generally no greater for myCompass users than for users of the control program at 3 months postintervention. These findings should be interpreted in light of near-normal mean baseline scores on several variables, the self-selected study sample, and sample attrition. Further attention to factors influencing uptake and engagement with mental health treatments by people with T2DM, and the impact of illness comorbidity on patient conceptualization and experience of mental health symptoms, is essential to reduce the burden of T2DM. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109&isReview=true (Archived by WebCite at http://www.webcitation.org/7850eg8pi).

Recruiting to a Randomized Controlled Trial of a Web-Based Program for People With Type 2 Diabetes and Depression: Lessons Learned at the Intersection of e-Mental Health and Primary Care.

BACKGROUND: E-mental health (eMH) interventions are now widely available and they have the potential to revolutionize the way that health care is delivered. As most health care is currently delivered by primary care, there is enormous potential for eMH interventions to support, or in some cases substitute, services currently delivered face to face in the community setting. However, randomized trials of eMH interventions have tended to recruit participants using online recruitment methods. Consequently, it is difficult to know whether participants who are recruited online differ from those who attend primary care. OBJECTIVE: This paper aimed to document the experience of recruiting to an eMH trial through primary care and compare the characteristics of participants recruited through this and other recruitment methods. METHODS: Recruitment to the SpringboarD randomized controlled trial was initially focused on general practices in 2 states of Australia. Over 15 months, we employed a comprehensive approach to engaging practice staff and supporting them to recruit patients, including face-to-face site visits, regular contact via telephone and trial newsletters, and development of a Web-based patient registration portal. Nevertheless, it became apparent that these efforts would not yield the required sample size, and we therefore supplemented recruitment through national online advertising and promoted the study through existing networks. Baseline characteristics of participants recruited to the trial through general practice, online, or other sources were compared using the analysis of variance and chi square tests. RESULTS: Between November 2015 and October 2017, 780 people enrolled in SpringboarD, of whom 740 provided information on the recruitment source. Of these, only 24 were recruited through general practice, whereas 520 were recruited online and 196 through existing networks. Key barriers to general practice recruitment included perceived mismatch between trial design and diabetes population, prioritization of acute health issues, and disruptions posed by events at the practice and community level. Participants recruited through the 3 different approaches differed in age, gender, employment status, depressive symptoms, and diabetes distress, with online participants being distinguished from those recruited through general practice or other sources. However, most differences reached only a small effect size and are unlikely to be of clinical importance. CONCLUSIONS: Time, labor, and cost-intensive efforts did not translate into successful recruitment through general practice in this instance, with barriers identified at several different levels. Online recruitment yielded more participants, who were broadly similar to those recruited via general practice.