Impact of fatigue as the primary determinant of functional limitations among patients with post-COVID-19 syndrome: a cross-sectional observational study.

OBJECTIVES: To describe self-reported characteristics and symptoms of treatment-seeking patients with post-COVID-19 syndrome (PCS). To assess the impact of symptoms on health-related quality of life (HRQoL) and patients' ability to work and undertake activities of daily living. DESIGN: Cross-sectional single-arm service evaluation of real-time user data. SETTING: 31 post-COVID-19 clinics in the UK. PARTICIPANTS: 3754 adults diagnosed with PCS in primary or secondary care deemed suitable for rehabilitation. INTERVENTION: Patients using the Living With Covid Recovery digital health intervention registered between 30 November 2020 and 23 March 2022. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the baseline Work and Social Adjustment Scale (WSAS). WSAS measures the functional limitations of the patient; scores of ≥20 indicate moderately severe limitations. Other symptoms explored included fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), depression (Patient Health Questionnaire-Eight Item Depression Scale), anxiety (Generalised Anxiety Disorder Scale, Seven-Item), breathlessness (Medical Research Council Dyspnoea Scale and Dyspnoea-12), cognitive impairment (Perceived Deficits Questionnaire, Five-Item Version) and HRQoL (EQ-5D). Symptoms and demographic characteristics associated with more severe functional limitations were identified using logistic regression analysis. RESULTS: 3541 (94%) patients were of working age (18-65); mean age (SD) 48 (12) years; 1282 (71%) were female and 89% were white. 51% reported losing ≥1 days from work in the previous 4 weeks; 20% reported being unable to work at all. Mean WSAS score at baseline was 21 (SD 10) with 53% scoring ≥20. Factors associated with WSAS scores of ≥20 were high levels of fatigue, depression and cognitive impairment. Fatigue was found to be the main symptom contributing to a high WSAS score. CONCLUSION: A high proportion of this PCS treatment-seeking population was of working age with over half reporting moderately severe or worse functional limitation. There were substantial impacts on ability to work and activities of daily living in people with PCS. Clinical care and rehabilitation should address the management of fatigue as the dominant symptom explaining variation in functionality.

Effectiveness of a mental health stepped-care programme for healthcare workers with psychological distress in crisis settings: a multicentre randomised controlled trial.

BACKGROUND: Evidence-based mental health interventions to support healthcare workers (HCWs) in crisis settings are scarce. OBJECTIVE: To evaluate the capacity of a mental health intervention in reducing anxiety and depression symptoms in HCWs, relative to enhanced care as usual (eCAU), amidst the COVID-19 pandemic. METHODS: We conducted an analyst-blind, parallel, multicentre, randomised controlled trial. We recruited HCWs with psychological distress from Madrid and Catalonia (Spain). The intervention arm received a stepped-care programme consisting of two WHO-developed interventions adapted for HCWs: Doing What Matters in Times of Stress (DWM) and Problem Management Plus (PM+). Each intervention lasted 5 weeks and was delivered remotely by non-specialist mental health providers. HCWs reporting psychological distress after DWM completion were invited to continue to PM+. The primary endpoint was self-reported anxiety/depression symptoms (Patient Health Questionnaire-Anxiety and Depression Scale) at week 21. FINDINGS: Between 3 November 2021 and 31 March 2022, 115 participants were randomised to stepped care and 117 to eCAU (86% women, mean age 37.5). The intervention showed a greater decrease in anxiety/depression symptoms compared with eCAU at the primary endpoint (baseline-adjusted difference 4.4, 95% CI 2.1 to 6.7; standardised effect size 0.8, 95% CI 0.4 to 1.2). No serious adverse events occurred. CONCLUSIONS: Brief stepped-care psychological interventions reduce anxiety and depression during a period of stress among HCWs. CLINICAL IMPLICATIONS: Our results can inform policies and actions to protect the mental health of HCWs during major health crises and are potentially rapidly replicable in other settings where workers are affected by global emergencies. TRIAL REGISTRATION NUMBER: NCT04980326.

Efficacy and safety of acupuncture for post-COVID-19 depression: a protocol for systematic review and meta-analysis.

INTRODUCTION: Post-COVID-19 depression (PCD) is a possible sequela of COVID-19. Some doctors have used acupuncture to treat PCD, but no systematic review or meta-analysis has yet evaluated its efficacy and safety for the treatment of PCD. The aim of this systematic review is to assess the efficacy and safety of acupuncture therapy for PCD. METHODS AND ANALYSIS: Two reviewers will independently search the Cochrane Central Register of Controlled Trials (CENTRAL), Medline (PubMed), Excerpt Medica Database (EMBASE), China National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature Database (CBM), Chinese Scientific Journal Database (VIP) and Wan-Fang Database from inception to 24 January 2023. Study selection, data extraction and assessment of study quality will be independently performed by two reviewers. If a meta-analysis is appropriate, Review Manager V.5.3 will be used for data synthesis; otherwise, a descriptive analysis will be conducted. Data will be synthesised using a fixed-effects or random-effects model, according to the results of a heterogeneity test. The results will be presented as risk ratios with 95% CIs for dichotomous data, and weighted mean differences or standardised mean differences with 95% CIs for continuous data. ETHICS AND DISSEMINATION: The entire process used for this systematic review does not use private information, so ethical approval is not required. The results of this meta-analysis will be disseminated through publication in a peer-reviewed journal and/or conference presentations. PROSPERO REGISTRATION NUMBER: CRD42022379312.

Antidepressant Advisor (ADeSS): a decision support system for antidepressant treatment for depression in UK primary care - a feasibility study.

OBJECTIVES: To develop and probe the first computerised decision-support tool to provide antidepressant treatment guidance to general practitioners (GPs) in UK primary care. DESIGN: A parallel group, cluster-randomised controlled feasibility trial, where individual participants were blind to treatment allocation. SETTING: South London NHS GP practices. PARTICIPANTS: Ten practices and eighteen patients with treatment-resistant current major depressive disorder. INTERVENTIONS: Practices were randomised to two treatment arms: (a) treatment-as-usual, (b) computerised decision support tool. RESULTS: Ten GP practices participated in the trial, which was within our target range (8-20). However, practice and patient recruitment were slower than anticipated and only 18 of 86 intended patients were recruited. This was due to fewer than expected patients being eligible for the study, as well as disruption resulting from the COVID-19 pandemic. Only one patient was lost to follow-up. There were no serious or medically important adverse events during the trial. GPs in the decision tool arm indicated moderate support for the tool. A minority of patients fully engaged with the mobile app-based tracking of symptoms, medication adherence and side effects. CONCLUSIONS: Overall, feasibility was not shown in the current study and the following modifications would be needed to attempt to overcome the limitations found: (a) inclusion of patients who have only tried one Selective Serotonin Reuptake Inhibitor, rather than two, to improve recruitment and pragmatic relevance of the study; (b) approaching community pharmacists to implement tool recommendations rather than GPs; (c) further funding to directly interface between the decision support tool and self-reported symptom app; (d) increasing the geographic reach by not requiring detailed diagnostic assessments and replacing this with supported remote self-report. TRIAL REGISTRATION NUMBER: NCT03628027.

Psychological treatments for the mental health symptoms among individuals infected with COVID-19: a scoping review protocol.

INTRODUCTION: Mental health symptoms such as depression, anxiety and sleep problems are commonly observed in individuals suffering from acute COVID-19 infection to post-COVID-19 syndrome. Studies have provided preliminary evidence for the efficacies of cognitive behavioural therapy, mindfulness-based interventions, acceptance and commitment therapy, and many other treatments for this population. Although there have been attempts to synthesise the literature on these psychological interventions, previous reviews have been limited in terms of the sources, symptoms and interventions that they included. Furthermore, most studies reviewed were conducted in early 2020, when COVID-19 had only recently been classified as a global pandemic. Since then, substantial research has been conducted. As such, we sought to provide an updated synthesis of the available evidence of treatments for the range of mental health symptoms associated with COVID-19. METHODS AND ANALYSIS: This scoping review protocol was developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Systematic searches were carried out on scientific databases (PubMed, Web of Science, PsycINFO and Scopus) and clinical trial registries (ClinicalTrials.gov, WHO ICTRP, EU Clinical Trials Register and Cochrane Central Register of Controlled Trials) to identify studies that have or will assess the efficacy or any aspects of psychological treatment for acute to post-COVID-19 syndrome. The search was conducted on 14 October 2022 and identified 17 855 potentially eligible sources/studies published since 1 January 2020 (duplicates removed). Six investigators will independently carry out titles and abstract screening, full-text screening and data charting and the results will be summarised using descriptive statistics and narrative synthesis. ETHICS AND DISSEMINATION: Ethical approval is not required for this review. The results will be disseminated through a peer-reviewed journal, conference presentations and/or academic newspapers. This scoping review has been registered with Open Science Framework (https://osf.io/wvr5t).

Acceptability of a behavioural intervention to mitigate the psychological impacts of COVID-19 restrictions in older people with long-term conditions: a qualitative study.

OBJECTIVES: The COVID-19 pandemic heightened the need to address loneliness, social isolation and associated incidence of depression among older adults. Between June and October 2020, the Behavioural Activation in Social IsoLation (BASIL) pilot study investigated the acceptability and feasibility of a remotely delivered brief psychological intervention (behavioural cctivation) to prevent and reduce loneliness and depression in older people with long-term conditions during the COVID-19 pandemic. DESIGN: An embedded qualitative study was conducted. Semi-structured interviews generated data that was analysed inductively using thematic analysis and then deductively using the theoretical framework of acceptability (TFA). SETTING: NHS and third sector organisations in England. PARTICIPANTS: Sixteen older adults and nine support workers participating in the BASIL pilot study. RESULTS: Acceptability of the intervention was high across all constructs of the TFA: Older adults and BASIL Support Workers described a positive Affective Attitude towards the intervention linked to altruism, however the activity planning aspect of the intervention was limited due to COVID-19 restrictions. A manageable Burden was involved with delivering and participating in the intervention. For Ethicality, older adults valued social contact and making changes, support workers valued being able to observe those changes. The intervention was understood by older adults and support workers, although less understanding in older adults without low mood (Intervention Coherence). Opportunity Cost was low for support workers and older adults. Behavioural Activation was perceived to be useful in the pandemic and likely to achieve its aims (Perceived Effectiveness), especially if tailored to people with both low mood and long-term conditions. Self-efficacy developed over time and with experience for both support workers and older adults. CONCLUSIONS: Overall, BASIL pilot study processes and the intervention were acceptable. Use of the TFA provided valuable insights into how the intervention was experienced and how the acceptability of study processes and the intervention could be enhanced ahead of the larger definitive trial (BASIL+).

Social support, distress and well-being in individuals experiencing Long-COVID: a cross-sectional survey study.

OBJECTIVES: Increasingly attention of the COVID-19 pandemic is directed towards its long-term effects, also known as Long-COVID. So far, Long-COVID was examined mainly from a medical perspective, leaving psychosocial effects of Long-COVID understudied. The present study advances the current literature by examining social support in the context of Long-COVID. The study not only examines received support reported by individuals with Long-COVID, but also provided support reported by relatives of individuals with Long-COVID. DESIGN: Cross-sectional study. SETTING: The study was conducted from June to October 2021 in Austria, Germany and the German-speaking part of Switzerland. PARTICIPANTS: We examined 256 individuals with Long-COVID (MAge=45.05 years, 90.2% women) and 50 relatives of individuals with Long-COVID (MAge=48.34 years, 66.1% female) in two separate online surveys, assessing social support, well-being and distress. PRIMARY OUTCOME MEASURES: Primary outcomes were positive and negative affect, anxiety and depressive symptoms and perceived stress. RESULTS: For individuals with Long-COVID, receiving emotional support was related to higher well-being (positive affect: b=0.29, p<0.01; negative affect: b=-0.31, p<0.05) and less distress (anxiety: b=-1.45, p<0.01; depressive symptoms: b=-1.04, p<0.05; perceived stress: b=-0.21, p<0.05) but no effects emerged for receiving practical support. For relatives of individuals with Long-COVID, providing emotional support was only related to lower depressive symptoms (b=-2.57, p<0.05). Again, provided practical support was unrelated to the outcomes considered. CONCLUSIONS: Emotional support is likely to play an important role in well-being and distress of patients and relatives, whereas practical support does not seem to make a difference. Future research should clarify under what conditions different kinds of support unfold their positive effects on well-being and distress in the context of Long-COVID.

Anxiety and depression among people with type 2 diabetes visiting diabetes clinics of Pokhara Metropolitan, Nepal: a cross-sectional study.

OBJECTIVES: To estimate the prevalence of anxiety and depression and identify the associated factors among people with type 2 diabetes mellitus (T2DM) visiting diabetes clinics of Pokhara Metropolitan, Nepal. DESIGN: Cross-sectional study. SETTING: Three diabetes clinics in Pokhara Metropolitan, Nepal, from May to July 2021. PARTICIPANTS: 283 people with T2DM visiting selected diabetes centres of Pokhara Metropolitan. OUTCOME MEASURES: Anxiety and depression were the outcome measures. Face-to-face interviews were conducted using a structured questionnaire comprising information related to participants' sociodemographic profile and several factors along with Hospital Anxiety and Depression-Anxiety subscale and Patient Health Questionnaire-9 to assess the levels of anxiety and depression, respectively. Pearson's Χ2 tests and binary logistic regression were performed to examine association between dependent and independent variables at 5% level of significance. RESULTS: The prevalence of anxiety and depression was 31.4% (95% CI 26.2% to 37.5%) and 36.4% (95% CI 30.8% to 42.0%), respectively. Anxiety was found to be associated with a lower level of perceived social support (adjusted OR (AOR) 2.442, 95% CI 1.020 to 5.845), multiple complications (AOR 2.758, 95% CI 1.015 to 7.334) and comorbidities (AOR 2.110, 95% CI 1.004 to 4.436), severe COVID-19 fear (AOR 2.343, 95% CI 1.123 to 4.887) and sleep dissatisfaction (AOR 1.912, 95% CI 1.073 to 3.047). Economical dependency (AOR 1.890, 95% CI 1.026 to 3.482), no insurance (AOR 2.973, 95% CI 1.134 to 7.093), lower perceived social support (AOR 2.883, 95% CI 1.158 to 7.181), multiple complications (AOR 2.308, 95% CI 1.585 to 6.422) and comorbidities (AOR 2.575, 95% CI 1.180 to 5.617), severe COVID-19 fear (AOR 2.117, 95% CI 1.009 to 4.573), alcohol use (AOR 2.401, 95% CI 1.199 to 4.806) and sleep dissatisfaction (AOR 1.995, 95% CI 1.093 to 3.644) were found to be associated with depression. CONCLUSION: This study showed high prevalence levels of anxiety and depression among people with T2DM. Strengthening social support and focusing on people with diabetes suffering from comorbidity and complications could help to reduce their risk of mental health problems.

Scalability of a singing-based intervention for postpartum depression in Denmark and Romania: protocol for a single-arm feasibility study.

INTRODUCTION: Postpartum depression (PPD) affects around one in seven women globally, with these women in need of non-pharmaceutical treatment strategies. There is a long history of the benefits of singing for maternal mental health, and promising research exists showing the clinical effectiveness of group singing. Group singing interventions are being scaled up to support new mothers in the United Kingdom, but we do not know if such an intervention may benefit women in different cultural contexts. This protocol focuses on exploring the feasibility of implementation and perceived impact of a 10-week group singing intervention for new mothers in Romania and Denmark eliciting signs of PPD. METHODS AND ANALYSIS: Data will be collected from up to 48 women with a score ≥10 on the Edinburgh Postnatal Depression Scale (EPDS) participating in a 10-week group singing intervention in Denmark or Romania, as well as a range of project stakeholders. The singing classes will take place in person and be facilitated by professional singing leaders. Feasibility of implementation will be analysed through qualitative data (eg, focus groups, interviews) and quantitative data (eg, the Feasibility of Intervention Measure). Perceived impact will be explored via surveys that include mental health measures (EPDS, Multidimensional Scale of Perceived Social Support, WHO Five Well-Being Index) from singing intervention participants (at weeks 1, 6, 10) and focus groups. Descriptive statistics, repeated measures analysis of variance and analysis of covariance will be used to analyse quantitative data. Framework method and thematic analysis will be used to analyse qualitative data. ETHICS AND DISSEMINATION: The national ethics committees in Romania (IRB-PH Protocol #2021-211217-012) and Denmark (case number 1-10-72-274-21) have approved the study, as has the Ethics Review Committee at the World Health Organization (ERC.0003714). All participants will be required to provide informed consent. Results will be disseminated by reports published by the WHO Regional Office for Europe, peer-reviewed publications and at conferences.

Mental health of pregnant and postpartum women during the third wave of the COVID-19 pandemic: a European cross-sectional study.

OBJECTIVE: To describe the mental health of perinatal women in five European countries during the third pandemic wave and identify risk factors related to depressive and anxiety symptoms. DESIGN: A cross-sectional, online survey-based study. SETTING: Belgium, Norway, Switzerland, the Netherlands and the UK, 10 June 2021-22 August 2021. PARTICIPANTS: Pregnant and up to 3 months postpartum women, older than 18 years of age. PRIMARY OUTCOME MEASURE: The Edinburgh Depression Scale (EDS) and the Generalised Anxiety Disorder scale (GAD-7) were used to assess mental health status. Univariate and multivariate generalised linear models were performed to identify factors associated with poor mental health. RESULTS: 5210 women participated (including 3411 pregnant and 1799 postpartum women). The prevalence of major depressive symptoms (EDS ≥13) was 16.1% in the pregnancy group and 17.0% in the postpartum . Moderate to severe generalised anxiety symptoms (GAD ≥10) were found among 17.3% of the pregnant and 17.7% of the postpartum women. Risk factors associated with poor mental health included having a pre-existing mental illness, a chronic somatic illness, having had COVID-19 or its symptoms, smoking, unplanned pregnancy and country of residence. Among COVID-19 restrictive measures specific to perinatal care, pregnant and postpartum women were most anxious about not having their partner present at the time of delivery, that their partner had to leave the hospital early and to be separated from their newborn after the delivery. CONCLUSION: Approximately one in six pregnant or postpartum women reported major depression or anxiety symptoms during the third wave of the pandemic. These findings suggest a continued need to monitor depression and anxiety in pregnancy and postpartum populations throughout and in the wake of the pandemic. Tailored support and counselling are essential to reduce the burden of the pandemic on perinatal and infant mental health.

Depression in older adults during the COVID-19 pandemic: a systematic review protocol.

INTRODUCTION: Depression is a common mental disorder and is a major cause of years lived with disability. The COVID-19 pandemic has caused an increase in the prevalence of depression worldwide. Our aim is to identify and synthesise the determinants of depression, the diagnostic assessment tools used to evaluate depression, and the interventions carried out since the beginning of the COVID-19 pandemic in the population aged 60 and older. METHODS AND ANALYSIS: A systematic review of the literature will be conducted. The following databases will be searched: CINAHL Plus with Full Text, MedicLatina, MEDLINE with Full Text, and Psychology and Behavioural Sciences Collection. The search strategy will include the following Medical Subject Headings or similar terms: "Depression", "Depressive Disorder", "Depressive Symptoms", "Older Adults", "Aging", "Elderly", Pandemic" and "COVID-19". Two independent reviewers will ascertain whether the resulting articles meet inclusion and exclusion criteria, and perform the analysis of data quality. Disagreements will be resolved by a third reviewer. All studies reported between December 2019 and March 2022 meeting the following criteria will be included: studies in adults aged 60 and over, and articles written in English, Portuguese, Spanish or German. Information on determinants of depression, assessment instruments used to assess depressive symptoms and/or interventions to decrease depression are reported. Studies will not be excluded based on geographical area study context (eg, community, culture or specific environment). All studies related to diagnostic assessment, care planning and/or intervention strategies specifically for older adults with depression will be included. ETHICS AND DISSEMINATION: As only secondary data will be analysed, no ethical approval is required for this study. This scientific article is a systematic review protocol for which data have not yet been extracted or analysed. The results will be disseminated through peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD42022299775.

Can we mitigate the psychological impacts of social isolation using behavioural activation? Long-term results of the UK BASIL urgent public health COVID-19 pilot randomised controlled trial and living systematic review.

BACKGROUND: Behavioural and cognitive interventions remain credible approaches in addressing loneliness and depression. There was a need to rapidly generate and assimilate trial-based data during COVID-19. OBJECTIVES: We undertook a parallel pilot RCT of behavioural activation (a brief behavioural intervention) for depression and loneliness (Behavioural Activation in Social Isolation, the BASIL-C19 trial ISRCTN94091479). We also assimilate these data in a living systematic review (PROSPERO CRD42021298788) of cognitive and/or behavioural interventions. METHODS: Participants (≥65 years) with long-term conditions were computer randomised to behavioural activation (n=47) versus care as usual (n=49). Primary outcome was PHQ-9. Secondary outcomes included loneliness (De Jong Scale). Data from the BASIL-C19 trial were included in a metanalysis of depression and loneliness. FINDINGS: The 12 months adjusted mean difference for PHQ-9 was -0.70 (95% CI -2.61 to 1.20) and for loneliness was -0.39 (95% CI -1.43 to 0.65).The BASIL-C19 living systematic review (12 trials) found short-term reductions in depression (standardised mean difference (SMD)=-0.31, 95% CI -0.51 to -0.11) and loneliness (SMD=-0.48, 95% CI -0.70 to -0.27). There were few long-term trials, but there was evidence of some benefit (loneliness SMD=-0.20, 95% CI -0.40 to -0.01; depression SMD=-0.20, 95% CI -0.47 to 0.07). DISCUSSION: We delivered a pilot trial of a behavioural intervention targeting loneliness and depression; achieving long-term follow-up. Living meta-analysis provides strong evidence of short-term benefit for loneliness and depression for cognitive and/or behavioural approaches. A fully powered BASIL trial is underway. CLINICAL IMPLICATIONS: Scalable behavioural and cognitive approaches should be considered as population-level strategies for depression and loneliness on the basis of a living systematic review.

Mental health literacy of school-going adolescents in sub-Saharan Africa: a regional systematic review protocol.

INTRODUCTION: Assessing mental health literacy has implications for the identification and treatment of mental health problems. Adolescents have been identified as a particularly important target group for initiating and improving mental health literacy. However, much of what we know about adolescent mental health literacy comes from high-income countries. This proposed review seeks to synthesise the available published primary evidence from sub-Saharan Africa on the status and measurement of mental health literacy among school-going adolescents. METHODS AND ANALYSIS: We will perform a systematic review reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement (PRISMA-2020). We will systematically search selected global databases (EMBASE, PsycINFO, PubMed and MEDLINE) and regional electronic databases (African Index Medicus and African Journals OnLine) up to December 2021 for observational and qualitative studies published in English and French. The standard quality assessment criteria for evaluating primary research papers from a variety of fields (QualSyst criteria) will be used to appraise the methodological quality of the included studies. The Petticrew-Roberts 3-step approach to narrative synthesis will be applied to the included studies. ETHICS AND DISSEMINATION: We will not seek ethical approval from an institutional review board, as this is a systematic review of available and accessible literature. When completed, the full report of this review will be submitted to a journal for peer-reviewed publication; the key findings will be presented at local and international conferences with-partial or full-focus on (adolescent) mental health (literacy). PROSPERO REGISTRATION NUMBER: CRD42021229011.

Impact of spiritual healing on moderate depression in adults: a study protocol of a pilot randomised controlled trial (RCT).

INTRODUCTION: Depression is a common mental disorder and the (global) leading cause of all non-fatal burden of disease worldwide. Currently, supported treatment for depression is antidepressant medication and different psychotherapeutic interventions. Many patients experience, however, adverse effects of antidepressant medication, while at the same time the access to psychotherapeutic interventions are limited. Many patients who suffer from depression turn to complementary medicine and among those modalities often spiritual healing. There is some evidence that consulting a spiritual healer can be beneficial for patients who suffer from depression, and that spiritual healing is associated with low risk. The aim of this protocol is to conduct a pilot randomised controlled trial (RCT) (spiritual healing as addition to usual care vs usual care alone) in preparation of a larger trial in adults with moderate depression, to examine feasibility and individuals' experience of spiritual healing. METHODS AND ANALYSIS: This study is a pilot RCT with two parallel groups. A total of 28 adult patients with moderate depression, diagnosed by the physician and according to the Montgomery and Åsberg Depression Rating Scale criteria will be randomised to spiritual healing in addition to usual care (n=14) or usual care alone (n=14). To determine if there is a statistical indication of an effect of healing warranting a full-scale study; the separation test will be used. To investigate participants' experience with spiritual healing, a qualitative study will be included using semistructured interviews. The data will be analysed based on a direct content analysis. ETHICS AND DISSEMINATION: This protocol was approved by regional committees for medical and health research ethics by the identifier (63692). The results will be disseminated through open-access, peer-reviewed publications, in addition to stakeholders' reporting and presenting at conferences. TRIAL REGISTRATION: Norwegian Centre for Research Data (845302) and clinicaltrials.gov (ID: NCT04766242).

Psychological and situational factors associated with COVID-19 vaccine intention among postpartum women in Pakistan: a cross-sectional study.

OBJECTIVES: Contributing factors to COVID-19 vaccination intention in low-income and middle-income countries have received little attention. This study examined COVID-19-related anxiety and obsessive thoughts and situational factors associated with Pakistani postpartum women's intention to get COVID-19 vaccination. DESIGN: Cross-sectional study administering a survey by a telephone interview format between 15 July and 10 September 2020. SETTING: Four centres of Aga Khan Hospital for Women and Children-Garden, Kharadar, Karimabad and Hyderabad-in Sindh Province, Pakistan. PARTICIPANTS: Women who were enrolled in our longitudinal Pakistani cohort study were approached (n=1395), and 990 women (71%) participated in the survey, of which 941 women who were in their postpartum period were included in the final analysis. PRIMARY OUTCOME MEASURE AND FACTORS: COVID-19 vaccine intention, sociodemographic and COVID-19-related factors, Coronavirus anxiety, obsession with COVID-19 and work and social adjustment were assessed. Multiple multinomial logistic regression analysis was used to identify factors associated with women's intentions. RESULTS: Most women would accept a COVID-19 vaccine for themselves (66.7%). Only 24.4% of women were undecided about vaccination against COVID-19, and a small number of women rejected the COVID-19 vaccine (8.8%). Women with primary education were less likely to take a COVID-19 vaccine willingly than those with higher education. COVID-19 vaccine uncertainty and refusal were predicted by having no experience of COVID-19 infection, childbirth during the pandemic, having no symptoms of Coronavirus anxiety and obsession with COVID-19. Predictors for women's intention to vaccinate themselves and their children against COVID-19 were similar. CONCLUSION: Understanding the factors shaping women's intention to vaccinate themselves or their children would enable evidence-based strategies by healthcare providers to enhance the uptake of the COVID-19 vaccine and achieve herd immunity against Coronavirus.

What are the mental health changes associated with the COVID-19 pandemic in people with medical conditions? An international survey.

OBJECTIVES: The COVID-19 pandemic has negatively impacted mental health worldwide but there is paucity of knowledge regarding the level of change in mental health in people with a medical condition (physical/psychiatric). The objectives of this study were (1) to compare the change in mental health in people with and without medical conditions, (2) to assess the change in various types of medical conditions, (3) to evaluate the association between change in mental health and number of comorbidities, and (4) to investigate the influence of receiving treatment and activity limitation imposed by the medical condition(s). DESIGN: Cross-sectional. SETTING: Online international survey. PARTICIPANT: English-speaking adults (age ≥18) were included in the study, with no exclusions based on sex/gender or location. 1276 participants (mean age 30.4, 77.7% female) were included. PRIMARY AND SECONDARY OUTCOME MEASURES: Pre and during COVID-19 pandemic symptoms of anxiety (Generalized Anxiety Disorder-2) and depression (Patient Health Questionnaire-9) were assessed. The Self-Administered Comorbidity Questionnaire was used to collect data regarding medical conditions.Repeated-measures analysis of covariance (objectives 1, 2 and 4) and Pearson's correlation coefficient (objective 3). RESULTS: 50.1% of participants had a medical condition. During the COVID-19 pandemic, compared with people with no medical condition, people with both psychiatric and physical conditions experienced significantly higher symptoms of anxiety (12%, p=0.009) and depression (9.4%, p<0.001). Although not statistically significant, the increase in anxiety and depression occurred across seven major categories of conditions. An association was found between having a higher number of medical conditions with higher anxiety and depression symptoms (r=0.16 anxiety, r=0.14 depression, p<0.001). Receiving treatment and being functionally limited by the disease did not have a significant impact on the amount of change (p>0.05). CONCLUSIONS: During the COVID-19 pandemic, people who had a combination of psychiatric and physical conditions experienced greater symptoms of anxiety and depression. Patients with chronic diseases may need extra support to address their mental health as a result of the pandemic.

Telephone-based cognitive behavioural therapy for patients with postoperative bariatric surgery to manage COVID-19 pandemic-related mental health issues and distress (TELE-BARICARE): a protocol for a randomised controlled trial.

INTRODUCTION: Bariatric surgery is currently the most effective treatment for obesity, and is performed yearly in over 8000 patients in Canada. Over 50% of those who live with obesity also have a history of mental health disorder. The COVID-19 pandemic has made it difficult for people living with obesity to manage their weight even after undergoing bariatric surgery, which combined with pandemic-related increases in mental health distress, has the potential to adversely impact obesity outcomes such as weight loss and quality of life. Reviews of virtual mental health interventions during COVID-19 have not identified any interventions that specifically address psychological distress or disordered eating in patients with obesity, including those who have had bariatric surgery. METHODS AND ANALYSIS: A randomised controlled trial will be conducted with 140 patients across four Ontario Bariatric Centres of Excellence to examine the efficacy of a telephone-based cognitive behavioural therapy intervention versus a control intervention (online COVID-19 self-help resources) in postoperative bariatric patients experiencing disordered eating and/or psychological distress. Patients will be randomised 1:1 to either group. Changes in the Binge Eating Scale and the Patient Health Questionnaire 9-Item Scale will be examined between groups across time (primary outcomes). Qualitative exit interviews will be conducted, and data will be used to inform future adaptations of the intervention to meet patients' diverse needs during and post-pandemic. ETHICS AND DISSEMINATION: This study has received ethics approvals from the following: Clinical Trials Ontario (3957) and the University Health Network Research Ethics Committee (22-5145), the Board of Record. All participants will provide written informed consent prior to enrolling in the study. Results will be made available to patients with bariatric surgery, the funders, the supporting organisations and other researchers via publication in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: NCT05258578.

Association of intranasal esketamine, a novel 'standard of care' treatment and outcomes in the management of patients with treatment-resistant depression: protocol of a prospective cohort observational study of naturalistic clinical practice.

INTRODUCTION: Esketamine is the S-enantiomer of racemic ketamine and has been approved by the Food and Drug Administration for the management of treatment resistant depression, demonstrating effective and long-lasting benefits. The objective of this observational study is to elucidate the association of intranasal (IN) esketamine with beneficial and negative outcomes in the management of treatment resistant major depressive disorder. METHODS AND ANALYSIS: This is a multicentre prospective cohort observational study of naturalistic clinical practice. We expect to recruit 10 patients per research centre (6 centres, total 60 subjects). After approval to receive IN esketamine as part of their standard of care management of moderate to severe treatment resistant depression, patients will be invited to participate in this study. Association of esketamine treatment with outcomes in the management of depression will be assessed by measuring the severity of depression symptoms using the Montgomery-Åsberg Depression Rating Scale (MADRS), and tolerability by systematically tracking common side effects of ketamine treatment, dissociation using the simplified 6-Item Clinician Administered Dissociative Symptom Scale and potential for abuse using the Likeability and Craving Questionnaire (LCQ). Change in depressive symptoms (MADRS total scores) over time will be evaluated by within-subject repeated measures analysis of variance. We will calculate the relative risk associated with the beneficial (reduction in total scores for depression) outcomes, and the side effect and dropout rates (tolerability) of adding IN esketamine to patients' current pharmacological treatments. Covariate analysis will assess the impact of site and demographic variables on treatment outcomes. ETHICS AND DISSEMINATION: Approval to perform this study was obtained through the Health Sciences Research Ethics Board at Queen's University. Findings will be shared among collaborators, through departmental meetings, presented on different academic venues and publishing our manuscript.

Feasibility of online mindfulness-based interventions for families affected with postpartum depression and anxiety: study protocol.

INTRODUCTION: Postpartum depression and anxiety (PPDA) is experienced by up to 20% of families in the first year. The condition impacts not only parents but also their developing child. While mindfulness-based interventions (MBI) have shown to be beneficial for this population, many parents do not have access to treatment or find it challenging to commit or complete the treatment. The COVID-19 pandemic has heightened some of the challenges that parents face. The ability to find time for needed self-care and health interventions is also affected by limited childcare support. The opportunity to attend a group online may significantly improve the accessibility to group MBI but may also bring challenges. This study aims to examine the feasibility and acceptability of online MBI groups for parents in families affected with PPDA. METHODS AND ANALYSIS: In this feasibility study, participants will include mothers diagnosed with PPDA and their partners. Two online MBI groups will run simultaneously for 8 weeks: one for mothers with PPDA and another one for their partners. The primary outcome will be feasibility of conducting the online groups, assessed from the facilitators' perspective, participants' perspective and attrition throughout the study. The participants' perspectives on feasibility will be assessed by questions including how difficult it was for them to make it to the sessions, specific obstacles encountered and their scheduling preferences. The facilitators' perspective will be assessed by frequency of technical difficulties encountered, of disruptions in the online sessions and of episodes where parents leave the screen (eg, to calm their child). Secondary outcomes will include mental health, couple relationship, satisfaction and acceptability which will also be evaluated through participant questionnaires. ETHICS AND DISSEMINATION: The study has received ethics approval from the University of British Columbia Children's and Women's Research Ethics Board. Study results will be disseminated through peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: NCT04617132.