Study protocol for Ketamine as an adjunctive therapy for major depression (2): a randomised controlled trial (KARMA-Dep [2]).

BACKGROUND: Depression is a common psychiatric disorder and a leading cause of disability worldwide. Conventional monoaminergic antidepressants have limited efficacy and take weeks to exert a therapeutic effect. Single infusions of subanaesthetic doses of ketamine exhibit rapid antidepressant action but effects are transient and relapse is common. One potential strategy for increasing ketamine's antidepressant efficacy and/or prolonging its therapeutic benefit may be serial infusions. There is limited evidence on the efficacy and safety of repeated ketamine infusions against an active comparator. METHODS: This protocol describes an ongoing pragmatic, randomised, controlled, parallel-group, patient- and rater-blind, superiority trial. Eligible adult inpatients with a confirmed DSM-5 diagnosis of a major depressive episode (unipolar or bipolar) are randomly allocated in a 1:1 ratio to a course of up to eight infusions of ketamine or midazolam twice-weekly over four weeks. The primary objective is to assess the efficacy of serial adjunctive ketamine infusions versus active comparator midazolam by measuring Montgomery-Åsberg Depression Rating Scale score difference between arms from before the first infusion to 24 h after the final infusion, supplemented by a 95% confidence interval. To facilitate generalisability of results, the trial takes place under "real world" conditions with both groups continuing to receive regular inpatient care including treatment-as-usual pharmacotherapy, nursing care, and psychological and other therapies during the randomised treatment phase and regular outpatient care thereafter. Participants are monitored for relapse during a 24-week follow-up after the end of the randomised phase. Secondary objectives of the trial are to assess: response and remission rates at the end of randomised phase; relapse status during the 24-week follow-up after the end of the randomised phase; the safety and tolerability of repeated ketamine infusions regarding psychotomimetic and other psychiatric side effects, cognitive side effects, as well as withdrawal symptoms, haemodynamic stability, neurological, urological, and other physical side effects; and quality of life and cost-effectiveness. DISCUSSION: There is an unmet clinical need for rapidly-acting novel antidepressants. This trial will provide efficacy, safety and health economic data on serial ketamine infusions and thus help inform clinical practice on the potential role of this treatment in the management of depression. TRIAL REGISTRATION: EudraCT 2019-003109-92. Registered 2 October 2019. CLINICALTRIALS: gov NCT04939649. Registered 25 June 2021.

Worsening of mental health outcomes in nursing home staff during the COVID-19 pandemic in Ireland.

BACKGROUND: Mental health issues in nursing home staff during the COVID-19 pandemic have been significant; however, it is not known if these issues persist following widespread vaccination and easing of restrictions. OBJECTIVE: To quantify the mental health of nursing home staff at different timepoints during the COVID-19 pandemic in the Republic of Ireland. DESIGN/METHODS: Two identical, online, cross-sectional, nationwide, anonymous surveys of Republic of Ireland nursing home staff at two timepoints (survey 1 (S1, n = 390): November 2020 to January 2021; survey 2 (S2, N = 229: November 2021 to February 2022) during the COVID-19 pandemic. Convenience sampling was used with staff self-selecting for participation. Methods included the World Health Organisation's Well-Being Index (WHO-5), the Impact of Events Scale-Revised (IES-R), the Moral Injury Events Scale (MIES), two Likert-scale items regarding suicidal ideation and planning, the Work Ability Score (WAS), the Brief Coping Orientation to Problems Experienced (Brief-COPE) Scale, and a 15-item questionnaire assessing perceptions of the outbreak with one additional Likert-scale item on altruism. Descriptive analysis examined differences between staff based on their classification in one of three groups: nurses, healthcare assistants (HCA) and nonclinical staff. Pseudonymous identifiers were used to link responses across surveys. RESULTS: An insufficient number of participants completed both surveys for linked analyses to be performed; therefore, we performed an ecological comparison between these two independent surveys. More staff reported moderate-severe post-traumatic stress symptoms (S1 45%; S2 65%), depression (S1: 39%; S2 57%), suicidal ideation (S1: 14%; S2 18%) and suicidal planning (S1: 9%; S2 15%) later in the pandemic. There was a higher degree of moral injury at S2 (S1: 20.8 standard deviation (SD) 9.1; S2: 25.7 SD (11.3)) and use of avoidant (maladaptive) coping styles at S2 (S1: 20.8 (6.3); S2 23.0 (6.3)) with no notable differences found in the use of approach (adaptive) coping styles. Staff reported more concerns at S2 regarding contracting COVID-19, social stigma, job stress, doubts about personal protective equipment and systems and processes. CONCLUSION: In comparison to our previous survey, mental health outcomes appear to have worsened, coping did not improve, and staff concerns, and worries appear to have increased as the pandemic progressed. Follow-up studies could help to clarify is there are any lingering problems and to assess if these issues are related to the pandemic and working conditions in nursing homes.

Dublin hospital workers' mental health during the peak of Ireland's COVID-19 pandemic.

BACKGROUND: Hospital-based healthcare workers have experienced significant psychological stressors during the COVID-19 pandemic. AIM: To evaluate the mental health of hospital workers during the third wave of the COVID-19 pandemic in Dublin, Ireland. METHODS: Cross-sectional anonymous online survey of hospital workers (n = 377; 181 doctors (48.0%), 166 nurses (44.0%), 30 radiographers (8.0%)), collecting demographic information, COVID-19 exposure history and mental health measures. RESULTS: There were significant differences between profession groups in gender, experience, COVID-19 infection history, exposure to COVID-19 positive acquaintances, and work areas. Moderate-severe post-traumatic stress disorder (PTSD) symptoms were found in 45.1% (95% CI 40.1-50.1%) of all participants; significantly fewer doctors reported moderate-severe PTSD symptoms (26%; 95% CI 22-36%). A World Health Organisation-5 Wellbeing Index (WHO-5) score ≤ 32, indicating low mood, was reported by 52% (95% CI 47-57%) of participants; significantly fewer doctors reported low mood (46%; 95% CI 39-53%). One-week suicidal ideation and planning were reported respectively by 13% (95% CI 10-16%) and 5% (95% CI 3-7%) of participants with no between-group differences. Doctors reported significantly less moral injury than other groups. There were no significant between-group differences regarding coping styles. Work ability was insufficient in 39% (95% CI 34-44%) of staff; no between-group differences. CONCLUSIONS: Dublin hospital workers reported high levels of PTSD symptoms, mood disturbance, and moral injury during the COVID-19 pandemic. Concerning levels of suicidal ideation and planning existed in this cohort. Differences in degrees of post-traumatic stress, moral injury, and wellbeing were found between profession groups, which should be considered when planning any supports.

Decision-making Capacity for Treatment After Electroconvulsive Therapy for Depression.

OBJECTIVES: Depression can impair decision-making capacity (DMC) for health care decisions. However, it is unclear whether DMC improves after treatments for depression such as electroconvulsive therapy (ECT). There is limited evidence available on DMC for treatment in patients with depression referred for ECT, and it is unknown whether ECT has any impact on DMC. We hypothesized that ECT will improve DMC in severely depressed patients and that this change will be associated with reduced depressive symptom severity. METHODS: Using the MacArthur Competence Assessment Tool-Treatment, 4 abilities related to DMC were evaluated: Understanding, Appreciation, Reasoning, and Expressing a choice. This prospective study compared DMC abilities, depression severity, and cognition scores in 24 patients hospitalized with a major depressive episode before and 3 to 5 days after a course of ECT. RESULTS: Although Understanding scores significantly improved after ECT (P = 0.004, r = 0.41), there was no change in other abilities related to DMC or cognition scores. As expected, there was a large improvement in mood ratings after ECT, but the change in DMC abilities was not associated with change in depressive symptoms. CONCLUSIONS: To our knowledge, this is the first study to provide data on the effects of ECT on DMC in patients with depression. Abilities related to DMC that may be affected in this group before treatment include Understanding and Reasoning. Findings indicate that DMC to consent to treatment mostly does not change after a course of ECT and some aspects can improve in patients with depression.

Nursing home staff mental health during the Covid-19 pandemic in the Republic of Ireland.

BACKGROUND: Nursing homes for older adults have been disproportionately affected by the Covid-19 pandemic with increased mortality of residents and staff distress. OBJECTIVE: To quantify the mental health of nursing home staff during the Covid-19 pandemic in the Republic of Ireland. DESIGN/METHODS: Cross-sectional anonymous study of Republic of Ireland nursing home staff (n = 390) during the third wave of the Covid-19 pandemic. Online survey collecting demographic information, Covid-19 exposure history and mental health measures. RESULTS: There were significant differences between nurses, healthcare assistants (HCA) and non-clinical staff history in age, ethnicity, years' experience, history of Covid-19 infection and contact with Covid-19 positive acquaintances. Moderate-severe post-traumatic stress disorder symptoms were found in 45.1% (95% confidence interval [CI] 40.2%-50.1%) of all staff. A World Health Organisation-5 (WHO-5) wellbeing index score ≤32, indicating low mood, was reported by 38.7% (95% CI, 33.9%-43.5%) of staff; significantly more nurses reported low mood. Suicidal ideation and suicide planning were reported, respectively, by 13.8% (95% CI, 10.4%-17.3%) and 9.2% (95% CI, 6.4%-12.1%) of participants with no between-group differences. HCAs reported a significantly higher degree of moral injury than non-clinical staff. Nurses were more likely to use approach coping styles than non-clinical staff. Work ability was insufficient in 24.6% (95% CI 20.3%-28.9%) of staff. CONCLUSION: Nursing home staff report high levels of post-traumatic stress, mood disturbance and moral injury during the Covid-19 pandemic. Differences in degree of moral injury, wellbeing and coping styles were found between staff groups, which need to be incorporated into planning supports for this neglected workforce.