Patient-reported outcome measures for monitoring primary care patients with depression: the PROMDEP cluster RCT and economic evaluation.

Background: Guidelines on the management of depression recommend that practitioners use patient-reported outcome measures for the follow-up monitoring of symptoms, but there is a lack of evidence of benefit in terms of patient outcomes. Objective: To test using the Patient Health Questionnaire-9 questionnaire as a patient-reported outcome measure for monitoring depression, training practitioners in interpreting scores and giving patients feedback. Design: Parallel-group, cluster-randomised superiority trial; 1 : 1 allocation to intervention and control. Setting: UK primary care (141 group general practices in England and Wales). Inclusion criteria: Patients aged ≥ 18 years with a new episode of depressive disorder or symptoms, recruited mainly through medical record searches, plus opportunistically in consultations. Exclusions: Current depression treatment, dementia, psychosis, substance misuse and risk of suicide. Intervention: Administration of the Patient Health Questionnaire-9 questionnaire with patient feedback soon after diagnosis, and at follow-up 10-35 days later, compared with usual care. Primary outcome: Beck Depression Inventory, 2nd edition, symptom scores at 12 weeks. Secondary outcomes: Beck Depression Inventory, 2nd edition, scores at 26 weeks; antidepressant drug treatment and mental health service contacts; social functioning (Work and Social Adjustment Scale) and quality of life (EuroQol 5-Dimension, five-level) at 12 and 26 weeks; service use over 26 weeks to calculate NHS costs; patient satisfaction at 26 weeks (Medical Informant Satisfaction Scale); and adverse events. Sample size: The original target sample of 676 patients recruited was reduced to 554 due to finding a significant correlation between baseline and follow-up values for the primary outcome measure. Randomisation: Remote computerised randomisation with minimisation by recruiting university, small/large practice and urban/rural location. Blinding: Blinding of participants was impossible given the open cluster design, but self-report outcome measures prevented observer bias. Analysis was blind to allocation. Analysis: Linear mixed models were used, adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering including practice as random effect. Quality of life and costs were analysed over 26 weeks. Qualitative interviews: Practitioner and patient interviews were conducted to reflect on trial processes and use of the Patient Health Questionnaire-9 using the Normalization Process Theory framework. Results: Three hundred and two patients were recruited in intervention arm practices and 227 patients were recruited in control practices. Primary outcome data were collected for 252 (83.4%) and 195 (85.9%), respectively. No significant difference in Beck Depression Inventory, 2nd edition, score was found at 12 weeks (adjusted mean difference -0.46, 95% confidence interval -2.16 to 1.26). Nor were significant differences found in Beck Depression Inventory, 2nd Edition, score at 26 weeks, social functioning, patient satisfaction or adverse events. EuroQol-5 Dimensions, five-level version, quality-of-life scores favoured the intervention arm at 26 weeks (adjusted mean difference 0.053, 95% confidence interval 0.013 to 0.093). However, quality-adjusted life-years over 26 weeks were not significantly greater (difference 0.0013, 95% confidence interval -0.0157 to 0.0182). Costs were lower in the intervention arm but, again, not significantly (-£163, 95% confidence interval -£349 to £28). Cost-effectiveness and cost-utility analyses, therefore, suggested that the intervention was dominant over usual care, but with considerable uncertainty around the point estimates. Patients valued using the Patient Health Questionnaire-9 to compare scores at baseline and follow-up, whereas practitioner views were more mixed, with some considering it too time-consuming. Conclusions: We found no evidence of improved depression management or outcome at 12 weeks from using the Patient Health Questionnaire-9, but patients' quality of life was better at 26 weeks, perhaps because feedback of Patient Health Questionnaire-9 scores increased their awareness of improvement in their depression and reduced their anxiety. Further research in primary care should evaluate patient-reported outcome measures including anxiety symptoms, administered remotely, with algorithms delivering clear recommendations for changes in treatment. Study registration: This study is registered as IRAS250225 and ISRCTN17299295. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 17/42/02) and is published in full in Health Technology Assessment; Vol. 28, No. 17. See the NIHR Funding and Awards website for further award information.

Depression is common, can be disabling and costs the nation billions. The National Health Service recommends general practitioners who treat people with depression use symptom questionnaires to help assess whether those people are getting better over time. A symptom questionnaire is one type of patient-reported outcome measure. Patient-reported outcome measures appear to benefit people having therapy and mental health care, but this approach has not been tested thoroughly in general practice. Most people with depression are treated in general practice, so it is important to test patient-reported outcome measures there, too. In this study, we tested whether using a patient-reported outcome measure helps people with depression get better more quickly. The study was a 'randomised controlled trial' in general practices, split into two groups. In one group, people with depression completed the Patient Health Questionnaire, or 'PHQ-9', patient-reported outcome measure, which measures nine symptoms of depression. In the other group, people with depression were treated as usual without the Patient Health Questionnaire-9. We fed the results of the Patient Health Questionnaire-9 back to the people with depression themselves to show them how severe their depression was and asked them to discuss the results with the practitioners looking after them. We found no differences between the patient-reported outcome measure group and the control group in their level of depression; their work or social life; their satisfaction with care from their practice; or their use of medicines, therapy or specialist care for depression. However, we did find that their quality of life was improved at 6 months, and the costs of the National Health Service services they used were lower. Using the Patient Health Questionnaire-9 can improve patients' quality of life, perhaps by making them more aware of improvement in their depression symptoms, and less anxious as a result. Future research should test using a patient-reported outcome measure that includes anxiety and processing the answers through a computer to give practitioners clearer advice on possible changes to treatment for depression.

Depression follow-up monitoring with the PHQ-9: open cluster-randomised controlled trial.

BACKGROUND: Outcome monitoring of depression is recommended but lacks evidence of patient benefit in primary care. AIM: To test monitoring depression using the PHQ-9 questionnaire with patient feedback. DESIGN AND SETTING: Open cluster-randomised controlled trial in 141 group practices. METHOD: Adults with new depressive episodes were recruited through records searches and opportunistically. EXCLUSION CRITERIA: dementia, psychosis, substance misuse, suicide risk. The PHQ-9 questionnaire was to be administered soon after diagnosis, and 10-35 days later. PRIMARY OUTCOME: Beck Depression Inventory (BDI-II) score at 12 weeks. SECONDARY OUTCOMES: BDI-II at 26 weeks; Work and Social Adjustment Scale and EuroQol EQ-5D-5L quality of life at 12 and 26 weeks; antidepressant treatment, mental health service use, adverse events, and Medical Informant Satisfaction Scale over 26 weeks. RESULTS: 302 intervention arm patients were recruited and 227 controls. At 12 weeks 252 (83.4%) and 195 (85.9%) were followed-up respectively. Only 41% of intervention arm patients had a GP follow-up PHQ-9 recorded. There was no significant difference in BDI-II score at 12 weeks (mean difference -0.46; 95% CI -2.16,1.26), adjusted for baseline depression, baseline anxiety, sociodemographic factors, and clustering by practice). EQ-5D-5L quality of life scores were higher in the intervention arm at 26 weeks (adjusted mean difference 0.053; 95% CI 0.093,0.013). A clinically significant difference in depression at 26 weeks could not be ruled out. No significant differences were found in social functioning, adverse events, or satisfaction. In a per-protocol analysis, antidepressant use and mental health contacts were significantly greater in intervention arm patients with a recorded follow-up PHQ-9. CONCLUSIONS: No evidence was found of improved depression outcome at 12 weeks from monitoring. The findings of possible benefits over 26 weeks warrant replication, investigating possible mechanisms, preferably with automated delivery of monitoring and more instructive feedback.

'The phoenix that always rises from the ashes': an exploratory qualitative study of the experiences of an initiative informed by principles of psychological first aid following the Beirut blast.

Background: On 4 August 2020, an explosion occurred in Beirut, Lebanon. Hundreds of people were killed, thousands injured and displaced. An initiative was rapidly initiated to provide remote support informed by psychological first aid for the mental health of Lebanese young adults affected by the blast. However, little is known about recipients' experiences of such initiatives.Objective: This study aimed to qualitatively explore the experiences of supporters and recipients in the community-led initiative following the blast.Method: We recruited a diverse sample of four supporters and four Lebanese recipients who took part in the Beirut initiative. Semi-structured interviews were conducted with participants. Reflexive thematic analysis was used to analyse the qualitative data.Results: We developed five themes from the qualitative interviews, which highlighted ideas around accessibility, alienation, the relationship, elements of the safe space created by the initiative, and unmet needs and areas for improvement. Recipients described the detrimental impact of the blast on their mental health within the Lebanese context and beyond. Recipients and supporters elucidated complex experiences of the support and its impact.Conclusions: Our findings suggest remote support has the potential to be acceptable for young adults in Lebanon. Further research into support informed by psychological first aid after similar crisis events is warranted.

Following the Beirut blast on 4 August 2020, an initiative was implemented to provide remote mental health support to Lebanese young adults.Reflexive thematic analysis was used to analyse qualitative data from interviews with supporters and recipients after support sessions were completed to identify themes across diverse experiences and views.Participants described a feeling of alienation after the blast, the development of a meaningful relationship between supporter and recipients, and gratitude for having a safe space to process and share difficult feelings. Possible avenues for improvement and implementation were suggested.

Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial.

BACKGROUND: Cognitive behavioural therapy (CBT) is an effective treatment for depression. Self-directed online CBT interventions have made CBT more accessible at a lower cost. However, adherence is often poor and, in the absence of therapist support, effects are modest and short-term. Delivering CBT online using instant messaging is clinically and cost-effective; however, most existing platforms are limited to instant messaging sessions, without the support of between-session "homework" activities. The INTERACT intervention integrates online CBT materials and 'high-intensity' therapist-led CBT, delivered remotely in real-time. The INTERACT trial will evaluate this novel integration in terms of clinical and cost-effectiveness, and acceptability to therapists and clients. METHODS: Pragmatic, two parallel-group multi-centre individually randomised controlled trial, with 434 patients recruited from primary care practices in Bristol, London and York. Participants with depression will be identified via General Practitioner record searches and direct referrals. INCLUSION CRITERIA: aged ≥ 18 years; score ≥ 14 on Beck Depression Inventory (BDI-II); meeting International Classification of Diseases (ICD-10) criteria for depression. EXCLUSION CRITERIA: alcohol or substance dependency in the past year; bipolar disorder; schizophrenia; psychosis; dementia; currently under psychiatric care for depression (including those referred but not yet seen); cannot complete questionnaires unaided or requires an interpreter; currently receiving CBT/other psychotherapy; received high-intensity CBT in the past four years; participating in another intervention trial; unwilling/unable to receive CBT via computer/laptop/smartphone. Eligible participants will be randomised to integrated CBT or usual care. Integrated CBT utilises the standard Beckian intervention for depression and comprises nine live therapist-led sessions, with (up to) a further three if clinically appropriate. The first session is 60-90 min via videocall, with subsequent 50-min sessions delivered online, using instant messaging. Participants allocated integrated CBT can access integrated online CBT resources (worksheets/information sheets/videos) within and between sessions. Outcome assessments at 3-, 6-, 9- and 12-month post-randomisation. The primary outcome is the Beck Depression Inventory (BDI-II) score at 6 months (as a continuous variable). A nested qualitative study and health economic evaluation will be conducted. DISCUSSION: If clinically and cost-effective, this model of integrated CBT could be introduced into existing psychological services, increasing access to, and equity of, CBT provision. TRIAL REGISTRATION: ISRCTN, ISRCTN13112900. Registered on 11/11/2020. Currently recruiting participants. Trial registration data are presented in Table 1.

Current state of the evidence on community treatments for people with complex emotional needs: a scoping review.

BACKGROUND: Improving the quality of care in community settings for people with 'Complex Emotional Needs' (CEN-our preferred working term for services for people with a "personality disorder" diagnosis or comparable needs) is recognised internationally as a priority. Plans to improve care should be rooted as far as possible in evidence. We aimed to take stock of the current state of such evidence, and identify significant gaps through a scoping review of published investigations of outcomes of community-based psychosocial interventions designed for CEN. METHODS: We conducted a scoping review with systematic searches. We searched six bibliographic databases, including forward and backward citation searching, and reference searching of relevant systematic reviews. We included studies using quantitative methods to test for effects on any clinical, social, and functioning outcomes from community-based interventions for people with CEN. The final search was conducted in November 2020. RESULTS: We included 226 papers in all (210 studies). Little relevant literature was published before 2000. Since then, publications per year and sample sizes have gradually increased, but most studies are relatively small, including many pilot or uncontrolled studies. Most studies focus on symptom and self-harm outcomes of various forms of specialist psychotherapy: most result in outcomes better than from inactive controls and similar to other specialist psychotherapies. We found large evidence gaps. Adaptation and testing of therapies for significant groups (e.g. people with comorbid psychosis, bipolar disorder, post-traumatic stress disorder, or substance misuse; older and younger groups; parents) have for the most part only reached a feasibility testing stage. We found little evidence regarding interventions to improve social aspects of people's lives, peer support, or ways of designing effective services. CONCLUSIONS: Compared with other longer term mental health problems that significantly impair functioning, the evidence base on how to provide high quality care for people with CEN is very limited. There is good evidence that people with CEN can be helped when specialist therapies are available and when they are able to engage with them. However, a much more methodologically robust and substantial literature addressing a much wider range of research questions is urgently needed to optimise treatment and support across this group.

Experiences of frontline healthcare workers and their views about support during COVID-19 and previous pandemics: a systematic review and qualitative meta-synthesis.

BACKGROUND: Healthcare workers across the world have risen to the demands of treating COVID-19 patients, potentially at significant cost to their own health and wellbeing. There has been increasing recognition of the potential mental health impact of COVID-19 on frontline workers and calls to provide psychosocial support for them. However, little attention has so far been paid to understanding the impact of working on a pandemic from healthcare workers' own perspectives or what their views are about support. METHODS: We searched key healthcare databases (Medline, PsychINFO and PubMed) from inception to September 28, 2020. We also reviewed relevant grey literature, screened pre-print servers and hand searched reference lists of key texts for all published accounts of healthcare workers' experiences of working on the frontline and views about support during COVID-19 and previous pandemics/epidemics. We conducted a meta-synthesis of all qualitative results to synthesise findings and develop an overarching set of themes and sub-themes which captured the experiences and views of frontline healthcare workers across the studies. RESULTS: This review identified 46 qualitative studies which explored healthcare workers' experiences and views from pandemics or epidemics including and prior to COVID-19. Meta-synthesis derived eight key themes which largely transcended temporal and geographical boundaries. Participants across all the studies were deeply concerned about their own and/or others' physical safety. This was greatest in the early phases of pandemics and exacerbated by inadequate Personal Protective Equipment (PPE), insufficient resources, and inconsistent information. Workers struggled with high workloads and long shifts and desired adequate rest and recovery. Many experienced stigma. Healthcare workers' relationships with families, colleagues, organisations, media and the wider public were complicated and could be experienced concomitantly as sources of support but also sources of stress. CONCLUSIONS: The experiences of healthcare workers during the COVID-19 pandemic are not unprecedented; the themes that arose from previous pandemics and epidemics were remarkably resonant with what we are hearing about the impact of COVID-19 globally today. We have an opportunity to learn from the lessons of previous crises, mitigate the negative mental health impact of COVID-19 and support the longer-term wellbeing of the healthcare workforce worldwide.

Experiences of mental health professionals supporting front-line health and social care workers during COVID-19: qualitative study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic is having a well-documented impact on the mental health of front-line health and social care workers (HSCWs). However, little attention has been paid to the experiences of, and impact on, the mental health professionals who were rapidly tasked with supporting them. AIMS: We set out to redress this gap by qualitatively exploring UK mental health professionals' experiences, views and needs while working to support the well-being of front-line HSCWs during the COVID-19 pandemic. METHOD: Mental health professionals working in roles supporting front-line HSCWs were recruited purposively and interviewed remotely. Transcripts of the interviews were analysed by the research team following the principles of reflexive thematic analysis. RESULTS: We completed interviews with 28 mental health professionals from varied professional backgrounds, career stages and settings across the UK. Mental health professionals were motivated and driven to develop new clinical pathways to support HSCWs they perceived as colleagues and many experienced professional growth. However, this also came at some costs, as they took on additional responsibilities and increased workloads, were anxious and uncertain about how best to support this workforce and tended to neglect their own health and well-being. Many were professionally isolated and were affected vicariously by the traumas and moral injuries that healthcare workers talked about in sessions. CONCLUSIONS: This research highlights the urgent need to consider the mental well-being, training and support of mental health professionals who are supporting front-line workers.