Trauma-focused therapy in early psychosis: results of a feasibility randomized controlled trial of EMDR for psychosis (EMDRp) in early intervention settings.

BACKGROUND: Trauma is prevalent amongst early psychosis patients and associated with adverse outcomes. Past trials of trauma-focused therapy have focused on chronic patients with psychosis/schizophrenia and comorbid Post-Traumatic Stress Disorder (PTSD). We aimed to determine the feasibility of a large-scale randomized controlled trial (RCT) of an Eye Movement Desensitization and Reprocessing for psychosis (EMDRp) intervention for early psychosis service users. METHODS: A single-blind RCT comparing 16 sessions of EMDRp + TAU v. TAU only was conducted. Participants completed baseline, 6-month and 12-month post-randomization assessments. EMDRp and trial assessments were delivered both in-person and remotely due to COVID-19 restrictions. Feasibility outcomes were recruitment and retention, therapy attendance/engagement, adherence to EMDRp treatment protocol, and the 'promise of efficacy' of EMDRp on relevant clinical outcomes. RESULTS: Sixty participants (100% of the recruitment target) received TAU or EMDR + TAU. 83% completed at least one follow-up assessment, with 74% at 6-month and 70% at 12-month. 74% of EMDRp + TAU participants received at least eight therapy sessions and 97% rated therapy sessions demonstrated good treatment fidelity. At 6-month, there were signals of promise of efficacy of EMDRp + TAU v. TAU for total psychotic symptoms (PANSS), subjective recovery from psychosis, PTSD symptoms, depression, anxiety, and general health status. Signals of efficacy at 12-month were less pronounced but remained robust for PTSD symptoms and general health status. CONCLUSIONS: The trial feasibility criteria were fully met, and EMDRp was associated with promising signals of efficacy on a range of valuable clinical outcomes. A larger-scale, multi-center trial of EMDRp is feasible and warranted.

Youth Culturally adapted Manual Assisted Problem Solving Training (YCMAP) in Pakistani adolescent with a history of self-harm: protocol for multicentre clinical and cost-effectiveness randomised controlled trial.

INTRODUCTION: Suicide is a global health concern. Sociocultural factors have an impact on self-harm and suicide rates. In Pakistan, both self-harm and suicide are considered as criminal offence's and are condemned on both religious and social grounds. The proposed intervention 'Youth Culturally Adapted Manual Assisted Problem Solving Training (YCMAP)' is based on principles of problem-solving and cognitive-behavioural therapy. YCMAP is a brief, culturally relevant, scalable intervention that can be implemented in routine clinical practice if found to be effective. METHOD AND ANALYSIS: A multicentre rater blind randomised controlled trial to evaluate the clinical and cost-effectiveness of YCMAP including a sample of 652 participants, aged 12-18 years, presenting to general physicians/clinicians, emergency room after self harm or self referrals. We will test the effectiveness of 8-10 individual sessions of YCMAP delivered over 3 months compared with treatment as usual. Primary outcome measure is repetition of self-harm at 12 months. The seconday outcomes include reduction in suicidal ideation, hopelessness and distress and improvement in health related quality of life. Assessments will be completed at baseline, 3, 6, 9 and 12 months postrandomisation. The nested qualitative component will explore perceptions about management of self-harm and suicide prevention among adolescents and investigate participants' experiences with YCMAP. The study will be guided by the theory of change approach to ensure that the whole trial is centred around needs of the end beneficiaries as key stakeholders in the process. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Ethics Committee of University of Manchester, the National Bioethics Committee in Pakistan. The findings of this study will be disseminated through community workshops, social media, conference presentations and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04131179.

Eye movement desensitization and reprocessing therapy for psychosis (EMDRp): Protocol of a feasibility randomized controlled trial with early intervention service users.

AIM: Traumatic events are involved in the development and maintenance of psychotic symptoms. There are few trials exploring trauma-focused treatments as interventions for psychotic symptoms, especially in individuals with early psychosis. This trial will evaluate the feasibility and acceptability of conducting a definitive trial of Eye Movement Desensitization and Reprocessing for psychosis (EMDRp) in people with early psychosis. METHODS: Sixty participants with first episode psychosis and a history of a traumatic/adverse life event(s)will be recruited from early intervention services in the North West of England and randomized to receive16 sessions of EMDRp + Treatment as Usual (TAU) or TAU alone. Participants will be assessed at baseline, 6 and 12 months post-randomization using several measures of psychotic symptoms, trauma symptoms, anxiety, depression, functioning, service-user defined recovery, health economics indicators and quality of life. Two nested qualitative studies to assess participant feedback of therapy and views of professional stakeholders on the implementation of EMDRp into services will also be conducted. The feasibility of a future definitive efficacy and cost-effectiveness evaluation of EMDRp will be tested against several outcomes, including ability to recruit and randomize participants, trial retention at 6- and 12-month follow-up assessments, treatment engagement and treatment fidelity. CONCLUSIONS: If it is feasible to deliver a multi-site trial of this intervention, it will be possible to evaluate whether EMDRp represents a beneficial treatment to augment existing evidence-based care of individuals with early psychosis supported by early intervention services.

Recruitment strategies for British South Asians in 5 depression trials: A mixed method study.

BACKGROUND: In the United Kingdom, ethnic minority group's particularly British South Asian women have higher rates of depression than their white counterparts. Despite this they remain under represented in mental health trials. Whilst the US legislation mandates the inclusion of ethnic minorities into research, there are no similar initiatives in the UK. Barriers in recruiting these hard to reach ethnic groups are cited as major reasons behind this under representation. Once these barriers are encountered it becomes a challenge for the researchers to overcome them. As there is paucity of research in this specific area through this paper we want to share our strategies in recruiting British South Asians thus encouraging other researchers to consider ethnic minority inclusion into research. METHODS: Our published systematic review on the barriers to recruitment of ethnic minority participants into mental health research developed a typology of thirty three ethnic recruitment barriers described under five themes. We aimed to find strategies to overcome these barriers from five depression trials for British South Asians conducted by our research group. Firstly we extracted data on recruitment strategies from the published papers. Later researchers involved in these five trials formed a working group to add to these extracted strategies. Finally these strategies were matched to the individual barriers described in the typology. RESULTS: Multiple recruitment strategies were described by the researchers. These strategies were matched to all but two recruitment barriers related to psychopathology/substance misuse by the participants and paucity of healthcare related resources. Multiple strategies were found to be effective against each barrier and appropriate ones could be selected by the researchers after considering available resources at hand. CONCLUSIONS: Findings from this paper have implications for the design of recruitment strategies for hard to recruit ethnic minority groups to health care research. There is need for wider training and support of researchers to give them the skills to recruit these ethnic groups. Further development and evaluation of these strategies will lead to increased recruitment accruals.

Development and evaluation of culturally sensitive psychosocial interventions for under-served people in primary care.

BACKGROUND: Psychological therapy is effective for symptoms of mental distress, but many groups with high levels of mental distress face significant barriers in terms of access to care, as current interventions may not be sensitive to their needs or their understanding of mental health. There is a need to develop forms of psychological therapy that are acceptable to these groups, feasible to deliver in routine settings, and clinically and cost effective. METHODS: We developed a culturally sensitive wellbeing intervention with individual, group and sign-posting elements, and tested its feasibility and acceptability for patients from ethnic minorities and older people in an exploratory randomised trial. RESULTS: We recruited 57 patients (57% of our target) from 4 disadvantaged localities in the NW of England. The results of the exploratory trial suggest that the group receiving the wellbeing interventions improved compared to the group receiving usual care. For elders, the largest effects were on CORE-OM and PHQ-9. For ethnic minority patients, the largest effect was on PHQ-9. Qualitative data suggested that patients found the intervention acceptable, both in terms of content and delivery. CONCLUSIONS: This exploratory trial provides some evidence of the efficacy and acceptability of a wellbeing intervention for older and ethnic minority groups experiencing anxiety and depression, although challenges in recruitment and engagement remain. Evidence from our exploratory study of wellbeing interventions should inform new substantive trial designs. TRIAL REGISTRATION: Current controlled trials ISRCTN68572159.

Patients' views of antidepressants: from first experiences to becoming expert.

BACKGROUND: The majority of patients discontinue antidepressant treatment earlier than prescribed. The factors behind this and the influences on patients' choices about whether to take medication remain poorly understood. AIM: To explore factors that influence patients' decisions about taking antidepressant medication. DESIGN OF STUDY: Qualitative interview study. SETTING: Interviews were conducted across three sites: London, East Lancashire, and North East England. METHOD: Semi-structured interviews were conducted with a purposive sample of 65 primary care patients who were prescribed antidepressants in the past year for depression or mixed anxiety/depression. RESULTS: Participants described their first course of antidepressants as typically occurring when they had 'hit rock bottom', having exhausted all other possibilities; therefore, there was little sense of a positive choice at this stage. There would typically follow a period of experimentation where it was usual to stop and restart medication, often several times. Ultimately, these recurring cycles lead to participants becoming more expert about their condition and better able to make an informed decision about medication. For younger participants, recovery typically remained a goal, although for older people there was often an acceptance that their condition, and medication use, would be long term. CONCLUSION: Participants' accounts demonstrated how they could become expert at managing their condition through a process of trial and error.

Access to primary mental health care for hard-to-reach groups: from 'silent suffering' to 'making it work'.

Equitable access to primary care for people with common mental health problems in the UK remains problematic. The experiences of people from hard-to-reach groups offer important insights into barriers to accessing care. In this study, we report on secondary analysis of qualitative data generated within seven previously-reported studies. Thirty-three of ninety-two available transcripts were re-analysed using a new heuristic of access, generated to frame narrative-based comparative case analysis. The remaining transcripts were used to triangulate the findings via a process of collaborative analysis between a secondary researcher, naïve to research findings of the original studies, and primary researchers involved in data generation and analysis within the original studies. This method provided a rich body of 'fine grain' insights into the ways in which problem formulation, help-seeking, use of services and perceptions of service quality are interlinked in a recursive and socially embedded matrix of inequitable access to primary mental health care. The findings indicate both extensive commonalities between experiences of people from different 'hard-to-reach groups', and considerable diversity within each group. An idiographic generalisation and aggregation of this variety of experiences points to one main common facilitator (communicated availability of acceptable mental health services) and two main common barriers (lack of effective information and multiple forms of stigma) to equitable access to primary mental health care. We conclude that there is a need to provide local care that is pluralistic, adaptive, holistic, resonant and socially conscious in order to ensure that equitable access to mental health services can become a reality.

Isolation, feeling 'stuck' and loss of control: understanding persistence of depression in British Pakistani women.

BACKGROUND: Persistent depression is more commonly experienced by British Pakistani women. The processes by which this results in an experience of chronic depression are not well understood. METHODS: Qualitative thematic analysis of 15 in-depth interviews with British Pakistani women being treated for depression in primary care, collected in the process of a larger three-centre research project to explore experience of depression and its treatment (the QUEST-D study) in England. RESULTS: Three key overlapping themes emerged: a) 'feeling stuck'--for many of the women, the persistence of depression was experienced as inescapable because it was related to family conflict that seemed impossible to resolve; b) 'isolation'--which might be externally determined by social and cultural factors but also in some cases appeared to be self-imposed; c) 'control'--issues related to loss of a sense of control in depression, and attempts to regain it. LIMITATIONS: The study was carried out in only one area of the United Kingdom, East Lancashire. It formed part of a larger study to explore views of treatment, and there were therefore limited opportunities for further development of some of the themes that have subsequently emerged in this secondary analysis of the data. CONCLUSIONS: Psychological therapy for this population needs to be tailored to specific needs by identifying and addressing both the underlying cause(s) and the specific consequences of depression and associated social isolation for each individual person.

Social intervention for British Pakistani women with depression: randomised controlled trial.

BACKGROUND: British Pakistani women have a high prevalence of depression. There are no reported psychosocial interventions for depression in ethnic minorities in the UK. AIMS: To determine the efficacy of a social group intervention compared with antidepressants, and whether the combination of the two is more efficacious than either alone. METHOD: A total of 123 women with depression participated in the primary care-based cluster randomised controlled trial (ISRCTN19172148). Outcome measures were severity of depression (Hamilton Rating Scale for Depression), social functioning and satisfaction at 3 and 9 months. RESULTS: Greater improvement in depression in the social intervention group and the combined treatment group compared with those receiving antidepressants alone fell short of significance. There was significantly greater improvement in social functioning in the social intervention and combined treatment groups than in the antidepressant group at both 3 and 9 months. CONCLUSIONS: Pakistani women with depression found the social groups acceptable and their social function and satisfaction improved if they received social treatment compared with the receipt of antidepressants alone.

Researching the mental health needs of hard-to-reach groups: managing multiple sources of evidence.

BACKGROUND: Common mental health problems impose substantial challenges to patients, carers, and health care systems. A range of interventions have demonstrable efficacy in improving the lives of people experiencing such problems. However many people are disadvantaged, either because they are unable to access primary care, or because access does not lead to adequate help. New methods are needed to understand the problems of access and generate solutions. In this paper we describe our methodological approach to managing multiple and diverse sources of evidence, within a research programme to increase equity of access to high quality mental health services in primary care. METHODS: We began with a scoping review to identify the range and extent of relevant published material, and establish key concepts related to access. We then devised a strategy to collect - in parallel - evidence from six separate sources: a systematic review of published quantitative data on access-related studies; a meta-synthesis of published qualitative data on patient perspectives; dialogues with local stakeholders; a review of grey literature from statutory and voluntary service providers; secondary analysis of patient transcripts from previous qualitative studies; and primary data from interviews with service users and carers.We synthesised the findings from these diverse sources, made judgements on key emerging issues in relation to needs and services, and proposed a range of potential interventions. These proposals were debated and refined using iterative electronic and focus group consultation procedures involving international experts, local stakeholders and service users. CONCLUSIONS: Our methods break new ground by generating and synthesising multiple sources of evidence, connecting scientific understanding with the perspectives of users, in order to develop innovative ways to meet the mental health needs of under-served groups.