Liraglutide and the management of overweight and obesity in people with severe mental illness: qualitative sub-study.

BACKGROUND: People with severe mental illness are two to three times more likely to be overweight or have obesity than the general population and this is associated with significant morbidity and premature mortality. Liraglutide 3 mg is a once daily injectable GLP-1 receptor agonist that is licensed for the treatment of obesity in the general population and has the potential to be used in people with severe mental illness. AIMS: To record the expectations and experiences of people with schizophrenia, schizoaffective disorders or first episode psychosis taking daily liraglutide 3 mg injections in a clinical trial for the treatment of obesity. To seek the views of healthcare professionals about the feasibility of delivering the intervention in routine care. METHODS: Qualitative interviews were undertaken with a purposive sub-sample of people with schizophrenia, schizoaffective disorders or first episode psychosis with overweight or obesity who were treated with a daily injection of liraglutide 3 mg in a double-blinded, randomised controlled pilot study evaluating the use of liraglutide for the treatment of obesity. Interviews were also conducted with healthcare professionals. RESULTS: Seventeen patient participants were interviewed. Sixteen took part in the baseline interview, eight completed both baseline and follow-up interviews, and one took part in follow-up interview only. Mean interview duration was thirteen minutes (range 5-37 min). Despite reservations by some participants about the injections before the study, most of those who completed the trial reported no challenges in the timing of or administering the injections. Key themes included despondency regarding prior medication associated weight gain, quality of life impact of weight loss, practical aspects of participation including materials received and clinic attendance. Healthcare professionals reported challenges with recruitment, however, overall it was a positive experience for them and for participants. CONCLUSION: Liraglutide appears to be an acceptable therapy for obesity in this population with limited side effects. The quality of life benefits realised by several intervention participants reinforce the biomedical benefits of achieved weight loss.

'Waiting for the verdict': the experience of being assessed under the Mental Health Act.

BACKGROUND: Following the Independent Mental Health Act review, there is increasing focus on this coercive part of mental health services and a call for service user views to be central to proposed changes. Although there are numerous studies into being detained in hospital, there is a lack of data exploring the service user experiences of the assessment process. AIM: To explore the subjective experience of being assessed under the Mental Health Act (MHA). METHOD: 10 participants were interviewed about their recent assessment experience and the transcribed interviews were analysed using framework approach. RESULTS: The overarching theme of person centred care emerged from these interviews with interconnecting sub themes: 1) information and options; 2) "the barrage of three"; 3) "sit down and listen"; and 4) service user voice. CONCLUSION: As one of the first studies into service user experiences of MHA assessments, this exploratory study indicates that there is lack of person centeredness. The Independent Mental Health Act review has set a challenge for treating person as individual and increasing rights and involvement of service users. This study suggests service user's experiences do not yet meet this aspiration and they want to discuss these experiences and have their voices heard.

The use of liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis: Results of a pilot randomized, double-blind, placebo-controlled trial.

AIM: To investigate the feasibility and acceptability of using liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis. MATERIALS AND METHODS: A double-blind, randomized, placebo-controlled pilot trial took place in mental health centres and primary care within Southern Health NHS Foundation Trust. The participants were adults with schizophrenia, schizoaffective or first-episode psychosis prescribed antipsychotic medication who were overweight or obese. The intervention was once-daily subcutaneous liraglutide or placebo, titrated to 3.0 mg daily, for 6 months. The primary outcomes were recruitment, consent, retention and adherence. The secondary exploratory outcomes were weight, HbA1c and Brief Psychiatric Rating Scale. RESULTS: Seven hundred and ninety-nine individuals were screened for eligibility. The most common reasons for exclusion were ineligibility (44%) and inability to make contact (28%). The acceptance rate, as a proportion of all eligible participants, was 12.2%. The most commonly stated reason why eligible candidates declined to participate related to the study-specific medication and protocol (n = 50). Forty-seven participants were randomized, with 79% completing the trial. Participants in the liraglutide arm lost a mean 5.7 ± 7.9 kg compared with no significant weight change in the placebo group (treatment difference -6.0 kg, p = .015). Body mass index, waist circumference and HbA1c were reduced in the intervention group. CONCLUSIONS: This study supports the need for a larger randomized controlled trial to evaluate the use of liraglutide (maximum dose 3.0 mg daily) in the management of obesity in people with severe mental illness.

Lessons from an evaluation of major change in adult mental health services: effects on quality.

BACKGROUND: The move from inpatient to community services in mental health has sparked debate internationally but the evidence base for successful service models is sparse. AIM: To evaluate the impact of bed reduction on quality of services when accompanied by redesign of community services. METHODS: Qualitative and quantitative data were collected 6 months before and 6 months after the redesign was implemented. RESULTS: Bed numbers reduced by 35%. Number of admissions and occupied bed days (OBD) reduced; bed occupancy and proportion of detained patients increased. Access to community services improved but quality of assessments did not. Transitions across pathways were rated as difficult by clinicians. There was an overall reduction in staff numbers; staff sickness levels and dissatisfaction with working conditions increased. Service users were generally positive about the redesign but GPs and staff were not. CONCLUSIONS: Multi-faceted evaluation of change in cost-pressured services is feasible and should guide developments to minimise negative effects on quality of care.

Evaluation of telepsychiatry during the COVID-19 pandemic across service users, carers and clinicians: an international mixed-methods study.

BACKGROUND: Worldwide uptake of telepsychiatry accelerated during the COVID-19 pandemic. OBJECTIVE: To conduct an evaluation of the opinions, preferences and attitudes to telepsychiatry from service users, carers and clinicians in order to understand how telepsychiatry can be best used in the peri/post-COVID-19 era. METHODS: This mixed-methods, multicentre, international study of telepsychiatry was set in two sites in England and two in Italy. Survey questionnaires and focus group topic guides were co-produced for each participant group (service users, carers and clinicians). FINDINGS: In the UK, 906 service users, 117 carers and 483 clinicians, and in Italy, 164 service users, 56 carers and 72 clinicians completed the surveys. In all, 17 service users/carers and 14 clinicians participated in focus groups. Overall, telepsychiatry was seen as convenient in follow-ups with a specific purpose such as medication reviews; however, it was perceived as less effective for establishing a therapeutic relationship or for assessing acutely disturbed mental states. In contrast to clinicians, most service users and carers indicated that telepsychiatry had not improved during the COVID-19 pandemic. Most service users and carers reported that the choice of appointment modality was most often determined by the service or clinician. CONCLUSION AND RELEVANCE: There were circumstances in which telepsychiatry was seen as more suitable than others and clear differences in clinician, carer and service user perspectives on telepsychiatry. CLINICAL IMPLICATIONS: All stakeholders should be actively engaged in determining a hybrid model of care according to clinical features and service user and carer preferences. Clinicians should be engaged in training programmes on telepsychiatry.

Reasons for illicit drug use in people with schizophrenia: Qualitative study.

BACKGROUND: Drug misuse is an important clinical problem associated with a poorer outcome in patients who have a diagnosis of schizophrenia. Qualitative studies have rarely been used to elicit reasons for drug use in psychosis, but not in schizophrenia. METHODS: Seventeen people with a diagnosis of schizophrenia and who had used street drugs were interviewed and asked to describe, in narrative form, their street drug use from their early experiences to the present day. Grounded theory was used to analyse the transcripts. RESULTS: We identified five reasons for continuing street drug use. The reasons were: as an 'identity defining vocation', 'to belong to a peer group', due to 'hopelessness', because of 'beliefs about symptoms and how street drugs influence them' and viewing drugs as 'equivalent to taking psychotropic medication'. Street drugs were often used to reduce anxiety aroused by voice hearing. Some participants reported street drugs to focus their attention more on persecutory voices in the hope of outwitting their perceived persecutors. CONCLUSIONS: It would be clinically useful to examine for the presence of the five factors in patients who have a diagnosis of schizophrenia and use street drugs, as this is likely to help the clinician to tailor management of substance misuse to the individual patient's beliefs.

Results of a prospective, mixed methods study to assess feasibility, acceptability and effectiveness of TRIumPH (Treatment and Recovery In PsycHosis): an integrated care pathway for psychosis, compared to usual treatment.

OBJECTIVES: To evaluate whether a newly developed care pathway, Treatment and Recovery In PsycHosis (TRIumPH), is feasible, acceptable and effective in meeting National Institute of Health and Care Excellence (NICE) quality standards in a timely manner. METHODS: This is a pragmatic, non-randomised, prospective, mixed methods study comparing an implementation (TRIumPH) and comparator site (not implementing TRIumPH) across three cohorts to assess feasibility, acceptability and effectiveness of the integrated pathway. SETTING: Early intervention in psychosis (EIP) services at two National Health Service organisations in South of England. PARTICIPANTS: All patients accepted into EIP services between 1 June 2014 and 31 May 2017 were each followed up for 1 year within their respective cohorts. METHODOLOGY: Quantitative data consisted of routinely collected clinical data retrieved from patient records to assess whether the implementation of TRIumPH achieved better concordance to NICE standards. These included time to access services, physical health assessments, clinical outcomes based timeliness of delivery and acute data. The controlled trial has evaluated the effect of TRIumPH (Intervention) with Care As Usual (Comparator). Qualitative measures consisted of questionnaires, interviews and focus groups to assess acceptability and satisfaction. Outcome measures were compared within the baseline, year 1 and year 2 cohorts and between the two sites. Quantitative data were statistically analysed by comparing means and proportions. RESULTS: Time to assessment improved in the implementation site and remained within the target in comparator site. Meeting of quality standards increased substantially in the implementation site but was more variable and reached lower levels in the comparator site especially for physical health standards. Cognitive therapy for psychosis, family intervention and carer and employment support were all offered to a greater extent in the implementation site and uptake increased over the period. CONCLUSIONS: Pathway implementation generally led to greater improvements in achievement of access and quality standards compared with comparator site. TRIAL REGISTRATION NUMBER: UK Clinical Research Network Portfolio (19187).

Liraglutide and the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first-episode psychosis: protocol for a pilot trial.

BACKGROUND: People with severe mental illness (SMI) are two to three times more likely to be overweight and obese than the general population and this is associated with significant morbidity and premature mortality. Although lifestyle interventions can support people with SMI to lose weight, some are unable to make the necessary lifestyle changes or, despite making the changes, continue to gain weight. OBJECTIVE: To assess the feasibility and acceptability of delivering a full-scale trial evaluating whether liraglutide 3.0 mg, a once-daily injectable therapy, may be an effective treatment of overweight and obesity in people with schizophrenia, schizoaffective disorder and first-episode psychosis. METHODS: Design: a single-centre, double-blind, randomised, placebo-controlled trial. SETTING: mental health facilities within Southern Health NHS Trust. PARTICIPANTS: 60 adults with schizophrenia, schizoaffective or first-episode psychosis prescribed antipsychotic medication will be recruited. Participants will be overweight or obese, defined by their baseline BMI which will be: • BMI ≥ 30 kg/m2 or • BMI ≥ 27 kg/m2 to < 30 kg/m2 in the presence of at least one weight-related consequence. This is in concordance with the current EU licence for liraglutide (maximum dosage 3.0 mg). INTERVENTION: participants will be allocated in a 1:1 ratio using a computer-based randomisation programme to either once-daily subcutaneously administered liraglutide or placebo, titrated to 3.0 mg daily, for 6 months. All participants will receive standardised written information about healthy eating and exercise at their randomisation visit. OUTCOMES: the main aim of the study is to gather data on recruitment, consent, retention and adherence. Qualitative interviews with a purposive sub-sample of participants and healthcare workers will provide data on intervention feasibility and acceptability. Secondary clinical outcome measurements will be assessed at 3 and 6 months and will include: weight, fasting plasma glucose, lipid profile, HbA1c level; and the Brief Psychiatric Rating Scale. DISCUSSION: This study should provide evidence of the potential benefits of liraglutide (maximum dosage 3.0 mg daily) on body weight and metabolic variables in people with schizophrenia, schizoaffective disorder and first-episode psychosis. It will also address the feasibility and acceptability of the use of liraglutide in mental health settings. This will inform the design of a longer outcome study that will be needed to determine whether any weight loss can be maintained in the long term. TRIAL REGISTRATION: Universal Trial Number (UTN), ID: U1111-1203-0068. Registered on on 2/10/2017. European Clinical Trials Database (EudraCT), ID: 2017-004064-35. Registered on 3/10/2017.

Protocol for a multicentre study to assess feasibility, acceptability, effectiveness and direct costs of TRIumPH (Treatment and Recovery In PsycHosis): integrated care pathway for psychosis.

INTRODUCTION: Duration of untreated psychosis (time between the onset of symptoms and start of treatment) is considered the strongest predictor of symptom severity and outcome. Integrated care pathways that prescribe timeframes around access and interventions can potentially improve quality of care. METHODS AND ANALYSIS: A multicentre mixed methods study to assess feasibility, acceptability, effectiveness and analysis of direct costs of an integrated care pathway for psychosis. A pragmatic, non-randomised, controlled trial design is used to compare the impact of Treatment and Recovery In PsycHosis (TRIumPH; Intervention) by comparison between NHS organisations that adopt TRIumPH and those that continue with care as usual (Control). Quantitative and qualitative methods will be used. We will use routinely collected quantitative data and study-specific questionnaires and focus groups to compare service user outcomes, satisfaction and adherence to intervention between sites that adopt TRIumPH versus sites that continue with usual care pathways. SETTING: 4 UK Mental health organisations. Two will implement TRIumPH whereas two will continue care as usual. PARTICIPANTS: Staff, carers, individuals accepted to early intervention in psychosis teams in participating organisations for the study period. INTERVENTION: TRIumPH-Integrated Care Pathway for psychosis that has a holistic approach and prescribes time frames against interventions; developed using intelligence from data; co-produced with patients, carers, clinicians and other stakeholders. OUTCOMES: Feasibility will be assessed through adherence to the process measures. Satisfaction and acceptability will be assessed using questionnaires and focus groups. Effectiveness will be assessed through data collection and evaluation of patient outcomes, including clinical, functional and recovery outcomes, physical health, acute care use. Outcome measures will be assessed at baseline, 12 and 24 months to measure whether there is an effect and if so, whether this is sustained over time. Outcomes measures at the adopter sites will be compared to their own baseline and against comparator sites. ETHICS AND DISSEMINATION: Ethics approval was obtained from East of Scotland Research Ethics Service (REC Ref no: LR/15/ES/0091). The results will be disseminated through publications, conference presentations, reports to the organisation. STUDY REGISTRATION: UK Clinical Research Network Portfolio: 19187.