Multicentre randomised controlled trial of a group psychological intervention for postnatal depression in British mothers of South Asian origin (ROSHNI-2): study protocol

Background: In the UK, postnatal depression is more common in British SouthAsian women than White Caucasion women. Cognitive–behavioural therapy (CBT) is recommended as a first-line treatment, but there is little evidence for the adaptation of CBT for postnatal depression to ensure its applicability to different ethnic groups.Aims: To evaluate the clinical and cost-effectiveness of a CBT-based positive health programme group intervention in British South Asian women with postnatal depression.Method: We have designed a multicentre, two-arm, partially nested, randomised controlled trial with 4- and 12-month follow-up, comparing a 12-session group CBT-based intervention (positive health programme) plus treatment as usual with treatment as usual alone, for British South Asian women with postnatal depression. Participants will be recruited from primary care and appropriate community venues in areas of high South Asian density across the UK. It has been estimated that randomising 720 participants (360 into each group) will be sufficient to detect a clinically important difference between a 55% recovery rate in the intervention group and a 40% recovery rate in the treatmentas-usual group. An economic analysis will estimate the costeffectiveness of the positive health programme. A qualitative process evaluation will explore barriers and enablers to study participation and examine the acceptability and impact of the programme from the perspective of British South Asian women and other key stakeholders

The long‐term impact of loneliness and social isolation on depression and anxiety in memory clinic attendees and their care partners: A longitudinal actor–partner interdependence model

Abstract Introduction This study examined the long‐term influence of loneliness and social isolation on mental health outcomes in memory assessment service (MAS) attendees and their care partners, with a focus on interdependence and bidirectionality. Methods Longitudinal data from 95 clinic attendees with cognitive impairment, and their care partners (dyads), from four MAS in the North of England were analyzed. We applied the actor–partner interdependence model, seeking associations within the dyad. At baseline and 12‐month follow‐up, clinic attendees and care partners completed measures of loneliness and social isolation, depression, and anxiety. Results Social isolation at baseline was more prevalent in care partners compared to MAS attendees. Social isolation in MAS attendees was associated with higher anxiety symptoms (β = 0.28, 95% confidence intervals [CIs] = 0.11 to 0.45) in themselves at 12 months. We found significant positive actor and partner effects of loneliness on depression (actor effect: β = 0.36, 95% CIs = 0.19 to 0.53; partner effect: β = 0.23, 95% CIs = 0.06 to 0.40) and anxiety (actor effect: β = 0.39, 95% CIs = 0.23 to 0.55; partner effect: β = 0.22, 95% CIs = 0.05 to 0.39) among MAS attendees 1 year later. Loneliness scores of the care partners have a significant and positive association with depressive (β = 0.36, 95% CIs = 0.19 to 0.53) and anxiety symptoms (β = 0.32, 95% CIs = 0.22 to 0.55) in themselves at 12 months. Discussion Loneliness and social isolation in MAS clinic attendees had a downstream effect on their own and their care partners’ mental health. This highlights the importance of including care partners in assessments of mental health and social connectedness and expanding the remit of social prescribing in the MAS context

Exploratory RCT of a group psychological intervention for postnatal depression in British mothers of South Asian origin – ROSHNI-D

Background: Postnatal depression (PND) is a global public health problem. There is a high prevalence of PND amongst ethnic minority women and major ethnic inequalities in mental health care in the U.K. Language and cultural barriers pose a significant challenge for access to timely treatment and interventions for British South Asian (BSA) women with PND. Methods: The study, carried out in Manchester and Lancashire, England, was a two-arm single-blind exploratory randomised controlled trial. BSA women (N = 83) having a baby <12 months were randomised either to the group receiving the culturally adapted Positive Health Programme (PHP) (n = 42) or to the group receiving treatment as usual (TAU) (n = 41). Follow-up assessments were at 3 months (end of intervention) and 6 months after randomisation. Results: Using an intention to treat analysis, there was no significant difference between PHP intervention and TAU groups in depression measured using Hamilton Depression Rating Scale both at 3 and 6 months follow up. Using modified intention to treat analysis, women who attended four or more sessions showed significant reduction in depression in the PHP group compared to the TAU group and the greater number of sessions attended was associated with greater reductions in depression scores. Limitations: The sample was relatively small and the study was conducted in one geographical area in Northwest England; hence, these results may not be generalizable to other regions and populations. Conclusion: The recruitment and trial retention figures highlighted the ability of the research team to engage with BSA women, having implications in planning services for this group. Trial registration: Clinicaltrials.gov NCT01838889

Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: study protocol for a multi-site, assessor-blinded, pilot Umbrella trial (the DEC:IDES trial)

Background:A high proportion of patients diagnosed with schizophrenia-spectrum disorders will at some point in their lives be assessed as not having the capacity to make their own decisions about pharmacological treatment or inpatient care (‘capacity’). Few will be helped to regain it before these interventions proceed. This is partly because effective and safe methods to do so are lacking. Our aim is to accelerate their development by testing, for the first time in mental healthcare, the feasibility, acceptability and safety of running an ‘Umbrella’ trial. This involves running, concurrently and under one multi-site infrastructure, multiple assessor-blind randomised controlled trials, each of which are designed to examine the effect on capacity of improving a single psychological mechanism (‘mechanism’). Our primary objectives are to demonstrate feasibility of (i) recruitment and (ii) data retention on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T; planned primary outcome for a future trial) at end-of-treatment. We selected three mechanisms to test; ‘self-stigma’, low self-esteem and the ‘jumping to conclusions’ bias. Each is highly prevalent in psychosis, responsive to psychological intervention, and hypothesised to contribute to impaired capacity. Methods:Sixty participants with schizophrenia-spectrum diagnoses, impaired capacity, and one or more mechanism(s) will be recruited from outpatient and inpatient mental health services in three UK sites (Lothian, Scotland; Lancashire and Pennine, North West England). Those lacking capacity to consent to research could take part if key criteria were met, including either proxy consent (Scotland) or favourable Consultee advice (England). They will be allocated to one of three randomised controlled trials, depending on which mechanism(s) they have. They will then be randomised to receive, over an 8-week period and in addition to treatment as usual (TAU), 6 sessions of either a psychological intervention which targets the mechanism, or 6 sessions of assessment of the causes of their incapacity (control condition). Participants are assessed at 0 (baseline), 8 (end-of-treatment) and 24 (follow-up) weeks post-randomisation using measures of capacity (MacCAT-T), mechanism, adverse events, psychotic symptoms, subjective recovery, quality of life, service use, anxiety, core schemata, and depression. Two nested qualitative studies will be conducted; one to understand participant and clinician experiences, and one to investigate the validity of MacCAT-T appreciation ratings. Discussion:This will be the first Umbrella trial in mental healthcare. It will produce the first 3 single-blind randomised controlled trials of psychological interventions to support treatment decision-making in schizophrenia-spectrum disorder. Demonstrating feasibility will have significant implications not only for those seeking to support capacity in psychosis, but also those who wish to accelerate the development of psychological interventions for other conditions.Trial registration: ClinicalTrials.gov NCT04309435. Pre-registered on 16th March 2020.https://clinicaltrials.gov/ct2/show/NCT0430943

Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: a study protocol for a multi-site, assessor-blinded, pilot Umbrella trial (the DEC:IDES trial)

Abstract Background A high proportion of patients diagnosed with schizophrenia-spectrum disorders will at some point in their lives be assessed as not having the capacity to make their own decisions about pharmacological treatment or inpatient care (‘capacity’). Few will be helped to regain it before these interventions proceed. This is partly because effective and safe methods to do so are lacking. Our aim is to accelerate their development by testing, for the first time in mental healthcare, the feasibility, acceptability and safety of running an ‘Umbrella’ trial. This involves running, concurrently and under one multi-site infrastructure, multiple assessor-blind randomised controlled trials, each of which is designed to examine the effect on capacity of improving a single psychological mechanism (‘mechanism’). Our primary objectives are to demonstrate feasibility of (i) recruitment and (ii) data retention on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T; planned primary outcome for a future trial) at end-of-treatment. We selected three mechanisms to test: ‘self-stigma’, low self-esteem and the ‘jumping to conclusions’ bias. Each is highly prevalent in psychosis, responsive to psychological intervention, and hypothesised to contribute to impaired capacity. Methods Sixty participants with schizophrenia-spectrum diagnoses, impaired capacity and one or more mechanism(s) will be recruited from outpatient and inpatient mental health services in three UK sites (Lothian, Scotland; Lancashire and Pennine; North West England). Those lacking capacity to consent to research could take part if the key criteria were met, including either proxy consent (Scotland) or favourable Consultee advice (England). They will be allocated to one of three randomised controlled trials, depending on which mechanism(s) they have. They will then be randomised to receive, over an 8-week period and in addition to treatment as usual (TAU), 6 sessions of either a psychological intervention which targets the mechanism, or 6 sessions of assessment of the causes of their incapacity (control condition). Participants are assessed at 0 (baseline), 8 (end-of-treatment) and 24 (follow-up) weeks post-randomisation using measures of capacity (MacCAT-T), mechanism, adverse events, psychotic symptoms, subjective recovery, quality of life, service use, anxiety, core schemata and depression. Two nested qualitative studies will be conducted; one to understand participant and clinician experiences and one to investigate the validity of MacCAT-T appreciation ratings. Discussion This will be the first Umbrella trial in mental healthcare. It will produce the first 3 single-blind randomised controlled trials of psychological interventions to support treatment decision-making in schizophrenia-spectrum disorder. Demonstrating feasibility will have significant implications not only for those seeking to support capacity in psychosis, but also for those who wish to accelerate the development of psychological interventions for other conditions. Trial registration ClinicalTrials.gov NCT04309435 . Pre-registered on 16 March 2020