Mental Health Prevention and Promotion in General Practice Settings: A Protocol for a Feasibility Study

Background A reactive approach is typically taken when addressing and intervening with mental health problems rather than a proactive or preventative one, yet preventative approaches can also reduce mental ill-health. This study protocol aims to evaluate the feasibility of recruiting general practice patients into a randomised feasibility study where they will receive either mental health treatment as usual or a brief psychological intervention for preventing the deterioration of mental health and promoting emotional wellbeing. Methods This is a two-arm RCT, where participants will be randomised to either: treatment-as-usual within GP; or treatment-as-usual within GP plus a mental health prevention and promotion intervention. Sixty patients, aged 16+ from GP surgeries, with mild to moderate mental health difficulties as indicated by the PHQ9 and GAD7 will be recruited. Data on engagement with the intervention will be summarised using descriptive statistics. Regression models will be fitted, using the 12-week post-intervention follow-up data as the outcome variable and age, gender, trial arm and the corresponding baseline data as covariates. Cost-effectiveness will be investigated in an explorative way. Descriptive statistics will be used to analyse participant's resource use and HRQoL. Qualitative data will understand factors that facilitate or challenge the successful implementation of interventions and a process evaluation will provide insight into the intervention's mechanisms of action. Discussion The research team will progress from a feasibility RCT to a larger definitive RCT and disseminate widely across stakeholders (clinical, academic, service users, caregivers, Integrated Care Board (ICB) colleagues), ensuring accessibility in collaboration with the PPI committee

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

Culturally-adapted cognitive behavioural therapy based intervention for maternal depression: A mixed-methods feasibility study.

Abstract Background British Pakistanis are one of the largest ethnic minority groups living in the UK, with high rates of maternal depression being reported in this population. Evidence suggests that culturally-adapted Cognitive Behavioural Therapy (CBT)-based interventions for depression, may improve clinical outcomes and patient satisfaction. This study was conducted to develop and test the feasibility and acceptability of a culturally-adapted, CBT-based, manual-assisted intervention in British Pakistani mothers experiencing maternal depression. Methods A mixed-method feasibility study that included qualitative interviews followed by the development of a CBT-based intervention for mothers with mild to moderate depression. Following the qualitative interviews, a CBT-based intervention called the Positive Health Program (PHP) was developed and delivered consisting of 12-weekly sessions. A before and after design was used to explore the feasibility and acceptability of the Positive Health Programme. Results A culturally-adapted CBT-based group intervention (PHP) was acceptable to this group and improvements were reported in depression and health-related quality of life. The women’s understanding of ‘depression’ as a general consensus was in physical terms, but with an onset triggered by psychosocial causes. The most commonly reported factors contributing to depression were marital disharmony, lack of social support, and financial difficulties. Past help offered was primarily antidepressants, which were not welcomed by most of the women. A lack of availability of culturally sensitive interventions and the limited cultural sensitivity of NHS staff was also reported. Conclusion This study provides preliminary evidence for the feasibility and acceptability of a CBT-based culturally-adapted group psychological intervention for British Pakistani mothers. Trial registration Study ethics registration number: 10/H1005/62 (University of Manchester)

Group psychological intervention for postnatal depression: a nested qualitative study with British South Asian women.

BACKGROUND: Postnatal depression affects 10–15 % of all mothers in Western societies and remains a major public health concern for women from diverse cultures. British Pakistani and Indian women have a higher prevalence of depression in comparison to their white counterparts. Research has shown that culturally adapted interventions using Cognitive Behavioural Therapy (CBT) may be acceptable and may help to address the needs of this population. The aim of this study was to assess the acceptability and overall experience of the Positive Health Programme by British South Asian mothers. METHODS: This was a nested qualitative study, part of an exploratory randomized controlled trial (RCT) conducted to test the feasibility and acceptability of a culturally-adapted intervention (Positive Health Programme or PHP) for postnatal depression in British South Asian women. In-depth interviews (N = 17) were conducted to determine the views of the participants on the feasibility and acceptability of the intervention. RESULTS: The participants found the intervention acceptable and experienced an overall positive change in their attitudes, behaviour, and increased self-confidence. CONCLUSIONS: The findings suggest that the culturally adapted Positive Health Programme is acceptable to British South Asian women. These results support that culturally sensitive interventions may lead to better health outcomes and overall satisfaction. TRIAL REGISTRATION: Protocol registered on Clinicaltrials.gov NCT0183888

Maternal depression and the role of psychosocial intervention: Perception of community health workers in Pakistan

Low-income countries have a critical shortage of health professionals. In countries such as Pakistan, Community Health Workers (CHWs) can play an important role in improving access to healthcare services and hence improve health outcomes.To explore the efficacy of a training program; Learning Through Play Plus, a combination of Learning Through Play (LTP) and Thinking Healthy Program (THP) on knowledge and attitudes of CHW's regarding child development, maternal depression and cognitive behaviour.To use focus groups and the training programmes to increase the knowledge of CHWs method: a qualitative approach was used to explore experiences of CHWs who delivered the intervention. Three-day training was provided to 216 CHWs on LTP and THP. Trained facilitators conducted focus groups before and after the training to explore their prior knowledge and expectations. A semi-structured topic guide was developed for this. All the focus groups were audio-recorded. The data were analysed using framework analysis principles.Four key themes emerged from the focus groups; the psychosocial context these women live in (poverty, work-overload, interpersonal conflicts, lack of support from family, lack of awareness of depression and scarcity of mental health services) CHWs perception of depression (role of negative thoughts in depression), the impact of maternal depression on children and the impact of training for CHWs (improvement in CHWs knowledge related to children).Training CHWs improves their knowledge about child development and psychological therapies. This can contribute to improving access to maternal healthcare services and improving child development outcomes

Group psychological intervention for maternal depression: A nested qualitative study from Karachi, Pakistan

AIMTo understand the experience of maternal depression, the factors implicated in accessing health, and the acceptability of the psychosocial intervention.METHODSThe participants were recruited from the paediatrics outpatient department of Civil Hospital Karachi, Pakistan. The study started in December 2009 and completed in December 2010. Women with maternal depression, aged 18-44 years with children aged 0-30 mo who had received nutritional supplements, and participated in the intervention programme [called Learning through Play (LTP) plus] were included in the study. Qualitative interviews were conducted with 8 participants before the intervention and 7 participants after the intervention. A semi structured topic guide was used to conduct the interviews.RESULTSFramework analysis procedures were used to analyse the qualitative data. Four themes emerged: (1) the women’s contextual environment: Interpersonal conflicts, lack of social support and financial issues being the major barriers in assessing healthcare; (2) women’s isolation and powerlessness within the environment: Sense of loneliness was identified as a restricting factor to access healthcare; (3) the impact of the intervention (LTP-Plus): Women felt “listened to” and seemed empowered; and (4) empowered transformed women within the same contextual environment: The facilitator provided a “gardening role” in nurturing the women resulting in a positive transformation within the same environment. The women’s homes seemed to be more happy homes and there was a positive change in their behaviour towards their children.CONCLUSIONFindings informed the further development and testing of culturally-appropriate psychosocial intervention (LTP+) for addressing maternal depression

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

A two-arm, randomised feasibility trial using link workers to improve dental visiting in people with severe mental illness: a protocol paper

Abstract Background People with severe mental illness (e.g. psychosis, bipolar disorder) experience poor oral health compared to the general population as shown by more decayed, missing and filled teeth and a higher prevalence of periodontal disease. Attending dental services allows treatment of oral health problems and support for prevention. However, people with severe mental illness face multiple barriers to attending routine dental appointments and often struggle to access care. Link work interventions use non-clinical support staff to afford vulnerable populations the capacity, opportunity, and motivation to navigate use of services. The authors have co-developed with service users a link work intervention for supporting people with severe mental illness to access routine dental appointments. The Mouth Matters in Mental Health Study aims to explore the feasibility and acceptability of this intervention within the context of a feasibility randomised controlled trial (RCT) measuring outcomes related to the recruitment of participants, completion of assessments, and adherence to the intervention. The trial will closely monitor the safety of the intervention and trial procedures. Methods A feasibility RCT with 1:1 allocation to two arms: treatment as usual (control) or treatment as usual plus a link work intervention (treatment). The intervention consists of six sessions with a link worker over 9 months. Participants will be adults with severe mental illness receiving clinical input from secondary care mental health service and who have not attended a planned dental appointment in the past 3 years. Assessments will take place at baseline and after 9 months. The target recruitment total is 84 participants from across three NHS Trusts. A subset of participants and key stakeholders will complete qualitative interviews to explore the acceptability of the intervention and trial procedures. Discussion The link work intervention aims to improve dental access and reduce oral health inequalities in people with severe mental illness. There is a dearth of research relating to interventions that attempt to improve oral health outcomes in people with mental illness and the collected feasibility data will offer insights into this important area. Trial registration The trial was preregistered on ISRCTN (ISRCTN13650779) and ClinicalTrials.gov (NCT05545228)