Developing a complex intervention to support pregnant women with mild to moderate anxiety: application of the Medical Research Council framework.

BACKGROUND: To design and develop an intervention to support women with symptoms of mild to moderate anxiety in pregnancy. METHODS: The development followed the MRC framework for complex interventions, utilising psychological theory, review level evidence and professional and public involvement. Two systematic reviews were completed which helped identify potentially beneficial intervention components. The theory underpinning the components was explored to consider the potential benefit for women with mild to moderate anxiety symptoms in pregnancy. Methods of delivering the intervention within maternity services were explored. The intervention comprised: group discussions, one to one support and assisted self-help resources. Midwives were identified as ideally placed to facilitate the intervention supported by midwifery support workers. A bespoke training package was provided by subject experts to prepare the facilitators. RESULTS: The absence of established interventions and a paucity of evidence based approaches for pregnant women with symptoms of mild to moderate anxiety indicated the need for a rigorous and systematic approach to the intervention design. This approach led to the development of an intervention feasible for implementation in maternity care systems tailored to the needs of pregnant women. The involvement of a multi-professional advisory team and active engagement of service users helped to consider the acceptability of the intervention for women and the feasibility of delivering the intervention in the context of maternity care. CONCLUSION: The MRC Framework provided useful overarching guidance to develop a midwife facilitated intervention for women with symptoms of anxiety in pregnancy. The framework assisted the development of a robust rationale for each intervention component and considered the processes of evaluation and implementation into maternity care systems.

Cost-effectiveness of PoNDER health visitor training for mothers at lower risk of depression: findings on prevention of postnatal depression from a cluster-randomised controlled trial.

BACKGROUND: There is evidence for the cost-effectiveness of health visitor (HV) training to assess postnatal depression (PND) and deliver psychological approaches to women at risk of depression. Whether this approach is cost-effective for lower-risk women is unknown. There is a need to know the cost of HV-delivered universal provision, and how much it might cost to improve health-related quality of life for postnatal women. A sub-study of a cluster-randomised controlled trial in the former Trent region (England) previously investigated the effectiveness of PoNDER HV training in mothers at lower risk of PND. We conducted a parallel cost-effectiveness analysis at 6-months postnatal for all mothers with lower-risk status attributed to an Edinburgh Postnatal Depression Scale (EPDS) score <12 at 6-weeks postnatal. METHODS: Intervention HVs were trained in assessment and cognitive behavioural or person-centred psychological support techniques to prevent depression. Outcomes examined: quality-adjusted life-year (QALY) gains over the period between 6 weeks and 6 months derived from SF-6D (from SF-36); risk-of-depression at 6 months (dichotomising 6-month EPDS scores into lower risk (<12) and at-risk (⩾12). RESULTS: In lower-risk women, 1474 intervention (63 clusters) and 767 control participants (37 clusters) had valid 6-week and 6-month EPDS scores. Costs and outcomes data were available for 1459 participants. 6-month adjusted costs were £82 lower in intervention than control groups, with 0.002 additional QALY gained. The probability of cost-effectiveness at £20 000 was very high (99%). CONCLUSIONS: PoNDER HV training was highly cost-effective in preventing symptoms of PND in a population of lower-risk women and cost-reducing over 6 months.

Systematic review and meta-analysis of non-pharmacological interventions to reduce the symptoms of mild to moderate anxiety in pregnant women.

AIM: To assess the effectiveness of non-pharmacological interventions for pregnant women with symptoms of mild to moderate anxiety. BACKGROUND: Many pregnant women experience mild to moderate symptoms of anxiety and could benefit from additional support. Non-pharmacological interventions have been suggested for use during pregnancy. DESIGN: A systematic review of randomized controlled trials. DATA SOURCES: Randomized controlled trials published since 1990, identified from electronic databases: Medline; CINAHL; Maternity and Infant Care; PsycINFO; Cochrane Database of Systematic Reviews; CENTRAL; EMBASE; Centre for Reviews and Dissemination; Social Sciences Citation Index; ASSIA; HTA Library; Joanna Briggs Institute Evidence-Based Practice database; Allied and Complementary Medicine. REVIEW METHODS: Conducted according to the Centre for Reviews and Dissemination procedure. Papers were screened (N = 5,222), assessed for eligibility (N = 57) and selected for inclusion (N = 25). The Cochrane Collaboration's tool for assessing risk of bias was used. Papers were assessed for clinical and statistical heterogeneity and considered for meta-analysis. Descriptive analysis of the data was conducted. RESULTS: Psychological, mind-body, educational and supportive interventions were delivered individually and to groups of pregnant women over single or multiple sessions. The State-Trait Anxiety Inventory was the most commonly used anxiety measure. In 60% of studies there were fewer than 40 participants. Meta-analysis of three studies indicated no observed beneficial effect in the reduction of anxiety. CONCLUSION: There was insufficient evidence from which to draw overall conclusions regarding the benefit of interventions. Results were predominantly based on small samples. Many papers provided an inadequate description of methods which prevented a full assessment of methodological quality.

Women's views on anxiety in pregnancy and the use of anxiety instruments: a qualitative study.

OBJECTIVE: To explore women's experience of anxiety in pregnancy and views on the use of anxiety instruments in antenatal care. BACKGROUND: Anxiety in pregnancy is associated with adverse birth outcomes, developmental and behavioural problems in infants and postnatal depression. Despite recommendations for routine psychological assessment in pregnancy, the optimal methods to identify anxiety in pregnancy have not been confirmed. METHODS: A qualitative study using two focus group discussions was undertaken. Focus group one included women in a community setting and focus group two included women in a hospital clinic setting who had received additional support for anxiety in pregnancy. Participants were women who had given birth within the past nine months and considered themselves to have been anxious during their pregnancy. RESULTS: Three main themes were identified using template analysis: sources of support, administration of anxiety instruments and the use of instruments to prompt discussion. Women stated that anxiety instruments could help them to identify their anxious feelings and prompt a discussion around those feelings. However, they expressed concerns surrounding the administration of anxiety instruments and questioned how useful they would be in helping women access help and support. CONCLUSIONS: The introduction of anxiety instruments in antenatal care may present an opportunity to discuss women's emotional health and anxieties. Providing women with sufficient time to discuss their anxious feelings, identified by such instruments, could facilitate access to additional support.

A psychometric systematic review of self-report instruments to identify anxiety in pregnancy.

AIMS: To report a systematic review of the psychometric properties of self-report instruments to identify the symptoms of anxiety in pregnancy to help clinicians and researchers select the most suitable instrument. BACKGROUND: Excessive anxiety in pregnancy is associated with adverse birth outcomes, developmental and behavioural problems in infants and postnatal depression. Despite recommendations for routine psychological assessment in pregnancy, the optimal methods to identify anxiety in pregnancy have not been confirmed. DESIGN: Psychometric systematic review. DATA SOURCES: A systematic literature search of the multiple databases (1990-September 2014). REVIEW METHODS: Identification of self-report instruments to measure anxiety in pregnancy using COSMIN guidelines to assess studies reporting a psychometric evaluation of validity and reliability. RESULTS: Thirty-two studies were included. Studies took place in the UK, Australia, Belgium, Canada, Germany, Italy, Scandinavia, Spain and the Netherlands. Seventeen different instruments were identified. Measures of validity were reported in 19 papers and reliability in 16. The overall quality of the papers was rated as fair to excellent using the COSMIN checklist. Only one paper scored excellent in more than one category. CONCLUSION: Many instruments have been adapted for use in different populations to those for which they were designed. The State Trait Anxiety Inventory, Edinburgh Postnatal Depression Scale and the Hospital Anxiety and Depression Scale have been tested more frequently than other instruments, yet require further assessment to confirm their value for use in pregnancy.

Perceptions and experiences of interventions to prevent postnatal depression. A systematic review and qualitative evidence synthesis.

BACKGROUND: More women experience depressive symptoms antenatally than postnatally. Supporting women through the antenatal period is recognised as important in mitigating negative outcomes and in preventing postnatal depression (PND). A systematic review was conducted which aimed to provide a detailed service user and service provider perspective on the uptake, acceptability, and perception of harms of antenatal interventions and postnatal interventions for preventing PND. METHODS: A comprehensive literature search was conducted in 12 major bibliographic databases in November 2012 and updated in December 2014. Studies were included if they contained qualitative evidence on the perspectives and attitudes of pregnant women and postnatal women who had taken part in, or healthcare professionals (HCPs) involved in delivering, preventive interventions for PND. RESULTS: Twenty-two studies were included. Support and empowerment through education were identified as particularly helpful to women as intervention components, across all intervention types. Implications for accessing the service, understanding the remit of the service and women's preferences for group and individual care also emerged. LIMITATIONS: The majority of the included studies were of moderate or low quality, which may result in a lack of rich data consistently across all studies, limiting to some degree interpretations that can be made. CONCLUSION: The synthesis demonstrated important considerations for devising new interventions or adapting existing interventions. Specifically, it is important that individual or group interventions are carefully tailored to women's needs or preferences and women are aware of the remit of the HCPs role to ensure they feel able to access the support required.

A systematic review, evidence synthesis and meta-analysis of quantitative and qualitative studies evaluating the clinical effectiveness, the cost-effectiveness, safety and acceptability of interventions to prevent postnatal depression.

BACKGROUND: Postnatal depression (PND) is a major depressive disorder in the year following childbirth, which impacts on women, their infants and their families. A range of interventions has been developed to prevent PND. OBJECTIVES: To (1) evaluate the clinical effectiveness, cost-effectiveness, acceptability and safety of antenatal and postnatal interventions for pregnant and postnatal women to prevent PND; (2) apply rigorous methods of systematic reviewing of quantitative and qualitative studies, evidence synthesis and decision-analytic modelling to evaluate the preventive impact on women, their infants and their families; and (3) estimate cost-effectiveness. DATA SOURCES: We searched MEDLINE, EMBASE, Science Citation Index and other databases (from inception to July 2013) in December 2012, and we were updated by electronic alerts until July 2013. REVIEW METHODS: Two reviewers independently screened titles and abstracts with consensus agreement. We undertook quality assessment. All universal, selective and indicated preventive interventions for pregnant women and women in the first 6 postnatal weeks were included. All outcomes were included, focusing on the Edinburgh Postnatal Depression Scale (EPDS), diagnostic instruments and infant outcomes. The quantitative evidence was synthesised using network meta-analyses (NMAs). A mathematical model was constructed to explore the cost-effectiveness of interventions contained within the NMA for EPDS values. RESULTS: From 3072 records identified, 122 papers (86 trials) were included in the quantitative review. From 2152 records, 56 papers (44 studies) were included in the qualitative review. The results were inconclusive. The most beneficial interventions appeared to be midwifery redesigned postnatal care [as shown by the mean 12-month EPDS score difference of -1.43 (95% credible interval -4.00 to 1.36)], person-centred approach (PCA)-based and cognitive-behavioural therapy (CBT)-based intervention (universal), interpersonal psychotherapy (IPT)-based intervention and education on preparing for parenting (selective), promoting parent-infant interaction, peer support, IPT-based intervention and PCA-based and CBT-based intervention (indicated). Women valued seeing the same health worker, the involvement of partners and access to several visits from a midwife or health visitor trained in person-centred or cognitive-behavioural approaches. The most cost-effective interventions were estimated to be midwifery redesigned postnatal care (universal), PCA-based intervention (indicated) and IPT-based intervention in the sensitivity analysis (indicated), although there was considerable uncertainty. Expected value of partial perfect information (EVPPI) for efficacy data was in excess of £150M for each population. Given the EVPPI values, future trials assessing the relative efficacies of promising interventions appears to represent value for money. LIMITATIONS: In the NMAs, some trials were omitted because they could not be connected to the main network of evidence or did not provide EPDS scores. This may have introduced reporting or selection bias. No adjustment was made for the lack of quality of some trials. Although we appraised a very large number of studies, much of the evidence was inconclusive. CONCLUSIONS: Interventions warrant replication within randomised controlled trials (RCTs). Several interventions appear to be cost-effective relative to usual care, but this is subject to considerable uncertainty. FUTURE WORK RECOMMENDATIONS: Several interventions appear to be cost-effective relative to usual care, but this is subject to considerable uncertainty. Future research conducting RCTs to establish which interventions are most clinically effective and cost-effective should be considered. STUDY REGISTRATION: This study is registered as PROSPERO CRD42012003273. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Training health visitors in cognitive behavioural and person-centred approaches for depression in postnatal women as part of a cluster randomised trial and economic evaluation in primary care: the PoNDER trial.

AIM: This paper aims to describe the training preparation for health visitors who took part in the intervention arm of a cluster randomised controlled trial and economic evaluation of training for health visitors - the POstNatal Depression Economic evaluation and Randomised (the PoNDER) trial. A secondary aim is to make available, by electronic links, the training manuals developed for and used for the cognitive behavioural approach (CBA) and the person-centred approach (PCA) training for the health visitors. The paper is of relevance to health visitors, general practitioners, nurse practitioners, midwives, clinical psychologists, mental health nurses, community psychiatric nurses, counsellors, and service commissioners. BACKGROUND: The trial clinical outcomes have been published, indicating the pragmatic effectiveness of the package of training for health visitors to identify depressive symptoms and provide a psychologically informed intervention. The training was associated with a reduction in depressive symptoms at six months postnatally among intervention group women and some evidence of a benefit for the intervention group for some of the secondary outcomes at 18 months follow-up. METHODS: The two experimental interventions examined in the PoNDER trial built upon promising work on the potential for psychological interventions to help women recover from postnatal depression as an alternative to pharmaceutical interventions and to address the limitations of previous research in the area. FINDINGS: The package of health visitor training comprised the development of clinical skills in assessing postnatal women and identifying depressive symptoms, and the delivery of a CBA or a PCA for eligible women. This was the largest trial a health visitor intervention and of postnatal depression ever conducted. We are aware of no other rigorously performed trial that has published details of an extensively tested training programme for the benefit of health-care professionals and clients.

Identification of depressive disorder among older people in care homes - a feasibility study.

BACKGROUND: Depression is common among older people but more common among those living in care homes. Depression is not easily detected among older adults because of the presentation, and the tendency for older people not to complain of depression, particularly those living in care homes. In general, care home staff have limited training in recognising depression. Depression is undertreated and residents may not receive a therapeutic dose of antidepressant. The true prevalence of depression among care home residents is uncertain. METHOD: This feasibility study aimed to explore the level of depression among older people in care homes by comparing the outcome of an assessment by care home staff with the outcome of a diagnostic clinical interview, using ICD-10 criteria and the 30-item Geriatric Depression Scale (GDS), conducted by a psychiatrist. RESULTS: In all, 47 older people from four care homes were interviewed by a psychiatrist. Of them, 39.1% (18/46) of residents were prescribed an antidepressant and were no longer depressed; 8.7% (4/46) were prescribed an antidepressant and remained depressed; and 6.5% (3/46) of residents assessed as being depressed, had not been prescribed an antidepressant. That is, 54% (25/46) of residents had been or were currently depressed. Using ICD-10 criteria, the sensitivity of the GDS at a threshold of 10 and 11 was 100%. In total, 89.4% of residents received a correct diagnosis (presence or absence of depression) using the GDS at the 11 threshold. SUMMARY: The prevalence of depression in these homes was 54%. Of the residents with depression, 72% (18/25) were managed with an antidepressant and 28% (7/25) were receiving ineffective or no treatment. The 30-item GDS can provide more useful information than a home care staff assessment for identifying depression. More research should explore the value of training home care staff to administer the 30-item GDS to optimise the management of depression in older people in care homes.

Postnatal women's experiences of management of depressive symptoms: a qualitative study.

BACKGROUND: Postnatal depression is a public health problem requiring intervention. To provide effective care, information is needed on the experiences of those with high levels of depressive symptoms who are offered and accept, or decline, psychological intervention postnatally. AIM: To provide the first integrated in-depth exploration of postnatal women's experiences of the identification and management of symptoms of depression and the offer and acceptance of postnatal care by health visitors taking part in the PoNDER trial. SETTING: General practice: primary care within the former Trent regional health authority, England. METHOD: Thirty women with 6-week Edinburgh Postnatal Depression Scale (EPDS) scores ≥ 18 and probable depression completed semi-structured interviews. All women had taken part in the Post-Natal Depression Economic Evaluation and Randomised controlled (PoNDER) trial where intervention group health visitors received training in identification of depressive symptoms and provided psychologically informed sessions based on cognitive-behavioural therapy or person-centred counselling principles. RESULTS: When accepted, psychological sessions were experienced as positive, effective, and 'ideal care'. Women approved of using the EPDS but did not understand the health visitor's role in supporting women. Seeking help and accepting sessions depended on women's perspectives of their health visitor as an individual. CONCLUSION: Women's experience of their health visitors providing psychological sessions to help with postnatal depressive symptoms is highly positive. Women will better accept support from health visitors if they recognise their role in postnatal depression and find them easy to relate to on personal matters. There is a case for specific enhancement of interpersonal skills in health visiting, or alternatively offering a choice of health visitors to women.

Clinical effectiveness of health visitor training in psychologically informed approaches for depression in postnatal women: pragmatic cluster randomised trial in primary care.

OBJECTIVE: To evaluate benefits for postnatal women of two psychologically informed interventions by health visitors. DESIGN: Prospective cluster trial randomised by general practice, with 18 month follow-up. SETTING: 101 general practices in Trent, England. PARTICIPANTS: 2749 women allocated to intervention, 1335 to control. INTERVENTION: Health visitors (n=89 63 clusters) were trained to identify depressive symptoms at six to eight weeks postnatally using the Edinburgh postnatal depression scale (EPDS) and clinical assessment and also trained in providing psychologically informed sessions based on cognitive behavioural or person centred principles for an hour a week for eight weeks. Health visitors in the control group (n=49 38 clusters) provided usual care. MAIN OUTCOME MEASURES: Score >or=12 on the Edinburgh postnatal depression scale at six months. Secondary outcomes were mean Edinburgh postnatal depression scale, clinical outcomes in routine evaluation-outcome measure (CORE-OM), state-trait anxiety inventory (STAI), SF-12, and parenting stress index short form (PSI-SF) scores at six, 12, 18 months. RESULTS: 4084 eligible women consented and 595 women had a six week EPDS score >or=12. Of these, 418 had EPDS scores available at six weeks and six months. At six months, 34% women (93/271) in the intervention group and 46% (67/147) in the control group had an EPDS score >or=12. The odds ratio for score >or=12 at six months was 0.62 (95% confidence interval 0.40 to 0.97, P=0.036) for women in the intervention group compared with women in the control group. After adjustment for covariates, the odds ratio was 0.60 (0.38 to 0.95, P=0.028). At six months, 12.4% (234/1880) of all women in the intervention group and 16.7% (166/995) of all women in the control group had scores >or=12 (0.67, 0.51 to 0.87, P=0.003). Benefit for women in the intervention group with a six week EPDS score >or=12 and for all women was maintained at 12 months postnatally. There was no differential benefit for either psychological approach over the other. CONCLUSION: Training health visitors to assess women, identify symptoms of postnatal depression, and deliver psychologically informed sessions was clinically effective at six and 12 months postnatally compared with usual care. TRIAL REGISTRATION: ISRCTN92195776.