Developing a healthy living intervention for people with early psychosis using the Medical Research Council's guidelines on complex interventions: phase 1 of the HELPER - InterACT programme.

BACKGROUND: Young people with early psychosis often gain a significant amount of weight after the initiation of anti-psychotic treatment. Despite the current policy guidance to develop and evaluate 'healthy living' interventions for people with psychosis there remains a paucity of research. Our aim was to develop an acceptable, feasible, culturally sensitive and potentially effective 'healthy living' intervention, specifically for young people with early psychosis. METHODS: Using the Medical Research Council guidelines for developing and evaluating complex interventions we conducted a number of studies to devise a 'healthy living' intervention. We used a 'top down' (published evidence), bottom up (stakeholder perspectives) approach, which included updating a systematic review, identifying a theoretical basis for the intervention, exploring the perspectives of service users and health professionals, and identifying key cultural issues. The results of these studies were synthesised to determine the content and delivery of the intervention. RESULTS: The intervention developed comprised eight individual sessions to be delivered by a support time recovery worker over a 12 month period with emphasis on individualised action plans to facilitate participatory exercise and changes in diet. To optimise engagement, choice and self management a booklet and website were developed to provide participants with educational advice, healthy eating recipes and other materials. CONCLUSION: Using the Medical Research Council guidelines we have developed a potentially effective, feasible and acceptable 'healthy living' intervention for people with psychosis using early intervention services in the UK.

Collaborative care for depression in UK primary care: a randomized controlled trial.

BACKGROUND: Collaborative care is an effective intervention for depression which includes both organizational and patient-level intervention components. The effect in the UK is unknown, as is whether cluster- or patient-randomization would be the most appropriate design for a Phase III clinical trial. METHOD: We undertook a Phase II patient-level randomized controlled trial in primary care, nested within a cluster-randomized trial. Depressed participants were randomized to 'collaborative care' - case manager-coordinated medication support and brief psychological treatment, enhanced specialist and GP communication - or a usual care control. The primary outcome was symptoms of depression (PHQ-9). RESULTS: We recruited 114 participants, 41 to the intervention group, 38 to the patient randomized control group and 35 to the cluster-randomized control group. For the intervention compared to the cluster control the PHQ-9 effect size was 0.63 (95% CI 0.18-1.07). There was evidence of substantial contamination between intervention and patient-randomized control participants with less difference between the intervention group and patient-randomized control group (-2.99, 95% CI -7.56 to 1.58, p=0.186) than between the intervention and cluster-randomized control group (-4.64, 95% CI -7.93 to -1.35, p=0.008). The intra-class correlation coefficient for our primary outcome was 0.06 (95% CI 0.00-0.32). CONCLUSIONS: Collaborative care is a potentially powerful organizational intervention for improving depression treatment in UK primary care, the effect of which is probably partly mediated through the organizational aspects of the intervention. A large Phase III cluster-randomized trial is required to provide the most methodologically accurate test of these initial encouraging findings.

Strategies for coping with labour: does antenatal education translate into practice?

There is little evidence to associate attendance at antenatal classes with a reduction in psychological distress or increased satisfaction with the experience of labour. There may be several reasons for this, including failure to implement coping strategies. A within-subjects research design explored the use in labour of coping strategies taught in antenatal classes and the role of practice. Women's views about using these strategies and their expectations of their midwives and birth companions were also identified. Following Ethics Committee approval and providing informed consent, 121 nulliparous women completed a questionnaire at their final antenatal class. This included questions on confidence and the amount of effort required to use coping strategies, the involvement hoped for from birth companions and midwives in using coping strategies in labour and satisfaction with the amount of practice of coping strategies. Within 72 hours of delivery, women were interviewed to obtain a narrative of the events of labour and their use of the coping strategies (sighing-out-slowly breathing, Laura Mitchell relaxation and postural change). A questionnaire obtained information on the involvement of the midwife and birth companion. Women used the three coping strategies to different extents. Midwives were not involved to the extent that women had hoped for antenatally. Birth companions achieved a level of involvement closer to women's hopes than that achieved by midwives. A significant proportion of women expressed dissatisfaction with the amount of practice of coping strategies during antenatal classes. The findings of this study of a group of well-prepared women raise questions about the correct components of antenatal classes and how midwives and birth companions can be involved optimally in this aspect of a woman's labour. Further research is required to determine how women can best be helped to cope with the experience of labour.