Patients' and Therapists' Views of Integrated Online CBT for Depression.

BACKGROUND: CBT is an effective treatment for depression, but access varies across the United Kingdom. Online CBT increases access. The INTERACT platform was designed to support patient engagement in CBT, enabling therapists to deliver high-intensity CBT via typed instant messaging and allowing patients and therapists access to an integrated online library of resources during and between sessions. METHODS: The INTERACT trial aimed to evaluate this integrated approach to delivering CBT for primary care patients with depression. A nested qualitative study was conducted within the trial. Interviews were conducted with 20 patients who received the intervention, 9 therapists who delivered it and 3 therapist supervisors. Data were analysed using thematic analysis. RESULTS: The combination of receiving support from a therapist and having access to integrated online CBT resources enabled patients to better manage their depression. Platform benefits included the opportunity to review transcripts to clarify how to complete homework tasks and track progress in managing their depression. The typing process allowed reflection and a focused discussion. However, less could be covered than during an in-person session, which reduced therapists' expectations around goal setting. Patients who did not complete therapy struggled with the typing and found the CBT approach too demanding. CONCLUSION: Findings highlight the importance of establishing patient and therapist goals and expectations about what can be achieved in CBT mediated by typing. Some patients are comfortable communicating via typing and are motivated to utilise online resources in between sessions. Exploring the benefits and challenges of typed CBT with patients will enable them to make an informed choice about referral for this novel approach to therapy. PATIENT OR PUBLIC CONTRIBUTION: Patients, service users and members of the public were involved in the study design and management. Substantial pilot work gathered stakeholder feedback and informed the design of the intervention, before undertaking the RCT. Coauthor P.L. is a service user representative co-applicant and member of the management group responsible for developing the intervention and the trial. Two PPI members sit on the Independent Steering Committee. PPI members provided valuable feedback on the study resources and documents.

Text Messages With Financial Incentives for Men With Obesity: A Randomized Clinical Trial.

Importance: Effective weight loss interventions are needed for men with obesity. Objective: To determine whether an intervention that combined text messaging with financial incentives attained significant weight loss at the 12-month follow-up compared with the control group and whether an intervention of text messaging alone attained significant weight loss at the 12-month follow-up compared with the control group. Design, Setting, and Participants: An assessor-blinded randomized clinical trial conducted in Belfast, Bristol, and Glasgow areas in the UK. A total of 585 men with body mass index (BMI) of 30 or more were enrolled between July 2021 and May 2022. Final follow-up occurred June 2023. Interventions: Participants were randomly assigned to 12 months of behavioral focused text messages combined with financial incentives (n = 196), 12 months of behavioral focused text messages alone (n= 194), or a waiting list (control group; n= 195). The financial incentive consisted of a monetary reward that was lost if weight loss targets were not met. All participants received weight management information and a pedometer at baseline. Main Outcomes and Measures: The 2 primary comparisons were the 12-month comparison of within-participant weight change between the text messaging with financial incentive group and the control group and the comparison between the text messaging alone group and the control group (minimum clinically important difference, 3%). The P value defined for statistical significance was P < .025 for each comparison. Results: Of the 585 men (mean [SD] age, 50.7 [13.3] years; mean weight, 118.5 [19.9] kg; mean BMI, 37.7 [5.7]; 525 [90%] White), 227 (39%) lived in postal code areas with lower socioeconomic status, and 426 (73%) completed the 12-month follow-up. At the 12-month follow-up, compared with the control group, the mean percent weight change was significantly greater in the text messaging with financial incentive group (mean difference, -3.2%; 97.5% CI, -4.6% to -1.9%; P < .001) but was not significantly greater in the text messaging alone group (mean difference, -1.4%; 97.5% CI, -2.9% to 0.0, P = .05). The mean (SD) weight changes were -5.7 (7.4) kg for the text messaging with financial incentives group, -3.0 (7.5) kg for the text messaging alone group, and -1.5 (6.6) kg for the control group. The 12-month mean (SD) percentage weight changes from baseline were -4.8% (6.1%) for the text messaging with financial incentives group, -2.7% (6.3%) for text messaging alone group, and -1.3% (5.5%) for the control group. Of 366 adverse events reported, the most common were infections (83 [23%]). Of the 23 serious adverse events (6.3%), 12 (52%) occurred in the text messaging with financial incentives group, 5 (22%) in the texts messaging alone group, and 6 (26%) in the control group. None were considered related to participating in a trial group. Conclusion and Relevance: Among men with obesity, an intervention with text messaging with financial incentive significantly improved weight loss compared with a control group, whereas text messaging alone was not significantly better than the control condition. These findings support text messaging combined with financial incentives to attain weight loss in men with obesity. Trial Registration: isrctn.org Identifier: ISRCTN91974895.

Mothers' accounts of the impact of being in nature on postnatal wellbeing: a focus group study.

BACKGROUND: The postnatal period is a vulnerable time for mothers to experience stress and mental health difficulties. There is increasing evidence that spending time in nature is beneficial for wellbeing. Nature-based interventions have been developed to support mental health, but not specifically tailored for mothers during the postnatal period. Understanding mothers' views and experiences of nature would help determine the suitability for and potential impact of such interventions on postnatal wellbeing. AIMS: To explore mothers' views on the impact of spending time in nature on their postnatal mental wellbeing. METHODS: Focus groups were held with mothers of young children (under five), including mothers from migrant and refugee communities, mothers living with mental health difficulties, and disabled mothers. Data were analysed using reflexive thematic analysis. RESULTS: Four focus groups were held, with a total of 30 participants. Six themes were developed: (1) mothers' experiences of what constitutes 'nature'; (2) sensing nature improves wellbeing; (3) natural spaces facilitate human connection; (4) nature provides escape and relief from daily indoor stressors; (5) nature allows new perspectives; and (6) mothers face a variety of environmental, practical, psychological, physical, socioeconomic, and cultural barriers to spending time in nature during the postnatal period. CONCLUSIONS: Mothers report significant benefits to their postnatal wellbeing when spending time in nature. Further research is warranted to understand whether nature-based interventions have the potential to support postnatal wellbeing, socially, mentally, and physically.

PTSD as a mediator of the relationship between trauma and psychotic experiences.

BACKGROUND: Traumatic experiences are associated with a higher risk of psychotic illnesses, but little is known about potentially modifiable mechanisms underlying this relationship. This study aims to examine whether post-traumatic stress disorder (PTSD) symptoms mediate the relationship between trauma and psychotic experiences (PEs). METHODS: We used data from the Avon Longitudinal Study of Parents and Children to examine whether: PTSD symptoms mediate the relationships between (a) childhood trauma and adolescent PEs (study of adolescent PEs; n = 2952), and (b) childhood/adolescent trauma and PEs in early adulthood (study of adult PEs; n = 2492). We examined associations between variables using logistic regression, and mediation using the parametric g-computation formula. RESULTS: Exposure to trauma was associated with increased odds of PEs (adolescent PEs: ORadjusted 1.48, 95% CI 1.23-1.78; adult PEs: ORadjusted 1.57, 95% CI 1.25-1.98) and PTSD symptoms (adolescent PTSD: ORadjusted 1.59, 95% CI 1.31-1.93; adult PTSD: ORadjusted 1.50, 95% CI 1.36-1.65). The association between PTSD symptoms and PE was stronger in adolescence (ORadjusted 4.63, 95% CI 2.34-9.17) than in adulthood (ORadjusted 1.62, 95% CI 0.80-3.25). There was some evidence that PTSD symptoms mediated the relationship between childhood trauma and adolescent PEs (proportion mediated 14%), though evidence of mediation was weaker for adult PEs (proportion mediated 8%). CONCLUSIONS: These findings are consistent with the hypothesis that PTSD symptoms partly mediate the association between trauma exposure and PEs. Targeting PTSD symptoms might help prevent the onset of psychotic outcomes.

Trends in the recording of anxiety in UK primary care: a multi-method approach.

PURPOSE: Anxiety disorders are common. Between 1998 and 2008, in the UK, GP recording of anxiety symptoms increased, but the recording of anxiety disorders decreased. We do not know whether such trends have continued. This study examined recent trends in the recording of anxiety and explored factors that may influence GPs' coding of anxiety. METHODS: We used data from adults (n = 2,569,153) registered with UK general practices (n = 176) that contributed to the Clinical Practice Research Datalink between 2003 and 2018. Incidence rates and 95% confidence intervals were calculated for recorded anxiety symptoms and diagnoses and were stratified by age and gender. Joinpoint regression was used to estimate the years trends changed. In addition, in-depth interviews were conducted with 15 GPs to explore their views and management of anxiety. Interviews were audio-recorded, transcribed verbatim and analysed thematically. RESULTS: The incidence of anxiety symptoms rose from 6.2/1000 person-years at risk (PYAR) in 2003 to 14.7/1000 PYAR in 2018. Between 2003 and 2008, the incidence of anxiety diagnoses fell from 13.2 to 10.1/1000 PYAR; markedly increasing between 2013 and 2018 to 15.3/1000 PYAR. GPs mentioned that they preferred using symptom codes to diagnostic codes to avoid assigning potentially stigmatising or unhelpful labels, and commented on a rise in anxiety in recent years, especially in young adults. CONCLUSION: Recent increases in the recording of both anxiety diagnoses and symptoms may reflect increased presentation to primary care, especially in young adults. There is a clear need to understand the reasons for this, and this knowledge may be critical in the prevention and treatment of anxiety.

The NetSage measurement and analysis framework in practice.

Data sharing is required for research collaborations, but effective data transfer performance continues to be difficult to achieve. The NetSage Measurement and Analysis Framework can assist in understanding research data movement. It collects a broad set of monitoring data and builds performance Dashboards to visualize the data. Each Dashboard is specifically designed to address a well-defined analysis need of the stakeholders. This paper describes the design methodology, the resulting architecture, the development approach and lessons learned, and a set of discoveries that NetSage Dashboards made possible.

Shared decision making in consultations for hypertension: Qualitative study in general practice.

BACKGROUND: Hypertension is mainly managed in primary care. Shared decision making is widely recommended as an approach to treatment decision making. However, no studies have investigated; in detail, what happens during primary care consultations for hypertension. AIM: To understand patients' and clinicians' experience of shared decision making for hypertension in primary care, in order to propose how it might be better supported. DESIGN: Longitudinal qualitative study. SETTING: Five general practices in south-west England. METHOD: Interviews with a purposive sample of patients with hypertension, and with the health-care practitioners they consulted, along with observations of clinical consultations, for up to 6 appointments. Interviews and consultations were audio-recorded and observational field notes taken. Data were analysed thematically. RESULTS: Forty-six interviews and 18 consultations were observed, with 11 patients and nine health-care practitioners (five GPs, one pharmacist and three nurses). Little shared decision making was described by participants or observed. Often patients' understanding of their hypertension was limited, and they were not aware there were treatment choices. Consultations provided few opportunities for patients and clinicians to reach a shared understanding of their treatment choices. Opportunities for patients to engage in choices were limited by structured consultations and the distribution of decisions across consultations. CONCLUSION: For shared decision making to be better supported, consultations need to provide opportunities for patients to learn about their condition, to understand that there are treatment choices, and to discuss these choices with clinicians. PATIENT OR PUBLIC CONTRIBUTION: A patient group contributed to the design of this study.

A multi-stakeholder approach to the co-production of the research agenda for medicines optimisation.

BACKGROUND: Up to 50% of medicines are not used as intended, resulting in poor health and economic outcomes. Medicines optimisation is 'a person-centred approach to safe and effective medicines use, to ensure people obtain the best possible outcomes from their medicines'. The purpose of this exercise was to co-produce a prioritised research agenda for medicines optimisation using a multi-stakeholder (patient, researcher, public and health professionals) approach. METHODS: A three-stage, multiple method process was used including: generation of preliminary research questions (Stage 1) using a modified Nominal Group Technique; electronic consultation and ranking with a wider multi-stakeholder group (Stage 2); a face-to-face, one-day consensus meeting involving representatives from all stakeholder groups (Stage 3). RESULTS: In total, 92 research questions were identified during Stages 1 and 2 and ranked in order of priority during stage 3. Questions were categorised into four areas: 'Patient Concerns' [e.g. is there a shared decision (with patients) about using each medicine?], 'Polypharmacy' [e.g. how to design health services to cope with the challenge of multiple medicines use?], 'Non-Medical Prescribing' [e.g. how can the contribution of non-medical prescribers be optimised in primary care?], and 'Deprescribing' [e.g. what support is needed by prescribers to deprescribe?]. A significant number of the 92 questions were generated by Patient and Public Involvement representatives, which demonstrates the importance of including this stakeholder group when identifying research priorities. CONCLUSIONS: A wide range of research questions was generated reflecting concerns which affect patients, practitioners, the health service, as well the ethical and philosophical aspects of the prescribing and deprescribing of medicines. These questions should be used to set future research agendas and funding commissions.

Synthesizing Qualitative Data Sets to Improve the Design of Trials and Complex Health Interventions: A Worked Example.

Qualitative researchers are increasingly reanalyzing and synthesizing data sets from different studies, and this method has now been used across trials to inform trial methodology and delivery. Despite this work, however, limited guidance exists about how this method should be employed. This article details an example in which interview data collected during three primary care depression trials were brought together to explore trial participants' study and treatment journeys. It details the process involved and the decisions made. It also presents findings from this synthesis to illustrate how this method can be used to inform the development of future trials and complex interventions, through raising questions about how researchers currently define and design treatment arms and indicating what factors may improve or hinder participants' engagement with their allocated treatment.

Interventions to support shared decision making for hypertension: A systematic review of controlled studies.

BACKGROUND: Hypertension (high blood pressure) is a common long-term health condition. Patient involvement in treating and monitoring hypertension is essential. Control of hypertension improves population cardiovascular outcomes. However, for an individual, potential benefits and harms of treatment are finely balanced. Shared decision making has the potential to align decisions with the preferences and values of patients. OBJECTIVE: Determine the effectiveness of interventions to support shared decision making in hypertension. SEARCH STRATEGY: Searches in MEDLINE, EMBASE, CINAHL, Web of Science and PsycINFO up to 30 September 2017. ELIGIBILITY CRITERIA: Controlled studies evaluating the effects of shared decision-making interventions for adults with hypertension compared with any comparator in any setting and reporting any outcome measures. RESULTS: Six studies (five randomized controlled trials) in European primary care were included. Main intervention components were as follows: training for health-care professionals, decision aids, patient coaching and a patient leaflet. Four studies, none at low risk of bias, reported a measure of shared decision making; the intervention increased shared decision making in one study. Four studies reported blood pressure between 6 months and 3 years after the intervention; there was no difference in blood pressure between intervention and control groups in any study. Lack of comparability between studies prevented meta-analysis. CONCLUSIONS: Despite widespread calls for shared decision making to be embedded in health care, there is little evidence to inform shared decision making for hypertension, one of the most common conditions managed in primary care.

"I've made this my lifestyle now": a prospective qualitative study of motivation for lifestyle change among people with newly diagnosed type two diabetes mellitus.

BACKGROUND: Diagnosis with Type 2 Diabetes is an opportunity for individuals to change their physical activity and dietary behaviours. Diabetes treatment guidelines recommend theory-based, patient-centred care and advocate the provision of support for patient motivation but the motivational experiences of people newly diagnosed with diabetes have not been well studied. Framed in self-determination theory, this study aimed to qualitatively explore how this patient group articulate and experience different types of motivation when attempting lifestyle change. METHODS: A secondary analysis of semi-structured interview data collected with 30 (n female = 18, n male = 12) adults who had been newly diagnosed with type two diabetes and were participants in the Early ACTID trial was undertaken. Deductive directed content analysis was performed using NVivo V10 and researcher triangulation to identify and describe patient experiences and narratives that reflected the motivation types outlined in self-determination theory and if/how these changed over time. RESULTS: The findings revealed the diversity in motivation quality both between and within individuals over time and that patients with newly-diagnosed diabetes have multifaceted often competing motivations for lifestyle behaviour change. Applying self-determination theory, we identified that many participants reported relatively dominant controlled motivation to comply with lifestyle recommendations, avoid their non-compliance being "found out" or supress guilt following lapses in behaviour change attempts. Such narratives were accompanied by experiences of frustrating slow behaviour change progress. More autonomous motivation was expressed as something often achieved over time and reflected goals to improve health, quality of life or family time. Motivational internalisation was evident and some participants had integrated their behaviour change to a new way of life which they found resilient to common barriers. CONCLUSIONS: Motivation for lifestyle change following diagnosis with type two diabetes is complex and can be relatively low in self-determination. To achieve the patient empowerment aspirations of current national health care plans, intervention developers, and clinicians would do well to consider the quality not just quantity of their patients' motivation. TRIAL REGISTRATION: ISRCTN ISRCTN92162869 . Retrospectively registered.

'You are labelled by your children's disability' - A community-based, participatory study of stigma among Somali parents of children with autism living in the United Kingdom.

OBJECTIVES: Social stigma is commonly experienced by parents of children with autism. Our aim was to understand the nature of stigma experienced by Somali parents of children with autism in the United Kingdom (UK), and to consider how they coped with or resisted such stigma. DESIGN: We used a community-based participatory research approach, collaborating with a community organisation of Somali parents. In-depth interviews with simultaneous translation were conducted with 15 Somali parents of children with autism living in Bristol, UK, in 2015. Parents were sampled purposively to capture diversity in children's age, severity of autism and time since diagnosis. Directed thematic analysis used Link and Phelan's model of stigma. RESULTS: Of the 15 participants, 12 were mothers (mean age 36). The 17 children with autism they cared for were 4-13 years' old, and five were girls. Two main themes with sub-themes were identified: the nature of stigma (labelling and stereotyping; separation; emotional reactions, discrimination and power), and coping and resistance (the power of language; faith as a resource; learning, peer support and community relationships). Children with autism were labelled and stereotyped (e.g. as 'sick', 'naughty', 'different') and parents blamed for not controlling them, leading to social rejection and isolation. Stigma was associated with a poor understanding of autism, a lack of vocabulary related to autism in the Somali community, and prejudice against mental illness and disability. There was evidence of enacted and felt stigma and examples of discrimination. Finding their own language to describe their child's condition and drawing on faith, learning and peer support were important resources in resisting stigma. CONCLUSIONS: Findings inform support for this community, highlighting the need to raise awareness of autism, enable parents to speak openly, and ensure appropriate professional services and interventions are available.

'She believed in me'. What patients with depression value in their relationship with practitioners. A secondary analysis of multiple qualitative data sets.

BACKGROUND: Clinical guidance promotes the practitioner-patient relationship as integral to good quality person-centred care for patients with depression. However, patients can struggle to engage with practitioners and practitioners have indicated that they want more guidance on how to establish effective relationships with their patients. OBJECTIVE: To identify what practitioner attributes patients with depression particularly value or find problematic. METHOD: A secondary analysis of data collected during four qualitative studies, all of which entailed interviewing patients diagnosed with depression about their treatment experiences. Patients in the four studies had received different treatments. These included antidepressants, cognitive behaviour therapy, facilitated physical activity and listening visits. We thematically analysed 32 patient accounts. RESULTS: We identified two complimentary sets of important practitioner attributes: the first based on the practitioner's bearing; the second based on the practitioner's enabling role. We found that patients value practitioners who consider their individual manner, share relevant personal information, show interest and acceptance, communicate clearly and listen carefully, collaborate on manageable goals and sanction greater patient self-care and self-compassion. It was also evident that patients receiving different treatments value the same practitioner attributes and that when these key practitioner qualities were not evident, patients were liable not to re-attend or comply with treatment. CONCLUSION: The practitioner attributes that patients with depression most value have a positive impact on their engagement with treatment. Patients emphasise the importance of a practitioner's demeanour and encouragement, rather than the amount of time or specific treatment a practitioner is able to provide.

Individuals' Long Term Use of Cognitive Behavioural Skills to Manage their Depression: A Qualitative Study.

BACKGROUND: Cognitive Behavioural Therapy (CBT) aims to teach people skills to help them self-manage their depression. Trial evidence shows that CBT is an effective treatment for depression and individuals may experience benefits long-term. However, there is little research about individuals' continued use of CBT skills once treatment has finished. AIMS: To explore whether individuals who had attended at least 12 sessions of CBT continued to use and value the CBT skills they had learnt during therapy. METHOD: Semi-structured interviews were held with participants from the CoBalT trial who had received CBT, approximately 4 years earlier. Interviews were audio-recorded, transcribed and analysed thematically. RESULTS: 20 participants were interviewed. Analysis of the interviews suggested that individuals who viewed CBT as a learning process, at the time of treatment, recalled and used specific skills to manage their depression once treatment had finished. In contrast, individuals who viewed CBT only as an opportunity to talk about their problems did not appear to utilize any of the CBT skills they had been taught and reported struggling to manage their depression once treatment had ended. CONCLUSIONS: Our findings suggest individuals may value and use CBT skills if they engage with CBT as a learning opportunity at the time of treatment. Our findings underline the importance of the educational model in CBT and the need to emphasize this to individuals receiving treatment.

Mothers' views of their preschool child's screen-viewing behaviour: a qualitative study.

BACKGROUND: Research on screen-viewing in preschool children has predominantly focused on television viewing. The rapid development of mobile devices (e.g. tablets, smart phones and e-readers) and the increase in their use by preschool children means there is a need to understand how and why these devices are used by this age group. The aim of this study was to explore mothers' views of their preschool children's screen viewing behaviour (including mobile devices) and investigate how preschool children use different screen-viewing devices. METHODS: One-to-one, semi-structured interviews with mothers of preschool children (aged between 2 and 4 years old). Mothers were recruited through preschools, nurseries, and mother and toddler groups located within four areas of varying socio-economic status within Bristol, UK. Data were analysed thematically using a framework approach. RESULTS: Twenty-six mothers were interviewed. Mobile devices were regularly used as a form of screen-viewing for most children but were used on an ad hoc basis rather than being a habitual activity. The reasons and influences of mobile device use described by mothers were similar to that of television viewing. However, the portability of mobile devices meant that they were often used outside of the home as a distraction tool. Their multi-functionality meant that they could be used as a portable television, or for purposeful learning through educational games and applications. Some mothers showed concerns over mobile device use by their child, whilst others felt it was an important and useful educational tool. Although the majority of mothers felt they needed to set rules and restrictions for mobile device use, many mothers felt that they are also a necessary and unavoidable part of life. CONCLUSIONS: Mothers in this study suggested that mobile device use by preschool children is common. More research is needed to determine the impact of mobile device use in preschool children, how much time preschool children spend using mobile devices and which activities their use may be replacing.

Conditional Beliefs of Primary-Care Patients with Treatment-Resistant Depression.

BACKGROUND: Cognitive behaviour therapy (CBT) for patients with treatment-resistant depression (TRD) aims to reframe underlying conditional beliefs that are thought to maintain depression. AIM: To systematically explore conditional beliefs expressed by primary-care based patients with TRD, defined as non-response to at least 6 weeks of antidepressants. METHOD: Conditional beliefs (stated in an "If. . .then. . ." format) were extracted from a random sample of 50 sets of therapist notes from the CoBalT trial, a large randomized controlled trial of CBT for TRD in primary care. The beliefs were separated into their two constituent parts; the demands (Ifs) and consequences (thens). An approach based on framework analysis provided a systematic way of organizing the data, and identifying key themes. RESULTS: Four main themes emerged from the demand part of the conditional beliefs (Ifs): 1. High standards; 2. Putting others first/needing approval; 3. Coping; and 4. Hiding "true" self. Three main themes emerged from the consequence part of the conditional beliefs (thens): 1. Defectiveness; 2. Responses of others; 3. Control of emotions. CONCLUSIONS: Identifying common themes in the conditional beliefs of patients with TRD adds to our clinical understanding of this client group, providing useful information to facilitate the complex process of collaborative case conceptualization and working with conditional beliefs within CBT interventions.

Patient and practitioners' views on the most important outcomes arising from primary care consultations: a qualitative study.

BACKGROUND: Primary care clinicians often address multiple patient problems, with a range of possible outcomes. There is currently no patient-reported outcome measure (PROM) which covers this range of outcomes. Consequently, many researchers use PROMs that do not capture the full impact of primary care services. In order to identify what outcomes a PROM for primary care would need to include, we conducted interviews with patients and practitioners. This paper reports these patient and practitioners' views on the outcomes arising from primary care consultations. METHODS: Semi-structured interviews were held with 30 patients and eight clinicians across five sites in Bristol. Interviews were audio-recorded, transcribed and analysed thematically. We used a broad definition of health outcome as 'the impacts of healthcare on health, or a patient's ability to impact health' to identify outcomes through this process. RESULTS: 10 outcome groups were identified. These occupied 3 domains: Health Empowerment: These are the internal and external resources which enable patients to improve their health. This involves 1) patients' understanding of their illnesses, 2) ability to self-care and stay healthy, 3) agreeing and adhering to a patient-clinician shared plan, 4) confidence in seeking healthcare and 5) access to support. Health Status: This involves 6) reduction of symptoms and 7) reducing the impact of symptoms on patients' lives. Health Perceptions: This involves 8) patients' satisfaction with their health, 9) health concerns, and 10) confidence in their future health. The structure, organisation and nature of primary care means it can affect all 3 domains. CONCLUSIONS: No existing PROM captures all these outcomes. For example, many health empowerment PROMs do not consider patient preference on empowerment. Many health status tools are not responsive to changes resulting from primary care. Health perceptions PROMs have generally been designed for measuring personality traits rather than outcomes. This study provides a platform for designing a new PROM containing outcomes that matter to patients and can be influenced by primary care. Such a PROM would greatly enhance the value of primary care research.

Cognitive behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial.

BACKGROUND: Only a third of patients with depression respond fully to antidepressant medication but little evidence exists regarding the best next-step treatment for those whose symptoms are treatment resistant. The CoBalT trial aimed to examine the effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment resistant depression compared with usual care alone. METHODS: This two parallel-group multicentre randomised controlled trial recruited 469 patients aged 18-75 years with treatment resistant depression (on antidepressants for ≥6 weeks, Beck depression inventory [BDI] score ≥14 and international classification of diseases [ICD]-10 criteria for depression) from 73 UK general practices. Participants were randomised, with a computer generated code (stratified by centre and minimised according to baseline BDI score, whether the general practice had a counsellor, previous treatment with antidepressants, and duration of present episode of depression) to one of two groups: usual care or CBT in addition to usual care, and were followed up for 12 months. Because of the nature of the intervention it was not possible to mask participants, general practitioners, CBT therapists, or researchers to the treatment allocation. Analyses were by intention to treat. The primary outcome was response, defined as at least 50% reduction in depressive symptoms (BDI score) at 6 months compared with baseline. This trial is registered, ISRCTN38231611. FINDINGS: Between Nov 4, 2008, and Sept 30, 2010, we assigned 235 patients to usual care, and 234 to CBT plus usual care. 422 participants (90%) were followed up at 6 months and 396 (84%) at 12 months, finishing on Oct 31, 2011. 95 participants (46%) in the intervention group met criteria for response at 6 months compared with 46 (22%) in the usual care group (odds ratio 3·26, 95% CI 2·10-5·06, p<0·001). INTERPRETATION: Before this study, no evidence from large-scale randomised controlled trials was available for the effectiveness of augmentation of antidepressant medication with CBT as a next-step for patients whose depression has not responded to pharmacotherapy. Our study has provided robust evidence that CBT as an adjunct to usual care that includes antidepressants is an effective treatment, reducing depressive symptoms in this population. FUNDING: National Institute for Health Research Health Technology Assessment.

Cost-effectiveness of cognitive-behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: economic evaluation of the CoBalT Trial.

BACKGROUND: Depression is expensive to treat, but providing ineffective treatment is more expensive. Such is the case for many patients who do not respond to antidepressant medication. AIMS: To assess the cost-effectiveness of cognitive-behavioural therapy (CBT) plus usual care for primary care patients with treatment-resistant depression compared with usual care alone. METHOD: Economic evaluation at 12 months alongside a randomised controlled trial. Cost-effectiveness assessed using a cost-consequences framework comparing cost to the health and social care provider, patients and society, with a range of outcomes. Cost-utility analysis comparing health and social care costs with quality-adjusted life-years (QALYs). RESULTS: The mean cost of CBT per participant was £910. The difference in QALY gain between the groups was 0.057, equivalent to 21 days a year of good health. The incremental cost-effectiveness ratio was £14 911 (representing a 74% probability of the intervention being cost-effective at the National Institute of Health and Care Excellence threshold of £20 000 per QALY). Loss of earnings and productivity costs were substantial but there was no evidence of a difference between intervention and control groups. CONCLUSIONS: The addition of CBT to usual care is cost-effective in patients who have not responded to antidepressants. Primary care physicians should therefore be encouraged to refer such individuals for CBT.

Exploring GPs' views on beta-blocker prescribing for people with anxiety disorders: a qualitative study.

BACKGROUND: Between 2003-2018, incident prescriptions of beta-blockers for anxiety increased substantially, particularly in young adults. NICE guidance for anxiety does not recommend beta-blockers, probably due to a lack of evidence to support such use. Recent reports have highlighted the potential risks of beta-blockers. AIM: To understand when and why GPs prescribe beta-blockers for people with anxiety. DESIGN AND SETTING: In-depth interviews with 17 GPs. METHOD: Interviews were held by telephone or videocall. A topic guide was used to ensure consistency across interviews. Interviews were audio-recorded, transcribed verbatim and analysed thematically. RESULTS: Many GPs viewed beta-blockers as 'low-risk', particularly in young adults. Some GPs viewed beta-blockers as an alternative to benzodiazepines, acting quickly and not leading to dependence. GPs reflected that some patients appeared to want an 'immediate fix' to their symptoms which GPs thought beta-blockers could potentially offer. This was salient in light of substantial waiting lists for talking therapies and delays in antidepressants taking effect. GPs described how some patients seemed more willing to try beta-blockers than antidepressants, as patients did not perceive them as 'mental health drugs' and therefore potentially more acceptable and less stigmatising. Further, GPs viewed beta-blockers as 'patient-led', with patients managing their own dose and frequency, without GP input. CONCLUSION: Many GPs think beta-blockers have a role to play in the management of anxiety. Given recent increases in the prescribing of these drugs in primary care, there is a need to assess their safety and effectiveness as a treatment for people with anxiety disorders.