A tailored psychological intervention for anxiety and depression management in people with chronic obstructive pulmonary disease: TANDEM RCT and process evaluation.

Background: People with chronic obstructive pulmonary disease have high levels of anxiety and depression, which is associated with increased morbidity and poor uptake of effective treatments, such as pulmonary rehabilitation. Cognitive-behavioural therapy improves mental health of people with long-term conditions and could potentially increase uptake of pulmonary rehabilitation, enabling synergies that could enhance the mental health of people with chronic obstructive pulmonary disease. Aim: Our aim was to develop and evaluate the clinical effectiveness and cost effectiveness of a tailored cognitive-behavioural approach intervention, which links into, and optimises the benefits of, routine pulmonary rehabilitation. Design: We carried out a pragmatic multicentre randomised controlled trial using a 1.25 : 1 ratio (intervention : control) with a parallel process evaluation, including assessment of fidelity. Setting: Twelve NHS trusts and five Clinical Commissioning Groups in England were recruited into the study. The intervention was delivered in participant's own home or at a local NHS facility, and by telephone. Participants: Between July 2017 and March 2020 we recruited adults with moderate/very severe chronic obstructive pulmonary disease and mild/moderate anxiety and/or depression, meeting eligibility criteria for assessment for pulmonary rehabilitation. Carers of participants were invited to participate. Intervention: The cognitive-behavioural approach intervention (i.e. six to eight 40- to 60-minute sessions plus telephone support throughout pulmonary rehabilitation) was delivered by 31 trained respiratory healthcare professionals to participants prior to commencing pulmonary rehabilitation. Usual care included routine pulmonary rehabilitation referral. Main outcome measures: Co-primary outcomes were Hospital Anxiety and Depression Scale - anxiety and Hospital Anxiety and Depression Scale - depression at 6 months post randomisation. Secondary outcomes at 6 and 12 months included health-related quality of life, smoking status, uptake of pulmonary rehabilitation and healthcare use. Results: We analysed results from 423 randomised participants (intervention, n = 242; control, n = 181). Forty-three carers participated. Follow-up at 6 and 12 months was 93% and 82%, respectively. Despite good fidelity for intervention delivery, mean between-group differences in Hospital Anxiety and Depression Scale at 6 months ruled out clinically important effects (Hospital Anxiety and Depression Scale - anxiety mean difference -0.60, 95% confidence interval -1.40 to 0.21; Hospital Anxiety and Depression Scale - depression mean difference -0.66, 95% confidence interval -1.39 to 0.07), with similar results at 12 months. There were no between-group differences in any of the secondary outcomes. Sensitivity analyses did not alter these conclusions. More adverse events were reported for intervention participants than for control participants, but none related to the trial. The intervention did not generate quality-of-life improvements to justify the additional cost (adjusted mean difference £770.24, 95% confidence interval -£27.91 to £1568.39) to the NHS. The intervention was well received and many participants described positive affects on their quality of life. Facilitators highlighted the complexity of participants' lives and considered the intervention to be of potential valuable; however, the intervention would be difficult to integrate within routine clinical services. Our well-powered trial delivered a theoretically designed intervention with good fidelity. The respiratory-experienced facilitators were trained to deliver a low-intensity cognitive-behavioural approach intervention, but high-intensity cognitive-behavioural therapy might have been more effective. Our broad inclusion criteria specified objectively assessed anxiety and/or depression, but participants were likely to favour talking therapies. Randomisation was concealed and blinding of outcome assessment was breached in only 15 participants. Conclusions: The tailored cognitive-behavioural approach intervention delivered with fidelity by trained respiratory healthcare professionals to people with chronic obstructive pulmonary disease was neither clinically effective nor cost-effective. Alternative approaches that are integrated with routine long-term condition care are needed to address the unmet, complex clinical and psychosocial needs of this group of patients. Trial registration: This trial is registered as ISRCTN59537391. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/146/02) and is published in full in Health Technology Assessment; Vol. 28, No. 1. See the NIHR Funding and Awards website for further award information.

People with long-standing lung problems, such as chronic obstructive pulmonary disease, often also have anxiety and depression, which further reduces their quality of life. Two existing treatments could help. Pulmonary rehabilitation (a programme of exercise and education) improves both the physical and mental health of people with chronic obstructive pulmonary disease. Cognitive­behavioural therapy (a talking therapy) may reduce anxiety and depression. The TANDEM [Tailored intervention for Anxiety and Depression Management in chronic obstructive pulmonary disease (COPD)] intervention linked these two treatments by providing talking therapy based on cognitive­behavioural therapy during the waiting time following referral for pulmonary rehabilitation. The TANDEM treatment was delivered by respiratory healthcare professionals (e.g. nurses or physiotherapists) trained to deliver the talking therapy in six to eight weekly sessions. The sessions were conducted in the participant's home (or another convenient location), with brief telephone support during the pulmonary rehabilitation. Of 423 participants recruited to the study, 242 participants received TANDEM talking therapy and 181 participants received usual care (including a referral to pulmonary rehabilitation). We measured mental health, quality of life, social life, attendance at pulmonary rehabilitation and healthcare use in both groups at 6 and 12 months. Forty-three carers joined the study and we assessed their mental well-being. We interviewed patients, carers and health professionals to find out their views and experience of the TANDEM treatment. We also examined whether or not the TANDEM treatment was good value for money. The TANDEM treatment did not improve the mental or the physical health of people with chronic obstructive pulmonary disease. In addition, the TANDEM treatment cost the NHS an extra £770 per patient, which was not good value for money. The TANDEM treatment was well received, and many participants told us how it had helped them. Heath-care professionals noted how participants did not just have chronic obstructive pulmonary disease, but were coping with many physical, mental and social problems. The TANDEM intervention was not effective and, therefore, other strategies will be needed to help people with chronic obstructive pulmonary disease and mental health problems live with their condition.

Cognitive behavioural therapy combined with physical activity behavioural modification strategies during pulmonary rehabilitation in patients with COPD.

Introduction: Patients with COPD who exhibit elevated levels of anxiety and/or depression are typically less able to improve symptoms and physical activity levels following a programme of pulmonary rehabilitation (PR). The objective of the present study was to provide proof of concept that offering an intervention comprising cognitive behavioural therapy (CBT) alongside physical activity behavioural modification strategies (BPA) during PR is more effective in improving physical activity outcomes compared to PR and CBT alone. Methods: 32 patients with COPD (mean±sd forced expiratory volume in 1 s 42±14% predicted) were assigned 1:1 to receive PR+CBT+BPA or PR+CBT. BPA comprised motivational interviews, step-count monitoring, feedback using a pedometer and goal setting. Assessments included accelerometer-derived steps per day, movement intensity, 6-min walk distance (6MWD) and Hospital Anxiety and Depression Scale (HADS) scores. Results: The magnitude of improvement across physical activity outcomes was greater for the PR+CBT+BPA compared to the PR+CBT intervention (by 829 steps per day (p=0.029) and by 80±39 vector magnitude units (p=0.042), respectively). Compared to PR and CBT alone, the PR+CBT+BPA intervention induced greater clinically meaningful improvements in HADS anxiety scores (by -2 units, 95% CI -4-1 units) and 6MWD (by 33±20 m). Conclusions: Providing anxious and/or depressed patients with COPD with a combined intervention of CBT and BPA during PR presents more favourable improvements in physical activity outcome measures compared to CBT alone during PR.

Self-management in chronic lung disease: what is missing?

Self-management, as a strategy to support those living with chronic respiratory conditions such as asthma and COPD, has been widely advocated in guidelines and adopted in practice. However, there can be a disconnect between the goals of patients and healthcare professionals. Goals and barriers to self-management are often compounded by the complex social, emotional and medical needs of patients. People living with chronic respiratory conditions also often have symptoms of anxiety and depression, which can impact on self-management. Self-management therefore requires patients and healthcare professionals to work together and it is essential to involve patients when designing, implementing and evaluating self-management interventions. Patient preferences are clearly important and goal setting needs an individual, flexible and responsive approach from healthcare professionals, which aligns to a more personalised approach to management of treatable traits and the burden of disease. To achieve these goals, healthcare professionals need education to support patients in self-management and behaviour change. This approach should lead to shared decision-making and partnership working that puts the patient right at the centre of their care.

Need and baseline for harmonising nursing education in respiratory care: preliminary results of a global survey.

Background: The COVID-19 pandemic confirmed that respiratory nurses are critical healthcare providers. Limited knowledge is available about appropriate education to prepare nurses to deliver high-quality respiratory care. A survey was developed by the International Coalition for Respiratory Nursing (ICRN) group to identify the need for a respiratory nursing core curriculum. Method: A 39-item survey was distributed to 33 respiratory nursing experts in 27 countries. Questions asked about current roles, perception of need, expectations for a core curriculum project and respiratory content in nursing education in their countries. Results: 30 responses from 25 countries were analysed; participants predominantly worked in academia (53.3%, 16/30) and clinical practice (40%, 12/30). In total, 97% (29/30) confirmed a need for a core respiratory nursing curriculum. Post-registration nursing programmes at bachelor (83.3%, 25/30) and masters (63.3%, 19/30) levels include internal/medical nursing care; less than half identified separate respiratory nursing content. The core educational programme developed should include knowledge (70%, 21/30), skills (60%, 18/30), and competencies (50%, 15/30), with separate paediatric and adult content. Conclusion: Survey results confirm a wide variation in nursing education and respiratory nursing education across the world, with many countries lacking any formal educational programmes to prepare nurses capable of providing enhanced quality respiratory care. These findings support the need for a core respiratory curriculum. To advance this significant work the ICRN group plans to conduct a Delphi study to identify core curriculum requirements for respiratory nursing education at pre-registration and advanced educational levels to flexibly meet each country's specific educational requirements for recognition of respiratory nursing speciality practice.

Feasibility and acceptability of a physical activity behavioural modification tele-coaching intervention in lung transplant recipients.

BACKGROUND: Despite improvements in pulmonary function following lung transplantation (LTx), physical activity levels remain significantly lower than the general population. To date, there is little research investigating interventions to improve daily physical activity in LTx recipients. This study assessed the feasibility and acceptability of a novel, 12-weeks physical activity tele-coaching (TC) intervention in LTx recipients. METHODS: Lung transplant recipients within 2 months of hospital discharge were recruited and randomised (1:1) to TC or usual care (UC). TC consists of a pedometer and smartphone app, allowing transmission of activity data to a platform that provides feedback, activity goals, education, and contact with the researcher as required. Recruitment and retention, occurrence of adverse events, intervention acceptability and usage were used to assess feasibility. RESULTS: Key criteria for progressing to a larger study were met. Of the 15 patients eligible, 14 were recruited and randomised to TC or UC and 12 completed (67% male; mean ± SD age; 58 ± 7 years; COPD n = 4, ILD n = 6, CF n = 1, PH n = 1): TC (n = 7) and UC (n = 5). TC was well accepted by patients, with 86% indicating that they enjoyed taking part. Usage of the pedometer was excellent, with all patients wearing it for over 90% of days and rating the pedometer and telephone contact as the most vital aspects. There were no adverse events related to the intervention. After 12 weeks, only TC displayed improvements in accelerometry steps/day (by 3475 ± 3422; p = .036) and movement intensity (by 153 ± 166 VMU; p = .019), whereas both TC and UC groups exhibited clinically important changes in physical SF-36 scores (by 11 ± 14 and 7 ± 9 points, respectively). CONCLUSION: TC appears to be a feasible, safe, and well-accepted intervention in LTx.

Developing a complex intervention whilst considering implementation: the TANDEM (Tailored intervention for ANxiety and DEpression Management) intervention for patients with chronic obstructive pulmonary disease (COPD).

BACKGROUND: Guidelines now call for a thorough and comprehensive description of the development of healthcare interventions to aid evaluation and understanding of the processes of change. This was the primary aim of this study but we also recognised that effective interventions are commonly not implemented in clinical practice. It is suggested that insufficient attention is given to the implementation process at the development phase of interventions. This study outlines the 5 step iterative process we adopted for considering both implementation and effectiveness issues from the outset of intervention development. We use the development of a complex intervention Tailored intervention for ANxiety and DEpression Management (TANDEM) in patients with chronic obstructive pulmonary disease to illustrate this process. METHODS: Intervention development built upon the Medical Research Council framework for developing complex interventions and the person-based approach for development of behavioural interventions. Building an expert team, specifying theory, qualitative data collection and pre-piloting were all critical steps in our intervention development and are described here. RESULTS: Contact with experts in the field, and explicitly building on previous work, ensured efficiency of design. Qualitative work suggested guiding principles for the intervention such as introducing mood in relation to breathlessness, and providing flexible tailoring to patients' needs, whilst implementation principles focused on training selected respiratory professionals and requiring supervision to ensure standards of care. Subsequent steps of intervention development, pre-piloting and intervention refinement led to an intervention that was deemed acceptable and if successful will be ready for implementation. CONCLUSIONS: The TANDEM study was developed efficiently by building on previous work and considering implementation issues from the outset, with the aim that if shown to be effective it will have more rapid translation in to the health care system with accelerated patient benefits. TRIAL REGISTRATION: ISRCTN ISRCTN59537391 . Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.

Tailored, psychological intervention for anxiety or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): protocol for a randomised controlled trial.

BACKGROUND: People with chronic obstructive pulmonary disease (COPD) are at increased risk of depression and anxiety, which greatly reduces their quality of life and is associated with worse outcomes; but these psychological co-morbidities are under-recognised and undertreated in COPD patients. Pulmonary rehabilitation (PR) improves mood for up to 6 months but health practitioners under-refer, and patients commonly fail to attend/complete PR. Research suggests that complex non-pharmacological interventions, including both psychological and exercise components, may reduce anxiety and depression in COPD. We have developed a tailored, cognitive behavioural approach (CBA) intervention for patients with COPD and co-morbid anxiety and/or depression ('TANDEM'), which precedes and optimises the benefits of currently offered PR. We hypothesise that such a psychological intervention, delivered by supervised, trained respiratory healthcare professionals, will improve mood in patients with mild to moderate anxiety and/or depression and encourage uptake and completion of PR. METHODS: We will conduct a multi-centre, pragmatic, randomised controlled trial of the TANDEM intervention compared to usual care across the Midlands, London, the South East and Bristol, UK. We will train healthcare professionals familiar with COPD to deliver the manualised, tailored, face-to-face, one-to-one intervention weekly for 6-8 weeks. We will recruit 430 participants from primary, community and secondary care with confirmed COPD and moderate to very severe airflow limitation, who are eligible for assessment for PR, and who screen positive for symptoms of mild/moderate depression and/or anxiety using the Hospital Anxiety and Depression scale (HADS). Participants will be randomised 1.25:1 (intervention: usual care). The co-primary outcomes are the HADS anxiety and depression subscale scores at 6 months; participants will be followed up to 12 months. Secondary outcomes include uptake and completion of PR and healthcare resource use. There will be a parallel process evaluation and a health economic evaluation. DISCUSSION: The TANDEM intervention has the potential to optimise the unrealised synergy between a psychological intervention and PR. The CBA sessions will precede PR and target individuals' cognitions, behaviours and symptoms associated with anxiety and depression to decrease psychological morbidity and increase effective self-management amongst patients with COPD. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN59537391. Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.

Impact of COVID-19 shielding on physical activity and quality of life in patients with COPD.

In response to #COVID19, healthcare professionals should scale up virtual consultations for assessing core patient-reported outcomes and providing home-based rehabilitation programmes #COPD https://bit.ly/30gQEpG.

The role of cognitive behavioural therapy in living well with COPD.

Psychological ill health is very common in COPD; CBT may be a key step towards improving the care of COPD patients http://ow.ly/fb8j30onfPj.

Randomised controlled trial of cognitive behavioural therapy in COPD.

Anxiety is an important comorbidity in chronic obstructive pulmonary disease (COPD). We investigated if cognitive behavioural therapy (CBT), delivered by respiratory nurses, reduced symptoms of anxiety and was cost-effective. Patients with COPD and anxiety were randomised to CBT or self-help leaflets. Anxiety, depression and quality of life were measured at baseline, 3, 6 and 12 months. A cost-effectiveness analysis was conducted from a National Health Service hospital perspective and quality-adjusted life-years estimated using the EuroQol-5D questionnaire. In total, 279 patients were recruited. Group mean change from baseline to 3 months in the Hospital Anxiety and Depression Anxiety Subscale was 3.4 (95% CI 2.62-4.17, p<0.001) for the CBT group and 1.88 (95% CI 1.19-2.55, p<0.001) in the leaflet group. The CBT group was superior to leaflets at 3 months (mean difference in the Hospital Anxiety and Depression Anxiety Subscale was 1.52, 95% CI 0.49-2.54, p=0.003). Importantly, the CBT intervention was more cost-effective than leaflets at 12 months, significantly lowering hospital admissions and attendance at emergency departments. CBT delivered by respiratory nurses is a clinically and cost-effective treatment for anxiety in patients with COPD relative to self-help leaflets.

Qualitative systematic review of barriers and facilitators to self-management of chronic obstructive pulmonary disease: views of patients and healthcare professionals.

Self-management interventions for chronic obstructive pulmonary disease (COPD) can improve quality of life, reduce hospital admissions, and improve symptoms. However, many factors impede engagement for patients and practitioners. Qualitative research, with its focus on subjective experience, can provide invaluable insights into such factors. Therefore, a systematic review and synthesis of qualitative evidence on COPD self-management from the perspective of patients, carers, and practitioners was conducted. Following a systematic search and screening, 31 studies were appraised and data extracted for analysis. This review found that patients can adapt to COPD; however, learning to self-manage is often a protracted process. Emotional needs are considerable; frustration, depression, and anxiety are common. In addition, patients can face an assortment of losses and limitations on their lifestyle and social interaction. Over time, COPD can consume their existence, reducing motivation. Support from family can prove vital, yet tinged with ambivalence and burden. Practitioners may not have sufficient time, resources, or appropriate skills or confidence to provide effective self-management support, particularly in regard to patients' psychosocial needs. This can compound patients' capability to engage in self-management. For COPD self-management to be effective, patients' psychosocial needs must be prioritised alongside medication and exacerbation management. In addition, patients' personal beliefs regarding COPD and its management should be reviewed periodically to avoid problematic behaviours and enhance positive adaptions to the disease. Patients with COPD are not a homogenous group and no one intervention will prove effective for all. Finally, practitioners require greater education, training, and support to successfully assist patients.

Understanding the factors affecting self-management of COPD from the perspectives of healthcare practitioners: a qualitative study.

Self-management is recognised as an essential criteria for the provision of high quality care for chronic obstructive pulmonary disease (COPD). The management of COPD is usually delivered by a wide range of healthcare practitioners. This study aimed to understand the factors affecting self-management of COPD from the perspectives of the different multidisciplinary healthcare teams involved in COPD care. Semi-structured interviews were conducted with participants from primary care, specialist respiratory and pulmonary rehabilitation (PR) teams. Purposive sampling and snowballing were employed in participant recruitment. All interviews were audio-recorded and transcribed verbatim and data were analysed thematically. A total of 20 participants (eight primary care practitioners, seven respiratory specialists and five PR practitioners) were interviewed until data saturation was reached. Participants identified a range of complex and interrelated factors affecting COPD self-management that were grouped into three broad categories-patient, practitioner and organisational/system-level factors. Patient-level factors were predominantly considered as barriers, with COPD knowledge and understanding, and the individual patients' life circumstances/context being the most prominent issues. Practitioner-level factors identified were practitioners' speciality, interest and experience in respiratory conditions as the overarching factor that influenced how self-management was understood and practiced. A number of organisational/system-level factors were identified by all practitioners, including inconsistency of referral pathways and the wide variations of different self-management planning tools. Factors affecting self-management of COPD across these three levels need to be tackled equally in order to improve the effectiveness of interventions and to embed and integrate self-management support approaches into routine practice. CHRONIC LUNG DISEASE: A BALANCED APPROACH FOR IMPROVED SELF-MANAGEMENT: Better co-ordination between healthcare services, practitioners and patients may help improve self-management for chronic lung disease. Self-management is crucial for patients with chronic obstructive pulmonary disease (COPD), but it can be difficult for healthcare workers to monitor and support patient progress. Oladapo Ogunbayo at Newcastle University, UK, and co-workers conducted interviews with healthcare practitioners to explore perceived barriers to successful self-management of COPD. Three distinct categories emerged; those at patient level, practitioner level and organisational level, the needs of which should be carefully balanced to improved self-management. Patient knowledge and understanding of COPD, alongside individual life circumstances, were often barriers to effective self-care. Those practitioners with specialist respiratory knowledge took a more holistic approach to self-management than their primary care counterparts. A lack of continuity between services and across self-management planning tools presented further barriers.

Features of self-management interventions for people with COPD associated with improved health-related quality of life and reduced emergency department visits: a systematic review and meta-analysis.

BACKGROUND: Self-management interventions (SMIs) are recommended for individuals with COPD to help monitor symptoms and optimize health-related quality of life (HRQOL). However, SMIs vary widely in content, delivery, and intensity, making it unclear which methods and techniques are associated with improved outcomes. This systematic review aimed to summarize the current evidence base surrounding the effectiveness of SMIs for improving HRQOL in people with COPD. METHODS: Systematic reviews that focused upon SMIs were eligible for inclusion. Intervention descriptions were coded for behavior change techniques (BCTs) that targeted self-management behaviors to address 1) symptoms, 2) physical activity, and 3) mental health. Meta-analyses and meta-regression were used to explore the association between health behaviors targeted by SMIs, the BCTs used, patient illness severity, and modes of delivery, with the impact on HRQOL and emergency department (ED) visits. RESULTS: Data related to SMI content were extracted from 26 randomized controlled trials identified from 11 systematic reviews. Patients receiving SMIs reported improved HRQOL (standardized mean difference =-0.16; 95% confidence interval [CI] =-0.25, -0.07; P=0.001) and made fewer ED visits (standardized mean difference =-0.13; 95% CI =-0.23, -0.03; P=0.02) compared to patients who received usual care. Patients receiving SMIs targeting mental health alongside symptom management had greater improvement of HRQOL (Q=4.37; P=0.04) and fewer ED visits (Q=5.95; P=0.02) than patients receiving SMIs focused on symptom management alone. Within-group analyses showed that HRQOL was significantly improved in 1) studies with COPD patients with severe symptoms, 2) single-practitioner based SMIs but not SMIs delivered by a multidisciplinary team, 3) SMIs with multiple sessions but not single session SMIs, and 4) both individual- and group-based SMIs. CONCLUSION: SMIs can be effective at improving HRQOL and reducing ED visits, with those targeting mental health being significantly more effective than those targeting symptom management alone.