Tailored psychological intervention for anxiety or depression in COPD (TANDEM): a randomised controlled trial.

BACKGROUND: The TANDEM multicentre, pragmatic, randomised controlled trial evaluated whether a tailored psychological intervention based on a cognitive behavioural approach for people with COPD and symptoms of anxiety and/or depression improved anxiety or depression compared with usual care (control). METHODS: People with COPD and moderate to very severe airways obstruction and Hospital Anxiety and Depression Scale subscale scores indicating mild to moderate anxiety (HADS-A) and/or depression (HADS-D) were randomised 1.25:1 (242 intervention and 181 control). Respiratory health professionals delivered the intervention face-to-face over 6-8 weeks. Co-primary outcomes were HADS-A and HADS-D measured 6 months post-randomisation. Secondary outcomes at 6 and 12 months included: HADS-A and HADS-D (12 months), Beck Depression Inventory II, Beck Anxiety Inventory, St George's Respiratory Questionnaire, social engagement, the EuroQol instrument five-level version (EQ-5D-5L), smoking status, completion of pulmonary rehabilitation, and health and social care resource use. RESULTS: The intervention did not improve anxiety (HADS-A mean difference -0.60, 95% CI -1.40-0.21) or depression (HADS-D mean difference -0.66, 95% CI -1.39-0.07) at 6 months. The intervention did not improve any secondary outcomes at either time-point, nor did it influence completion of pulmonary rehabilitation or healthcare resource use. Deaths in the intervention arm (13/242; 5%) exceeded those in the control arm (3/181; 2%), but none were associated with the intervention. Health economic analysis found the intervention highly unlikely to be cost-effective. CONCLUSION: This trial has shown, beyond reasonable doubt, that this cognitive behavioural intervention delivered by trained and supervised respiratory health professionals does not improve psychological comorbidity in people with advanced COPD and depression or anxiety.

The Recovery Journey and the Rehabilitation Boat - A qualitative study to explore experiences of COVID-19 rehabilitation.

INTRODUCTION: There are early data to suggest that a rehabilitation programme can help with on-going symptoms of COVID-19, including breathlessness, exercise limitation and fatigue. As yet, there are no published data to understand patients' perceived acceptability of a rehabilitation programme for COVID-19. METHODS: 2 focus groups (n = 9) and 4 one to one interviews were conducted with participants who attended a rehabilitation program following COVID-19. Interviews were analysed using reflexive thematic analysis with an inductive approach. RESULTS: Two overarching themes were generated from the data. The first, The Recovery Journey is sub-divided into five sub-themes of Expectations, Individual and Varied Journeys, Mental and Physical Improvements, Self-values and The Journey Continues. The second overarching theme, The Rehabilitation boat contains five subthemes: Programme Delivery, Safe and Supportive, Validation and Assurance, Shared Reflections and Education. CONCLUSION: A rehabilitation programme for post COVID-19 symptoms was considered to be acceptable and viewed positively in terms of improving physical and mental symptoms. The opportunity to share the experience with others in the same boat was highly valued in the context of an unexpected and potentially lonely COVID-19 recovery.

The Training to Improve Dyspnoea Study- Patient Experiences of Using a High Frequency Airway Oscillating Device.

Introduction: The High Frequency Airway Oscillating device (HFAO) was developed to help patients with COPD feel less breathless through flow resistive respiratory muscle training and fixed rate oscillations. Previous work has demonstrated that this device can improve inspiratory muscle strength over and above a sham device. Both groups improved their breathlessness and preserved clinical benefits though there were no statistically significant differences seen over and above the sham device. It is important to understand patient perceptions of using a device and how this may influence their treatment and therefore a qualitative analysis was conducted to understand participant experiences of a HFAO device. Methods: This was an exploratory qualitative analysis involving participants recruited to the Training to Improve Dyspnoea (TIDe) study. Participants completed a satisfaction survey and were invited to take part in a focus group. Focus groups were conducted by a researcher independent to the randomised controlled trial. Data was analysed independently by two researchers using inductive thematic analysis, and themes/sub-themes were agreed jointly. Data is presented in themes and sub themes and triangulated with survey response data. Results: Fourteen participants were recruited to two focus groups (71% male, mean [SD] age 64[9] years). The key themes were patient selection, device use, and investment. Patient selection explores the disease characteristics, emotional impact and management of care. Device use explores the device prescription and usage, routine and lifestyle and effectiveness. Investment covers accessibility, understanding, benefits vs participation and overall perceptions of the device. Conclusion: This research demonstrates the complexity of device interventions and that key considerations should be given to patient selection, the device use itself and, the time and cost investment required for participants to successfully implement the device into daily life.

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.

Exploring the Presence of Implicit Bias Amongst Healthcare Professionals Who Refer Individuals Living with COPD to Pulmonary Rehabilitation with a Specific Focus Upon Smoking and Exercise.

Background: We are developing a shared decision-making intervention for individuals with COPD who are deciding between Pulmonary Rehabilitation (PR) programme options. Previously, we identified Healthcare Professional (HCP) beliefs about the characteristics of COPD individuals as a barrier to PR conversations. Beliefs can lead to implicit biases which influence behaviour. To inform our shared decision-making intervention, we aimed to measure the presence of implicit bias amongst HCPs who refer individuals with COPD to PR. Methods: We utilised the Implicit Association Test to measure HCPs response times when categorising words related to smoking or exercise (eg stub, run) to matching concepts or evaluations of concepts (eg "smoking, unpleasant" or "exercise, pleasant") and unmatching concepts or evaluations of concepts (eg "smoking, pleasant" or "exercise, unpleasant"). We approached HCPs across the UK. Following consent, we collected demographic data and then administered the test. The primary outcome was the standardised mean difference in response times from the matching and unmatching categorisations (D4-score), measured using a one-sample Wilcoxon Signed Rank Test. We explored the relationship between HCP demographics and their D4-scores using Spearman Rho correlation analysis and logistic regression. Results: Of 124 HCPs screened, 104 (83.9%) consented. Demographic data were available for 88 (84.6%). About 68.2% were female and most (28.4%) were in the 45-54 years age category. Test data were available for 69 (66.3%) participants. D4-scores ranged from 0.99 to 2.64 indicating implicit favouring of matching categorisation (MD-score = 1.69, SDD-score = 0.38, 95% CID-score 1.60-1.78, p < 0.05). This was significantly different from zero, z = -7.20, p < 0.05, with a large effect size (r = 0.61, (28)). No demographic predictors of implicit bias were identifiable. Conclusion: HCPs demonstrated negative bias towards smoking and positive bias towards exercising. Since implicit bias impacts behaviour, we plan to develop intervention components (eg decision coaching training) to enable HCPs to fully and impartially support shared decision-making for a menu of PR options.

Systematic review of shared decision-making interventions for people living with chronic respiratory diseases.

OBJECTIVE: Shared decision-making (SDM) supports patients to make informed and value-based decisions about their care. We are developing an intervention to enable healthcare professionals to support patients' pulmonary rehabilitation (PR) decision-making. To identify intervention components we needed to evaluate others carried out in chronic respiratory diseases (CRDs). We aimed to evaluate the impact of SDM interventions on patient decision-making (primary outcome) and downstream health-related outcomes (secondary outcome). DESIGN: We conducted a systematic review using the risk of bias (Cochrane ROB2, ROBINS-I) and certainty of evidence (Grading of Recommendations Assessment, Development and Evaluation) tools. DATA SOURCES: MEDLINE, EMBASE, PSYCHINFO, CINAHL, PEDRO, Cochrane Central Register of Controlled Trials, the International Clinical Trials Registry Platform Search Portal, ClinicalTrials.gov, PROSPERO, ISRCTN were search through to 11th April 2023. ELIGIBILITY CRITERIA: Trials evaluating SDM interventions in patients living with CRD using quantitative or mixed methods were included. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers extracted data, assessed risk of bias and certainty of evidence. A narrative synthesis, with reference to The Making Informed Decisions Individually and Together (MIND-IT) model, was undertaken. RESULTS: Eight studies (n=1596 (of 17 466 citations identified)) fulfilled the inclusion criteria.Five studies included components targeting the patient, healthcare professionals and consultation process (demonstrating adherence to the MIND-IT model). All studies reported their interventions improved patient decision-making and health-related outcomes. No outcome was reported consistently across studies. Four studies had high risk of bias, three had low quality of evidence. Intervention fidelity was reported in two studies. CONCLUSIONS: These findings suggest developing an SDM intervention including a patient decision aid, healthcare professional training, and a consultation prompt could support patient PR decisions, and health-related outcomes. Using a complex intervention development and evaluation research framework will likely lead to more robust research, and a greater understanding of service needs when integrating the intervention within practice. PROSPERO REGISTRATION NUMBER: CRD42020169897.

A pulmonary rehabilitation shared decision-making intervention for patients living with COPD: PReSent: protocol for a feasibility study.

Background: Despite the variety of pulmonary rehabilitation programmes for patients living with COPD, uptake remains low. To improve this, it is recommended that health professionals engage patients in informed decisions about pulmonary rehabilitation. Shared decision-making (SDM) facilitates informed and value-based decision-making between patients and health professionals. This protocol describes the development and evaluation of a complex SDM intervention for patients living with COPD, who are referred for pulmonary rehabilitation, and their pulmonary rehabilitation health professional. Methods and analysis: We are developing a complex SDM intervention involving a patient decision aid (PtDA) and a decision coaching workshop. Prior to patient recruitment, pulmonary rehabilitation health professionals will attend the workshop. Upon referral to pulmonary rehabilitation, patients will receive the PtDA to support their decision-making prior to and during their pulmonary rehabilitation assessment with a health professional. The intervention will be evaluated in a one-arm exploratory study to investigate its feasibility and acceptability for patients and health professionals, with an integrated fidelity assessment. The primary outcome is recruitment feasibility, data collection feasibility and intervention fidelity. Secondary outcomes include routine pulmonary rehabilitation data, decisional conflict, patient activation, intervention attendance/attrition and patient and pulmonary rehabilitation health professional experience of the intervention. Quantitative outcomes will be evaluated using the most appropriate statistical test, dependent on the sample distribution. Qualitative outcomes will be evaluated using reflexive thematic analysis. Fidelity will be assessed using the Observer OPTION 5 scale. Conclusion: This intervention will provide structure for an informed and values-based decision-making consultation between a patient with COPD and a pulmonary rehabilitation health professional with the potential for optimising pulmonary rehabilitation decision-making.

Web-Based Self-management Program (SPACE for COPD) for Individuals Hospitalized With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Nonrandomized Feasibility Trial of Acceptability.

BACKGROUND: Hospital admissions due to the acute exacerbation of chronic obstructive pulmonary disease (AECOPD) are costly for individuals and health services. Pulmonary rehabilitation (PR) is known to reduce hospital readmissions when delivered after hospitalization, but the uptake and completion of PR following hospitalization remains poor (<10% of those eligible in the UK audit data). A web-based platform of the SPACE (Self-management Program of Activity Coping and Education) for COPD (chronic obstructive pulmonary disease) has previously shown promising results in patients with stable COPD but has not been tested following an AECOPD. OBJECTIVE: This study aims to assess the feasibility and acceptability of a web-based self-management program. METHODS: A nonrandomized feasibility study for patients with confirmed AECOPD who were deemed web literate was conducted. All patients consented during their hospitalization and received access to the website following discharge in addition to usual care. The program aims to facilitate patients to better understand and manage their condition through education and home-based exercises. Participants were asked to complete the Bristol COPD Knowledge Questionnaire at baseline and after 6 months. A total of 14 participants were also interviewed (n=8 completers; n=6 noncompleters) regarding their experiences with the web-based program and trial. The interviews were analyzed using thematic analysis. RESULTS: In total, 2080 patients were screened for eligibility, of which 100 patients (age: mean 71.2 years, SD 9.3 years; male: 55/100, 55%; forced expiratory volume in 1 second/forced vital capacity ratio: mean 0.46, SD 0.14; pack-years: mean 50.2, SD 31.0; current smokers: 35/100, 35%) were recruited (4.8% of those screened). The main reason for ineligibility was a lack of web literacy (1366/1980, 68.98%). In total, 18% (18/100) of patients had completed the web program by 6 months, with others still registered in the program (27/100, 27%), and more than half did not register (55/100, 55%). There was a mean change in Bristol COPD Knowledge Questionnaire scores at 6 months of 7.8 (SD 10.2) points. Qualitative interviews identified three main themes: preparing for, engagement with, and benefits of the study and program. A total of 57% (57/100) accepted a referral to PR on discharge and 19% (19/100) had completed the program after 6 months. CONCLUSIONS: On the basis of the challenges of recruiting, retaining, and engaging participants in a web-based self-management program, it is not a feasible approach to roll out widely. This study acknowledges that this is a challenging time for patients with an AECOPD to engage in exercise and self-management education. However, for patients who were able to engage in such an intervention, the completion rate of PR was double the previous audit estimates from the United Kingdom, disease knowledge improved, and the intervention was of value to patients. TRIAL REGISTRATION: ISRCTN Registry 13081008; https://www.isrctn.com/ISRCTN13081008.

The TANDEM trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety and/or depression in people living with chronic obstructive pulmonary disease (COPD).

BACKGROUND: TANDEM is a randomised controlled trial of a complex healthcare intervention to improve the psychological and physical health of people living with chronic obstructive pulmonary disease (COPD) and anxiety and/or depression. Based on health psychology theory set out in a logic model, respiratory health professionals were recruited and trained to deliver a cognitive behavioural approach intervention (The TANDEM intervention) under the supervision of senior cognitive behavioural practitioners. Here, we describe the protocol for the process evaluation commissioned alongside the trial. A realist approach that includes attention to describing contexts and mechanisms has been adopted. METHODS: We set up a multi-disciplinary team to develop and deliver the process evaluation. The mixed-methods design incorporates quantitative process data; monitoring of intervention fidelity; qualitative interviews with patients, carers, health professionals (facilitators) and clinical supervisors about their perspectives on acceptability of the intervention; and exploration with all stakeholders (including management/policy-makers) on future implementation. Normalisation process theory (NPT) will inform data collection and interpretation with a focus on implementation. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before the trial outcomes are known using analytic induction and constant comparison to develop themes. Findings from the different elements will be reported separately and then integrated. CONCLUSION: Detailed description and analysis of study processes in a research trial such as TANDEM enables research teams to describe study contexts and mechanisms and to examine the relationship with outcomes. In this way, learning from the trial goes beyond the randomised control trial (RCT) model where effectiveness is prioritised and makes it possible to explore issues arising for post-trial study implementation. TRIAL REGISTRATION: ISRCTN ISRCTN59537391 . Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018. Process evaluation protocol version 4.0, 1 November 2020.

British Thoracic Society survey of rehabilitation to support recovery of the post-COVID-19 population.

OBJECTIVE: A proportion of those recovering from COVID-19 are likely to have significant and ongoing symptoms, functional impairment and psychological disturbances. There is an immediate need to develop a safe and efficient discharge process and recovery programme. Established rehabilitation programmes are well placed to deliver a programme for this group but will most likely need to be adapted for the post-COVID-19 population. The purpose of this survey was to rapidly identify the components of a post-COVID-19 rehabilitation assessment and elements of a successful rehabilitation programme that would be required to deliver a comprehensive service for those post-COVID-19 to inform service delivery. DESIGN: A survey comprising a series of closed questions and a free-text comment box allowing for a qualitative analysis. SETTING: Online survey. PARTICIPANTS: Multiprofessional clinicians across specialties were invited to take part. RESULTS: 1031 participants responded from a broad range of specialties. There was overwhelming support for an early posthospital discharge recovery programme to advise patients about the management of fatigue (95% agreed/strongly agreed), breathlessness (94%) and mood disturbances (including symptoms of anxiety and depression, 92%). At the time point of 6-8 weeks, an assessment was considered important, focusing on a broad range of possible symptoms and supporting a return to work. Recommendations for the intervention described a holistic programme focusing on symptom management, return of function and return to employment. The free-text comments added depth to the survey and the need 'not to reinvent the wheel' but rather adapt well-established rehabilitation services to individually tailor needs-based care with continued learning for service development. CONCLUSION: The responses indicate a huge interest and the urgent need to establish a programme to support and mitigate the long-term impact of COVID-19 by optimising and individualising existing rehabilitation programmes.