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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.

ABSTRACT: 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.

SUBMITTER: Sohanpal R

PROVIDER: S-EPMC6945421 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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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.

Sohanpal Ratna R Pinnock Hilary H Steed Liz L Heslop Marshall Karen K Chan Claire C Kelly Moira M Priebe Stefan S Roberts C Michael CM Singh Sally S Smuk Melanie M Saqi-Waseem Sarah S Healey Andy A Underwood Martin M White Patrick P Warburton Chris C Taylor Stephanie J C SJC

Trials 20200106 1

<h4>Background</h4>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-pharmacolog ...[more]

PMID: 31907074

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Project description:BackgroundGuidelines 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.MethodsIntervention 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.ResultsContact 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.ConclusionsThe 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 registrationISRCTN ISRCTN59537391 . Registered on 20 March 2017. Protocol version 6.0, 22 April 2018.

Project description:Chronic obstructive pulmonary disease (COPD) is commonly associated with anxiety/depression which can affect self-management and quality of life. The TANDEM trial evaluated a cognitive behavioural approach intervention targeting COPD-related symptoms of anxiety and/or depression, comprising up to eight one-to-one sessions delivered by respiratory healthcare professionals prior to pulmonary rehabilitation (PR). The intervention showed no improvement in anxiety/depression or uptake/completion of PR. We present patient perspectives of the intervention to help understand these results. Semi-structured individual interviews, using a semi-structured topic guide informed by Sekhon's Theoretical Framework of Acceptability, were conducted with 19 patients between September 2019 and April 2020. The interviews were audio-recorded, transcribed verbatim and analysed thematically. The following could have limited the impact of the intervention: (1) The lives of patients were complex and commonly affected by competing comorbidities or other external stressors which they managed through previously adopted long-standing coping strategies. (2) Some patients were reluctant to talk about their mood despite the Facilitators' training and person centred-skills which aimed to enable patients to talk freely about mood. (3) The intervention handouts and 'home-practice' were perceived as helpful for some, but not suitable for all. (4) Many patients perceived improvements in their physical and mental health, but this was not sustained due to a mix of personal and external factors, and some did not perceive any benefits. (5) PR non-attendance/non-completion was a result of personal and PR service-related reasons. (6) Discussing COPD and mental health with the Facilitator was a novel experience. Many patients felt that TANDEM could be of benefit if it was offered earlier on/at different time points in the COPD illness journey. We found the delivery of TANDEM prior to PR was not helpful for patients with advanced COPD often experiencing other comorbidities, and/or difficult personal/external events. These patients already utilised long-standing coping strategies to manage their COPD. Holistic interventions, that address the impact of COPD in relation to wider aspects of a patients' life, may be more beneficial. ISRCTN Registry 59,537,391. Registration date 20 March 2017.

Project description:BackgroundDevelopment of complex interventions for management of chronic conditions has become increasingly common, with guidance now provided. Fidelity (whether the intervention is designed, delivered and received as intended) is critical to understanding if, and how an intervention works (or not). However, methods for achieving this are still evolving. This study describes the methods used in the TANDEM trial - a large multicentre study evaluating the impact of a cognitive behavioural intervention preceding routine pulmonary rehabilitation for people with chronic obstructive pulmonary disease and anxiety and or depression. Results for enhancement and training aspects of fidelity, are presented.MethodsUsing the National Institute for Health Behaviour Change Consortium (NIH BCC) framework of fidelity, a set of enhancement strategies and a fidelity measurement strategy were developed with input from a multidisciplinary team. The Cognitive First Aid Rating Scale (CFARS) was used to assess Facilitator (the respiratory professional delivering TANDEM) therapeutic competence at the end of the initial training and throughout treatment delivery (on a randomly selected set of cases). A TANDEM specific treatment adherence measure was developed following previously recommended procedures. Together these (the CFARS and adherence measure) comprised the TANDEM treatment delivery fidelity tool.ResultsHiring of respiratory professionals to the initial training programme was successful, with 44% of those expressing initial interest in being a Facilitator successfully completing the process. Video recordings of potential Facilitators conducting standardized patient role plays at the end of the initial training demonstrated fidelity of training.ConclusionsAddressing fidelity in complex intervention trials is a time and resource intensive process but has significant potential to increase understanding of results and strengthen the evidence base for effective interventions. By defining a full fidelity assessment method prior to analysis we aimed to minimise bias when interpreting results.Trial registrationISRCTN59537391 . Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018. Process evaluation protocol version 4.0, 1 November 2020.

Project description:BackgroundThere is a lack of data from low- and middle-income countries on whether anxiety independently predicts a more chronic course for depression.MethodsWe undertook secondary data analysis of a cluster randomised controlled trial in Zimbabwe which had tested the effectiveness of the Friendship Bench intervention for common mental disorders compared to enhanced usual care. Inclusion for the current study was participants from the trial who had probable major depression at baseline, defined as scoring => 11 on the locally validated Patient Health Questionnaire (PHQ9). This emerged to be 354 of the original 573 (61.78%) of the original trial sample. Anxiety was measured using the locally validated cut-point on the Generalised Anxiety Disorder scale (GAD-7). Persistent depression was defined as scoring => 11 on the PHQ-9 at six-months follow-up. Analysis in Stata 15 used random-effects logistic regression to adjust for clustering by clinic.OutcomesOf the 354 participants who were eligible for treatment, 329 (92·9%) completed 6-month follow-up assessment. 37% of the trial sample had persistent depression at 6-months follow-up; 59% in the control arm and 17% in the intervention arm. Co-morbid anxiety present at trial baseline was independently associated with persistent depression after adjusting for age, gender and baseline depression severity (adjusted OR = 2·83, 95% CI 1·32-6·07). There was no evidence of effect modification by trial arm. Baseline depression severity also predicted persistent depression. Interpretation Treatment for depression in low and middle-income countries (LMIC) should be directed towards those with greatest need. This includes people with co-morbid anxiety and greater depression severity at initial assessment who are less likely to remit at six months. Advice on coping with anxiety, psychological treatments which target common anxiety symptoms such as fear, avoidance, excessive worry and intrusive thoughts, and Selective Serotonin Reuptake Inhibitors (SSRIs) should be made more widely available in LMIC and offered to those with persistent mixed depression and anxiety.

Dataset Information

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.

Publications

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.

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