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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: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.

Project description:IntroductionAnxiety and depressive disorders are a significant problem that starts in childhood or adolescence and should be addressed early to avoid chronic mental conditions. There is strong evidence to demonstrate that psychological treatments are effective for these disorders, however, little is known on mediators and mechanisms of change of psychological treatment in adolescents and young adults. Understanding the pathways through which psychological treatments operate will facilitate more effective treatments.AimWe aim to conduct a systematic review, exploring the available evidence on mediators of psychological treatments for anxiety and depression in adolescents and young adults.MethodsA systematic search has been performed on PubMed and PsycINFO databases to identify studies from inception to 23rd February 2020. Eligible studies include randomized controlled trials and trials (quasi-experimental) designs that have enrolled adolescents and young adults presenting with depression and/or anxiety and that have examined mediators of psychological treatments. A group of 20 reviewers from the COST-Action TREATme (CA16102) divided into 10 pairs independently screen studies for inclusion, extract information from the included studies, and assess the methodological quality of the included studies and the requirements for mediators. The methodological quality will be assessed by The Mixed Methods Appraisal Tool. Extracted data from the included studies will be collected and presented using a narrative approach.DiscussionThis systematic review will summarize and provide a comprehensive overview of the current evidence on mediators of psychological treatments for anxiety and depression for adolescents and young adults. Results will allow the identification of strategies to optimize intervention to enhance clinical outcomes.Ethics and disseminationEthics approval is not required. Findings from this systematic review will be published in a peer-reviewed journal and disseminated at conferences and meetings. PROSPERO registration number: CRD42021234641.

Project description:Chronic obstructive pulmonary disease (COPD) and farming are two conditions that have been associated with an increased risk of anxiety and depression. Dairy farming is an independent risk factor for COPD.To test the hypotheses that the prevalence of anxiety and/or depression is higher in dairy farmers with COPD than in farmers without COPD, and higher in dairy farmers with COPD than in non-farmers with COPD.Anxiety and depression were evaluated using the Hospital Anxiety and Depression Scale in 100 dairy farmers with COPD (DF-COPD), 98 dairy farmers without COPD (DF-controls), 85 non-farming patients with COPD (NF-COPD) and 89 non-farming subjects without COPD (NF-controls), all identified by screening in the Franche-Comté region of France. Anxiety and depression were considered present when the Hospital Anxiety and Depression Scale score was ?8. COPD was defined by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity ratio <0.7.The crude prevalence of anxiety did not differ between the four groups, ranging from 36% in NF-controls to 47% in NF-COPD (p=0.15 between groups). Similarly, the prevalence of depression did not differ significantly between the four groups (p=0.16 between groups). In dairy farmers (n=198), the only factors associated with anxiety were quality of life and current smoking. Depression in dairy farmers was associated with airflow limitation (lower forced expiratory volume in 1 second and COPD grade 2 or more) as well as with some COPD-related features (dyspnea severity, current smoking, and poorer quality of life). In non-farmers, both anxiety and depression were associated with airflow limitation and COPD-related features.In our population, the prevalence of anxiety and/or depression was similar in dairy farmers with and without COPD and in non-farmers with COPD. Nevertheless, the degree of airway obstruction and some COPD-related features were associated with depression among dairy farmers, whereas these factors were not associated with 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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