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TANDEM

 

TANDEM                                              

Full title: A tailored, psychological intervention for mild to moderate anxiety or depression in people with chronic
obstructive pulmonary disease(COPD).

Acronym: TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD).

Research Funder: Health Technology Assessment Programme 

Research Group: Translational Research, Pragmatic Clinical Trials Unit, Complex Intervention and Social Practice in Health Care unit

Research status: Started

Investigators

Chief investigator:

Professor Stephanie JC Taylor, Professor in Public Health and Primary Care , Queen Mary University of London, Barts and The London School of Medicine and Dentistry, Centre for Primary Care and Public Health, Blizard Institute 
Email: s.j.c.taylor@qmul.ac.uk

Co-Chief Investigator:

Professor Hilary Pinnock, Reader, Allergy and Respiratory Research Group, University of Edinburgh, Email: Hilary.Pinnock@ed.ac.uk

Co-investigators:

Dr Ratna Sohanpal, Centre for Primary Care and Public Health, Blizard Institute, Queen Mary University of London, Email: r.sohanpal@qmul.ac.uk

Ms Monica Julie Fletcher, Education for Health, Email: M.Fletcher@educationforhealth.org

Professor Christopher Michael Roberts,Consultant Physician, Respiratory medicine, Barts Health NHS Trust Email: c.m.roberts@qmul.ac.uk

Professor Martin Underwood, Professor of Primary Care Research, Warwick Medical School Clinical Trials Unit, University of Warwick Email: m.underwood@warwick.ac.uk

Dr Liz Steed, Lecturer in Health Psychology, Director, Centre for Primary Care and Public Health, The Barts and The London School of Medicine and Dentistry Email: e.a.steed@qmul.ac.uk

Professor Sally Singh, Head of Cardiac and Pulmonary Rehabilitation, Department of Respiratory Medicine (Acute Division), University Hospitals of Leicester NHS Trust, Email: sally.singh@uhl-tr.nhs.uk

Professor Stefan Priebe, Professor of Social and Community Psychiatry, Unit for Social and Community Psychiatry (Queen Mary), Barts & The London Queen Mary’s School of Medicine & Dentistry, Email: S.Priebe@qmul.ac.uk

Ms Karen Heslop-Marshall, Nurse Consultant, Chest Clinic, The Newcastle Upon Tyne Hospitals NHS Foundation Trut, Email: Karen.Heslop@nuth.nhs.uk

Dr Moira Josephine Kelly, Senior Lecturer, Institute of Health Sciences Education, The Barts and the London Queen Mary
University of London, Email: m.j.kelly@qmul.ac.uk

Mr Brennan Kahan, Statistician, Queen Mary, University of London, Email: b.kahan@qmul.ac.uk

Dr Sarah Saqi-Waseem, Consultant Clinical Psychologist, Compass Wellbeing CIC, Email: sarah.saqi-waseem@nhs.net

Dr Patrick White, Senior Clinical Lecturer, Department of Primary Care & Public Health Sciences, King’s College London, Email: patrick.white@kcl.ac.uk

Mr Chris Warburton, Patient representatiive, Email: chris@working.co.uk

Dr Andy Thomas Healey, Senior Research Fellow, Institute of Psychiatry, King’s College London, Email: andy.healey@kcl.ac.uk

TANDEM Project Manager:

Dr Ratna Sohanpal, Centre for Primary Care and Public Health, Blizard Institute, Queen Mary University of London, Ph: 02078822492, Emailtandemcopd@qmul.ac.uk or r.sohanpal@qmul.ac.uk

Scientific Summary

Aim:
To refine, pilot and evaluate a tailored, psychological intervention, which links into, and optimises the
benefits of routine pulmonary rehabilitation, with the aim of reducing mild/moderate anxiety and/or
depression in people with moderate or severe COPD.
Objectives:
PHASE I
1) To complete the integration of the components of the psychological intervention
2) To complete the development of a training programme for those who will deliver the
programme and to document it in a manual
3) To refine, and document in a manual, the intervention via focus groups and one-to-one
interviews with patients, carers, and HCPs.
4) To conduct a pre-pilot study in which we will administer the one-to-one psychological
component of the intervention to six patients with mild to moderate depression and/or anxiety
PHASE II
5) To undertake a feasibility study (consisting of a pilot RCT and a process evaluation) to
inform: the feasibility of delivering the intervention, the trial processes, and progression to a full scale
trial, specifically:
a. Recruiting, training, standardising and assessing HCPs to deliver the psychological, one-toone
intervention
b. Identifying and recruiting eligible patients and their carers (where present)
c. Recruitment of GP practices and intermediate and secondary care
d. Intervention acceptability
e. Acceptability of standard pulmonary rehabilitation (PR) as the control intervention
f. Maintaining intervention fidelity
g. Informing intervention uptake and completion rates
h. Testing data collection for the cost-effectiveness analyses
i. Checking our sample size calculation assumptions
j. Designing the process evaluation
Across PHASES I & II
1) To recruit PR providers, CCGs, GP practices and intermediate and secondary care for the
main trial.
PHASE III
Our trial objectives will be:
1) To examine the clinical effectiveness of the intervention on clinical outcomes (Primary:
depression, anxiety. Secondary: dyspnoea, health related quality of life, functional activity, smoking
status, social engagement and health care use at six and 12 months) compared to pulmonary
rehabilitation alone
2) To examine the process outcomes (Primary: completion of PR. Secondary: attrition from the
intervention)
3) To examine the effect of the intervention on carers (where appropriate)
4) To determine the cost effectiveness of the intervention from an NHS and societal perspective
5) To conduct a process evaluation alongside the main trial, this will inform the implementation
of the intervention if the trial is positive, or assist interpretation of findings if it is negative.

Design

Seamless three phase study (Phase I preparation, Phase II pilot, Phase III contingent on funder’s approval of progress report submitted six months before completion of Phase II).

Phase I&II

Includes qualitative studies to refine the intervention and a two centre (Leicester, London) pilot randomised controlled trial (RCT).

Phase III

A fully powered multi-centre (North & South London, Leicestershire, Coventry and Warwickshire), individually randomised controlled trial to determine the clinical and cost effectiveness of the intervention with a parallel process evaluation. NB There is the potential to use the Phase II pilot RCT as an internal pilot if no intervention or significant changes are required between Phases II and III.

Target population

Adults living with COPD recruited from primary care, community clinics, secondary care clinics or following referral to PR services who have symptoms of mild to moderate co-morbid anxiety or depression on screening. Where eligible patients have a caregiver we will invite them to be included in a sub-study of carers.

Inclusion/Exclusion Criteria, patients:

  • Adults with a confirmed diagnosis of COPD, post bronchodilator FEV1:FVC ratio <70%
  • Moderate or severe COPD severity on spirometry, FEV130-80% predicted
  • Probable mild or moderate anxiety as defined by the Hospital Anxiety and Depression Scale Anxiety Subscale (HADS-A) scores =8 to =15; and/or probable mild or moderate depression as defined by Hospital Anxiety and Depression Scale – Depression Subscale (HADS-D) scores =8 to =15
  • Eligible for attendance at their local pulmonary rehabilitation (PR) service at time of randomisation

Exclusion criteria, patients:

  • Patients with HADS-A score and a HADS-D score <8 (within normal range)
  • Unable to give valid consent
  • HADS-A score or HADS-D score > 15 (severe anxiety/depression)
  • Severe psychological or psychiatric disorder
  • Not be eligible for pulmonary rehabilitation at their local PR service at the time of randomisation
  • A co-morbidity so severe it would prevent the patient from engaging fully in the trial
  • Patients with moderate/severe cognitive impairment
  • In receipt of a psychological intervention primarily directed at helping to manage anxiety or depression in the last 6 months (NB those on antidepressants/ anxiolytics not excluded)
  • Currently involved in another clinical trial related to COPD
  • Not sufficiently fluent in English to be able to complete the questionnaires

Health technologies being assessed

Tailored, one to one psychological intervention combined with practical problem solving components based on:

  • Our Self-Management Programme of Activity Coping and Education (SPACE), a COPD self-management programme, and
  • The Lung Manual - a nurse led intervention based on cognitive behavioural principles and self-management, and developed to address mood disorders of anxiety in COPD. and linked to usual PR.

Measurement of trial costs and outcomes

All quantitative data collected via a questionnaire completed prior to randomisation and at six and 12 months (supervised self-complete in the presence of a research assistant).

Co-primary outcomes: HADS-A and HADS-D at 6 months (also collected at 12 months). Other outcomes collected at six and 12 months: Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI), Illness Perception Questionnaire (IPQ-R), MRC breathlessness score Ctd. under Other Info.

Depression makes you feel down and you don’t enjoy life. Anxiety can make you feel nervous, on edge, or keep you worrying about things. Longstanding health problems can lead to depression and anxiety.

Chronic obstructive pulmonary disease (COPD), causes breathlessness with intermittent flare ups (attacks). About 25% of people with COPD have depression and up to 50% of outpatients have anxiety. Many have both depression and anxiety. Recent research tells us that psychological and lifestyle treatments which include exercise may be most effective in relieving depression and anxiety. Our study aims to test the effect of psychological treatment linked to physical activity for people with mild or moderate anxiety or depression (or both) and moderate or severe COPD.

Psychological (talking) treatments are very effective for anxiety and depression. CBT (cognitive behaviour therapy) targets how people think about their problems and promotes positive changes.

Pulmonary rehabilitation (PR), a group course run by physiotherapists, is the cornerstone physical treatment for COPD. It increases most people’s ability to exercise, reduces breathlessness and improves wellbeing reducing anxiety and depression. However many COPD sufferers are not keen on joining PR, even though many want to know more about their condition and how to manage it better. Because breathlessness can be so troubling in COPD sufferers may be anxious about exercise. Currently only around 40% of those who might benefit from PR complete the course.

We propose to link the psychological (proven) CBT with the practical (proven) PR. Our new intervention involves up to 8 home visits by a trained respiratory nurse (or physiotherapist) to COPD patients with mild/moderate anxiety or depression. After this they will be supported in taking up an offer of PR with their local service, during which the nurse will continue to support them through phone calls. The intervention will be tailored to the needs of patients. We will train the nurses to deliver the principles of CBT and they will also be able to support patients around the many practical aspects of living with COPD. The intervention will be designed and refined in close consultation with groups of COPD sufferers and their carers. Questions that we hope to answer about the new intervention are: Can it reduce anxiety and depression? Does it encourage sufferers to start (and finish) a PR course? Will it lead to reduced breathlessness, increased exercise capacity and wellbeing, reduced days spent in hospital? How much would it cost the NHS?

 The study is in two parts - a small study followed by a second, much larger, study which will show decisively if the new treatment works. The second study will only go ahead if the small study proves it can be done. Patients will be recruited from hospital clinics, GP surgeries and referrals to PR. Those who agree to join the study will be screened for anxiety and depression with a simple questionnaire. Those with anxiety or depression will then be offered the new treatment or standard PR with allocation to either treatment entirely by chance so we can measure the effect of the new intervention. All participants will get a £5 voucher for their contribution in completing their follow up questionnaires.

Baseline and follow-up information (at 6 and 12 months) will be collected in person by a researcher, or by post, and with permission we will collect information from medical records.

“What is it really like to live with severe COPD?

TANDEM PPI lead Chris Warburton explains in this new British Lung Foundation video”

https://www.blf.org.uk/your-stories/copd-affects-every-part-of-my-daily-living

 

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