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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

  • To complete the integration of the components of the psychological intervention
  • To complete the development of a training programme for those who will deliver the programme and to document it in a manual
  • To refine, and document in a manual, the intervention via focus groups and one-to-one interviews with patients, carers, and Healthcare Professionals.
  • 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

  • To undertake a feasibility study (consisting of a pilot Randomised Controlled Trial 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 Healthcare Professionals to deliver the psychological, one-to-one intervention
  • Identifying and recruiting eligible patients and their carers (where present)
  • Recruitment of GP practices and intermediate and secondary care teams/practices/providers/clinics
  • Intervention acceptability
  • Acceptability of standard pulmonary rehabilitation (PR) as the control intervention
  • Maintaining intervention fidelity
  • Informing intervention uptake and completion rates
  • Testing data collection for the cost-effectiveness analyses
  • Checking our sample size calculation assumptions
  • Designing the process evaluation
  • Recruitment of GP practices and intermediate and secondary care teams/practices/providers/clinics.

PHASE III

Our trial objectives will be:
  • 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
  • To examine the process outcomes (Primary: completion of PR. Secondary: attrition from the intervention)
  • To examine the effect of the intervention on carers (where appropriate)
  • To determine the cost effectiveness of the intervention from an NHS and societal perspective
  • 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.