Condition category
Respiratory
Date applied
06/03/2017
Date assigned
20/03/2017
Last edited
20/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name given to a collection of diseases which affect the lungs. It is characterised by breathlessness, cough and excess mucus production and is often caused by smoking. Many people with chronic obstructive pulmonary disease (COPD) are affected by anxiety and/or depression and their illness can feel burdensome both physically and emotionally. One main treatment for patients with COPD is pulmonary rehabilitation (PR); a program of exercise, education and support that is used in patients with COPD to help them improve their physical condition. PR aims to help break the cycle of physical disability, associated anxiety, despondency, inactivity and isolation. Although PR is known to be an effective treatment for COPD, many patients unfortunately do not take part in or complete treatment programs, particularly those with anxiety and depression. This study is looking at a cognitive behavioural approach (CBA) program (a type of mental health therapy which aims to help people change the way they think and behave), which links into and enhances the benefits of PR, with the aim of reducing mild/moderate anxiety and/or depression in people with moderate to severe COPD.

Who can participate?
Adult patients with COPD who have mild anxiety and/or depression and their carers.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive usual care only. Those in the second group receive the CBA treatment program. This involves between five and eight 30-40 minute weekly sessions from trained respiratory health care professionals. 10-15 minute weekly telephone follow ups are also scheduled with patients if they decide to attend the PR programme after completion of the CBA intervention. At the start of the study and then after six and 12 months, participants in both groups are followed up to assess their anxiety and/or depression levels. In addition, carers of patient participants are also invited to the join the study (with patient permission) and are interviewed about their experiences of being a carer and their mental wellbeing.

What are the possible benefits and risks of participating?
There are no direct benefits of taking part in the trial but the information collected and feedback provided will help to improve the care of people with COPD in future. There are no notable risks involved for those taking part in the study, however, if during the one-to-one sessions or interview a participant says something that may indicate a risk to themselves or others, their GP or other healthcare professional will be contacted so appropriate arrangements can be made.

Where is the study run from?
Pulmonary rehabilitation (PR) services within NHS Trusts in England (UK)

When is the study starting and how long is it expected to run for?
November 2013 to July 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Ms Ratna Sohanpal (public)
r.sohanpal@qmul.ac.uk
2. Professor Stephanie Taylor (scientific)
s.j.c.taylor@qmul.ac.uk

Trial website

http://www.blizard.qmul.ac.uk/research-project/1481-tandem.html

Contact information

Type

Public

Primary contact

Ms Ratna Sohanpal

ORCID ID

Contact details

Centre for Primary Care and Public Health
Blizard Institute
Barts and The London School of Medicine and Dentistry
Queen Mary University of London
Yvonne Carter Building
58 Turner Street
London
E1 2AB
United Kingdom
+44 20 7882 2492
r.sohanpal@qmul.ac.uk

Type

Scientific

Additional contact

Prof Stephanie Taylor

ORCID ID

http://orcid.org/0000-0001-7454-6354

Contact details

Barts and the London School of Medicine and Dentistry
Queen Mary University of London
London
E1 2AB
United Kingdom
+44 20 7882 2495
s.j.c.taylor@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32713

Study information

Scientific title

A tailored, cognitive behavioural approach intervention for mild to moderate anxiety and/or depression in people with chronic obstructive pulmonary disease (COPD): A randomised controlled trial

Acronym

TANDEM COPD

Study hypothesis

The aim of this study is to evaluate a psychological cognitive behavioural approach (CBA) intervention, which links into and optimises the benefits of pulmonary rehabilitation (PR), with the aim of reducing mild to moderate anxiety and/or depression in people with moderate to severe chronic obstructive pulmonary disease (COPD).

Ethics approval

London - Queen Square Research Ethics Committee, 27/02/2017, ref: 17/LO/0095

Study design

Randomised; Interventional; Design type: Treatment, Process of Care, Education or Self-Management, Psychological & Behavioural, Complex Intervention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Chronic lower respiratory diseases, Mental Health/ Mood [affective] disorders

Intervention

Following patient recruitment and collection of baseline data, participants will be randomised to the TANDEM intervention or usual care (control) using minimisation with a random element: this will be done in order to minimise potential imbalances at baseline for anxiety (HADS-A), depression (HADS-D), dyspnoea (mMRC) and smoking. The randomisation will be at the individual patient level with 1.25:1 allocation ratio.

TANDEM intervention: Participants in the intervention arm will receive between 5 and 8 (depending on individual patient need) approx. 40 minute long, weekly, one-to-one cognitive behavioural approach (CBA) sessions by a TANDEM trained respiratory health care professionals (termed 'facilitators') prior to commencement of pulmonary rehabilitation. Following completion of the patient facing intervention, participants may attend routine pulmonary rehabilitation at their local service. In the gap between the intervention being finished and pulmonary rehabilitation commencing, participants will receive one-to-one phone calls by the facilitators on a weekly basis (duration of each call approx.10-15 minutes). Weekly phone calls will continue whilst the participant is attending pulmonary rehabilitation and for 2 weeks after its completion.

Usual care (Control group): Participants in the control arm will follow local arrangements for the provision of pulmonary rehabilitation referred to the service (including any psychological treatment provided routinely in that service). In agreement with the local service (who may prefer to use their own materials), participants will be offered the British Lung Foundation DVD on living with COPD and additional booklets on COPD and pulmonary rehabilitation.

All participants will be followed up at 6 and 12 months post enrolment.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Anxiety and depression are measured using the Hospital Anxiety and Depression Scale (HADS) subscales (HADS-A and HADS-D) at baaseline, 6 and 12 months.

Secondary outcome measures

Patient outcomes:
1. Degree of breathlessness is measured by the modified Medical Research Council (mMRC) Breathlessness scale at baseline only.
2. Depression is measured using the Beck’s Depression Inventory-II (BDI-II) at baseline, 6 and 12 months.
3. Anxiety is measured using the Beck’s Anxiety Inventory (BAI) at baseline, 6 and 12 months
4. Respiratory health-related quality of life is measured using the St George's Respiratory Questionnaire (SGRQ) at baseline, 6 and 12 months
5. Illness perception about COPD is measured using the Brief-Illness Perception Questionnaire (B-IPQ) at baseline, 6 and 12 months
6. Social engagement is measured using the Health Education Impact Questionnaire (heiQ) at baseline, 6 and 12 months
7. Functional/social activity is measure using the Time Use Survey at baseline, 6 and 12 months

Carer outcomes:
1. Carer burden is measured using the Zarit Burden Interview (ZBI) (22 item) at baseline, 6 and 12 months
2. Carer mental well-being is measured using the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) (14 item) at baseline, 6 and 12 months

Overall trial start date

08/11/2013

Overall trial end date

31/07/2020

Reason abandoned

Eligibility

Participant inclusion criteria

Patients:
1. Adults with a confirmed diagnosis of COPD, post bronchodilator FEV1/FVC ratio <70%
2. Moderate or severe COPD severity on spirometry, FEV1 30-80% predicted
3. Patients with probable mild or moderate anxiety as determined by the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A) scores ≥8 to ≤15; and/or probable mild or moderate depression as determined by Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D) scores ≥8 to ≤15
4. Eligible for attendance at their local pulmonary rehabilitation service at the time of randomisation i.e. 12 months have elapsed since last undertook pulmonary rehabilitation or participant has another indication for pulmonary rehabilitation referral (e.g. recent deterioration; recent hospitalisation with an acute exacerbation of COPD)

Carers:
Identified by a participant with COPD in the study as a ‘particular family caregiver or friend who helps them’ whom they would be happy for us to invite to join the study.

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 430; UK Sample Size: 430

Participant exclusion criteria

Exclusion Criteria - Patients:
1. Patients with both HADS-A score and a HADS-D score < 8 (within normal range)
2. Unable to give valid consent
3. HADS depression or anxiety subscale score greater than 15 (suggestive of possible severe anxiety/depression)
4. Severe uncontrolled psychological or psychiatric disorder that would make them unsuitable for the intervention
5. Ineligible for pulmonary rehabilitation at their local PR service at the time of randomisation (typically if they had undertaken a course of PR in the last 12 months and there were no new clinical indications for PR). Patients who have been offered PR previously but declined the offer will not be excluded.
6. A co-morbidity so severe it would prevent the patient from engaging fully in the intervention/ control
7. Patients with moderate/severe cognitive impairment
8. In receipt of a psychological intervention primarily directed at helping to manage anxiety or depression in the last 6 months (Those on antidepressants/ anxiolytics not excluded)
9. Patients currently involved in another clinical trial related to COPD (to reduce study participation burden on participants)
10. Not sufficiently fluent in English to be able to complete the questionnaires (the questionnaires are supervised self-complete, but can be read to participants if necessary, so poor literacy would not exclude individuals who are otherwise sufficiently fluent in English)

Exclusion Criteria - Carers:
1. Unable to give valid consent
2. Not sufficiently fluent in English to be able to complete the questionnaires

Recruitment start date

03/04/2017

Recruitment end date

30/09/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Community cardio-respiratory service, Imperial College Healthcare NHS Trust
St Mary’s Hospital, Praed Street
London
W2 1NY
United Kingdom

Trial participating centre

Acute COPD Early Response Service (ACERS), Homerton University Hospital NHS Foundation Trust
Homerton Row
London
E9 6SR
United Kingdom

Trial participating centre

Glenfield General Hospital
University Hospitals of Leicester NHS Trust
Groby Road
LE3 9QP
United Kingdom

Trial participating centre

Loughborough Hospital
Leicestershire Partnership NHS Trust, Hospital Way
Loughborough
LE11 5JY
United Kingdom

Trial participating centre

Pulmonary rehabilitation service, St Thomas' Hospital
Guy's and St Thomas' NHS Foundation Trust, Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

Atrium Health Ltd
Centre for Exercise and Health Unit 1, University Hospitals Coventry and Warwickshire NHS Trust, Watch Close
Coventry
CV1 3LN
United Kingdom

Trial participating centre

South Warwickshire Rehab service
Warwick Hospital, South Warwickshire NHS Foundation Trust, Lakin Road
Warwick
CV34 5BW
United Kingdom

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Queen Mary Innovation Centre
Joint Research Management Office (JRMO)
Lower Ground Floor
5 Walden Street
London
E1 2EF
United Kingdom
+44 20 7882 7265
sponsorsrep@bartshealth.nhs.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication of anticipate at least five peer-reviewed scientific publications from this project. These will focus on the protocol, the pilot/feasibility study, development of the intervention, clinical effectiveness of intervention and cost-effectiveness analysis paper.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository [Secure virtualised environment at the Barts Cancer Centre (BCC)] All trial data supported by Pragmatic Clinical Trials Unit is stored here.

Intention to publish date

01/07/2021

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes