Anxiety and/or depression in people with chronic obstructive pulmonary disease (COPD) Mental and Behavioural Disorders Chronic obstructive pulmonary disease (COPD), Anxiety disorder, unspecified, Depressive episode, unspecified
Conditions
Interventions
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
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactRatna Sohanpal
Outcome results
None listed