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Table 1 Study inclusion and exclusion criteria

From: 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

Inclusion criteria Exclusion criteria
Patients
• Adults with a confirmed diagnosis of COPD, post-bronchodilator FEV1/FVC ratio < 70% on spirometry
• Moderate, severe or very severe COPD severity on spirometry, FEV1 < 80% predicted
• Probable mild/moderate anxiety and/or depression as determined by the HADS-A and/or HADS-D scores ≥ 8 to ≤ 15
• Eligible to attend assessment appointment at their local pulmonary rehabilitation service at the time of randomisation i.e. 12 months have elapsed since last undertook PR or participant has another indication for PR referral (e.g. recent deterioration; recent hospitalisation with an acute exacerbation of COPD) [31]
(Patients who have been offered PR previously but declined the offer or did not complete PR will be included)
• Unable to give valid consent
• Patients with both HADS-A and HADS-D score < 8 (within normal range)
• Severe anxiety/depression suggested by HADS-A or HAD-D score > 15
• If a patient has an appointment to commence PR < 4 weeks after the screening visit (because there is insufficient time to receive the TANDEM CBA intervention prior to PR starting)
• Ineligible for PR at their local service at the time of randomisation (e.g. <  12 months since undertaking a course of PR and no new clinical indications [31]
• A co-morbidity so severe that it would prevent the patient from engaging fully in the intervention and/or trial processes. (including: severe uncontrolled psychological or psychiatric disorder; 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 taking antidepressants/anxiolytics not excluded)
• Patients currently involved in another clinical trial related to COPD (to avoid over-burdening participants)
• Insufficiently fluent in English to be able to complete the intervention and/or questionnaires
Carers
• Identified by a participant as a ‘particular family caregiver or friend who helps them’ whom they would be happy for us to invite to join the study • Unable to give valid consent
• Not sufficiently fluent in English to be able to complete the questionnaires
  1. Abbreviations: COPD chronic obstructive pulmonary disease, FEV1 forced expiratory volume in 1 second, FVC forced vital capacity, HADS Hospital Anxiety and Depression Scale (D Depression subscale, A Anxiety subscale) [34]; PR pulmonary rehabilitation