ISRCTN59537391已完成未知
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
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 428
研究概览
简要总结
2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31907074 protocol (added 08/01/2019) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33823935/ intervention development (added 08/04/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35668365/ development of methods and recommendations for research design (added 07/06/2022) 2022 Abstract results in https://www.ipcrg.org/13444 (added 14/11/2022) 2022 Abstract results in https://www.ipcrg.org/13491 (added 14/11/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38229579/ (added 22/01/2024) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/39169308/ qualitative evaluation (added 22/08/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
- •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.
排除标准
- •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
研究者
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