Authors' objectives: People with chronic obstructive pulmonary disease have high levels of anxiety and depression, which is associated with increased morbidity and poor uptake of effective treatments, such as pulmonary rehabilitation. Cognitive–behavioural therapy improves mental health of people with long-term conditions and could potentially increase uptake of pulmonary rehabilitation, enabling synergies that could enhance the mental health of people with chronic obstructive pulmonary disease. Chronic obstructive pulmonary disease (COPD) is a major public health problem globally, and is associated with socioeconomic deprivation and with high morbidity and mortality. In the UK, about 1.2 million people have diagnosed COPD, incurring more than 140,000 hospital admissions, over a million bed-days and about 30,000 deaths each year. The condition costs the NHS around £1.9B annually. Symptoms of anxiety and depression are common comorbidities in people with COPD, with a prevalence of 30–40% or higher. These mood disorders may reduce people’s ability to manage their COPD effectively, reduce physical activity capacity and make patients susceptible to exacerbations (i.e. acute worsening of the condition), hospital admissions and re-admissions. There is robust evidence that pulmonary rehabilitation (PR), which is a multidisciplinary exercise and education intervention, improves health-related outcomes, including functional exercise capacity, quality of life and emotional well-being, and reduces breathlessness in COPD. National and international COPD guidelines recommend offering PR to patients. Unfortunately, more than one-third of people referred to PR do not attend and only two-thirds of attendees complete the course. A recent Cochrane review concluded that psychological interventions, including cognitive–behavioural therapy (CBT), may improve depression in people with COPD, but the reviewers called for larger, more methodologically robust studies. The current study was proposed in response to a National Institute for Health and Care Research (NIHR) Health Technology Assessment brief based on a systematic review that concluded that psychological interventions combined with exercise training resulted in clinically significant improvements in symptoms of anxiety and depression in COPD, compared with CBT alone. A more recent Cochrane review has concluded that a psychological therapy combined with a PR programme reduced depressive symptoms more than a PR programme alone.

Authors' results and conclusions: We analysed results from 423 randomised participants (intervention, n = 242; control, n = 181). Forty-three carers participated. Follow-up at 6 and 12 months was 93% and 82%, respectively. Despite good fidelity for intervention delivery, mean between-group differences in Hospital Anxiety and Depression Scale at 6 months ruled out clinically important effects (Hospital Anxiety and Depression Scale – anxiety mean difference –0.60, 95% confidence interval –1.40 to 0.21; Hospital Anxiety and Depression Scale – depression mean difference –0.66, 95% confidence interval –1.39 to 0.07), with similar results at 12 months. There were no between-group differences in any of the secondary outcomes. Sensitivity analyses did not alter these conclusions. More adverse events were reported for intervention participants than for control participants, but none related to the trial. The intervention did not generate quality-of-life improvements to justify the additional cost (adjusted mean difference £770.24, 95% confidence interval –£27.91 to £1568.39) to the NHS. The intervention was well received and many participants described positive affects on their quality of life. Facilitators highlighted the complexity of participants’ lives and considered the intervention to be of potential valuable; however, the intervention would be difficult to integrate within routine clinical services. Our well-powered trial delivered a theoretically designed intervention with good fidelity. The respiratory-experienced facilitators were trained to deliver a low-intensity cognitive–behavioural approach intervention, but high-intensity cognitive–behavioural therapy might have been more effective. Our broad inclusion criteria specified objectively assessed anxiety and/or depression, but participants were likely to favour talking therapies. Randomisation was concealed and blinding of outcome assessment was breached in only 15 participants. The tailored cognitive–behavioural approach intervention delivered with fidelity by trained respiratory healthcare professionals to people with chronic obstructive pulmonary disease was neither clinically effective nor cost-effective. Alternative approaches that are integrated with routine long-term condition care are needed to address the unmet, complex clinical and psychosocial needs of this group of patients. Forty-nine per cent (2191/4491) of potentially eligible participants approached agreed to be contacted by the research team, with 48% (n = 1062) of participants formally assessed for eligibility. Of these participants, 441 (41.5%) were eligible, 426 were recruited to the study and 423 were randomised and analysed (intervention, n = 242; control, n = 181). HADS-A and HADS-D primary outcome data were available for 205 (85%) and 204 (84%) of participants randomised to the intervention, respectively, and for 164 (90%) of control participants. At 12 months. HADS-A and HADS-D secondary outcome data were available for 191 (79%) and 190 (79%) of participants randomised to the intervention and for 150 (83%) and 152 (84%) control participants. More participants withdrew from the intervention arm (n = 16, 6.6%) than from the control arm (n = 5, 2.8%) and there were more deaths in the intervention arm than in the control arm [13 (5.4%) vs. 3 (1.7%), respectively]. No deaths or other AEs were associated with the study. Of the participants recruited, the median age was 69 (interquartile range 62–75) years, 50% (n = 213) were male and 42% (n = 176) lived alone. Only 40 (9.5%) participants were working and most (329/416, 79%) had completed full-time education by age 16 years. Overall, participants’ COPD was disabling. Participants has significant breathlessness and low health-related quality-of-life scores, and 78 (18%) participants were too breathless to leave the house. Comorbidities were common and 30% (n = 128) of participants were still smoking. Forty-three carers were recruited to the substudy. Twenty-four carers cared for intervention participants and 19 carers cared for control participants. A total of 196 (81%) intervention participants received at least two sessions of the TANDEM intervention (i.e. the predefined minimum dose) and 136 (56%) intervention participants received six or more sessions. Clinical effectiveness results At 6 months, the mean difference between the two study arms for anxiety [HADS-A –0.60, 95% confidence interval (CI) –1.40 to 0.21] and depression (HADS-D –0.66, 95% CI –1.39 to 0.07) was less than the minimal clinically important differences for these scales, and the 95% CIs ruled out clinically important effects on these outcomes. As in the primary outcome analysis, CIs for HADS-A and HADS-D at 12 months, and for all other questionnaire scores at 6 and 12 months, ruled out clinically important effects of the intervention. Overall, smoking prevalence fell across the 12 months of the study, but there was no discernible difference between participants in the two study arms (odds ratio at 12 months for intervention vs. control 0.90, 95% CI 0.54 to 1.50) and around one-quarter of participants were still smoking at 12 months. In the intervention arm, 122 (50%) participants were referred to PR, 121 participants attended at least one PR session and 73 (30%) participants completed the course. In the control arm, 88 (49%) participants were referred, 77 (43%) participants attended at least one PR session and 54 (30%) participants completed the course. No differences were seen in outcome measures at 6 or 12 months for carers of participants in the study arms. The study demonstrated that it is possible to train healthcare professionals to deliver a CBA competently and with fidelity, and that, overall, the TANDEM CBA intervention appeared to be popular with both those receiving it and those delivering it. However, the intervention did not improve mood or health status, nor did it improve any of our important secondary outcomes, such as uptake and completion of PR, healthcare resource use and smoking cessation.

Authors' recommendations: Given the considerable unmet need, alternative interventions to support people with advanced COPD and symptoms of anxiety and depression are required. It is worth exploring whether or not an intervention like the TANDEM intervention might be effective for people with COPD much earlier in their disease trajectories. We suggest evaluating the incorporation of development of cognitive–behavioural skills as part of undergraduate and postgraduate training for a variety of different healthcare professionals, with the aim of integrating this approach into routine healthcare delivery for long-term conditions.

Authors' methods: We carried out a pragmatic multicentre randomised controlled trial using a 1.25 : 1 ratio (intervention : control) with a parallel process evaluation, including assessment of fidelity. Twelve NHS trusts and five Clinical Commissioning Groups in England were recruited into the study. The intervention was delivered in participant’s own home or at a local NHS facility, and by telephone. Between July 2017 and March 2020 we recruited adults with moderate/very severe chronic obstructive pulmonary disease and mild/moderate anxiety and/or depression, meeting eligibility criteria for assessment for pulmonary rehabilitation. Carers of participants were invited to participate. Co-primary outcomes were Hospital Anxiety and Depression Scale – anxiety and Hospital Anxiety and Depression Scale – depression at 6 months post randomisation. Secondary outcomes at 6 and 12 months included health-related quality of life, smoking status, uptake of pulmonary rehabilitation and healthcare use. Design We carried out a pragmatic multicentre parallel-arm individual patient randomised controlled trial with an internal pilot, evaluating clinical effectiveness and health economics. A parallel process evaluation included assessing fidelity of intervention delivery. Co-primary outcomes were symptoms of anxiety and depression determined by the Hospital Anxiety and Depression Scale – anxiety (HADS-A) and Hospital Anxiety and Depression Scale – depression (HADS-D) at 6 months post randomisation. Participants were followed up for 12 months. There was full allocation concealment and baseline measures were collected before randomisation. Participants were inevitably aware of their allocation status, but all healthcare professionals were blind to allocation, as were the researchers who collected or analysed outcome measures. Study participants were recruited from primary and secondary care and from referral to PR in 12 geographic areas in England. Inclusion criteria Patients who were willing to provide informed consent. Patients with a confirmed diagnosis of COPD and spirometry with moderate to severe airflow limitation (note that, following the internal pilot, this was extended to include very severe airflow limitation). Patients who were eligible for referral to PR. Patients with a Hospital Anxiety and Depression Scale (HADS) score at the baseline screening suggestive of mild to moderate anxiety or depression, or both (i.e. a subscale score from 8 to 15).

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/HTA 13/146/02

Year Published: 2024

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/PAWA7221

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/PAWA7221

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk