The study aimed to determine the effects of adding cognitive behavioural therapy (CBT) to pulmonary rehabilitation to treat patients with chronic lung disease and comorbid anxiety and/or depression symptoms. An open, parallel group, randomised controlled trial (RCT) was conducted, with longitudinal follow-up of 12 months. CBT was delivered in 2 face-to-face sessions and 4 phone sessions to patients with depression or anxiety undergoing pulmonary rehabilitation. The main outcome measures were change in Geriatric Depression Scale (GDS) and Geriatric Anxiety Inventory (GAI); secondary outcomes were St. Georges Respiratory Questionnaire (SGRQ), 6-minute walk test (6MWT) and pulmonary rehabilitation attendance. A total of 65 patients were randomized to Intervention (n=24) and Control (n=41) groups. Of the 24 patients in the Intervention group, 6 patients (25%) withdrew and 4 patients (12.5%) failed to attend more than 2 CBT sessions, which was significantly more than the Control group. The majority of patients (75.4%) had chronic obstructive pulmonary disease. Fourteen (21.5%) had symptoms of depression only, 12 (18.4%) had symptoms of anxiety only, and 39 (60.0%) had symptoms of both anxiety and depression. In the Intervention group, GDS significantly improved at the end of pulmonary rehabilitation (mean difference -3.1, 95% CI: -4.39 to -1.70; P=0.0001), 3 months follow-up (mean difference -1.5, 95% CI: -4.17 to -0.75; P=0.008), and at 12 months follow-up (mean difference -1.6, 95% CI: -3.29 to -0.03, P=0.04), compared to baseline. The Control group demonstrated improvement in GDS by the end of pulmonary rehabilitation (mean difference -1.3, 95% CI: -2.4 to -0.27; P=0.01) which was not maintained at 3 months (P=0.14) and 12 months (P=0.25). GAI significantly improved by the end of rehabilitation in both the Intervention (mean difference -2.6, 95% -4.69 to -0.57; P=0.01) and Control groups (mean difference -2.6, 95% -4.16 to -1.14; P=0.001) and there was no significant improvement at 3 and 12 months. No statistically significant differences in changes in GDS or GAI were observed between the Intervention and Control groups at any time point. There was no significant improvement in SGRQ or 6MWT. There was a significant increase in attended pulmonary rehabilitation sessions in the Intervention group, compared to the Control group (mean difference 1.59; 95% CI: 0.11 to 3.07; P=0.03). In this RCT of patients with chronic lung diseases attending pulmonary rehabilitation, there was no evidence found for improved symptoms of anxiety or depression or health-related quality of life with the addition of CBT given in a mixed face-to-face and telephone format, compared to usual care. Slower than anticipated recruitment, leading to a smaller than planned sample size, and a high dropout rate in the group allocated to CBT may have limited the effectiveness of the behavioural intervention approach in this study.
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