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Randomised controlled trial of cognitive behavioural therapy in COPD

Karen Heslop-Marshall, Christine Baker, Debbie Carrick-Sen, Julia Newton, Carlos Echevarria, Chris Stenton, Michelle Jambon, Joanne Gray, Kim Pearce, Graham Burns, Anthony De Soyza
ERJ Open Research 2018 4: 00094-2018; DOI: 10.1183/23120541.00094-2018
Karen Heslop-Marshall
1Chest Clinic, Newcastle upon Tyne Hospitals NHS Foundation Trust, RVI Hospital, Newcastle upon Tyne, UK
2Institute of Cellular Medicine, Medical School, Newcastle University, Newcastle upon Tyne, UK
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  • For correspondence: karen.marshall1@ncl.ac.uk
Christine Baker
3Dept of Clinical Health Psychology, Newcastle upon Tyne Hospitals NHS Foundation Trust, RVI Hospital, Newcastle upon Tyne, UK
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Debbie Carrick-Sen
4Nursing Dept, School of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
5Heart of England NHS Trust, Birmingham, UK
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Julia Newton
2Institute of Cellular Medicine, Medical School, Newcastle University, Newcastle upon Tyne, UK
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Carlos Echevarria
1Chest Clinic, Newcastle upon Tyne Hospitals NHS Foundation Trust, RVI Hospital, Newcastle upon Tyne, UK
2Institute of Cellular Medicine, Medical School, Newcastle University, Newcastle upon Tyne, UK
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Chris Stenton
1Chest Clinic, Newcastle upon Tyne Hospitals NHS Foundation Trust, RVI Hospital, Newcastle upon Tyne, UK
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Michelle Jambon
6Community Chest Team, Newcastle Upon Tyne Hospitals NHS Foundation Trust, RVI Hospital, Newcastle upon Tyne, UK
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Joanne Gray
7Faculty of Health and Life Science, Northumbria University, Newcastle upon Tyne, UK
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Kim Pearce
2Institute of Cellular Medicine, Medical School, Newcastle University, Newcastle upon Tyne, UK
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Graham Burns
1Chest Clinic, Newcastle upon Tyne Hospitals NHS Foundation Trust, RVI Hospital, Newcastle upon Tyne, UK
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Anthony De Soyza
2Institute of Cellular Medicine, Medical School, Newcastle University, Newcastle upon Tyne, UK
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  • ORCID record for Anthony De Soyza
  • Article
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  • Supplementary Materials
  • FIGURE 1
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    FIGURE 1

    Patient flow diagram. HADS: Hospital Anxiety and Depression Scale; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; COPD: chronic obstructive pulmonary disease; CBT: cognitive behavioural therapy.

  • FIGURE 2
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    FIGURE 2

    Cost-effectiveness plane. Quadrant 1: more costly/less effective; quadrant 2: more costly/more effective; quadrant 3: less costly/less effective; quadrant 4: less costly/more effective; CBT: cognitive behavioural therapy; QALYs: quality-adjusted life-years.

Tables

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  • TABLE 1

    Inclusion and exclusion criteria

    Inclusion criteriaExclusion criteria
    • A confirmed diagnosis of COPD (FEV1/FVC ratio <70% [5]

    • All levels of COPD disease severity (mild–very severe)

    • HADS-Anxiety Subscale score of ≥8

    • Consent to 2–6 sessions of CBT [23]

    • A HADS-Anxiety Subscale score of <8

    • Known psychiatric history such as psychosis

    • Patients currently receiving psychological talking therapy including CBT treatment

    • Patients with cognitive impairment (e.g. dementia)

    • Patients involved in any other interventional clinical trial

    COPD: chronic obstructive pulmonary disease; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; HADS: Hospital Anxiety and Depression Scale; CBT: cognitive behavioural therapy.

    • TABLE 2

      Content of cognitive behavioural therapy (CBT) nurse training

      Day 1Day 2Day 3
      Course aimsRevisionFeedback from homework
      Basic introduction to CBTFeedback from homeworkRevision
      Using CBT in physical health settingGoal settingCase presentations
      AnxietyCognitive techniquesSupervision
      PanicBehavioural techniquesCourse evaluation
      DepressionCase study
      Screening for anxiety and depressionPractical session (theory into practice)
      Risk management (suicide assessment)Summary
      Formulation of patients difficultiesHomework
      Socratic questioning and guided discovery
      Unhelpful thinking
      Practical session
    • TABLE 3

      Baseline characteristics

      CBT groupLeaflet groupTotal patients
      Subjects n139140279
      Mean±sd age years66±10.267±9.666.5±9.9
      Males/females61 (44)/78 (56)67 (48)/73 (52)128 (46)/151 (54)
      Ethnic group, Caucasian139 (100)140 (100)279 (100)
      Mean±sd HADS-Anxiety Subscale12.3±3.1912.0±2.9412.2±3.06
      HADS-Anxiety Subscale 8–1051 (37)49 (35)100 (36)
      HADS-Anxiety Subscale 11–1452 (37)63 (45)115 (41)
      HADS-Anxiety Subscale 15–2136 (26)28 (20)64 (23)
      Mean±sd HADS-Depression Subscale9.2±4.08.8±3.79.0±3.85
      Severity of airflow obstruction based on GOLD criteria
       Mild16 (11)13 (9)29 (10)
       Moderate44 (32)47 (34)91 (33)
       Severe50 (36)49 (35)99 (35)
       Very Severe29 (21)31 (22)60 (22)
      MRC Breathlessness score
       0–28 (6)12 (9)20 (7)
       325 (18)19 (14)44 (16)
       439 (28)44 (31)83 (30)
       567 (48)65 (46)132 (47)
      Current smoker39 (28)40 (29)79 (28)
      Mean±sd BMI kg·m−226±6.427±6.026.5±6.22
      No educational qualifications100 (72)103 (74)203 (73)

      Data are presented as n (%), unless otherwise stated. CBT: cognitive behavioural therapy; HADS: Hospital Anxiety and Depression Scale; GOLD: Global Initiative for Chronic Obstructive Lung Disease; MRC: Medical Research Council; BMI: body mass index.

      • TABLE 4

        Group mean Hospital Anxiety and Depression (HADS)-Anxiety Subscale at each time point

        Group mean±sd HADS-Anxiety Subscores
        Baseline3 months6 months12 months
        Cognitive behavioural therapy12.3±3.19
        (n=139)
        8.8±4.49
        (n=115)
        8.6±4.02
        (n=93)
        8.7±4.06
        (n= 93)
        Leaflet12.0±2.94
        (n=140)
        10.0±4.42
        (n=121)
        9.7±4.31
        (n=99)
        10.2±4.33
        (n=79)
      • TABLE 5

        Differences in mean anxiety from baseline and between groups

        Mean improvement from baselineDifference in mean improvement
        (95% CI, p-value)
        CBT groupLeaflet group
        HADS-Anxiety Subscale at 3 months3.40 (n=115)1.88 (n=121)1.52# (0.49–2.54, p=0.003)
        HADS-Anxiety Subscale at 6 months3.42 (n=101)2.36 (n=99)1.05 (−0.04–2.14, p=0.05)
        HADS-Anxiety Subscale at 12 months3.35 (n=93)1.89 (n=79)1.43 (0.28–2.66, p=0.016)

        CBT: cognitive behavioural therapy; HADS: Hospital Anxiety and Depression Scale. #: the mean difference is higher than the HADS-Anxiety Score minimal clinically important difference of 1.50 [17].

        • TABLE 6

          Costs and QALYs of cognitive behavioural therapy (CBT) intervention and self-help leaflets

          CBT intervention mean (95% CI)Leaflets mean (95% CI)Bootstrapped mean difference (95% CI, p-value)
          Intervention costs GBP175 (165–185)175 (165–185, p=0.001)
          Number of respiratory admissions0.6 (0.35–0.85)1.01 (0.61–1.4)
          Costs of respiratory admissions GBP1601 (936–2267)2689 (1632–3746)−1089 (−2370–227, p=0.076)
          Number of ED attendances0.37 (0.16–0.59)0.81 (0.48–1.14)
          Costs of ED attendances GBP55 (23–86)118 (70–166)−63 (−121– −7, p=0.036)
          Total mean cost GBP1830 (1143–2517)2807 (1706–3909)−997 (−2349–228, p=0.158)
          Mean difference in effect QALYs0.079 (0.023–0.140, p=0.008)

          ED: emergency department; QALYs: quality-adjusted life-years.

          • TABLE 7

            Results from the cost-effectiveness acceptability curve

             Probability of each management strategy being considered cost-effective at different threshold values for society's willingness to pay for a QALY
            GBP 0GBP 5000GBP 10 000GBP 20 000GBP 30 000
            Cognitive behavioural therapy0.940.981.001.001.00
            Leaflets0.060.020.000.000.00

            QALY: quality-adjusted life-years.

            Supplementary Materials

            • Figures
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            • Supplementary Material

              Please note: supplementary material is not edited by the Editorial Office, and is uploaded as it has been supplied by the author.

              00094-2018_Supplementary_material

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            Randomised controlled trial of cognitive behavioural therapy in COPD
            Karen Heslop-Marshall, Christine Baker, Debbie Carrick-Sen, Julia Newton, Carlos Echevarria, Chris Stenton, Michelle Jambon, Joanne Gray, Kim Pearce, Graham Burns, Anthony De Soyza
            ERJ Open Research Oct 2018, 4 (4) 00094-2018; DOI: 10.1183/23120541.00094-2018

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            Randomised controlled trial of cognitive behavioural therapy in COPD
            Karen Heslop-Marshall, Christine Baker, Debbie Carrick-Sen, Julia Newton, Carlos Echevarria, Chris Stenton, Michelle Jambon, Joanne Gray, Kim Pearce, Graham Burns, Anthony De Soyza
            ERJ Open Research Oct 2018, 4 (4) 00094-2018; DOI: 10.1183/23120541.00094-2018
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