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Effect of cognitive behaviour therapy on anxiety, depression and breathlessness in patients with Chronic Obstructive Pulmonary Disease

Effect of cognitive behaviour therapy on anxiety, depression and breathlessness in patients with Chronic Obstructive Pulmonary Disease (COPD): A randomised controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000653369
Enrollment
52
Registered
2017-05-05
Start date
2017-07-07
Completion date
2026-09-06
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the current study, is to investigate the efficacy of an 8 session Cognitive Behaviour Therapy intervention as an adjunct to a breathlessness clinic intervention on mastery of breathlessness and anxiety/depression scores compared to a waitlist control. Participants will have recently completed the breathlessness clinic at Westmead Hospital and still have high scores for depression and anxiety related to their disease symptoms. They will then be invited to participate in this study. They will be randomised to one of two groups, immediate enrolment in cognitive behaviour therapy or to an 10 week waitlist control group. This will allow comparison between the two groups. The cognitive behaviour therapy will be identical for each group. Questionnaires, lung function and activity tracker will be completed by all participants, at baseline and end of 10 week.

Interventions

Cognitive Behaviour Therapy: The intervention will be delivered by an experienced Clinical Psychologist weekly in individual sessions of approximately one hour duration. While the aim is for face-to-face sessions, 2 telephone sessions have been factored in, given this population is likely to suffer from ill health during the 10 week treatment time. In addition, the eight session will be delivered over 10 weeks, allowing time to reschedule appointments due to ill health. As patients will be pr

Cognitive Behaviour Therapy: The intervention will be delivered by an experienced Clinical Psychologist weekly in individual sessions of approximately one hour duration. While the aim is for face-to-face sessions, 2 telephone sessions have been factored in, given this population is likely to suffer from ill health during the 10 week treatment time. In addition, the eight session will be delivered over 10 weeks, allowing time to reschedule appointments due to ill health. As patients will be presenting with different anxiety and depressive disorders, therapy needs to be individualised to the patient. Thus a number of core and optional CBT modules are described. Adherence to the scheduled visits will be recorded by study staff and all efforts to flexible with times and dates will be made by study staff to improve adherence The core modules contain such things as 1. Psychoeducation: Anxiety, Depression, CBT model Aim: To increase awareness of how COPD may affect psychological well-being and how psychological symptoms and behavioural patterns associated with anxiety/depression may add to the burden of COPD. 2. Exploring feelings of loss associated with losing their wellness role Aim: To explore the experience of adjusting to ill health/COPD, validating feelings of loss, and exploring what may help with adjustment to their new role. 3. Breathlessness-related anxiety action plan. Aim: To help contain anxiety about becoming breathless, through the provision of a concrete individualised “plan” that outlines the steps involved in managing breathlessness and anxiety about being breathless, and thus reinforcing strategies learnt in their involvement in the Westmead Hospital Breathlessness Clinic. Optional modules such as : Mood monitoring Aim: To gain insight into patient’s thoughts and activities that influence mood, and patterns of mood over time. Fear-based exposure Aim: To address avoidance of anxiety-provoking situations with graded exposure (imaginary and in vivo), in order to desensitise the patient and increase tolerance. Desensitisation to traumatic breathlessness-related memories. Aim: To reduce the impact and intensity of distressing memories related to disturbing life experiences related to breathlessness in the past, using eye-movement desensitisation and reprocessing (EMDR).

Sponsors

Westmead hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

a) Severe or very severe COPD by Gold criteria (FEV1<60% predicted; FEV1/FVC ratio <70%). b) Breathlessness (modified Medical Research Council dyspnea scale scores (mMRC > 2). c) Completion of the Westmead Hospital Breathlessness Clinic within 9 months d) Elevated anxiety or depression scores (Hospital Anxiety and Depression Scale - Anxiety score > 8 or Hospital Anxiety and Depression Scale - Depression score> 8).

Exclusion criteria

a) A history of a recent (< 4 weeks) moderate to severe exacerbation of COPD, requiring hospitalisation. b) Bed bound. c) A diagnosis of dementia or cognitive impairment. d) Insufficient proficiency in English for participation in CBT. e) A current active diagnosis of cancer, other primary respiratory disease, substance abuse, other uncontrolled medical disorder. f) Inability to comply with study procedures in the opinion of the investigators or the participant’s usual medical team g) already receiving psychological intervention

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 9, 2026