Exploring Mental Health Changes After Kaftrio in Cystic Fibrosis
Research type
Research Study
Full title
An exploration of mental health changes in people with cystic fibrosis after starting triple CFTR modulator therapy (Kaftrio): an Interpretative Phenomenological Analysis
IRAS ID
362747
Contact name
Anna Pearse
Contact email
Sponsor organisation
University Hospitals of North Midlands NHS Trust
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
Aim:
To explore the nature of psychological side effects linked to triple CFTR modulator therapy, as experienced by patients with cystic fibrosis.Background:
In 2020, triple CFTR modulator therapy was made available in the UK. In clinical trials, this medication has significantly improved the quality of life and lung function of patients. However, in May 2025, the MHRA published an update noting a small increased risk of psychological side effects in patients treated with Kaftrio (elexacaftor/tezacaftor/ivacaftor), including low mood, sleep disturbance, and anxiety.
There have been several interview studies exploring patients’ general experiences after starting Kaftrio, and while many participants in these studies have described positive life changes after starting medication, some raise themes of identity loss and the challenges associated with an extended life expectancy. However, there is a notable lack of studies looking specifically at patients who have experienced psychological side effects and exploring these experiences in depth.Design:
The study will involve patients under the care of the cystic fibrosis team at University Hospitals of North Midlands NHS Trust being invited to take part in an individual interview (maximum 1 hour). Interviews will be semi-structured with questions asked in accordance with a pre-prepared interview schedule, in addition to further exploration of topics felt to be relevant by either participant or interviewer. The interviews will be conducted face-to-face or on MS Teams (depending on participant preference) and recorded to facilitate analysis. Recordings will be transcribed prior to analysis and at this stage will be de-identified through the use of pseudonyms. Following transcription, recordings will be destroyed. The qualitative interview data will then be analysed using Interpretive Phenomenological Analysis (IPA) methodology.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
25/LO/0866
Date of REC Opinion
6 Jan 2026
REC opinion
Further Information Favourable Opinion