Feasibility trial SMILE_PH for insomnia patients
Research type
Research Study
Full title
A feasibility trial of SMILE_PH for insomnia patients (Sense-Making Interviews Looking at Elements of Philosophical Health) (SMILE_PHi trial)
IRAS ID
354190
Contact name
John Hughes
Contact email
Sponsor organisation
University of West London
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
The proposed study will employ a pragmatic mixed methods randomised parallel-group exploratory design to determine the feasibility of delivering Sense Making Interviews Looking at Elements of Philosophical Health (SMILE_PH) within an NHS insomnia care setting. The trial will explore the feasibility and acceptability of all aspects of a definitive clinical trial of teaching insomnia patients the SMILE_PH intervention to alleviate symptoms of insomnia and quality of life. In addition the feasibility trial will provide preliminary data on effectiveness to inform the sample size calculation for a controlled clinical trial. Patients will be randomly allocated to receive either: 1) SMILE_PH in addition to standard care or 2) standard care alone. Participants randomised to the SMILE_PH arm will be asked to attend 8 sessions of 45 minutes duration each, delivered by experienced practitioners. Patients will be recruited from the Royal London Hospital for Integrated Medicine Insomnia Service. Participants will complete baseline outcome measures and be asked to complete follow up outcomes measures at the end of treatment (10 weeks), and 3 months post treatment. At the end of treatment participants will also be asked to take part in a qualitative focus group to explore their views on the design of the study and if allocated to SMILE_PH their views on the intervention. Qualitative focus groups will also be conducted with stakeholders (practitioners delivering the SMILE_PH intervention and Royal London Hospital for Integrated Medicine Insomnia Service staff) to explore their views on the feasibility of teaching insomnia patients SMILE_PH.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
25/LO/0921
Date of REC Opinion
22 Dec 2025
REC opinion
Favourable Opinion