intEgrating Smoking Cessation treatment As part of usual Psychological care for dEpression and anxiety (ESCAPE): A randomised and controlled, multi-centre, acceptability and feasibility trial with nested qualitative methods
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Authors
Gemma M. J. Taylor
Katherine Sawyer
Pamela Jacobsen
Tom P. Freeman
Anna Blackwell
Shadi Daryan
Chris Metcalfe
David Kessler
Marcus R. Munafò
Paul Aveyard
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Issue Date
30/05/2025
Type
Journal Article
Language
Keywords
Mental Health
Alternative Title
Abstract
Background Stigma of mental health conditions hinders recovery and well-being. The Honest, Open, Proud (HOP) program shows promise in reducing stigma but there is uncertainty about the feasibility of a randomized trial to evaluate a peer-delivered, individual adaptation of HOP for psychosis (Let's Talk). Methods A multi-site, Prospective Randomized Open Blinded Evaluation (PROBE) design, feasibility randomised controlled trial (RCT) comparing the peer-delivered intervention (Let's Talk) to treatment as usual (TAU). Follow-up was 2.5 and 6 months. Randomization was via a web-based system, with permuted blocks of random size. Up to 10 sessions of the intervention over 10 weeks were offered. The primary outcome was feasibility data (recruitment, retention, intervention attendance). Primary outcomes were analyzed by intention to treat. Safety outcomes were reported by as treated status. The study was prospectively registered: https://doi.org/10.1186/ISRCTN17197043 . Results 149 patients were referred to the study and 70 were recruited. 35 were randomly assigned to intervention + TAU and 35 to TAU. Recruitment was 93% of the target sample size. Retention rate was high (81% at 2.5 months primary endpoint), and intervention attendance rate was high (83%). 21% of 33 patients in Let's talk + TAU had an adverse event and 16% of 37 patients in TAU. One serious adverse event (pre-randomization) was partially related and expected. Conclusions This is the first trial to show that it is feasible and safe to conduct a RCT of HOP adapted for people with psychosis and individual delivery. An adequately powered trial is required to provide robust evidence.
Description
Citation
Addiction, 120(5), 922-936
Publisher
License
Journal
Addiction
Volume
120
Issue
5