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Promoting smoking cessation and preventing relapse to tobacco use following a smoke-free mental health inpatient stay (SCEPTRE feasibility study): a multicentre randomised controlled feasibility study protocol

Por: Petersen Williams · P. · Huddlestone · L. · Shoesmith · E. · Brady · S. · Mitchell · A. · Exley · V. · Wiggins · F. · Sinclair · L. · Pervin · J. · Horspool · M. · Leahy · M. · Paul · C. · Colley · L. · Shahab · L. · Watson · J. · Hewitt · C. · Hough · S. · Britton · J. · Coleman · T. · Gilb
Introduction

Thousands of patients with mental illness are admitted to acute adult mental health wards every year in England, where local guidance recommends that all mental health settings be entirely smokefree. Mental health Trusts presently invest substantial effort and resources to implement smoke-free policies and to deliver tobacco dependence treatment to patients. Providing adequate support can help those who smoke remain abstinent or quit smoking during their smoke-free inpatient stay and beyond. At present, little is known about how best to support patients to prevent their return to pre-admission smoking behaviours after discharge from a smoke-free mental health inpatient stay. We have developed an intervention which includes targeted resources to support smoking-related behaviour change in patients following discharge from a smoke-free mental health setting. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the SCEPTRE intervention, compared with usual care.

Methods and analysis

This feasibility study will be an individually randomised, controlled trial in eight National Health Service mental health Trusts recruiting adults (≥18 years) admitted to an acute adult mental health inpatient setting who smoke tobacco on admission, or at any point during their inpatient stay. Consenting participants will be randomised to receive a 12-week intervention consisting of components aimed at promoting or maintaining positive smoking-related behaviour change following discharge from a smoke-free mental health inpatient setting or usual care. Data will be collected at baseline, 3 months and a second timepoint between 4 and 6 months post-randomisation. With 64 participants (32 in each group), the trial will allow a participation rate of 15% and completion rate of 80% to be estimated within a 95% CI of ±3% and ±10%, respectively. The analysis will be descriptive and follow a prespecified plan.

Ethics and dissemination

Ethics approval was obtained from the North West—Greater Manchester West Research Ethics Committee. We will share results widely through local, national and international academic, clinical and patient and public involvement networks. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: https://sceptreresearch.com/.

Trial registration number

ISRCTN77855199.

Behavioural activation for low mood and anxiety in male frontline NHS workers (BALM): a pre-post intervention study

Por: Galdas · P. · Bailey · D. · Bell · S. · Bosanquet · K. · Chew-Graham · C. · Ekers · D. · Gilbody · S. · Littlewood · E. · Mawhinney · M. · Stevens · H. · Webb · K. · McMillan · D.
Objectives

To evaluate the impact and acceptability of a tailored, gender-responsive behavioural activation (BA) intervention for improving depression and anxiety in male National Health Service (NHS) frontline workers.

Design

Pre-post intervention study.

Setting

Three NHS organisations in the North of England.

Participants

45 men aged ≥18 years working in a frontline NHS role scoring in the subclinical range (5–14) on the Patient Health Questionnaire-9 (PHQ-9) (depression) and/or the Generalised Anxiety Disorder-7 (GAD-7) (anxiety) at baseline.

Interventions

A tailored BA treatment programme consisting of up to eight telephone support sessions over a period of 4–6 weeks, accompanied by a BA self-help manual.

Main outcome measures

Self-reported symptom severity of depression, assessed by PHQ-9, and anxiety, assessed by GAD-7, at baseline and 4 and 6 months. Acceptability from the perspectives of male study participants and coaches who delivered the intervention was assessed in a nested qualitative study using the theoretical framework of acceptability (TFA).

Results

PHQ-9 and GAD-7 scores decreased from baseline to 4 months on both the PHQ-9 and GAD-7. While scores increased from 4 months to 6 months, the 6-month scores remained below those of the baseline scores. Acceptability of the intervention was high across all constructs of the TFA. The practical and action-oriented strategies of the intervention, and the confidential, flexible, convenient mode of delivery, worked to support men’s engagement with the intervention.

Conclusions

Delivery of a tailored, gender-responsive BA intervention was appealing to, and beneficial for, men working in frontline NHS roles with less severe depression and anxiety. The BALM intervention offers promise as a tailored workplace mental health programme that is aligned with men’s needs and preferences and can help overcome a reticence to engage with mental health support in NHS staff and beyond.

Trial registration number

ISRCTN48636092.

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