Evaluating the feasibility of an intervention to support smoking cessation and prevent relapse after a smokefree mental health inpatient stay

Not Applicable

• Conditions: Smoking cessation in persons with mental health disorders; Mental and Behavioural Disorders

• Registration Number: ISRCTN77855199
• Lead Sponsor: Sheffield Health and Social Care NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-17
• Last Update Posted: 22 July 2024
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Current participant inclusion criteria as of 10/07/2024:
1. Adults (18 years+) who smoked prior to/during admission on acute NHS mental health wards and express an interest in maintaining abstinence or positively changing their smoking behaviour following discharge
2. Planned discharge within seven to fourteen days to address/accommodation within Trust’s catchment area
3. Able to understand and communicate in English
4. Access to a telephone or alternative digital advice to receive post-discharge support
5. Willing and able to provide informed consent
Exclusion criteria:
6. Admitted under the care of older adult, learning disability, psychiatric intensive-care unit or forensic mental health services
7. Patients deemed not clinically appropriate to participate (at clinician discretion)

Previous participant inclusion criteria:
1. Adults aged 18 years and older (no maximum age)
2. Current admission to an acute adult mental health inpatient setting
3. Planned discharge within seven to fourteen days to address/accommodation within the Trust’s catchment area
4. Tobacco smokers at time of admission or at any point after (as patients occasionally still commence smoking after admission) who express an interest in maintaining abstinence (if smokefree at time of assessment) or in positively changing their smoking behaviour following discharge (including cigarette reduction and e-cigarette approaches)
5. Able to understand and communicate in English
6. Access to a telephone or computer/alternative digital device to receive post-discharge support
7. Willing and able to provide informed consent

Exclusion Criteria

1. Admitted under the care of older adult, learning disability, psychiatric intensive-care unit (PICU) or forensic mental health services.
2. Patients deemed not clinically appropriate to participate in study (at clinician discretion).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Recruitment and retention measured using screening data and retention rates captured throughout the duration of the study.<br>2. Compliance with the protocol measured using self-assessment checklists completed by the MTS's and reported protocol deviations throughout the duration of the study.<br>3. Level of contamination and suitability of randomisation approach measured using qualitative data collected at 3-months post randomisation and quantitative data collected at 3- and 6-months post randomisation from control participants who quit or reduce smoking. <br>4. Additional qualitative and quantitative measures of acceptability by undertaking semi-structured interviews with control and intervention group participants at 3 months post-randomisation.