Evaluating the feasibility of an intervention to support smoking cessation and prevent relapse after a smokefree mental health inpatient stay
| ISRCTN | ISRCTN77855199 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77855199 |
| IRAS number | 329622 |
| Secondary identifying numbers | CPMS 58805, NIHR200607, IRAS 329622 |
- Submission date
- 24/10/2023
- Registration date
- 17/11/2023
- Last edited
- 23/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
The proportion of people with mental illness who smoke tobacco is very high compared to the general population. It can reach figures over 70% among those in certain subgroups, such as hospitalised patients with mental illness compared to 15% in the general population. As people with mental illness are usually heavily addicted to tobacco, smoking causes large amounts of disease and deaths in this group, often from cardiovascular, respiratory illness and cancer. Smoking has been recognised as the single largest cause of health inequalities for people with mental illness. People with mental illness lose up to 20 years of life mainly to the consequences of smoking. Although mental health patients often want to quit and can do so successfully, smoking is rarely addressed in mental health care. Guidance from the National Institute of Health and Care Excellence (NICE) recommends that mental health settings become entirely smokefree, and mental health patients should have access to evidence-based stop smoking treatment.
For many patients, receiving treatment in a smokefree inpatient environment will be a rare experience of abstaining from tobacco. Currently, no strategies to help maintain or achieve a smokefree lifestyle and avoid relapse post-discharge exist, meaning most patients will return to old smoking behaviours within days of discharge.
We have developed the SCEPTRE intervention to support mental health inpatients after discharge to maintain abstinence or positively change their smoking behaviour, building on existing evidence, behaviour change theory, and working closely with service users and mental healthcare professionals. The intervention was tested in a small-scale pilot study to test the research materials and processes, and preliminary acceptability to people with mental illness. Based on these findings, the SCEPTRE intervention has been revised and will be tested in the current feasibility trial.
Who can participate?
Adults who are 18 years or older who were smokers before their stay in a hospital's mental health ward and are interested in either maintaining the positive changes to their smoking behaviour or improving their smoking habits once they leave hospital.
What does the study involve?
A support package has been developed to help people with mental health conditions to maintain the positive changes they have made to their smoking behaviour while in hospital. This package will last for 12 weeks after participants have been discharged and will be delivered by a mental health worker trained to provide personalised support to assist them in meeting their smoking behaviour change goals. All participants in the study will have a random chance of receiving the SCEPTRE support package. This means a computer programme will choose if someone receives the support or their usual care. ‘Usual care’ might mean receiving advice to quit smoking on discharge, offering a short supply of Nicotine Replacement Therapy (NRT) products (smoking cessation medication), or a referral to a local stop-smoking service.
Participants will be asked to complete a questionnaire three months and six months after joining the study. The questionnaires can be completed either by email through a secure link, with a member of the research team in person, or via telephone or video call. The questionnaires will take approximately 30 minutes to complete and will ask participants about their smoking habits, mental and physical health, and the health services they use. If someone reports they have not smoked, they will be asked to provide another sample of their breath so that we can measure the Carbon monoxide (CO) in their body.
What are the possible benefits and risks of participating?
If they are allocated to receive the SCEPTRE support package, participants will benefit through the provision of personalised support to change smoking behaviours following a smokefree stay in a mental health hospital. By positively changing their smoking behaviours, this may have both physical and mental health benefits.
Where is the study run from?
Sheffield Health and Social Care NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
June 2023 to November 2024
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
victoria.exley@york.ac.uk
Contact information
Scientific
York Trials Unit
University of York
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0002-9326-9046 |
|---|---|
| Phone | +44 1904 326856 |
| victoria.exley@york.ac.uk |
Principal Investigator
Mental Health and Addictions Group
University of York
York
YO10 5DD
United Kingdom
| ORCID ID |
0000-0003-4128-9608 |
|---|---|
| Phone | +44 1904 321678 |
| elena.ratschen@york.ac.uk |
Scientific
Mental Health and Addictions Group
University of York
York
YO10 5DD
United Kingdom
| ORCID ID |
0000-0002-8054-4475 |
|---|---|
| Phone | +44 1904 321949 |
| lisa.huddlestone@york.ac.uk |
Public
York Trials Unit
University of York
York
YO10 5DD
United Kingdom
| ORCID ID |
0000-0002-2210-8181 |
|---|---|
| Phone | +44 1904 324158 |
| lesley.sinclair@york.ac.uk |
Study information
| Study design | Randomized controlled feasibility trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Hospital |
| Study type | Other |
| Participant information sheet | 44476 SCEPTRE feasibility trial_PIS_Participant_v1.0_19.10.2023.pdf |
| Scientific title | A randomised, controlled feasibility study of the SCEPTRE intervention to support smoking cessation and prevent relapse to tobacco use following a smoke free mental health inpatient stay |
| Study acronym | SCEPTRE Feasibility Trial |
| Study hypothesis | The aim of this study is to assess the feasibility and acceptability of a new intervention to support smoking cessation and prevent relapse after a smoke-free mental health inpatient stay. |
| Ethics approval(s) |
Approved 13/10/2023, North West- Greater Manchester West Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8278; gmwest.rec@hra.nhs.uk), ref: 23/NW/0312 |
| Condition | Smoking cessation in persons with mental health disorders |
| Intervention | Baseline data collection: Once participant eligibility has been confirmed and consent has been obtained, a baseline visit will be completed to collect all baseline data. The following measures will be collected at baseline: - Demographic measures (gender, age, marital status, ethnicity, primary mental health diagnosis, smoking status, housing/accommodation status) - Mental and physical health measures: The nine-item Patient Health Questionnaire depression scale (PHQ-9), the Generalised Anxiety Disorder 7-item scale (GAD-7), and the quality of life scale (EQ-5D-5L), will be included. The frequency of use of health services during the inpatient stay and in the last six months (before hospital admission and during inpatient stay) will also be collected. Smoking history and behaviour: Smoking history and behaviour prior to admission (including number of cigarettes smoked per day, number of past quit attempts, use of e-cigarettes and NRT); smoking history and behaviour during inpatient stay (including number of cigarettes smoked per day, greatest length of time abstinent during stay, Heaviness of Smoking Index (HSI), Strength of urges to smoke, Motivation to Quit Questionnaire, and use of e-cigarettes and NRT. Participants will also be asked about their smoking status intention post-discharge. Participants will be asked to provide a carbon monoxide (CO) reading. Randomisation: Following a baseline assessment, randomisation will be undertaken by a member of the Trusts research team using REDCap. The outcome of the allocation will be communicated to the participant where possible in person but may also be communicated by text or telephone call. Follow up data collection: Participants will be asked to complete questionnaires at 3 and 6 months post-randomisation. Participants will be asked the same questions as the baseline visit minus the demographic questions. Depending on participant preference, they will be able to complete these via email, in person with a researcher or over the phone/video call. Participants who self-report that they have not smoked will be asked to provide a carbon monoxide (CO) reading. Qualitative interviews: Patient and relative/friend participants will also be invited to take part in short semi-structured interviews at the 3 month follow-up time point to gain a more in-depth understanding of the feasibility of the study procedures and intervention delivery, as well as the impact of the intervention on the patient participant. Semi-structured interviews will also be conducted with the MTSs to explore their experience and perceptions of delivering the intervention. Patient and public involvement: The SCEPTRE PPI group have contributed to the design of both the intervention components, participant study documents, intervention resources, and have provided input to the design of intervention delivery mechanisms and measures. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Recruitment and retention measured using screening data and retention rates captured throughout the duration of the study. 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. 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. 4. Additional qualitative and quantitative measures of acceptability by undertaking semi-structured interviews with control and intervention group participants at 3 months post-randomisation. |
| Secondary outcome measures | Measured using self report (unless otherwise noted): 1. Self-reported 7-day point prevalence abstinence from tobacco validated by exhaled CO <10ppm at 3 and 6 months, 2. Self-reported relapse following discharge from hospital at 3 and 6 months, 3. 1, 2, and 3-month continuous abstinence at 3 months post randomisation, 4. 4, 5, and 6-month continuous abstinence at 6 months post randomisation 5. Tobacco consumption at baseline, 3- and 6-months post-randomisation, 6. Number of quit attempts at baseline, 3 and 6 months, 7. Motivation to quit at baseline 3 and 6 months, 8. Heaviness of Smoking Index at baseline, 3 and 6 months, 9. Use of NRT/e-cigarettes at baseline, 3 and 6 months, 10. Self-efficacy related to smoking cessation at baseline, 3 and 6 months, 11. Change in mental health PHQ-9 at baseline, 3 and 6 months, 12. Change in mental health GAD-7 at baseline, 3 and 6 months, 13. Change in mental health EQ-5D at baseline, 3 and 6 months, 14. Cost of delivering the SCEPTRE intervention and the control condition and feasibility of collecting health economic data measured using a bespoke health resource use questionnaire at 3 and 6 months post-randomisation. |
| Overall study start date | 01/06/2023 |
| Overall study end date | 27/11/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 64; UK Sample Size: 64 |
| Total final enrolment | 38 |
| Participant 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 |
| Participant 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). |
| Recruitment start date | 23/01/2024 |
| Recruitment end date | 12/07/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
St. Marys Road
Leeds
LS7 3JX
United Kingdom
9 Alie Street
London
E1 8DE
United Kingdom
Beaconsfield Close
Hatfield
AL10 8YE
United Kingdom
Bridge Park Plaza
Bridge Park Road
Leicester
LE4 8PQ
United Kingdom
Kingsway Hospital
Kingsway
Derby
DE22 3LZ
United Kingdom
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom
Sponsor information
Hospital/treatment centre
Centre Court, Atlas Way
Sheffield
S4 7QQ
England
United Kingdom
| Phone | +44 1142716605 |
|---|---|
| wendy.swann@shsc.nhs.uk | |
| Website | http://shsc.nhs.uk/ |
"ROR" |
https://ror.org/05cn4v910 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/08/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from the Chief Investigator- Elena Ratschen (elena.ratschen@york.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.0 | 19/10/2023 | 17/11/2023 | No | Yes |
| Protocol file | version 1.0 | 05/09/2023 | 17/11/2023 | No | No |
| Participant information sheet | version 1.2 | 30/04/2024 | 11/07/2024 | No | Yes |
| Protocol file | version 2.0 | 30/04/2024 | 11/07/2024 | No | No |
Additional files
Editorial Notes
23/01/2025: The overall study end date was changed from 01/01/2025 to 27/11/2024. Total final enrolment added.
10/07/2024: The following changes were made:
1. The public contact was updated.
2. The recruitment end date was changed from 23/05/2024 to 12/07/2024.
3. The participant inclusion criteria were changed.
4. The Oxford Health NHS Foundation Trust was added as a study participating centre.
5. Protocol version 2.0 30/04/2024 (not peer reviewed) and patient information sheet version 1.2 30/04/2024 were uploaded.
01/03/2024: The following changes were made to the study record:
1. The recruitment start date was changed from 30/11/2023 to 23/01/2024.
2. The recruitment end date was changed from 30/03/2024 to 23/05/2024.
24/10/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
