The ESCAPE study: offering smoking cessation treatment as part of routine psychological care
| ISRCTN | ISRCTN99531779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99531779 |
| Integrated Research Application System (IRAS) | 239339 |
| Protocol serial number | Funder ID: C56067/A21330, IRAS 239339 |
| Sponsor | University of Bath |
| Funder | Cancer Research UK |
- Submission date
- 09/05/2018
- Registration date
- 15/05/2018
- Last edited
- 13/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Smoking is the world’s leading cause of preventable illness and death. In the UK, smoking rates have decreased from 46% during the 1970s to about 19% in recent years. However, smoking rates in people with mental illness have remained around 37%. People with depression/anxiety are twice as likely to smoke compared to people without depression/anxiety. Importantly, research suggests that if you give up smoking, this could result in improvements in mental health. People with mental illness are more likely to quit smoking if they receive psychological support, as well as receiving smoking cessation medication. For these reasons, this study will offer mental health service users help to quit smoking alongside their routine psychological therapy, to see if quit smoking treatments are accepted by service users and psychologists, and are feasible and successfully implemented in this setting. A smoking cessation intervention has been designed with service users, psychologists, and smoking cessation specialists. This study is testing the feasibility of incorporating this smoking cessation treatment into routine psychological care for people with depression and anxiety, to see whether it is accepted by service users and psychologists and whether it can be successfully implemented in NHS psychological therapy settings.
Who can participate?
Patients aged 18 or older with depression who are about to start psychological therapy, and who smoke and want to quit
What does the study involve?
Participants are randomly allocated to one of two treatments. Both treatments are very similar and involve behavioural, psychological support and medicine to help participants to quit. The difference between the treatments is that one is delivered alongside psychology therapy, and the other treatment involves being referred to the local stop smoking service at the end of the IAPT therapy. Participants allocated to receive the smoking treatment alongside their psychology therapy talk to their Psychological Wellbeing Practitioner about their smoking for up to 15 minutes during each therapy appointment. They are guided through behavioural techniques to support them through the quit attempt. The Psychological Wellbeing Practitioner also talks about the psychology of quitting, and how quitting might improve mental health. In addition, participants receive a smoking cessation medication of their choice to help with withdrawal symptoms. Participants allocated to receive smoking treatment after their psychology therapy is finished receive a referral to their local stop smoking service, who offer a very similar treatment as described above based at their service. Treatment lasts a maximum of 12 weeks over 7 appointments.
What are the possible benefits and risks of participating?
Quitting smoking is the best thing one can do for your physical health and your overall wellbeing. By taking part one might increase your chances of quitting smoking. Also, the results from this study will help to inform a large study examining the effectiveness of offering smoking cessation treatment in psychological therapy settings. There are unlikely to be risks to participants' personal safety or health by taking part in this study, as all of the treatments offered are clinically proven to be safe. Due to the nature of mental health, participants may find taking part overwhelming, and they are welcome to leave the session and withdraw their information at any time and can contact Dr Gemma Taylor to discuss this afterwards. Alternatively, participants can contact Sane Mental Health Helpline on 0300 304 7000, or their health care provider.
Where is the study run from?
Bath and North East Somerset Primary Care Talking Therapies Service (UK), Black Country Healthcare NHS Foundation Trust (UK), and North East London NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2018 to December 2022
Who is funding the study?
Cancer Research UK
Who is the main contact?
Dr Gemma Taylor, gmjm20@bath.ac.uk
Contact information
Public
University of Bath
Department of Psychology
Claverton Down
Bath
BA2 7AY
United Kingdom
| Phone | +44 (0)1225 383379 |
|---|---|
| g.m.j.taylor@bath.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled multicentre trial with nested qualitative methods |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | intEgrating Smoking Cessation treatment As part of usual Psychological care for dEpression and anxiety (ESCAPE): a randomised and controlled, multicentre, acceptability, feasibility and implementation trial |
| Study acronym | ESCAPE |
| Study objectives | The aim of this study is to examine if it is possible to treat tobacco addiction alongside usual IAPT care. |
| Ethics approval(s) | National Health Service Research Ethics Committee, 19/03/2018, IRAS ID: 239339 |
| Health condition(s) or problem(s) studied | Tobacco addiction (smoking) |
| Intervention | The randomisation sequence will be generated using computer software, RedCap (i.e., an online central randomisation service provided by Bristol Medical School). Randomisation will be stratified by site and blocked, and participants will be randomised using a 1:1 algorithm to ensure an equal number of participants in the treatment and control arms. Allocation concealment will be ensured as the randomisation code will not be released until the IAPT client has been recruited into the trial, which takes place after participant eligibility has been assessed, participant identifier has been recorded and consent gained to take part in the trial and to being randomly allocated to treatment condition. Randomisation will be requested via RedCap by the researcher who recruited and consented the participant into the trial. RedCap will send a response to the researcher informing them which treatment the participant will be receiving. Randomisation can only be requested once and after participant identifier, eligibility and consent has been recorded, and therefore implementation cannot be influenced by the PWP, participant, the research or clinical team. Both treatments are very similar and involve behavioural, psychological support and medicine to help participants to quit. The difference between the treatments is that one will be delivered alongside psychology therapy, and the other treatment will involve being referred to the local stop smoking service at the end of the IAPT therapy. Participants assigned to receive the smoking treatment alongside their psychology therapy will talk to their Psychological Wellbeing Practitioner about their smoking for up to 15 minutes during each therapy appointment. They will be guided through behavioural techniques to support them through the quit attempt. The Psychological Wellbeing Practitioner will also talk about the psychology of quitting, and how quitting might improve mental health. In addition, participants receive a smoking cessation medication of their choice to help with withdrawal symptoms. Participants assigned to receive smoking treatment after their psychology therapy is finished will receive a referral to their local stop smoking service, who will offer a very similar treatment as described above based at their service. Treatment will last a maximum of 12 weeks over 7 appointments. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Retention in the smoking cessation treatment, measured at treatment appointments 1 to 6 |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 08/02/2021: |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 157 |
| Total final enrolment | 135 |
| Key inclusion criteria | 1. Aged 18 years or older 2. Has current diagnosis of depression (clinician administered PHQ-9 score of ≥ 10) and/or anxiety (clinician administered GAD-7 score of ≥8) (note: other mental health comorbidities are allowable) 3. Self-reported, daily tobacco smoker of at least 1 year 4. Interested in receiving help to quit smoking tobacco 5. Eligible for IAPT treatment on a one-to-one basis over the telephone or face-to-face 6. About to start psychological therapy for depression/anxiety in IAPT |
| Key exclusion criteria | 1. Already started IAPT treatment 2. Considered too unwell by research or clinical team (i.e. the IAPT provider) 3. Pregnant or breastfeeding |
| Date of first enrolment | 01/06/2018 |
| Date of final enrolment | 31/08/2021 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Royal United Hospital
Combe Park
Bath
BA1 3NG
United Kingdom
Penn Hospital
Penn Road
Wolverhampton
WV4 5HN
United Kingdom
1st floor Maggie Lilley Suite
Goodmayes Hospital
lford
IG3 8XJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | This project will have a restricted-access sharing policy because of the sensitive nature of the data being collected from participants (https://data.bris.ac.uk/sensitive-research-data/). Data will be made available to approved bona fide researchers, after they have signed a data access agreement, the person will be granted access to the University of Bristol’s Data Repository (https://data.bris.ac.uk) by the Research Data Services (https://data.blogs.ilrt.org/). Data will be stored for 25 years. Administration, transcript and audio data will be destroyed after the study period and will not be shared. All data listed on the University’s online Research Data Repository (https://data.bris.ac.uk) will be noted formally in academic citations with a Digital Object Identifier (DOI). During dissemination to academic, NHS, and IAPT client collaborators – access to the Research Data Repository will be noted. The study will have a webpage, which will also include a link to the online Research Data Repository and details about applying for access. Please contact Dr Gemma Taylor for access. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/03/2025 | 13/03/2025 | Yes | No | |
| Protocol article | 22/01/2019 | 05/11/2019 | Yes | No | |
| Other publications | Service-user experiences | 08/12/2022 | 12/12/2022 | Yes | No |
| Other publications | Embedded qualitative study | 12/10/2022 | 10/07/2024 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Statistical Analysis Plan | version 1 | 19/10/2021 | 19/10/2021 | No | No |
| Statistical Analysis Plan | version 1.1 | 04/11/2021 | 04/11/2021 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN99531779_SAP_v1_19Oct21.pdf
- Statistical Analysis Plan
- ISRCTN99531779_SAP_v1.1_04Nov2021.pdf
- Statistical Analysis Plan
Editorial Notes
13/03/2025: Publication reference and total final enrolment added.
10/07/2024: Publication reference added.
12/12/2022: Publication reference added.
31/01/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/03/2022 to 31/12/2022.
2. The intention to publish date was changed from 31/08/2022 to 31/12/2023.
3. The plain English summary was updated to reflect these changes.
04/11/2021: The statistical analysis plan has been uploaded as an additional file.
19/10/2021: The statistical analysis plan has been uploaded as an additional file.
03/08/2021: The following changes were made to the trial record:
1. The intention to publish date was changed from 31/12/2021 to 31/08/2022.
2. The public contact was changed.
3. The plain English summary was updated to reflect these changes.
08/02/2021: Recruitment for this study is no longer paused and the following changes have been made:
1. The recruitment end date has been changed from 31/08/2020 to 31/08/2021.
2. The overall trial end date has been changed from 28/02/2021 to 31/03/2022.
3. The secondary outcome measures have been updated.
4. The trial participating centres "Bristol Wellbeing Therapies" and "TalkingSpace Plus" have been removed.
5. The trial participating centres "Bath and North East Somerset Primary Care Talking Therapies Service", "Black Country Healthcare NHS Foundation Trust", and "North East London NHS Foundation Trust" have been added.
6. The plain English summary has been updated to reflect the changes above.
01/02/2021: The public contact details have been changed.
12/06/2020: The public contact details have been changed.
23/03/2020: Internal review.
20/03/2020: Due to current public health guidance, recruitment for this study has been paused.
06/01/2019: The sponsor was changed from University of Bristol to University of Bath.
05/11/2019: Publication reference added.
03/10/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2019 to 31/08/2020.
2. The overall end date was changed from 28/02/2019 to 28/02/2021.
3. The intention to publish date was changed from 31/12/2019 to 31/12/2021.
4. The plain English summary was updated to reflect these changes.
02/10/2019: The email address for the study contact was updated.
11/03/2019: The recruitment end date has been changed from 28/02/2019 to 30/09/2019.
30/11/2018: The secondary outcome measures were updated.
