The ESCAPE study: offering smoking cessation treatment as part of routine psychological care
| ISRCTN | ISRCTN99531779 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99531779 |
| IRAS number | 239339 |
| Secondary identifying numbers | Funder ID: C56067/A21330, IRAS 239339 |
- 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
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
| Study design | Randomized controlled multicentre trial with nested qualitative methods |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 hypothesis | 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 |
| Condition | 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 | Retention in the smoking cessation treatment, measured at treatment appointments 1 to 6 |
| Secondary outcome measures | Current secondary outcome measures as of 08/02/2021: Smoking-related: 1. Biochemically-verified 7-day point prevalence smoking cessation at 3 and 6 months after baseline 2. Number of cigarettes smoked per day, measured at enrolment, treatment appointments 1 to 6, and 3 and 6 months after baseline 3. Heaviness of Smoking Index, measured at enrolment, treatment appointments 1 to 6, and 3 and 6 months after baseline Mental health-related: 1. Symptoms of depression, measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline, treatment appointments 1 to 6, and 3 and 6 months after baseline 2. Symptoms of anxiety, measured with General Anxiety Disorder-7 (GAD-7) questionnaire at baseline, treatment appointments 1 to 6, and 3 and 6 months after baseline Service-related: 1. Number of “Did Not Attends”, number of planned and completed IAPT sessions, measured at treatment appointments 1 to 6 Acceptability and feasibility 1. Participant and clinician acceptability and satisfaction of intervention as assessed by questionnaires and qualitative interviews at 3 months after baseline. Interviews also explore the acceptability and feasibility of data collection procedures and the impact of smoking cessation treatment on usual care and psychological recovery. Implementation-related 1. Intervention delivery checklist and qualitative analysis of intervention delivery measured at treatment appointments 1 to 6 Secondary outcome measures as of 03/10/2019: Smoking-related: 1. Biochemically-verified 7-day point prevalence smoking cessation at 3 and 6 months after baseline 2. Number of cigarettes smoked per day, measured at enrolment, treatment appointments 1 to 6, and 3 and 6 months after baseline 3. Heaviness of Smoking Index, measured at enrolment, treatment appointments 1 to 6, and 3 and 6 months after baseline Mental health-related: Symptoms of depression, measured using PHQ-9 Service-related: Number of “Did Not Attends”, number of planned and completed IAPT sessions, measured at treatment appointments 1 to 6 Acceptability and feasibility Participant and clinician acceptability and satisfaction of intervention as assessed by questionnaires and qualitative interviews, interviews also explore acceptability and feasibility of data collection procedures, and impact of smoking cessation treatment on usual care and psychological recovery. Assessed at 3 months after baseline Implementation-related intervention delivery checklist, qualitative analysis of intervention delivery, measured at treatment appointments 1 to 6 Secondary outcome measures as of 30/11/2018: Smoking-related: 1. Biochemically-verified 7-day point prevalence smoking cessation at 3 months after baseline 2. Number of cigarettes smoked per day, measured at enrolment, treatment appointments 1 to 6 and 3 months after baseline 3. Heaviness of Smoking Index, measured at enrolment, treatment appointments 1 to 6 and 3 months after baseline Mental health-related: Symptoms of depression, measured using PHQ-9 Service-related: Number of “Did Not Attends”, number of planned and completed IAPT sessions, measured at treatment appointments 1 to 6 Acceptability and feasibility Participant and clinician acceptability and satisfaction of intervention as assessed by questionnaires and qualitative interviews, interviews also explore acceptability and feasibility of data collection procedures, and impact of smoking cessation treatment on usual care and psychological recovery. Assessed at 3 months after baseline Implementation-related intervention delivery checklist, qualitative analysis of intervention delivery, measured at treatment appointments 1 to 6 Previous secondary outcome measures: Smoking-related: 1. Biochemically-verified 7-day point prevalence smoking cessation at 3 months after baseline 2. Number of cigarettes smoked per day, measured at enrolment, treatment appointments 1 to 6 and 3 months after baseline 3. Heaviness of Smoking Index, measured at enrolment, treatment appointments 1 to 6 and 3 months after baseline Mental health-related: 1. Symptoms of depression, measured using PHQ-9 2. Symptoms of anxiety, measured using GAD-7 Service-related: Number of “Did Not Attends”, number of planned and completed IAPT sessions, measured at treatment appointments 1 to 6 Acceptability and feasibility Participant and clinician acceptability and satisfaction of intervention as assessed by questionnaires and qualitative interviews, interviews also explore acceptability and feasibility of data collection procedures, and impact of smoking cessation treatment on usual care and psychological recovery. Assessed at 3 months after baseline Implementation-related intervention delivery checklist, qualitative analysis of intervention delivery, measured at treatment appointments 1 to 6 |
| Overall study start date | 01/01/2018 |
| Overall study end date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 157 |
| Total final enrolment | 135 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/06/2018 |
| Recruitment end date | 31/08/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
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
Sponsor information
University/education
c/o Jonathan Knight
Bath
BA2 7AY
England
United Kingdom
| Phone | +44 (0)1225 383162 |
|---|---|
| pro-vc-research@bath.ac.uk | |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | The trialists will be submitting the protocol to a peer reviewed journal and will submit the results in a peer-reviewed medical journal at the end of 2019. |
| 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? |
|---|---|---|---|---|---|
| Protocol article | 22/01/2019 | 05/11/2019 | Yes | No | |
| 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 |
| 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 |
| Results article | 11/03/2025 | 13/03/2025 | Yes | No |
Additional files
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.
