Condition category
Mental and Behavioural Disorders
Date applied
09/05/2018
Date assigned
15/05/2018
Last edited
15/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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?
1. Bristol Wellbeing Therapies (UK)
2. TalkingSpace Plus (UK)

When is the study starting and how long is it expected to run for?
January 2018 to February 2019

Who is funding the study?
Cancer Research UK

Who is the main contact?
Dr Gemma Taylor

Trial website

https://www.escapestudy.com/

Contact information

Type

Public

Primary contact

Dr Gemma Taylor

ORCID ID

http://orcid.org/0000-0003-2185-0162

Contact details

MRC Integrative Epidemiology Unit
UK Centre for Tobacco and Alcohol Studies
School of Experimental Psychology
The University of Bristol
12A Priory Road
Bristol
BS8 1TU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Funder ID: C56067/A21330

Study information

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

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

National Health Service Research Ethics Committee, 19/03/2018, IRAS ID: 239339

Study design

Randomised controlled multicentre trial with nested qualitative methods

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Drug names

Primary outcome measure

Retention in the smoking cessation treatment, measured at treatment appointments 1 to 6

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 trial start date

01/01/2018

Overall trial end date

28/02/2019

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

157

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

28/02/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Wellbeing Therapies
BS11 0QE

Trial participating centre

TalkingSpace Plus
OX2 0ES

Sponsor information

Organisation

University of Bristol

Sponsor details

Research Governance Team
Research & Enterprise Development
University of Bristol
Senate House
Tyndall Avenue
Bristol
BS8 1TH
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

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 statement
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.

Intention to publish date

31/12/2019

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes