Smoking CessationNCT05654545
Smoking Cessation Coaching in High-Risk Situations: A Virtual Reality Study
A study testing Lapse prevention dialog: Boost motivation and self-efficacy, Lapse prevention dialog: Future-selves and implementation intentions and Lapse prevention dialog: Identity-related positive self-talk in people with Smoking Cessation, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Smoking tobacco is an important preventable risk factor for chronic illnesses and premature death and is most prevalent among groups with a lower socio-economic position (SEP). High relapse rates show that smoking cessation interventions are often not sufficiently effective on the long-term. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Lapse prevention dialog: Boost motivation and self-efficacy, Lapse prevention dialog: Future-selves and implementation intentions and Lapse prevention dialog: Identity-related positive self-talk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Nov 2022to 19 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Being able to read and understand Dutch
- Smoking ≥ 10 cigarettes a day
- Intention to quit smoking sometime in the future
- Being able to wear a VR helmet for approximately 30 minutes, with breaks in between
- Willingness to take and send videos and audio of three locations where the participant is most likely to smoke (i.e., highest chance of smoking when in the environment)
Who cannot join
- Visual problems (e.g., limited visibility without glasses) that affect viewing VR environments (based on self-report)
- Currently involved in smoking cessation activity or therapy (based on self-report)
- When patients are deemed unfit to participate (due to, for example, psychological problems or medication). This decision is left to the discretion of the responsible researcher.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center (LUMC)
Leiden, South Holland, 2333 RC
About this study
Official title: Examining the Effect of Personalized Advice of a Conversational Agent for Smoking Cessation in High Risk Situations: An Experimental Study Using Virtual Reality
Smoking tobacco is an important preventable risk factor for chronic illnesses and premature death and is most prevalent among groups with a lower socio-economic position (SEP). High relapse rates show that smoking cessation interventions are often not sufficiently effective on the long-term. Potential reasons for this limited effectiveness are that these interventions are not tailored to lower-SEP smokers and do not provide sufficient support in situations when the (re)lapse risk is high; that is, high-risk situations (HRSs). A mobile phone application using an automated conversational agent could be a useful approach to promote long-term smoking cessation, as it can be tailored to lower-SEP smokers and provide support at any time of the day (also in HRSs). However, evidence on the effectiveness of this kind of applications is scarce and it is still unclear how automated conversational agents can effectively promote lapse prevention. Therefore, it is important to explore what type of lapse prevention strategies these conversational agents should use in HRSs and how these different types of support are experienced by smokers.
This virtual reality (VR) experiment will examine the preliminary effectiveness and usability of a conversational agent that supports smokers in personal HRSs. More specifically, the investigators primarily aim to examine whether the three different lapse prevention dialogs increase abstinence self-efficacy in adult smokers from different SEP groups during simulated HRSs, compared to a neutral dialog (i.e., control condition). In addition, the investigators examine the effect of the lapse prevention dialogs, compared to the neutral dialog, in simulated HRSs on subjective craving and affect. Finally, the investigators examine how adult smokers from different SEP groups experience the personalized support of a simulated conversational agent in simulated HRSs.
VR will be used to expose smokers to their personal HRSs and let them interact with a conversational agent via a simulated mobile phone. Using computer-based VR technology, three-dimensional environments can be created based on environments that smokers encounter in their daily lives (e.g., their living room or the train station from where they travel to work). This way, controlled but at the same time natural-looking environments can be used to expose smokers to their personal HRSs and measure their responses in this situation.
- Conditions
- Smoking Cessation
- Being tested
- Lapse prevention dialog: Boost motivation and self-efficacy, Lapse prevention dialog: Future-selves and implementation intentions, Lapse prevention dialog: Identity-related positive self-talk, Attention control dialog: neutral topic
- Keywords
- Smoking Cessation, Coaching, Chatbot, High-Risk situations, eHealth, Virtual Reality, Smoking, Relapse prevention
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lapse prevention dialog: Boost motivation and self-efficacyBehavioural
In the boost motivation and self-efficacy dialog, the conversational agent will tell the participant that they can successfully resist smoking, try to take away their self-doubts and assert that the participant can and will succeed. For example, the conversational agent will send text messages such as: "Even though the temptation can be high, I have no doubts that you can resist smoking in this situation. If you want something, you can do it. Believe in yourself!".
Lapse prevention dialog: Future-selves and implementation intentionsBehavioural
In the future-selves and implementation intentions dialog, the conversational agent will first tell the participant to imagine themselves in a future in which they successfully quit smoking (i.e., desired future self). The conversational agent can send text messages such as: "Please think about yourself in the future. Imagine that you have quit smoking successfully. Think about the person you will be. What do you look like? What does your life look like? Consider this future image as well as you can.". This procedure will be repeated for a future in which the participant continued smoking (i.e., the undesired future self). Finally, the conversational agent will explain to the participant that it is important to think about how to resist smoking in HRSs (i.e., implementation intentions) to ensure that the participant comes closer to becoming their desired future self as non-smoker and to avoid their undesired future self as a smoker.
Lapse prevention dialog: Identity-related positive self-talkBehavioural
In the identity-related positive self-talk dialog, the conversational agent will tell the participant to use positive self-talk focused on their identity to motivate themselves to successfully resist smoking. For example, the conversational agent will send text messages such as: "When you feel tempted to smoke, it can help to say positive things to yourself and motivate yourself to resist the temptation. What positive things can you say about yourself to motivate yourself to resist smoking? For instance, 'I am a strong person who can resist smoking' or 'I am a person who is persistent and has control over the urge to smoke'. Now say the sentence(s) you find motivating or your own motivating words to yourself, by thinking it, and repeating it in your head or out loud.".
Attention control dialog: neutral topicBehavioural
The neutral dialog will act as an attention control condition. In this dialog, the conversational agent will not provide support using relapse prevention strategies. Instead, the conversational agent will start with a short introduction (e.g., "Hi, how are you doing?"), ask questions to show interest (e.g., "How are you feeling today?") and will talk about a neutral topic (e.g., animals; "What is your favorite animal?"), and then closes the conversation (e.g., "It was nice speaking with you. I hope you have a good rest of the day!").
| Study group | Role | What they receive |
|---|---|---|
| Chatbot coaching | Other | Due to the single-group design there will only be one arm. All participants will be exposed to four different chatbot relapse prevention coaching dialogs, which are presented in a random order. Receives: Behavioral: Lapse prevention dialog: Boost motivation and self-efficacy; Behavioral: Lapse prevention dialog: Future-selves and implementation intentions; Behavioral: Lapse prevention dialog: Identity-related positive self-talk; Behavioral: Attention control dialog: neutral topic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence self-efficacy
Smoking abstinence self-efficacy will be assessed with a single question derived from the 'Smoking Abstinence Self-efficacy Questionnaire' (Spek et al., 2013). The six-item questionnaire measures self-efficacy regarding smoking abstinence in six different situations. However, in this experiment the situation is shown using VR (e.g., a personalized VR environment of a participant's favorite bar). Therefore, participants will only answer the question "Are you confident that you will not smoke in this situation?" while being exposed to the VR environment. Total scores range from 0 to 4, with a higher score indicating higher abstinence self-efficacy.
Measured: Four times during the experiment which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4).
Secondary outcomes (4)
Phasic (state) tobacco craving
To identify the level of subjective smoking craving experienced (in the VR environments), a single-item will be used (Shadel \& Cervone, 2006; Vinci et al., 2020). Participants are asked to indicate how strong their craving for a cigarette is right now. Answers are given on a scale ranging from 1 (no craving at all) to 10 (extremely strong craving), with a higher score indicating stronger subjective tobacco craving.
Measured: Four times during the experiment which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4).
Positive and negative affect
The level of positive and negative affect is assessed by having participants indicate to what extent they experienced the four basic emotions on a scale from 1 (not at all) to 10 (very much; Versluis et al., 2018). The scores on anger, anxiety and sadness will be averaged to represent negative affect. The average score on negative affect ranges from 3 to 30, with a higher score indicating stronger feelings of negative affect. The happiness-rating will represent positive affect. The average score on positive affect ranges from 1 to 10, with a higher score indicating stronger feelings of positive affect.
Measured: At the start of the experiment (baseline) and four times during the experiment, which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4)
Acceptance of the conversational agent
Acceptance of the conversational agent will be assessed using a set of six items. Two example items are: "How satisfied were you with the virtual coach?" and "How easy was it talking to the virtual coach?". Answers are given on a 7-point scale. The questionnaire was originally used in an intervention study (Provoost et al., 2020). Three of the items of the questionnaire had to be adjusted to make them applicable to the experimental set-up of this study. For example, the item "How much would you like to continue working with the virtual coach if the course continued?" was changed into "How much would you like to continue working with the virtual coach if it was available on your smartphone?". Total scores range from 6 to 42, with a higher score indicating higher acceptance of the conversational agent.
Measured: At the end of the experiment (post-intervention); experiment has a duration of 1.5 hours
User-experience / usability
The usability of the conversational agent will be measured with a number of items of the System Usability Scale (Brooke, 1996). The total questionnaire consists of ten items and items are rated on a 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). Four questions of the original questionnaire are used in this study. In addition, to get a better in-depth understanding of the participants' user experience with the virtual coach, the following open-ended question will be asked: "Would it be useful to have a virtual coach available on your phone to assist with smoking cessation? Please explain.".
Measured: At the end of the experiment (post-intervention); experiment has a duration of 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start4 Nov 2022
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A repeated measures within-subjects design will be employed. Conditions (the type of dialog) will be counterbalanced to minimize carryover effects. Baseline questionnaires measuring demographic characteristics, previous experience with VR, and smoking-specific characteristics will be administered at the start of the experiment. In addition, questionnaires measuring abstinence self-efficacy (i.e., the endpoint for the primary objective), phasic (state) tobacco craving, positive and negative affect, and sense of presence will be administered after every VR session (four times in total) to investigate the study objectives. Positive and negative affect will also be assessed before the VR sessions as a baseline measure. Finally, questionnaires measuring acceptance of the conversational agent and user-experiences will be administered after the last VR session.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aversluis, Leiden University Medical Center
- Investigators
- Anke Versluis, Dr., Principal investigator, Leiden University Medical CenterEline Meijer, Dr., Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654545
- Sponsor's protocol ID
- N22.013 METC-LDD
- Other IDs
- 628.011.211
- Status last verified
- May 2023
- First submitted
- 28 Nov 2022
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized data will be made available for reuse at the end of the project. Certain demographic characteristics might have to be removed from the data set, to prevent traceability of individual participants. It has yet to be decided whether data can best be made available through a repository or through reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Personalized Advice of a Conversational Agent for Smoking Cessation in High Risk Situations: An Experimental Study Using Virtual Reality
- ClinicalTrials.gov ID
- NCT05654545
- Acronym / sponsor ID
- N22.013 METC-LDD
- Conditions
- Smoking Cessation
- Keywords
- Smoking Cessation, Coaching, Chatbot, High-Risk situations, eHealth, Virtual Reality, Smoking, Relapse prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smoking tobacco is an important preventable risk factor for chronic illnesses and premature death and is most prevalent among groups with a lower socio-economic position (SEP). High relapse rates show that smoking cessation interventions are often not sufficiently effective on the long-term. Potential reasons for this limited effectiveness are that these interventions are not tailored to lower-SEP smokers and do not provide sufficient support in situations when the (re)lapse risk is high; that is, high-risk situations (HRSs). A mobile phone application using an automated conversational agent could be a useful approach to promote long-term smoking cessation, as it can be tailored to lower-SEP smokers and provide support at any time of the day (also in HRSs). However, evidence on the effectiveness of this kind of applications is scarce and it is still unclear how automated conversational agents can effectively promote lapse prevention. Therefore, it is important to explore what type of lapse prevention strategies these conversational agents should use in HRSs and how these different types of support are experienced by smokers.
This virtual reality (VR) experiment will examine the preliminary effectiveness and usability of a conversational agent that supports smokers in personal HRSs. More specifically, the investigators primarily aim to examine whether the three different lapse prevention dialogs increase abstinence self-efficacy in adult smokers from different SEP groups during simulated HRSs, compared to a neutral dialog (i.e., control condition). In addition, the investigators examine the effect of the lapse prevention dialogs, compared to the neutral dialog, in simulated HRSs on subjective craving and affect. Finally, the investigators examine how adult smokers from different SEP groups experience the personalized support of a simulated conversational agent in simulated HRSs.
VR will be used to expose smokers to their personal HRSs and let them interact with a conversational agent via a simulated mobile phone. Using computer-based VR technology, three-dimensional environments can be created based on environments that smokers encounter in their daily lives (e.g., their living room or the train station from where they travel to work). This way, controlled but at the same time natural-looking environments can be used to expose smokers to their personal HRSs and measure their responses in this situation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A repeated measures within-subjects design will be employed. Conditions (the type of dialog) will be counterbalanced to minimize carryover effects. Baseline questionnaires measuring demographic characteristics, previous experience with VR, and smoking-specific characteristics will be administered at the start of the experiment. In addition, questionnaires measuring abstinence self-efficacy (i.e., the endpoint for the primary objective), phasic (state) tobacco craving, positive and negative affect, and sense of presence will be administered after every VR session (four times in total) to investigate the study objectives. Positive and negative affect will also be assessed before the VR sessions as a baseline measure. Finally, questionnaires measuring acceptance of the conversational agent and user-experiences will be administered after the last VR session.
| Arm | Type | Receives |
|---|---|---|
| Chatbot coaching | Other | Behavioral: Lapse prevention dialog: Boost motivation and self-efficacy, Behavioral: Lapse prevention dialog: Future-selves and implementation intentions, Behavioral: Lapse prevention dialog: Identity-related positive self-talk, Behavioral: Attention control dialog: neutral topicDue to the single-group design there will only be one arm. All participants will be exposed to four different chatbot relapse prevention coaching dialogs, which are presented in a random order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Being able to read and understand Dutch
- Smoking ≥ 10 cigarettes a day
- Intention to quit smoking sometime in the future
- Being able to wear a VR helmet for approximately 30 minutes, with breaks in between
Key exclusion criteria (3 listed)
- Visual problems (e.g., limited visibility without glasses) that affect viewing VR environments (based on self-report)
- Currently involved in smoking cessation activity or therapy (based on self-report)
- When patients are deemed unfit to participate (due to, for example, psychological problems or medication). This decision is left to the discretion of the responsible researcher.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lapse prevention dialog: Boost motivation and self-efficacyIn the boost motivation and self-efficacy dialog, the conversational agent will tell the participant that they can successfully resist smoking, try to take away their self-doubts and assert that the participant can and will succeed. For example, the conversational agent will send text messages such as: "Even though the temptation can be high, I have no doubts that you can resist smoking in this situation. If you want something, you can do it. Believe in yourself!". | Behavioural | Chatbot coaching |
| Lapse prevention dialog: Future-selves and implementation intentionsIn the future-selves and implementation intentions dialog, the conversational agent will first tell the participant to imagine themselves in a future in which they successfully quit smoking (i.e., desired future self). The conversational agent can send text messages such as: "Please think about yourself in the future. Imagine that you have quit smoking successfully. Think about the person you will be. What do you look like? What does your life look like? Consider this future image as well as you can.". This procedure will be repeated for a future in which the participant continued smoking (i.e., the undesired future self). Finally, the conversational agent will explain to the participant that it is important to think about how to resist smoking in HRSs (i.e., implementation intentions) to ensure that the participant comes closer to becoming their desired future self as non-smoker and to avoid their undesired future self as a smoker. | Behavioural | Chatbot coaching |
| Lapse prevention dialog: Identity-related positive self-talkIn the identity-related positive self-talk dialog, the conversational agent will tell the participant to use positive self-talk focused on their identity to motivate themselves to successfully resist smoking. For example, the conversational agent will send text messages such as: "When you feel tempted to smoke, it can help to say positive things to yourself and motivate yourself to resist the temptation. What positive things can you say about yourself to motivate yourself to resist smoking? For instance, 'I am a strong person who can resist smoking' or 'I am a person who is persistent and has control over the urge to smoke'. Now say the sentence(s) you find motivating or your own motivating words to yourself, by thinking it, and repeating it in your head or out loud.". | Behavioural | Chatbot coaching |
| Attention control dialog: neutral topicThe neutral dialog will act as an attention control condition. In this dialog, the conversational agent will not provide support using relapse prevention strategies. Instead, the conversational agent will start with a short introduction (e.g., "Hi, how are you doing?"), ask questions to show interest (e.g., "How are you feeling today?") and will talk about a neutral topic (e.g., animals; "What is your favorite animal?"), and then closes the conversation (e.g., "It was nice speaking with you. I hope you have a good rest of the day!"). | Behavioural | Chatbot coaching |
Primary outcome
Abstinence self-efficacy
Time frame: Four times during the experiment which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4).
Smoking abstinence self-efficacy will be assessed with a single question derived from the 'Smoking Abstinence Self-efficacy Questionnaire' (Spek et al., 2013). The six-item questionnaire measures self-efficacy regarding smoking abstinence in six different situations. However, in this experiment the situation is shown using VR (e.g., a personalized VR environment of a participant's favorite bar). Therefore, participants will only answer the question "Are you confident that you will not smoke in this situation?" while being exposed to the VR environment. Total scores range from 0 to 4, with a higher score indicating higher abstinence self-efficacy.
4 secondary outcomes
Phasic (state) tobacco craving
Time frame: Four times during the experiment which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4).
Positive and negative affect
Time frame: At the start of the experiment (baseline) and four times during the experiment, which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4)
Acceptance of the conversational agent
Time frame: At the end of the experiment (post-intervention); experiment has a duration of 1.5 hours
User-experience / usability
Time frame: At the end of the experiment (post-intervention); experiment has a duration of 1.5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: Yes. Pseudonymized data will be made available for reuse at the end of the project. Certain demographic characteristics might have to be removed from the data set, to prevent traceability of individual participants. It has yet to be decided whether data can best be made available through a repository or through reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anke Versluis, Dr. principal investigator
Leiden University Medical Center
Eline Meijer, Dr. principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lapse prevention dialog: Boost motivation and self-efficacy, Lapse prevention dialog: Future-selves and implementation intentions and Lapse prevention dialog: Identity-related positive self-talk in people with Smoking Cessation, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinence self-efficacy (time frame: Four times during the experiment which has a duration of 1.5 hours. Assessed directly after each chatbot dialog (T1-T4).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.