Tobacco DependenceVHS_TNCT07910214
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
A study testing Smoking-Specific Volitional Help Sheet in people with Tobacco Dependence, run by Clinique de la Mitterie at 1 site in France.
Trial summary
Smoking is a major public health concern associated with substantial morbidity and premature mortality. Planning may help people who wish to change their smoking behavior by translating their intentions into action. Volitional help sheets (VHS) are brief, low-cost tools designed to support behavior change. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Smoking-Specific Volitional Help Sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2026to 11 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who have just completed their first consultation in the tobacco treatment department at the Clinique de la Mitterie.
- Ability to understand written and spoken French.
- Affiliation with a social security scheme.
- Provision of informed consent.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique la Mitterie
Lille
Michaël RACODON, Ph.D, +33320223457, m.racodon@clinique-peupliers.com
About this study
Official title: Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking (VHS_T)
Smoking is a major public health concern associated with substantial morbidity and premature mortality. Planning may help people who wish to change their smoking behavior by translating their intentions into action.
Volitional help sheets (VHS) are brief, low-cost tools designed to support behavior change. They help individuals create personalized "if-then" plans by linking situations in which they may be tempted to smoke with strategies for responding to those situations.
Read more
Previous studies suggest that VHS may support changes in smoking and other health behaviors. However, they have mainly been evaluated in English-speaking populations, outside clinical settings, and as stand-alone interventions.
This pilot study aims to evaluate the effectiveness of a smoking-specific volitional help sheet as an adjunct to care in a clinical setting.
Read the detailed description
Smoking is a major public health concern. For people who wish to change their smoking behavior, planning strategies may help translate intentions into action. Volitional help sheets (VHS) are brief tools that support this process by helping individuals create personalized "if-then" plans. These plans link situations in which a person may be tempted to smoke with strategies for responding to those situations.
Previous studies suggest that VHS may support changes in smoking and other health behaviors. However, they have mainly been evaluated in English-speaking populations, outside clinical settings, and as stand-alone interventions. This pilot study will evaluate a smoking-specific VHS as an adjunct to usual care in a clinical setting.
This is a single-center, randomized, controlled, single-blind interventional study conducted in the tobacco treatment department of the Clinique de la Mitterie. Patients will be invited to participate after their first tobacco treatment consultation. Eligible patients who provide informed consent will complete baseline assessments and be assigned to one of two groups:
- VHS group: participants will receive usual tobacco treatment care and complete a volitional help sheet. They will select situations and strategies relevant to their personal smoking-related goal and link them to form "if-then" plans.
- Control group: participants will receive usual tobacco treatment care. Usual care is tailored to each patient's needs and goals. It may include individual consultations or participation in a day-hospital program addressing topics such as tobacco use and emotions, motivation for change, and well-being.
Data will be analyzed using a sequential Bayesian approach. Recruitment may stop when the prespecified threshold for evidence in favor of an effect or no effect is reached, or when the maximum planned sample size is reached. The planned recruitment period is up to 60 months, and each participant will be followed for approximately one month
- Conditions
- Tobacco Dependence
- Being tested
- Smoking-Specific Volitional Help Sheet
- Keywords
- Smoking, Smoking Behavior, Behavior Change, Volitional Help Sheet
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking-Specific Volitional Help SheetBehavioural
Participants complete a smoking-specific volitional help sheet after their first tobacco treatment consultation. They select personally relevant situations in which they may be tempted to smoke and strategies to respond to those situations. They then link these situations and strategies to form personalized "if-then" plans.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Participants will receive usual tobacco treatment care according to their individual needs and goals. They will not complete the volitional help sheet. |
| Volitional Help Sheet plus Usual Care | Experimental | Participants will receive usual tobacco treatment care and complete a smoking-specific volitional help sheet after their first tobacco treatment consultation. They will select personally relevant situations in which they may be tempted to smoke and strategies to respond to those situations, then link them to form "if-then" plans. Receives: Behavioral: Smoking-Specific Volitional Help Sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cigarette dependence as measured by the Cigarette Dependence Scale (CDS-12)
Change in cigarette dependence between baseline and the one-month follow-up, assessed using the 12-item Cigarette Dependence Scale (CDS-12). Changes will be compared between the volitional help sheet plus usual care group and the usual care alone group.
Total scores range from 12 to 60, with higher scores indicating greater cigarette dependence and a worse outcome.
Measured: Baseline and one month after the intervention
Secondary outcomes (2)
Change in smoking behavioral automaticity
Change in the subjective automaticity of smoking behavior between baseline and the one-month follow-up, assessed using the Self-Report Behavioral Automaticity Index (SRBAI).
Mean scores range from 1 to 7, with higher scores indicating greater automaticity of smoking behavior and a worse outcome.
Measured: Baseline and one month after the intervention
Change in smoking-related behavioral identity
Change in smoking-related behavioral identity between baseline and the one-month follow-up, assessed using the Self-Report Behavioral Identity Index (SRBII).
The questionnaire comprises four items rated from 1 to 7. The overall score is calculated as the mean of the four items and ranges from 1 to 7, with higher scores indicating stronger identification with smoking behavior and a worse outcome. A decrease in score indicates improvement. Changes will be compared between the volitional help sheet plus usual care group and the usual care alone group.
Measured: Baseline and one month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start11 Mar 2026
- Primary completion11 Mar 2028 (estimated)
- Study completion11 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique de la Mitterie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910214
- Sponsor's protocol ID
- MR-P0012
- Other IDs
- 2025-A01739-40
- Acronym
- VHS_T
- Status last verified
- Nov 2026
- First submitted
- 27 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking (VHS_T)
- ClinicalTrials.gov ID
- NCT07910214
- Acronym / sponsor ID
- VHS_T / MR-P0012
- Conditions
- Tobacco Dependence
- Keywords
- Smoking, Smoking Behavior, Behavior Change, Volitional Help Sheet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Clinique de la MitterieUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 11 Mar 2028 (estimated)
- Study completion
- 11 Mar 2028 (estimated)
- First posted
- 2 Nov 2026 (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 is a major public health concern associated with substantial morbidity and premature mortality. Planning may help people who wish to change their smoking behavior by translating their intentions into action.
Volitional help sheets (VHS) are brief, low-cost tools designed to support behavior change. They help individuals create personalized "if-then" plans by linking situations in which they may be tempted to smoke with strategies for responding to those situations.
Previous studies suggest that VHS may support changes in smoking and other health behaviors. However, they have mainly been evaluated in English-speaking populations, outside clinical settings, and as stand-alone interventions.
This pilot study aims to evaluate the effectiveness of a smoking-specific volitional help sheet as an adjunct to care in a clinical setting.
Detailed description
Smoking is a major public health concern. For people who wish to change their smoking behavior, planning strategies may help translate intentions into action. Volitional help sheets (VHS) are brief tools that support this process by helping individuals create personalized "if-then" plans. These plans link situations in which a person may be tempted to smoke with strategies for responding to those situations.
Previous studies suggest that VHS may support changes in smoking and other health behaviors. However, they have mainly been evaluated in English-speaking populations, outside clinical settings, and as stand-alone interventions. This pilot study will evaluate a smoking-specific VHS as an adjunct to usual care in a clinical setting.
This is a single-center, randomized, controlled, single-blind interventional study conducted in the tobacco treatment department of the Clinique de la Mitterie. Patients will be invited to participate after their first tobacco treatment consultation. Eligible patients who provide informed consent will complete baseline assessments and be assigned to one of two groups:
- VHS group: participants will receive usual tobacco treatment care and complete a volitional help sheet. They will select situations and strategies relevant to their personal smoking-related goal and link them to form "if-then" plans.
- Control group: participants will receive usual tobacco treatment care. Usual care is tailored to each patient's needs and goals. It may include individual consultations or participation in a day-hospital program addressing topics such as tobacco use and emotions, motivation for change, and well-being.
Data will be analyzed using a sequential Bayesian approach. Recruitment may stop when the prespecified threshold for evidence in favor of an effect or no effect is reached, or when the maximum planned sample size is reached. The planned recruitment period is up to 60 months, and each participant will be followed for approximately one month
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Participants will receive usual tobacco treatment care according to their individual needs and goals. They will not complete the volitional help sheet. |
| Volitional Help Sheet plus Usual Care | Experimental | Behavioral: Smoking-Specific Volitional Help SheetParticipants will receive usual tobacco treatment care and complete a smoking-specific volitional help sheet after their first tobacco treatment consultation. They will select personally relevant situations in which they may be tempted to smoke and strategies to respond to those situations, then link them to form "if-then" plans. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have just completed their first consultation in the tobacco treatment department at the Clinique de la Mitterie.
- Ability to understand written and spoken French.
- Affiliation with a social security scheme.
- Provision of informed consent.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Smoking-Specific Volitional Help SheetParticipants complete a smoking-specific volitional help sheet after their first tobacco treatment consultation. They select personally relevant situations in which they may be tempted to smoke and strategies to respond to those situations. They then link these situations and strategies to form personalized "if-then" plans. | Behavioural | Volitional Help Sheet plus Usual Care |
Primary outcome
Change in cigarette dependence as measured by the Cigarette Dependence Scale (CDS-12)
Time frame: Baseline and one month after the intervention
Change in cigarette dependence between baseline and the one-month follow-up, assessed using the 12-item Cigarette Dependence Scale (CDS-12). Changes will be compared between the volitional help sheet plus usual care group and the usual care alone group. Total scores range from 12 to 60, with higher scores indicating greater cigarette dependence and a worse outcome.
2 secondary outcomes
Change in smoking behavioral automaticity
Time frame: Baseline and one month after the intervention
Change in smoking-related behavioral identity
Time frame: Baseline and one month after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking-Specific Volitional Help Sheet in people with Tobacco Dependence, run by Clinique de la Mitterie at 1 site in France.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michaël RACODON, Ph.D (+33320223457, mracodon@clinique-mitterie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cigarette dependence as measured by the Cigarette Dependence Scale (CDS-12) (time frame: Baseline and one month after the intervention). 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 6 Nov 2026.