An interventional study of Smoking-Specific Volitional Help Sheet in Tobacco Dependence, sponsored by Clinique de la Mitterie. Recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Clinique de la Mitterie · Not applicable, Interventional, and Treatment
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.
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:
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
1,027 studies on the registry are indexed under Tobacco Use Disorder; 128 are open to participants now.
This study's planned enrollment of 376 is above the median of 90 across 892 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Clinique de la Mitterie is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive usual tobacco treatment care according to their individual needs and goals. They will not complete the volitional help sheet.
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.
Behavioral: Smoking-Specific Volitional Help Sheet
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.
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.
Time frame: Baseline and one month after the intervention
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.
Time frame: 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.
Time frame: Baseline and one month after the intervention
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Mar 2028, 24 months after the start.
Of 255 non-industry interventional studies with no phase under Tobacco Use Disorder, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's planned 24 months is below that.
Counting every sponsor, half of 265 studies reached it within 32 months; a quarter within 17 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Clinique de la Mitterie