Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking (VHS_T)
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.
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Michaël RACODON, Ph.D
- Numer telefonu: +33320223457
- E-mail: mracodon@clinique-mitterie.com
Lokalizacje studiów
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Lille, Francja
- Rekrutacyjny
- Clinique la Mitterie
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Kontakt:
- Michaël RACODON, Ph.D
- Numer telefonu: +33320223457
- E-mail: m.racodon@clinique-peupliers.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- None
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Brak interwencji: Usual care
Participants will receive usual tobacco treatment care according to their individual needs and goals. They will not complete the volitional help sheet. |
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Eksperymentalny: Volitional Help Sheet plus Usual Care
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. |
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in cigarette dependence as measured by the Cigarette Dependence Scale (CDS-12)
Ramy czasowe: Baseline and one month after the intervention
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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. |
Baseline and one month after the intervention
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in smoking behavioral automaticity
Ramy czasowe: Baseline and one month after the intervention
|
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. |
Baseline and one month after the intervention
|
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Change in smoking-related behavioral identity
Ramy czasowe: Baseline and one month after the intervention
|
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. |
Baseline and one month after the intervention
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- MR-P0012
- 2025-A01739-40 (Inny identyfikator: National Agency for Safety and Medicines)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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