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.
調査の概要
詳細な説明
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
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Michaël RACODON, Ph.D
- 電話番号：+33320223457
- メール：mracodon@clinique-mitterie.com
研究場所
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Lille、フランス
- 募集
- Clinique la Mitterie
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コンタクト：
- Michaël RACODON, Ph.D
- 電話番号：+33320223457
- メール：m.racodon@clinique-peupliers.com
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：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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実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in cigarette dependence as measured by the Cigarette Dependence Scale (CDS-12)
時間枠：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. |
Baseline and one month after the intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in smoking behavioral automaticity
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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