Bewertung der Wirksamkeit von Umsetzungsabsichten zur Stärkung des Ansatzvermeidungstrainings (IMBA)
Bewertung der Wirksamkeit von Umsetzungsabsichten zur Stärkung des Ansatzvermeidungstrainings: Pilotstudie zur Alkoholkonsumstörung
Approach Bias Modifcation corresponds to computerized interventions designed to change a cognitive bias (i.e., the approach bias) that may contribute to the maintenance of Alcohol Use Disorder. This study aims to compare the effectiveness of a classical Approach Bias Modification program, an Approach Bias Modification program integrating a planning strategy (i.e., implementation intentions) and a Sham-training to decrease the approach bias (from pre to post-test), and Alcohol Use Disorder symptomatology (from baseline to follow-up). 112 patients will be recruited for this study.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The Approach Bias is considered to be a maintenance factor of Alcohol Use Disorder. It correspond to the relative ease to approach alcohol rather than to avoid it. Approach Bias Modifcation correspond to computerized interventiond designed to change it by training participants to emit avoidance response (e.g., pull the joystick away) toward alcohol stimuli (e.g., alcohol pictures). Those programs have shown their effectiveness to promote abstinence among Alcohol Use Disorder patients. This study aims to compare the effectiveness of a classical Approach Bias Modification program to the one of a similar program integrating a planning add-on strategy named implementation intentions and to a Sham-training. 112 patients will be recruited for this study at Clinic de la Mitterie rehab center. During their hospitalization, participants will have to complete: a baseline that assess Alcohol Use Disorder symptomatology (i.e., alcohol consumption, alcohol consumption, and alcohol-related consequences) and other alcohol-related variables (e.g., motivation and self-efficacy), a pre-test that assess the approach bias, 6 sessions of one of the three experimental interventions {classical Approach Bias Modification, Approach Bias Modification with Implementation Intentions, Sham-training}, and a post-test that reassess the approach bias. After their hospitalization, they will have to complete a 2, 4 and 6-month online follow-up that reasses Alcohol Use Disorder symptomatology. It is expect that the Approach Bias Modification program with implementation intentions will decrease the approach bias and Alcohol Use Disorder symptomatology more than the classical program, that will also decrease it more than the Sham-training.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Lille, Frankreich, 59160
- Clinique la Mitterie
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- care at the clinic for Alcohol Use Disorder,
- have an e-mail address,
- written and spoken French,
- signing informed consent.
Exclusion Criteria:
- not currently remissioned for the Alcohol Use Disorder,
- no other Substance Use Disorder (except tobaco one)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Classical Approach Bias Modification
The 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions. |
Participants in each experimental condition will perform different variants of the Approach-Avoidance Task (i.e., a task that is widely used in the litterature to assess and modify the approach bias toward alcohol - the relative ease to approach alcohol rather than to avoid it). Participants in the classical Approach Bias Modification conditions will perform a version of this task which will train them to (almost-)systematically emit an avoidance response toward alcohol ; Participants in the Approach Bias Modification with Implementation Intentions condition will perform the same version of the task but will additionnaly have to complete a planning intervention (i.e., implementation intentions) to help them avoiding alcohol; Participants in the Sham-training condition will perform a version of this task which require them to approach alcohol as often as they have to avoid it (i.e., no real training).
Andere Namen:
|
|
Experimental: Approach Bias Modification with Implementation Intentions
The 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions. |
Participants in each experimental condition will perform different variants of the Approach-Avoidance Task (i.e., a task that is widely used in the litterature to assess and modify the approach bias toward alcohol - the relative ease to approach alcohol rather than to avoid it). Participants in the classical Approach Bias Modification conditions will perform a version of this task which will train them to (almost-)systematically emit an avoidance response toward alcohol ; Participants in the Approach Bias Modification with Implementation Intentions condition will perform the same version of the task but will additionnaly have to complete a planning intervention (i.e., implementation intentions) to help them avoiding alcohol; Participants in the Sham-training condition will perform a version of this task which require them to approach alcohol as often as they have to avoid it (i.e., no real training).
Andere Namen:
|
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Placebo-Komparator: Sham-training
The 3 arms will follow a similar procedure, except that they will receive 3 different experimental interventions, dependly on their conditions. |
Participants in each experimental condition will perform different variants of the Approach-Avoidance Task (i.e., a task that is widely used in the litterature to assess and modify the approach bias toward alcohol - the relative ease to approach alcohol rather than to avoid it). Participants in the classical Approach Bias Modification conditions will perform a version of this task which will train them to (almost-)systematically emit an avoidance response toward alcohol ; Participants in the Approach Bias Modification with Implementation Intentions condition will perform the same version of the task but will additionnaly have to complete a planning intervention (i.e., implementation intentions) to help them avoiding alcohol; Participants in the Sham-training condition will perform a version of this task which require them to approach alcohol as often as they have to avoid it (i.e., no real training).
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Approach-Avoidance Task (AAT)
Zeitfenster: 2 weeks
|
The approach bias toward alcohol |
2 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Alcohol consumption
Zeitfenster: 2 weeks
|
The Alcohol Use Disorder Identification Test - Consumption (AUDIT) |
2 weeks
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Alcohol dependence
Zeitfenster: 2 weeks
|
The Short Alcohol Dependence Data questionnaire (SAAD) |
2 weeks
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Alcohol-related consequences
Zeitfenster: 2 weeks
|
The Short Inventory of Problems - Revised (SIP-R) |
2 weeks
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2020-A02415-34
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
- sign an informed consent and to complete a baseline that assess the secondary outcomes measures as well as other alcohol-related measures (e.g., motivation and self-efficacy to change alcohol consumption).
- complete a pre-test that asssess the primary outcome measure (i.e., the approach bias).
- receive 6 session of their respective experimental intervention
- complete a post-test to reassess the primary outcome measure (i.e., the approach bias).
Follow-up Phase. After participants hospitalization, participants will have to complete a 2, 4, and 6-month online follow-up that reassess the secondary outcome measures (i.e., alcohol consumption, alcohol dependence, and alcohol-related-consequences).
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
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