- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07621822
Telephone-Based Acceptance and Commitment Therapy for Young Adult Hazardous Drinkers
A Randomized Controlled Trial of Telephone-Based Acceptance and Commitment Therapy to Assist Young Adults With Hazardous or Harmful Alcohol Use to Quit Drinking
The goal of this clinical trial is to learn if telephone-based Acceptance and Commitment Therapy (ACT) works to help young adults with hazardous or harmful alcohol use quit drinking. It will also learn about the psychological effects of ACT on participants.
The main questions it aims to answer are:
- Does telephone-based ACT increase the number of participants who quit drinking, as confirmed by a urine test?
- Does telephone-based ACT help participants reduce their alcohol consumption and improve their psychological flexibility?
Researchers will compare telephone-based ACT to a telephone-based social support programme to see if ACT works to help young adults quit drinking.
Participants will:
- Receive telephone-based ACT or social support once a week for 6 weeks Complete questionnaires about their alcohol use and psychological flexibility.
- Keep a record of their daily alcohol consumption throughout the study using a standardised diary method.
- Provide a urine sample at the 6-month follow-up if they report having quit drinking
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ka Wai Katherine LAM, Doctor of Philosophy
- Numéro de téléphone: +852 27666420
- E-mail: kw-katherine.lam@polyu.edu.hk
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- (1) aged 18-35 years
- (2) able to read Chinese and speak Cantonese
- (3) have AUDIT scores ≥ 8
Exclusion Criteria:
- (1) currently receiving other behavioural therapies for drinking
- (2) has serious mental illnesses, defined as a Kessler Psychological Distress Scale score ≥ 13
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Telephone-Based ACT Intervention
Telephone-based Acceptance and Commitment Therapy for participants
|
Participants in the intervention group will receive six weekly telephone sessions of ACT (45-60 min each) from interventionist.
|
|
Autre: Waitlist control with Telephone-Based Social Support
|
Participants in the control group will receive six weekly telephone sessions of social support (45 min each) from interventionist.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Biochemically-Validated Abstinence
Délai: T4 (6 months after the end of the intervention)
|
Participants who self-report quitting drinking in the past 30 days are tested for ethyl glucuronide (a by-product of alcohol metabolism) via urine strips to confirm abstinence biochemically.
|
T4 (6 months after the end of the intervention)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Self-Reported 30-Day Abstinence
Délai: T0 (baseline), T1 (immediately after completion of the 6-week intervention), T2 (1 month after completing the intervention), T3 (3 months after completing the intervention), T4 (6 months after completing the intervention)
|
Reduction in alcohol consumption and self-reported 30-day abstinence will be recorded using TLFB.
Participants will be asked to report the number of drinks they have consumed within the past 30 days.
|
T0 (baseline), T1 (immediately after completion of the 6-week intervention), T2 (1 month after completing the intervention), T3 (3 months after completing the intervention), T4 (6 months after completing the intervention)
|
|
Reduction in Alcohol Consumption
Délai: T1 (immediately after completion of the 6-week intervention), T2 (1 month after the intervention), T3 (3 months after the intervention), T4 (6 months after the intervention)
|
Defined as 50% or more reduction in average alcohol consumption per day compared to baseline, measured using the Timeline Follow-Back (TLFB) questionnaire.
|
T1 (immediately after completion of the 6-week intervention), T2 (1 month after the intervention), T3 (3 months after the intervention), T4 (6 months after the intervention)
|
|
Psychological Flexibility Index
Délai: T0 (baseline), T1 (immediately after completion of the 6-week intervention), T2 (1 month after completing the intervention), T3 (3 months after completing the intervention), T4 (6 months after completing the intervention)
|
Personalised Psychological Flexibility Index(PPFI) will be used to measure psychological flexibility by 19 items rating on a 7-point scale.
Higher scores represent greater psychological flexibility.
It has been validated among Chinese college students
|
T0 (baseline), T1 (immediately after completion of the 6-week intervention), T2 (1 month after completing the intervention), T3 (3 months after completing the intervention), T4 (6 months after completing the intervention)
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ACT Alcohol
Informations sur les médicaments et les dispositifs, documents d'étude
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