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- Klinische proef 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
Studie Overzicht
Toestand
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ka Wai Katherine LAM, Doctor of Philosophy
- Telefoonnummer: +852 27666420
- E-mail: kw-katherine.lam@polyu.edu.hk
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Ander: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Biochemically-Validated Abstinence
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Self-Reported 30-Day Abstinence
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- ACT Alcohol
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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