- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07926880
Letter-Writing Add-On to Brief Motivational Intervention for Alcohol Use
Enhancing Brief Motivational Interventions for Alcohol Use With Self-Determination Theory: A Pilot Letter-Writing Add-On
The goal of this pilot clinical trial is to learn whether adding a brief letter-writing exercise, grounded in Self-Determination Theory (SDT), to a brief motivational intervention (BMI) for alcohol use is feasible and acceptable, and to obtain preliminary estimates of its effects on psychological needs and motivation among adults who drink heavily and sometimes think about or wish they could cut back on their drinking.
The main questions it aims to answer are: (1) Is it feasible to integrate the letter-writing task into an SDT-informed BMI (recruitment, session completion, letter completion, retention)? (2) Do participants rate the letter-writing task as acceptable, appropriate, and feasible? (3) Compared with a neutral writing task, is the letter-writing task associated with higher perceived autonomy, competence, and relatedness, perceived competence for reducing drinking, and autonomous motivation?
Researchers will compare a BMI plus a neutral writing task with the same BMI plus the letter-writing task. Participants will complete a brief online screening survey; take part in a single 45-60-minute Zoom session that includes questionnaires, a 25-30-minute motivational interview, random assignment to either write an advice letter to another participant who has also thought about reducing their drinking or copy a neutral paragraph, and post-session questionnaires; and complete a 10-15-minute online follow-up survey about motivation, perceived competence, and alcohol use approximately one month later.
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: Mariam A Souweidane
- Numéro de téléphone: 734-707-8185
- E-mail: msouweidane@wayne.edu
Lieux d'étude
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Michigan
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Detroit, Michigan, États-Unis, 48202
- Wayne State University
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Contact:
- Mariam A Souweidane, M.A.
- Numéro de téléphone: 734-707-8185
- E-mail: msouweidane@wayne.edu
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age 18 years or older
- Resides in the United States
- Meets the National Institute on Alcohol Abuse and Alcoholism heavy-drinking criteria in the past month
- Answers Yes to "Do you sometimes think about reducing or wish you could reduce your alcohol use?"
- Has internet access and a device capable of video conferencing via Zoom
Exclusion Criteria:
- Failure to meet the inclusion criteria
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: BMI + Letter-Writing Condition
|
Participants will receive a brief, one-on-one, motivational intervention delivered via Zoom by a doctoral student in clinical psychology. Immediately after the brief motivational intervention, participants write a brief advice letter to another study participant who has also thought about reducing their drinking but sometimes struggles with motivation. Prompts target autonomy, competence, and relatedness. |
|
Comparateur actif: BMI + Neutral Writing Condition
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Participants will receive a brief, one-on-one, motivational intervention delivered via Zoom by a doctoral student in clinical psychology. Immediately after the brief motivational intervention, participants copy a technical paragraph on office supply inventory management that matches the letter-writing task in length and duration. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Recruitment Feasibility: Enrollment Rate Among Eligible Individuals Who Accept an Invitation
Délai: From accepting the invitation to the Zoom session (up to 21 days)
|
Percentage of eligible people who accept an invitation and then enroll (attend the Zoom session, consent, and begin the baseline survey). |
From accepting the invitation to the Zoom session (up to 21 days)
|
|
Session Completion Rate
Délai: Day 1
|
Percentage of enrolled participants who complete all parts of the Zoom session. |
Day 1
|
|
Letter Completion Rate
Délai: Day 1
|
Percentage of participants assigned to letter writing who complete a letter during the session. |
Day 1
|
|
Acceptability of the Letter-Writing Task (Acceptability of Intervention Measure)
Délai: Day 1
|
Mean of 4 Acceptability of Intervention Measure items, rated 1 (completely disagree) to 5 (completely agree); higher scores mean greater acceptability. Letter-writing participants only. |
Day 1
|
|
Appropriateness of the Letter-Writing Task (Intervention Appropriateness Measure)
Délai: Day 1
|
Mean of 4 Intervention Appropriateness Measure items, rated 1 (completely disagree) to 5 (completely agree); higher scores mean greater appropriateness. Letter-writing participants only. |
Day 1
|
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Feasibility of the Letter-Writing Task (Feasibility of Intervention Measure)
Délai: Day 1
|
Mean of 4 Feasibility of Intervention Measure items, rated 1 (completely disagree) to 5 (completely agree); higher scores mean greater feasibility. Letter-writing participants only. |
Day 1
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Retention at One-Month Follow-Up
Délai: Days 30 to 44 after the Zoom session
|
Proportion of randomized participants who complete the one-month follow-up survey within the 14-day response window (days 30-44 after the session), overall and by arm. |
Days 30 to 44 after the Zoom session
|
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State Autonomy for Drinking Decisions
Délai: Start of the Zoom session (baseline), immediately post-intervention (Day 1), and 1 month after the Zoom session
|
Single item rated 1 (not at all) to 7 (completely); higher scores mean greater autonomy. |
Start of the Zoom session (baseline), immediately post-intervention (Day 1), and 1 month after the Zoom session
|
|
State Competence for Reducing Drinking
Délai: Start of the Zoom session (baseline), immediately post-intervention (Day 1), and 1 month after the Zoom session
|
Single item rated 1 (not capable at all) to 7 (extremely capable); higher scores mean greater competence. |
Start of the Zoom session (baseline), immediately post-intervention (Day 1), and 1 month after the Zoom session
|
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State Relatedness
Délai: Start of the Zoom session (baseline), immediately post-intervention (Day 1), and 1 month after the Zoom session
|
Single item rated 1 (not at all connected) to 7 (extremely connected); higher scores mean greater relatedness. |
Start of the Zoom session (baseline), immediately post-intervention (Day 1), and 1 month after the Zoom session
|
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Perceived Competence for Reducing Alcohol Use (Perceived Competence Scale)
Délai: Start of the Zoom session (baseline), immediately post-intervention (Day 1), and 1 month after the Zoom session
|
Mean of 4 items rated 1 (not at all true) to 7 (very true); higher scores mean greater perceived competence. |
Start of the Zoom session (baseline), immediately post-intervention (Day 1), and 1 month after the Zoom session
|
|
Autonomous Motivation to Reduce Alcohol Use (Treatment Self-Regulation Questionnaire)
Délai: Start of the Zoom session (baseline) and 1 month after the Zoom session
|
Autonomous motivation score (mean of items rated 1 to 7); higher scores mean more autonomous motivation. |
Start of the Zoom session (baseline) and 1 month after the Zoom session
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Heavy Drinking Days (Timeline Followback)
Délai: Start of the Zoom session (baseline) and 1 month after the Zoom session
|
Number of days in the past 30 with 5 or more (men) or 4 or more (women) standard drinks, measured with the Timeline Followback. |
Start of the Zoom session (baseline) and 1 month after the Zoom session
|
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB-25-12-8326
Informations sur les médicaments et les dispositifs, documents d'étude
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