- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Mariam A Souweidane
- Número de telefone: 734-707-8185
- E-mail: msouweidane@wayne.edu
Locais de estudo
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Wayne State University
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Contato:
- Mariam A Souweidane, M.A.
- Número de telefone: 734-707-8185
- E-mail: msouweidane@wayne.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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. |
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Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment Feasibility: Enrollment Rate Among Eligible Individuals Who Accept an Invitation
Prazo: 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)
|
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Session Completion Rate
Prazo: Day 1
|
Percentage of enrolled participants who complete all parts of the Zoom session. |
Day 1
|
|
Letter Completion Rate
Prazo: Day 1
|
Percentage of participants assigned to letter writing who complete a letter during the session. |
Day 1
|
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Acceptability of the Letter-Writing Task (Acceptability of Intervention Measure)
Prazo: 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
|
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Appropriateness of the Letter-Writing Task (Intervention Appropriateness Measure)
Prazo: 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)
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Retention at One-Month Follow-Up
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
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Autonomous Motivation to Reduce Alcohol Use (Treatment Self-Regulation Questionnaire)
Prazo: 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
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Heavy Drinking Days (Timeline Followback)
Prazo: Start of the Zoom session (baseline) and 1 month after the Zoom session
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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
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB-25-12-8326
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