- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Mariam A Souweidane
- Telefonnummer: 734-707-8185
- E-post: msouweidane@wayne.edu
Studieorter
-
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Michigan
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Detroit, Michigan, Förenta staterna, 48202
- Wayne State University
-
Kontakt:
- Mariam A Souweidane, M.A.
- Telefonnummer: 734-707-8185
- E-post: msouweidane@wayne.edu
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Aktiv komparator: BMI + Neutral 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 copy a technical paragraph on office supply inventory management that matches the letter-writing task in length and duration. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recruitment Feasibility: Enrollment Rate Among Eligible Individuals Who Accept an Invitation
Tidsram: 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
Tidsram: Day 1
|
Percentage of enrolled participants who complete all parts of the Zoom session. |
Day 1
|
|
Letter Completion Rate
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
|
Feasibility of the Letter-Writing Task (Feasibility of Intervention Measure)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Retention at One-Month Follow-Up
Tidsram: 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
|
|
State Autonomy for Drinking Decisions
Tidsram: 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
Tidsram: 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
|
|
State Relatedness
Tidsram: 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
|
|
Perceived Competence for Reducing Alcohol Use (Perceived Competence Scale)
Tidsram: 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)
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Heavy Drinking Days (Timeline Followback)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB-25-12-8326
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