- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mariam A Souweidane
- Phone Number: 734-707-8185
- Email: msouweidane@wayne.edu
Study Locations
-
-
Michigan
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Detroit, Michigan, United States, 48202
- Wayne State University
-
Contact:
- Mariam A Souweidane, M.A.
- Phone Number: 734-707-8185
- Email: msouweidane@wayne.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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. |
|
Active Comparator: 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment Feasibility: Enrollment Rate Among Eligible Individuals Who Accept an Invitation
Time Frame: 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
Time Frame: Day 1
|
Percentage of enrolled participants who complete all parts of the Zoom session. |
Day 1
|
|
Letter Completion Rate
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention at One-Month Follow-Up
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heavy Drinking Days (Timeline Followback)
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-25-12-8326
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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