Heavy DrinkingBRAINCT04075773
Brief Religious Alcohol Intervention
A study testing Expressive Writing in people with Heavy Drinking, run by University of Houston at 1 site in United States.
Trial summary
This study is a trial of a brief alcohol intervention, a brief expressive writing intervention that incorporates religious identity. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Heavy Drinking
- What is being tested?
- Expressive Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2019to 11 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 29 years old
- Have had a binge episode (4/5 drinks on one occasion for women/men) at least once in the past month
- UH students
Who cannot join
- Participants who are currently enrolled in treatment for alcohol or other substances
- Participants who have been diagnosed with and/or treated for verbal learning disabilities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Houston Psychology Department
Houston, Texas, 77004
About this study
This study is a trial of a brief alcohol intervention, a brief expressive writing intervention that incorporates religious identity.
- Conditions
- Heavy Drinking
- Being tested
- Expressive Writing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive WritingBehavioural
The participants are asked to write for a period of time about specific concepts so that they think carefully and cognitively process the information they are generating.
| Study group | Role | What they receive |
|---|---|---|
| Religious Prompt | Experimental | Participants will be provided a writing prompt that describes their self-reported drinking, then asks them to write for 5 to 10 minutes about how that drinking is associated with their self-reported religious identity. After completing that writing assignment, participants will be shown their response, and asked to spend 5 to 10 minutes describing how their drinking behaviors in the next month might change. Receives: Behavioral: Expressive Writing |
| Age Prompt | Sham comparator | Participants will be provided a writing prompt that describes their self-reported drinking, then asks them to write for 5 to 10 minutes about how that drinking is associated with their self-reported age. After completing that writing assignment, participants will be shown their response, and asked to spend 5 to 10 minutes describing how their drinking behaviors in the next month might change. Receives: Behavioral: Expressive Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Timeline Follow-Back one month following the intervention
Participants report number of drinks consumed each day over the last month.
Measured: It will be assessed before the intervention and one month following the intervention.
Secondary outcomes (1)
Chang in the Young Adult Alcohol Consequences Questionnaire one month following the intervention
Participants respond to a list of common consequences of alcohol use indicating whether or not they have experienced them. The scale name is the "Young Adult Alcohol Consequences Questionnaire" (Read, Kahler, Strong, \& Colder, 2006). The construct of interest measured by this scale is the alcohol problems experienced by the participant. The total score is used, and the range for the total score is 0 to 48.
Measured: It will be assessed before the intervention and one month following the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start4 Sep 2019
- Primary completion11 Aug 2020
- Study completion11 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either an intervention condition, where they will write about how their drinking relates to their religious identity, or to a control condition, where they will write about how their drinking relates to their age.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary M. Tomkins, University of Houston
- Investigators
- Mary M Tomkins, M.S., Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075773
- Sponsor's protocol ID
- STUDY00001734
- Acronym
- BRAI
- Status last verified
- Aug 2020
- First submitted
- 28 Aug 2019
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not have any plans at this time to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Religious Alcohol Intervention
- ClinicalTrials.gov ID
- NCT04075773
- Acronym / sponsor ID
- BRAI / STUDY00001734
- Conditions
- Heavy Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 11 Aug 2020 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a trial of a brief alcohol intervention, a brief expressive writing intervention that incorporates religious identity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants will be randomized to either an intervention condition, where they will write about how their drinking relates to their religious identity, or to a control condition, where they will write about how their drinking relates to their age.
| Arm | Type | Receives |
|---|---|---|
| Religious Prompt | Experimental | Behavioral: Expressive WritingParticipants will be provided a writing prompt that describes their self-reported drinking, then asks them to write for 5 to 10 minutes about how that drinking is associated with their self-reported religious identity. After completing that writing assignment, participants will be shown their response, and asked to spend 5 to 10 minutes describing how their drinking behaviors in the next month might change. |
| Age Prompt | Sham comparator | Behavioral: Expressive WritingParticipants will be provided a writing prompt that describes their self-reported drinking, then asks them to write for 5 to 10 minutes about how that drinking is associated with their self-reported age. After completing that writing assignment, participants will be shown their response, and asked to spend 5 to 10 minutes describing how their drinking behaviors in the next month might change. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 29 years old
- Have had a binge episode (4/5 drinks on one occasion for women/men) at least once in the past month
- UH students
Key exclusion criteria (2 listed)
- Participants who are currently enrolled in treatment for alcohol or other substances
- Participants who have been diagnosed with and/or treated for verbal learning disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive WritingThe participants are asked to write for a period of time about specific concepts so that they think carefully and cognitively process the information they are generating. | Behavioural | Age Prompt, Religious Prompt |
Primary outcome
Change in the Timeline Follow-Back one month following the intervention
Time frame: It will be assessed before the intervention and one month following the intervention.
Participants report number of drinks consumed each day over the last month.
1 secondary outcome
Chang in the Young Adult Alcohol Consequences Questionnaire one month following the intervention
Time frame: It will be assessed before the intervention and one month following the intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- Individual participant dataSharing planned: No. We do not have any plans at this time to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary M Tomkins, M.S. principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive Writing in people with Heavy Drinking, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Timeline Follow-Back one month following the intervention (time frame: It will be assessed before the intervention and one month following the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.