Alcohol DependenceNCT01180829
Pilot Study of Text Message Brief Interventions for Problem Drinkers
A study testing Personalized feedback text messages and Consciousness raising text messages in people with Alcohol Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
This study will provide a pilot test of two different text message interventions for problem drinkers. Participants will be recruited using a general population telephone survey. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Personalized feedback text messages and Consciousness raising text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2010to Jan 2012
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resident of Ontario
- 19 years of age or over
- Have consumed alcohol in the one month prior to the telephone survey.
- A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
- Are willing to participate in follow-up at three months
Who cannot join
- •None
Trial locations and contacts
1 site in 1 country.
About this study
This study will provide a pilot test of two different text message interventions for problem drinkers. Participants will be recruited using a general population telephone survey. Participants in a control group (who will not receive text messages) will be compared to participants who receive one of two different types of text message packages (12 text messages sent once per week in each) - a series of personalized feedback text messages or a series of consciousness raising test messages (i.e., messages that keep the thought of cutting down on their drinking in the participants' mind). Participants in the three different conditions will be followed-up in three months time to assess changes in drinking. It is predicted that participants who receive either of the text message packages will report reduced drinking as compared to those participants in the control condition who do not receive any text messages.
- Conditions
- Alcohol Dependence
- Being tested
- Personalized feedback text messages, Consciousness raising text messages
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized feedback text messagesBehavioural
A series of 12 text messages, each of which contains one personalized feedback item about the person's drinking.
Consciousness raising text messagesBehavioural
A series of 12 text messages, each of which consists of an item designed to get the person to think about his or her drinking
| Study group | Role | What they receive |
|---|---|---|
| Control condition | No intervention | No interventions text messages sent |
| Personalized feedback text messages | Experimental | A series of 12 text messages, each of which contains one personalized feedback item about the person's drinking Receives: Behavioral: Personalized feedback text messages |
| Consciousness raising text message | Experimental | A series of 12 text messages, each of which contains text designed to get the person to think about his or her drinking Receives: Behavioral: Consciousness raising text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of drinks in a typical week
Measured: Three months
Secondary outcomes (4)
Frequency of consumption
Measured: Three months
usual number of drinks per occasion
Measured: Three months
Frequency of consuming 5 or more drinks on one occasion
Measured: three months
highest number of drinks on one occasion
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Health Canada
- Responsible party
- Principal investigator, John Cunningham, Centre for Addiction and Mental Health
- Investigators
- John Cunningham, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180829
- Sponsor's protocol ID
- 088/2010
- Status last verified
- Aug 2012
- First submitted
- 9 Aug 2010
- Last updated
- 30 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Text Message Brief Interventions for Problem Drinkers
- ClinicalTrials.gov ID
- NCT01180829
- Acronym / sponsor ID
- 088/2010
- Conditions
- Alcohol Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Health Canada
- Study start
- Oct 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Aug 2010 (estimated)
- 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 will provide a pilot test of two different text message interventions for problem drinkers. Participants will be recruited using a general population telephone survey. Participants in a control group (who will not receive text messages) will be compared to participants who receive one of two different types of text message packages (12 text messages sent once per week in each) - a series of personalized feedback text messages or a series of consciousness raising test messages (i.e., messages that keep the thought of cutting down on their drinking in the participants' mind). Participants in the three different conditions will be followed-up in three months time to assess changes in drinking. It is predicted that participants who receive either of the text message packages will report reduced drinking as compared to those participants in the control condition who do not receive any text messages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control condition | No intervention | –No interventions text messages sent |
| Personalized feedback text messages | Experimental | Behavioral: Personalized feedback text messagesA series of 12 text messages, each of which contains one personalized feedback item about the person's drinking |
| Consciousness raising text message | Experimental | Behavioral: Consciousness raising text messagesA series of 12 text messages, each of which contains text designed to get the person to think about his or her drinking |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Resident of Ontario
- 19 years of age or over
- Have consumed alcohol in the one month prior to the telephone survey.
- A score of 8 or over on the Alcohol Use Disorders Identification Test (AUDIT)
- Are willing to participate in follow-up at three months
Key exclusion criteria (1 listed)
- •None
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 |
|---|---|---|
| Personalized feedback text messagesA series of 12 text messages, each of which contains one personalized feedback item about the person's drinking. | Behavioural | Personalized feedback text messages |
| Consciousness raising text messagesA series of 12 text messages, each of which consists of an item designed to get the person to think about his or her drinking | Behavioural | Consciousness raising text message |
Primary outcome
Number of drinks in a typical week
Time frame: Three months
4 secondary outcomes
Frequency of consumption
Time frame: Three months
usual number of drinks per occasion
Time frame: Three months
Frequency of consuming 5 or more drinks on one occasion
Time frame: three months
highest number of drinks on one occasion
Time frame: 3 months
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 30 Aug 2012.
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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.
John Cunningham principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized feedback text messages and Consciousness raising text messages in people with Alcohol Dependence, run by Centre for Addiction and Mental Health at 1 site in Canada.
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 5 inclusion and 1 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 30 Aug 2012. 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 Canada. 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. 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?
Number of drinks in a typical week (time frame: Three months). 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 30 Aug 2012.