Alcohol-Related DisordersNCT01885312
Tailored Mobile Text Messaging to Reduce Problem Drinking
A study testing Adaptive Tailored Intervention, Consequence-based Intervention and Tailored, not adaptive, based Intervention in people with Alcohol-Related Disorders and Alcohol Use Disorders, run by Northwell Health at 1 site in United States.
Trial summary
This study is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in stopping or reducing their alcohol consumption; and test and compare it to tailored but static, once a day messaging, gain framed messaging, and ecological momentary… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol-Related Disorders, Alcohol Use Disorders, Alcohol Drinking
- What is being tested?
- Adaptive Tailored Intervention, Consequence-based Intervention and Tailored, not adaptive, based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Aug 2016
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must:
- be fluent and able to read in English at the eighth grade level
- be between the ages of 21 and 65
- have an estimated average weekly consumption of greater than 15 or 24 standard drinks per week for women and men, respectively
- be willing to reduce their drinking to non-hazardous levels
- be willing to provide informed consent
- own a mobile phone and have an active email address and are willing to receive and respond to up to 115 text messages total per month (average = 50)
Who cannot join
- Participants will be excluded from the study if they
- present with significant substance use or a current substance use disorder (for any substance other than alcohol, nicotine, or caffeine), which is defined as greater than once weekly use in the past month
- present with a serious psychiatric illness or suicide risk as measured by previous inpatient treatment, medications for psychosis or recent suicidality; demonstrate clinically severe alcoholism, as evidenced by physical withdrawal symptoms or a history of serious withdrawal symptoms (e.g., hallucinations, seizures, or delirium tremens), and score greater than 12 on the Short Alcohol Withdrawal Scale (SAWS)
- express a desire or intent to obtain additional substance abuse treatment while in the study
- report a medical condition that precludes drinking any alcohol; or
- demonstrate cognitive impairment as evidenced a score of less than 7 out of 10 on the consent form quiz
Trial locations and contacts
1 site in 1 country.
United States1 site
Feinstein Institute for Medical Research / North Shore-LIJ Health System
Great Neck, New York, 11021
About this study
This study is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in stopping or reducing their alcohol consumption; and test and compare it to tailored but static, once a day messaging, gain framed messaging, and ecological momentary assessment only.
Read the detailed description
The proposed development study entitled, Tailored Mobile Text Messaging to Reduce Problem Drinking is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in stopping or reducing their alcohol consumption. This intervention includes messages tailored to baseline assessment results (including drinking times) that are adaptive to ongoing drinking patterns and goal achievement via interactive ecological momentary assessment (EMA). Other features include participant initiated help messaging and support network alerts. We will conduct beta research with 40 problem drinkers to assess messaging preferences and acceptability, and then conduct a pilot test with 10 PDs. In Stage 1b, we aim to test this intervention and understand the mechanisms of action of different text messaging interventions with 200 problem drinkers over a 12-week period. We propose to compare four types of messaging: 1) Tailored content and timed messaging adaptive to the participants current state (Stage 1a intervention); 2) Tailored content messaging (not adaptive or timed) sent at 3 pm every day; 3) Untailored consequence based messages sent at 3 pm every day; and 4) Brief feedback and EMA only. Assessments will be completed at baseline, through weekly EMA via SMS and at week 12 via a web-based follow-up assessment. Primary outcomes include drinks per drinking day, days of heavy drinking, and average drinks per week as measured through weekly EMA. Additional outcomes will include drinking related consequences, goal commitment and intervention satisfaction. Outcomes will be used to modify the intervention and to prepare for a larger Stage 1c RCT.
- Conditions
- Alcohol-Related Disorders, Alcohol Use Disorders, Alcohol Drinking, Alcoholism, Alcohol Abuse
- Being tested
- Adaptive Tailored Intervention, Consequence-based Intervention, Tailored, not adaptive, based Intervention, Assessment only
- Keywords
- Drinking, Heavy Drinking, Technology, Mobile Phone, Text Message, Problem Drinking, Alcohol Problems, Alcoholism, Moderation-Oriented Treatment, Controlled Drinking, Reduced Drinking
- Medical subject headings
- Alcohol-Related Disorders, Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Tailored InterventionBehavioural
Adaptive
Consequence-based InterventionBehavioural
Loss Framed
Tailored, not adaptive, based InterventionBehavioural
Baseline tailored not adaptive
Assessment onlyOther
EMA only
| Study group | Role | What they receive |
|---|---|---|
| Tailored not adaptive based Intervention | Active comparator | Tailored Text Messaging - not adaptive in the moment and once a day intervention to reduce problem drinking Receives: Behavioral: Tailored, not adaptive, based Intervention |
| Ecological Momentary Assessment | Other | Mobile Assessment only Receives: Other: Assessment only |
| Tailored Adaptive Text Messaging | Experimental | Tailored Adaptive Text Messaging intervention to reduce problem drinking Receives: Behavioral: Adaptive Tailored Intervention |
| Consequence based text messaging | Active comparator | Consequence based Text Messaging intervention to reduce problem drinking Receives: Behavioral: Consequence-based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of Heavy Drinking (DHD)
Measured: 12 weeks
Average Drinks per Week (ADW)
Measured: 12 weeks
Secondary outcomes (2)
Drinking Related Consequences
Measured: 12 weeks
Goal Commitment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-Related DisordersStudies 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
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Fred Muench, PhD, Principal investigator, Feinstein Institute for Medical Research / North Shore-LIJ Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885312
- Sponsor's protocol ID
- AA021502-2
- Other IDs
- 1R34AA021502-01
- Status last verified
- Oct 2016
- First submitted
- 20 Jun 2013
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Once cleaned and published will make available
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Mobile Text Messaging to Reduce Problem Drinking
- ClinicalTrials.gov ID
- NCT01885312
- Acronym / sponsor ID
- AA021502-2
- Conditions
- Alcohol-Related Disorders, Alcohol Use Disorders, Alcohol Drinking, Alcoholism, Alcohol Abuse
- Keywords
- Drinking, Heavy Drinking, Technology, Mobile Phone, Text Message, Problem Drinking, Alcohol Problems, Alcoholism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Jun 2013 (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 is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in stopping or reducing their alcohol consumption; and test and compare it to tailored but static, once a day messaging, gain framed messaging, and ecological momentary assessment only.
Detailed description
The proposed development study entitled, Tailored Mobile Text Messaging to Reduce Problem Drinking is designed to develop and test a tailored adaptive text messaging/short message service (SMS) intervention for individuals interested in stopping or reducing their alcohol consumption. This intervention includes messages tailored to baseline assessment results (including drinking times) that are adaptive to ongoing drinking patterns and goal achievement via interactive ecological momentary assessment (EMA). Other features include participant initiated help messaging and support network alerts. We will conduct beta research with 40 problem drinkers to assess messaging preferences and acceptability, and then conduct a pilot test with 10 PDs. In Stage 1b, we aim to test this intervention and understand the mechanisms of action of different text messaging interventions with 200 problem drinkers over a 12-week period. We propose to compare four types of messaging: 1) Tailored content and timed messaging adaptive to the participants current state (Stage 1a intervention); 2) Tailored content messaging (not adaptive or timed) sent at 3 pm every day; 3) Untailored consequence based messages sent at 3 pm every day; and 4) Brief feedback and EMA only. Assessments will be completed at baseline, through weekly EMA via SMS and at week 12 via a web-based follow-up assessment. Primary outcomes include drinks per drinking day, days of heavy drinking, and average drinks per week as measured through weekly EMA. Additional outcomes will include drinking related consequences, goal commitment and intervention satisfaction. Outcomes will be used to modify the intervention and to prepare for a larger Stage 1c RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tailored not adaptive based Intervention | Active comparator | Behavioral: Tailored, not adaptive, based InterventionTailored Text Messaging - not adaptive in the moment and once a day intervention to reduce problem drinking |
| Ecological Momentary Assessment | Other | Other: Assessment onlyMobile Assessment only |
| Tailored Adaptive Text Messaging | Experimental | Behavioral: Adaptive Tailored InterventionTailored Adaptive Text Messaging intervention to reduce problem drinking |
| Consequence based text messaging | Active comparator | Behavioral: Consequence-based InterventionConsequence based Text Messaging intervention to reduce problem drinking |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- be fluent and able to read in English at the eighth grade level
- be between the ages of 21 and 65
- have an estimated average weekly consumption of greater than 15 or 24 standard drinks per week for women and men, respectively
- be willing to reduce their drinking to non-hazardous levels
- be willing to provide informed consent
Key exclusion criteria (6 listed)
- Participants will be excluded from the study if they
- present with significant substance use or a current substance use disorder (for any substance other than alcohol, nicotine, or caffeine), which is defined as greater than once weekly use in the past month
- present with a serious psychiatric illness or suicide risk as measured by previous inpatient treatment, medications for psychosis or recent suicidality; demonstrate clinically severe alcoholism, as evidenced by physical withdrawal symptoms or a history of serious withdrawal symptoms (e.g., hallucinations, seizures, or delirium tremens), and score greater than 12 on the Short Alcohol Withdrawal Scale (SAWS)
- express a desire or intent to obtain additional substance abuse treatment while in the study
- report a medical condition that precludes drinking any alcohol; or
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 |
|---|---|---|
| Adaptive Tailored InterventionAdaptive | Behavioural | Tailored Adaptive Text Messaging |
| Consequence-based InterventionLoss Framed | Behavioural | Consequence based text messaging |
| Tailored, not adaptive, based InterventionBaseline tailored not adaptive | Behavioural | Tailored not adaptive based Intervention |
| Assessment onlyEMA only | Other | Ecological Momentary Assessment |
Primary outcome
Days of Heavy Drinking (DHD)
Time frame: 12 weeks
Average Drinks per Week (ADW)
Time frame: 12 weeks
2 secondary outcomes
Drinking Related Consequences
Time frame: 12 weeks
Goal Commitment
Time frame: 12 weeks
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 13 Oct 2016.
- Individual participant dataSharing planned: Undecided. Once cleaned and published will make available
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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.
Fred Muench, PhD principal investigator
Feinstein Institute for Medical Research / North Shore-LIJ Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Tailored Intervention, Consequence-based Intervention and Tailored, not adaptive, based Intervention in people with Alcohol-Related Disorders and Alcohol Use Disorders, run by Northwell Health 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 7 inclusion and 6 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 13 Oct 2016. 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. 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?
Days of Heavy Drinking (DHD) (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 13 Oct 2016.