Alcohol-Related DisordersNCT01642381
Component Analysis for Motivational Interviewing
A study testing Full Motivational Interviewing ("FMI") and Spirit Only Motivational Interviewing ("SOMI") in people with Alcohol-Related Disorders and Alcohol Use Disorders, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to investigate the critical components of motivational interviewing (MI), a psychotherapeutic intervention, in reducing heavy or problematic drinking. The study will disaggregate MI into its component parts and test full MI compared to MI without its directive strategies. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol-Related Disorders, Alcohol Use Disorders, Alcohol Drinking
- What is being tested?
- Full Motivational Interviewing ("FMI") and Spirit Only Motivational Interviewing ("SOMI")
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary current diagnosis of Alcohol Use Disorder
- Meets DSM-IV criteria for inability to control or cut down on drinking
- Have an average weekly consumption of >24 standard drinks for men and >15 standard drinks for women
- Show no evidence of significant cognitive impairment
- Are willing to reduce drinking to non-hazardous levels
- Not seeking to quit drinking
- Agree not to seek additional substance abuse treatment during treatment period
- Fluent in English
Who cannot join
- Have a current DSM-IV diagnosis of drug dependence (other than nicotine/marijuana)
- Have a serious psychiatric illness (e.g., psychotic disorder, bipolar disorder, major depression) or substantial suicide or violence risk
- Have clinically severe alcoholism as evidenced by a history of significant medical problems associated with drinking, seizures or severe withdrawal symptoms, or an inpatient treatment episode for drinking
- Legally mandated to receive substance abuse treatment
- Sufficiently socially unstable as to preclude completion of study requirements (e.g., homeless)
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore LIJ Health Systems
Great Neck, New York, 11021
About this study
The purpose of this study is to investigate the critical components of motivational interviewing (MI), a psychotherapeutic intervention, in reducing heavy or problematic drinking. The study will disaggregate MI into its component parts and test full MI compared to MI without its directive strategies. This study will test whether the directive elements of MI are critical or whether MI effects may be attributable solely to its Rogerian, non-directive components. For more information, go to http://caspirnyc.org/p_motion.html
Read the detailed description
Project Motion is a clinical research study for people seeking to reduce, but not stop their drinking. Individuals who qualify will receive a comprehensive assessment and brief individual psychotherapy at no cost. The study is being conducted by a team of scientists at Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute and is funded by the National Institutes of Health (NIH). Our offices are located next to Columbus Circle and we offer convenient hours for appointments.
The purpose of our study is to understand how brief psychotherapy helps people reduce alcohol consumption and drinking problems. For example, we know that some people can reduce drinking with little or no treatment, whereas others benefit from one-on-one psychotherapy. However, we do not know why this happens. Individuals who qualify and decide to participate will be assigned by chance to one of three conditions. Individuals assigned to the first two conditions will receive brief psychotherapy, beginning the first week of their participation in the study. Individuals in the third condition will receive feedback on their drinking and be asked to reduce their drinking with the aid of telephone self-monitoring for a period of 8 weeks. Individuals in the third condition will then receive psychotherapy as well. The delay of 8 weeks will allow us to understand how the psychotherapy works compared to how people change without counseling.
- Conditions
- Alcohol-Related Disorders, Alcohol Use Disorders, Alcohol Drinking, Alcoholism, Alcohol Abuse
- Being tested
- Full Motivational Interviewing ("FMI"), Spirit Only Motivational Interviewing ("SOMI")
- Keywords
- Drinking, Alcohol Problems, Alcoholism, Moderation-Oriented Treatment, Controlled Drinking, Reduced Drinking, Heavy Drinking, Problematic Drinking, Non-Abstinence-based 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.
Full Motivational Interviewing ("FMI")Behavioural
Relational and technical technical (directive) strategies in counselling sessions to significantly increase commitment strength to reduce drinking.
Spirit Only Motivational Interviewing ("SOMI")Behavioural
Empathic and non-directive counselling based on Rogerian psychotherapy model.
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | Active comparator | Not described Receives: Behavioral: Full Motivational Interviewing ("FMI"); Behavioral: Spirit Only Motivational Interviewing ("SOMI") |
| Self-Change Control ("SCC") | No intervention | SCC participants will be told that they should attempt to reduce their drinking over the course of 8 weeks. (If unsuccessful, they will be offered Full Motivational Interviewing therapy sessions.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Line Follow Back
Calendar-based method of recording drinking patterns. Data will be aggregated into summary variables including sum of standard drinks, mean drinks per drinking day, and percent days heavy drinking at multiple time points.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionApr 2016
- 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
- 139 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
- Principal investigator, Jonathan Morgenstern, Northwell Health
- Investigators
- Jonathan Morgenstern, PhD, Principal investigator, North Shore LIJ Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642381
- Sponsor's protocol ID
- AA 020077-01A1
- Status last verified
- Sep 2016
- First submitted
- 13 Jul 2012
- Last updated
- 12 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Component Analysis for Motivational Interviewing
- ClinicalTrials.gov ID
- NCT01642381
- Acronym / sponsor ID
- AA 020077-01A1
- Conditions
- Alcohol-Related Disorders, Alcohol Use Disorders, Alcohol Drinking, Alcoholism, Alcohol Abuse
- Keywords
- Drinking, Alcohol Problems, Alcoholism, Moderation-Oriented Treatment, Controlled Drinking, Reduced Drinking, Heavy Drinking, Problematic Drinking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- May 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Jul 2012 (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.
The purpose of this study is to investigate the critical components of motivational interviewing (MI), a psychotherapeutic intervention, in reducing heavy or problematic drinking. The study will disaggregate MI into its component parts and test full MI compared to MI without its directive strategies. This study will test whether the directive elements of MI are critical or whether MI effects may be attributable solely to its Rogerian, non-directive components. For more information, go to http://caspirnyc.org/p_motion.html
Detailed description
Project Motion is a clinical research study for people seeking to reduce, but not stop their drinking. Individuals who qualify will receive a comprehensive assessment and brief individual psychotherapy at no cost. The study is being conducted by a team of scientists at Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute and is funded by the National Institutes of Health (NIH). Our offices are located next to Columbus Circle and we offer convenient hours for appointments.
The purpose of our study is to understand how brief psychotherapy helps people reduce alcohol consumption and drinking problems. For example, we know that some people can reduce drinking with little or no treatment, whereas others benefit from one-on-one psychotherapy. However, we do not know why this happens. Individuals who qualify and decide to participate will be assigned by chance to one of three conditions. Individuals assigned to the first two conditions will receive brief psychotherapy, beginning the first week of their participation in the study. Individuals in the third condition will receive feedback on their drinking and be asked to reduce their drinking with the aid of telephone self-monitoring for a period of 8 weeks. Individuals in the third condition will then receive psychotherapy as well. The delay of 8 weeks will allow us to understand how the psychotherapy works compared to how people change without counseling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Active comparator | Behavioral: Full Motivational Interviewing ("FMI"), Behavioral: Spirit Only Motivational Interviewing ("SOMI") |
| Self-Change Control ("SCC") | No intervention | –SCC participants will be told that they should attempt to reduce their drinking over the course of 8 weeks. (If unsuccessful, they will be offered Full Motivational Interviewing therapy sessions.) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary current diagnosis of Alcohol Use Disorder
- Meets DSM-IV criteria for inability to control or cut down on drinking
- Have an average weekly consumption of >24 standard drinks for men and >15 standard drinks for women
- Show no evidence of significant cognitive impairment
- Are willing to reduce drinking to non-hazardous levels
Key exclusion criteria (5 listed)
- Have a current DSM-IV diagnosis of drug dependence (other than nicotine/marijuana)
- Have a serious psychiatric illness (e.g., psychotic disorder, bipolar disorder, major depression) or substantial suicide or violence risk
- Have clinically severe alcoholism as evidenced by a history of significant medical problems associated with drinking, seizures or severe withdrawal symptoms, or an inpatient treatment episode for drinking
- Legally mandated to receive substance abuse treatment
- Sufficiently socially unstable as to preclude completion of study requirements (e.g., homeless)
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 |
|---|---|---|
| Full Motivational Interviewing ("FMI")Relational and technical technical (directive) strategies in counselling sessions to significantly increase commitment strength to reduce drinking. | Behavioural | Psychotherapy |
| Spirit Only Motivational Interviewing ("SOMI")Empathic and non-directive counselling based on Rogerian psychotherapy model. | Behavioural | Psychotherapy |
Primary outcome
Time Line Follow Back
Time frame: 36 weeks
Calendar-based method of recording drinking patterns. Data will be aggregated into summary variables including sum of standard drinks, mean drinks per drinking day, and percent days heavy drinking at multiple time points.
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 12 Sep 2016.
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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.
Jonathan Morgenstern, PhD principal investigator
North Shore LIJ Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Motivational Interviewing ("FMI") and Spirit Only Motivational Interviewing ("SOMI") 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 8 inclusion and 5 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 12 Sep 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?
Time Line Follow Back (time frame: 36 weeks). 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 12 Sep 2016.