Alcohol DependenceNCT00665249
Project Motion, A Study of Motivational Interviewing to Reduce Heavy or Problematic Drinking
A study testing Motivational Interviewing, Spirit-Only Motivational Interviewing and Self-Change in people with Alcohol Dependence and Alcohol Abuse, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this pilot 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 Dependence, Alcohol Abuse
- What is being tested?
- Motivational Interviewing, Spirit-Only Motivational Interviewing and Self-Change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jul 2009
- 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
- age 18-65
- primary current diagnosis of alcohol use disorder
- have an average weekly consumption of >24 standard drinks (A standard drink is defined as 1.5 oz of 80 proof distilled spirits, a 5 oz. glass of wine, or a 12 oz. beer. These are all estimated to have about 0.5 oz or 9 grams of pure ethanol.)
- able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment
- are willing to reduce drinking to non-hazardous levels
- are willing to provide signed informed consent to participate
- agree not to seek additional substance abuse treatment during study period
Who cannot join
- have significant current substance use or substance dependence (with the exception of marijuana, nicotine and caffeine),defined as, any substance use (with the exception of marijuana, nicotine and caffeine) greater than weekly use in the past month
- have a serious psychiatric illness (e.g., psychotic disorder, bipolar disorder, major depression, etc.) or substantial suicide or violence risk
- having clinically severe alcoholism as evidenced by a history of significant medical problems associated with drinking, a history of seizures or severe withdrawal symptoms, or more than one 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)
- state desire to pursue a goal of lifetime abstinence
- report current participation in or report an intent to participate in an additional substance abuse treatment method during the course of the study
- stated desire or intent to become pregnant or stated inconsistent use of birth control while sexually active
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Foundation for Mental Hygiene, Inc., Columbia Addiction Services and Psychotherapy Intervention Research
New York, New York, 10019
About this study
Official title: Component Analysis of Motivational Interviewing
The purpose of this pilot 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 www.projectmotion.org
Read the detailed description
Motivational interviewing (MI) has been demonstrated to be an effective intervention for alcohol use disorders (AUD). The consistency, magnitude, and durability of its effects suggest powerful mechanisms of behavior change (MOBC) operate to reduce drinking. A better understanding of the MOBC in MI is therefore important. Existing MOBC studies of MI have yielded limited and contradictory findings. The project proposes to conduct a small pilot study to disaggregate MI into its component parts and test full MI compared to MI without its directive strategies. This test will compare whether the directive elements of MI (Full MI, or FMI) are critical or whether MI effects may be attributable solely to its Rogerian, non-directive components (aka, Spirit-Only MI, or SOMI).
In addition, we will test whether hypothesized main effects of FMI are mediated via increases in commitment to reduce drinking early in treatment. Further, we will examine whether non-specific therapy factors alone (SOMI) significantly reduce drinking when compared to a Feedback Followed by Counseling (FFC) condition that controls for non-therapy factors and incorporates assessment and self-monitoring. We will also test whether SOMI's main effects are mediated by increases in mood and greater belief in the ability to change, as hypothesized by various theories.
Our work on MOBC for MI will take place in the context of studying brief, stand-alone treatments for individuals with primary AUD who seek to reduce, but not stop, drinking. We will recruit 90 individuals with AUD seeking treatment; collect daily process data during a pre-treatment week; and then assess and randomly assign them to 3 conditions: FMI, SOMI, and FFC. All participants will be followed for 9 weeks using daily Interactive Voice Recording (IVR) and in-laboratory assessments at weeks 0, 1, 4, and 8. Those in treatment conditions will receive 4 sessions of treatment at weeks 1, 2, 4, and 8. FFC will receive treatment after completing the week 8 assessment period. Participants in FMI and SOMI will be followed for an additional 4 weeks post-treatment (week 12).
- Conditions
- Alcohol Dependence, Alcohol Abuse
- Being tested
- Motivational Interviewing, Spirit-Only Motivational Interviewing, Self-Change
- Keywords
- problem drinking, heavy drinking, Alcohol, moderation, motivational interviewing
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Also called 4 one-hour Psychotherapy Sessions over 8 weeks.
See MotivationalInterviewing.org
Spirit-Only Motivational InterviewingBehavioural
Also called SOMI, Non-Directive Psychotherapy
Non-directive elements encompass the use of MI-consistent, and avoidance of MI-inconsistent, behaviors, as well as attention to MI-spirit.
Self-ChangeOther
Also called Waitlist Control
Participants are followed for 8 weeks, without therapeutic intervention. At end of assessment period, they receive 4 sessions of full MI.
| Study group | Role | What they receive |
|---|---|---|
| Full Motivational Interviewing | Active comparator | This condition consisted of all the standard elements of MI, both the non-directive and directive strategies (Miller \& Rollnick, 2002). Rogerian elements, such as warmth, egalitarianism, genuineness, and a client-centered approach to the therapeutic relationship, are commonly referred to as "MI Spirit" (Moyers, Martin, Manual, Hendricksen, \& Miller, 2005). MI is comprised of MI spirit and includes specific directive strategies geared to focus the client toward targeted behavior change, such as confidence and importance rulers, visualization of behavior change, or a decisional balance. The directive elements of MI are those that selectively reinforce positive change talk or enhance discrepancy between a client's wish to change and stay with the status quo. Receives: Behavioral: Motivational Interviewing |
| No Intervention: Self Change | Active comparator | Participants in this condition were not assigned to treatment, but were asked to attempt to change on their own during the 8-week follow-up period. SC participants were told that research had shown that some individuals could reduce their drinking without professional help; that participating in the IVR might facilitate their efforts; and that they would be offered professional treatment at the end of the 8-week period. As noted in the Introduction, SC was selected rather than a traditional wait-list control because the aim of the study was to decompose MI into its 3 hypothesized components that include self-change. Receives: Other: Self-Change |
| Spirit-Only Motivational Interviewing | Active comparator | While this condition retained the Rogerian elements to MI, directive elements were excluded. For example, SOMI consisted of the non-directive elements including therapist stance (warmth, genuineness, egalitarianism), emphasis on client responsibility to change, extensive use of reflective listening skills (e.g., open-ended questions, simple reflections), and avoidance of MI-inconsistent behaviors (advise, confront, take expert role, interpretation). Reflective listening was focused on the whole experience of the client and the client's affect, and targeting a particular behavior or eliciting change talk about drinking was proscribed. Furthermore, tools utilized frequently in MI to develop discrepancy, such as amplified or double-sided reflections, were proscribed. Receives: Behavioral: Spirit-Only Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeline Followback (TLFB)--Measures frequency and intensity of drinking by self-report
Daily record of drinking--measured in standard drink equivalents. The TLFB (Sobell, et al, 1980) assesses frequency of alcohol use during the previous 8 weeks. TLFB data is aggregated to provide weekly summary variables (sum of standard drinks per week, mean drinks per drinking day, and the mean number of drinking days) across the 8 weeks prior to randomization through the end of treatment. In order to compare baseline drinking, weekly summary variables were averaged across the 8 weeks prior to randomization.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMay 2009
- Study completionJul 2009
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.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Morgenstern, Northwell Health
- Investigators
- Jon Morgenstern, Ph.D., Principal investigator, Columbia UniversityAlexis N Kuerbis, MSW, PhD, Study director, Research Foundation for Mental Hygiene, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665249
- Sponsor's protocol ID
- R21AA017135-01
- Other IDs
- R21AA017135-01
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2008
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Component Analysis of Motivational Interviewing
- ClinicalTrials.gov ID
- NCT00665249
- Acronym / sponsor ID
- R21AA017135-01
- Conditions
- Alcohol Dependence, Alcohol Abuse
- Keywords
- problem drinking, heavy drinking, Alcohol, moderation, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 23 Apr 2008 (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 pilot 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 www.projectmotion.org
Detailed description
Motivational interviewing (MI) has been demonstrated to be an effective intervention for alcohol use disorders (AUD). The consistency, magnitude, and durability of its effects suggest powerful mechanisms of behavior change (MOBC) operate to reduce drinking. A better understanding of the MOBC in MI is therefore important. Existing MOBC studies of MI have yielded limited and contradictory findings. The project proposes to conduct a small pilot study to disaggregate MI into its component parts and test full MI compared to MI without its directive strategies. This test will compare whether the directive elements of MI (Full MI, or FMI) are critical or whether MI effects may be attributable solely to its Rogerian, non-directive components (aka, Spirit-Only MI, or SOMI).
In addition, we will test whether hypothesized main effects of FMI are mediated via increases in commitment to reduce drinking early in treatment. Further, we will examine whether non-specific therapy factors alone (SOMI) significantly reduce drinking when compared to a Feedback Followed by Counseling (FFC) condition that controls for non-therapy factors and incorporates assessment and self-monitoring. We will also test whether SOMI's main effects are mediated by increases in mood and greater belief in the ability to change, as hypothesized by various theories.
Our work on MOBC for MI will take place in the context of studying brief, stand-alone treatments for individuals with primary AUD who seek to reduce, but not stop, drinking. We will recruit 90 individuals with AUD seeking treatment; collect daily process data during a pre-treatment week; and then assess and randomly assign them to 3 conditions: FMI, SOMI, and FFC. All participants will be followed for 9 weeks using daily Interactive Voice Recording (IVR) and in-laboratory assessments at weeks 0, 1, 4, and 8. Those in treatment conditions will receive 4 sessions of treatment at weeks 1, 2, 4, and 8. FFC will receive treatment after completing the week 8 assessment period. Participants in FMI and SOMI will be followed for an additional 4 weeks post-treatment (week 12).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full Motivational Interviewing | Active comparator | Behavioral: Motivational InterviewingThis condition consisted of all the standard elements of MI, both the non-directive and directive strategies (Miller \& Rollnick, 2002). Rogerian elements, such as warmth, egalitarianism, genuineness, and a client-centered approach to the therapeutic relationship, are commonly referred to as "MI Spirit" (Moyers, Martin, Manual, Hendricksen, \& Miller, 2005). MI is comprised of MI spirit and includes specific directive strategies geared to focus the client toward targeted behavior change, such as confidence and importance rulers, visualization of behavior change, or a decisional balance. The directive elements of MI are those that selectively reinforce positive change talk or enhance discrepancy between a client's wish to change and stay with the status quo. |
| No Intervention: Self Change | Active comparator | Other: Self-ChangeParticipants in this condition were not assigned to treatment, but were asked to attempt to change on their own during the 8-week follow-up period. SC participants were told that research had shown that some individuals could reduce their drinking without professional help; that participating in the IVR might facilitate their efforts; and that they would be offered professional treatment at the end of the 8-week period. As noted in the Introduction, SC was selected rather than a traditional wait-list control because the aim of the study was to decompose MI into its 3 hypothesized components that include self-change. |
| Spirit-Only Motivational Interviewing | Active comparator | Behavioral: Spirit-Only Motivational InterviewingWhile this condition retained the Rogerian elements to MI, directive elements were excluded. For example, SOMI consisted of the non-directive elements including therapist stance (warmth, genuineness, egalitarianism), emphasis on client responsibility to change, extensive use of reflective listening skills (e.g., open-ended questions, simple reflections), and avoidance of MI-inconsistent behaviors (advise, confront, take expert role, interpretation). Reflective listening was focused on the whole experience of the client and the client's affect, and targeting a particular behavior or eliciting change talk about drinking was proscribed. Furthermore, tools utilized frequently in MI to develop discrepancy, such as amplified or double-sided reflections, were proscribed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18-65
- primary current diagnosis of alcohol use disorder
- have an average weekly consumption of >24 standard drinks (A standard drink is defined as 1.5 oz of 80 proof distilled spirits, a 5 oz. glass of wine, or a 12 oz. beer. These are all estimated to have about 0.5 oz or 9 grams of pure ethanol.)
- able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment
- are willing to reduce drinking to non-hazardous levels
Key exclusion criteria (8 listed)
- have significant current substance use or substance dependence (with the exception of marijuana, nicotine and caffeine),defined as, any substance use (with the exception of marijuana, nicotine and caffeine) greater than weekly use in the past month
- have a serious psychiatric illness (e.g., psychotic disorder, bipolar disorder, major depression, etc.) or substantial suicide or violence risk
- having clinically severe alcoholism as evidenced by a history of significant medical problems associated with drinking, a history of seizures or severe withdrawal symptoms, or more than one 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 |
|---|---|---|
| Motivational InterviewingAlso: 4 one-hour Psychotherapy Sessions over 8 weeks.See MotivationalInterviewing.org | Behavioural | Full Motivational Interviewing |
| Spirit-Only Motivational InterviewingAlso: SOMI, Non-Directive PsychotherapyNon-directive elements encompass the use of MI-consistent, and avoidance of MI-inconsistent, behaviors, as well as attention to MI-spirit. | Behavioural | Spirit-Only Motivational Interviewing |
| Self-ChangeAlso: Waitlist ControlParticipants are followed for 8 weeks, without therapeutic intervention. At end of assessment period, they receive 4 sessions of full MI. | Other | No Intervention: Self Change |
Primary outcome
Timeline Followback (TLFB)--Measures frequency and intensity of drinking by self-report
Time frame: 8 weeks
Daily record of drinking--measured in standard drink equivalents. The TLFB (Sobell, et al, 1980) assesses frequency of alcohol use during the previous 8 weeks. TLFB data is aggregated to provide weekly summary variables (sum of standard drinks per week, mean drinks per drinking day, and the mean number of drinking days) across the 8 weeks prior to randomization through the end of treatment. In order to compare baseline drinking, weekly summary variables were averaged across the 8 weeks prior to randomization.
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 28 Apr 2015.
- Project MotionLink provided by the sponsor.
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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.
Jon Morgenstern, Ph.D. principal investigator
Columbia University
Alexis N Kuerbis, MSW, PhD study director
Research Foundation for Mental Hygiene, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing, Spirit-Only Motivational Interviewing and Self-Change in people with Alcohol Dependence and Alcohol Abuse, 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 8 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 28 Apr 2015. 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?
Timeline Followback (TLFB)--Measures frequency and intensity of drinking by self-report (time frame: 8 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 28 Apr 2015.