Project Motion, A Study of Motivational Interviewing to Reduce Heavy or Problematic Drinking
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00665249|
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : April 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence Alcohol Abuse||Behavioral: Motivational Interviewing Behavioral: Spirit-Only Motivational Interviewing Other: Self-Change||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Component Analysis of Motivational Interviewing|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||July 2009|
Active Comparator: Full Motivational Interviewing
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.
Behavioral: Motivational Interviewing
Other Name: 4 one-hour Psychotherapy Sessions over 8 weeks.
Active Comparator: No Intervention: Self Change
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.
Participants are followed for 8 weeks, without therapeutic intervention. At end of assessment period, they receive 4 sessions of full MI.
Other Name: Waitlist Control
Active Comparator: Spirit-Only Motivational Interviewing
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.
Behavioral: Spirit-Only Motivational Interviewing
Non-directive elements encompass the use of MI-consistent, and avoidance of MI-inconsistent, behaviors, as well as attention to MI-spirit.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665249
|United States, New York|
|Research Foundation for Mental Hygiene, Inc., Columbia Addiction Services and Psychotherapy Intervention Research|
|New York, New York, United States, 10019|
|Principal Investigator:||Jon Morgenstern, Ph.D.||Columbia University|
|Study Director:||Alexis N Kuerbis, MSW, PhD||Research Foundation for Mental Hygiene, Inc.|