Changing Impulsivity With Mindful Breathing Therapy to Reduce Problem Drinking (BBMT)

September 11, 2019 updated by: Carl W. Lejuez, University of Maryland, College Park

The investigators plan to establish the efficacy of a novel breathing-based mindfulness training (BBMT, a much simplified, easy-to-use version of standard MM) for problem drinking, and test whether impulsivity mediates this effect among a sample of student problem drinkers (i.e., > 8 on AUDIT, the problem drinking Screening Test). The specific aims of this pilot study are as follows:

  1. to modify and further develop the easy-to-use BBMT program for directly targeting impulsivity to produce an indirect reduction in problem drinking among college students;
  2. to investigate the feasibility and preliminary efficacy of applying BBMT for reducing problem drinking with a pilot randomized controlled trial (RCT);
  3. to examine changes in impulsivity, as measured by both behavioral and self-report assessments, as one of the possible mediators in the effect of BBMT on problem drinking, with control for changes in perceived stress and anxiety.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

An efficacious strategy for addressing problem substance use among college student drinkers is to target core risk factors. Arguably one of the most clearly documented risk factors for problem drinking among college students is impulsivity, with the relationship holding across various dimensions of impulsivity. Available evidence supports the importance of intervening with impulsivity to limit problem drinking among college students, but there are few proven treatments for any dimension of impulsivity. This notable lack may be due to the traditional view of impulsivity as an unchangeable personality trait. However, recent research suggests personality can change and is sensitive to behavior manipulation. As a result there is clear need for novel approaches targeted at core changes in the individual and their behavior patterns. Mindfulness meditation (MM) is a unique option in this direction as MM is especially useful in reducing impulsive behaviors including problem drinking, but its exact role in affecting different dimensions of impulsivity and in effecting change in problem drinking has yet to be explored. Based on evidence from recent studies, as well as our own pilot work, the investigators hypothesize that one of the mechanisms by which MM reduces problem drinking among college students is by lessening impulsivity - moreover, the focus on changing college student problem drinking is done without any explicit focus on drinking behavior itself. The specific aims of this Stage 1 therapy development study are to: 1) modify and further develop a breathing-based mindfulness therapy (BBMT) for reducing impulsivity and problem drinking among college youth; 2) investigate the feasibility and preliminary efficacy of applying BBMT for reducing problem drinking with a pilot randomized controlled trial (RCT); 3) examine changes in impulsivity, as measured by both behavioral and self-report assessments, as one of possible mediators in the observed effect of BBMT on problem drinking. These aims will be achieved in two phases. In Phase 1 the investigators will expand and fully develop the existing BBMT program with manuals to determine the effective treatment dosage for both problem drinking and impulsivity in an open label trial (n = 10). Using the modified treatment materials from Phase 1, in Phase 2 the investigators will conduct a RCT comparing the effects of modified BBMT to a Supportive Counseling + Progressive Muscle Relaxation (SC + PMR) control condition (n = 36 each) on problem drinking, assessed at baseline, weeks 4 and 8, and a 3-month follow-up. Other potential mediators such as perceived stress and anxiety also will be examined in the final model. This study has great potential implications for reaching college students drinkers less willing to acknowledge their drinking problems as it addresses a core vulnerability (impulsivity) among at-risk students in a manner that limits stigma and may reduce resistance to change. A diverse team experienced in mindfulness, impulsivity and behavior therapy development has been assembled to conduct the proposed R34 project and prepare for a full therapy development study in the future.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • College Park, Maryland, United States, 20742
        • 2103 Cole Field House

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. UM College Park students aged 18-30
  2. AUDIT score of 8 or higher (Babor et al., 2004)
  3. A total score on the Barratt Impulsiveness Scale of 73 or higher, which is the mean plus half (1/2) standard deviation, (M=64; SD=17) (Patton et al., 1995)
  4. A commitment to adhere to the study protocol with a weekly therapy meeting (about 40 minutes each), and an extra 1.5 to 2 hours for study data collection at week 4 and week 8
  5. No plan to move away from the UM campus area for next 2 months

Exclusion Criteria:

  1. At current risk of suicide, including suicidal behavior or attempts in the past 30 days
  2. A history of schizophrenia or other psychotic disorders
  3. Current participation in other clinical studies of addiction or impulsive behavior
  4. Severe physical and mental health problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness Therapy
For the current study the investigators have developed a breathing-based, adapted for feasible application among SUD populations, and easy to carry out in clinical or non-clinical settings referred to as breathing-based mindfulness training (BBMT). BBMT is a simplified form of MM. Its core components are near resonance-frequency breathing (RFB), mindfulness training, positivity and inward attention (more details below).
Behavioral: Mindfulness Therapy
BBMT is a simplified form of MM. Its core components are near resonance-frequency breathing (RFB), mindfulness training, positivity and inward attention. A key component in BBMT is to be mindful of breathing whenever possible, and breathe at near resonance frequency (RF), known as heart rate variability biofeedback. The human cardiovascular system is known to have resonance characteristics, with the first RF at ~0.1 Hz. RF varies between 4.5 and 7 cycles per minute. Breathing at RF stimulates the cardiovascular system to oscillate at that frequency at a very high amplitude and greatly stimulates the baroreflex system. RFB is known to reduce depression and stress symptoms as well as various diseases related to malfunction of the autonomic nervous system, such as asthma and hypertension.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in substance use utilizing the Timeline Follow Back from the baseline to 3 months
Time Frame: Weeks 1-8 and 3 month follow up
Timeline Follow-back (TLFB) (C. Sobell & B. Sobell, 1992) will be used to record and track participants' recent (past 30 days and 7 days) alcohol-use as well as other drug use frequency. Alcohol-use and other drug use quantity will be recorded for each day on which use was reported. The TLFB method has been shown to have good reliability and validity in college students (Sobell et al., 1989)
Weeks 1-8 and 3 month follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Audit
Time Frame: Baseline
Alcohol Use Diagnostic Identification Test (AUDIT) (Babor et al., 2004), has 10 items which assess frequency of drinking, typical quantity, frequency of heavy drinking, impaired control over drinking, increased salience of drinking, morning drinking, blackouts, and alcohol-related injuries within the past year. A total score of 8 or more has been found to indicate a strong likelihood of hazardous or harmful alcohol consumption
Baseline
Readiness to Change
Time Frame: Baseline , Week 4 , Week 8, and 3 month Follow Up
Readiness to Change: Drug and Alcohol version of SOCRATES (Miller & Tonigan, 1996) will be used to evaluate motivation for change
Baseline , Week 4 , Week 8, and 3 month Follow Up
Customary Drinking and Drug Use Record
Time Frame: Baseline , Week 4 , Week 8, and 3 month Follow Up
Customary Drinking and Drug Use Record (CDDR; Brown et al., 1998) measures lifetime alcohol use and problems to provide a baseline and examine the impact of treatment. The CDDR records age at first use and makes separate lifetime frequency use estimations for beer, wine, and distilled spirits. The CDDR has good reliability for assessing substance use behaviors among adolescents and young adults (Brown et al., 1998) and has been used specifically in college-student samples Doran et al., 2007)
Baseline , Week 4 , Week 8, and 3 month Follow Up
Barratt Impulsiveness Scale
Time Frame: Baseline , Week 4 , Week 8, and 3 month Follow Up
Barratt Impulsiveness Scale (BIS-11) , includes questions focusing on motor impulsivity (acting without thinking), cognitive impulsivity (making quick cognitive decisions), and future-planning impulsivity (lack of concern about the future), with good internal consistency (alpha = 0.89 to 0.92) and test-retest reliability (0.80). Mean plus one SD in total BIS score from UM study (M = 64; SD = 17) will be used to screen and select those with high impulsivity to be included in this study to assess possible change over time.
Baseline , Week 4 , Week 8, and 3 month Follow Up
UPPS Impulsive Behavioral Scale
Time Frame: Baseline , Week 4 , Week 8, and 3 month Follow Up
UPPS Impulsive Behavior scale (Whiteside & Lynam, 2001) assesses five personality pathways to impulsive behavior: negative urgency, positive urgency, (lack of) premeditation, (lack of) perseverance, and sensation seeking
Baseline , Week 4 , Week 8, and 3 month Follow Up
Delay Discounting of Hypothetical Money Gains
Time Frame: Baseline , Week 4 , Week 8, and 3 month Follow Up
Delay Discounting of Hypothetical Money Gains, is a computerized binary-choice procedure. On each trial, two outcomes will be presented on the screen: one is an amount of money available immediately; the other is a larger amount of money ($50, $1,000) available after some delay (1 week, 1 year, etc.). The computerized algorithm (Holt et al., 2003) will adjust the immediate outcome for each amount/delay pairing over 6 trials to determine an indifference point, resulting in 6 indifference points (corresponding to the 6 delays) for each of 2 amounts ($50, $1,000).
Baseline , Week 4 , Week 8, and 3 month Follow Up
Stop-Signal Task (SST)
Time Frame: Baseline , Week 4 , Week 8, and 3 month Follow Up
A personal computer will be used to conduct the SST, which presents two types of trials: GO and STOP. In GO trials, participants will respond with a keystroke as quickly as possible following the presentation of a visual go stimulus. In STOP trials (25% of all trials), an auditory stop signal will follow the presentation of the visual go signal. Subjects will be instructed to inhibit the go response on hearing the stop signal. The latency between onset of the go and stop signals will be titrated in the following manner: failure on a STOP trial will result in a 50ms increase in this latency, and success will result in a 50ms decrease. This method will converge on a latency, the stop signal delay (SSD) at which a participant succeeds on half of all STOP trials. After 16 GO practice trials, participants will complete five blocks of 64 trials.
Baseline , Week 4 , Week 8, and 3 month Follow Up
Spielberger State-Trait Anxiety Inventory (STAI):
Time Frame: Baseline , Week 4 , Week 8, and 3 month Follow Up
both trait and state anxiety will be measured monthly to monitor changes over time
Baseline , Week 4 , Week 8, and 3 month Follow Up
The Center for Epidemiological Studies Depression Scale (CES-D)
Time Frame: Baseline , Week 4 , Week 8, and 3 month Follow Up
The Center for Epidemiological Studies Depression Scale (CES-D) (Radloff, 1977) is a 20-item self-report inventory measuring mood and symptoms of depression.
Baseline , Week 4 , Week 8, and 3 month Follow Up
Perceived Stress Scale
Time Frame: Baseline , Week 4 , Week 8, and 3 month Follow Up
Perceived Stress Scale is a global measure of perceived stress in daily life (Chiang et al., 2005) designed to gauge the degree to which common situations are appraised as stressful
Baseline , Week 4 , Week 8, and 3 month Follow Up
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Time Frame: Baseline , Week 4 , Week 8, and 3 month Follow Up
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) is a well-validated 36-item, self-report questionnaire that assesses multiple aspects of emotion dysregulation. The DERS yields a total score that is comprised of scores on six subscales: nonacceptance of emotional responses, lack of emotional awareness, impulse control difficulties, difficulties engaging in goal directed behavior, lack of emotional clarity, and limited access to emotion regulation strategies.
Baseline , Week 4 , Week 8, and 3 month Follow Up
Five-Facet Mindfulness Questionnaire
Time Frame: Baseline , Week 4 , Week 8, and 3 month Follow Up
Five-Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006) is an instrument based on factor analysis of five independently developed mindfulness scales. The five factors appear to represent elements of mindfulness as it is currently conceptualized. The five facets are observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. The FFMQ is one of the most popular scales used in study of mindfulness.
Baseline , Week 4 , Week 8, and 3 month Follow Up
Perceived Quality of Life Measure
Time Frame: Baseline , Week 4 , Week 8, and 3 month Follow Up
Perceived Quality of Life Measure (Burckhardt & Anderson, 2003) will be employed to assess general well-being. These measures will be given at baseline and every 4 weeks during treatment.
Baseline , Week 4 , Week 8, and 3 month Follow Up
Therapist adherence and competence
Time Frame: Week 4, Week 8, and 3 month Follow Up
Therapist adherence and competence. During the open trial all treatment sessions will be audio taped and rated by independent raters (e.g., not associated with treatment delivery) so as to assess therapist adherence to the treatment protocol. Specific therapist behaviors will be considered "prescribed" and "proscribed" (Waltz et al., 1993) in order to assure that BBMT and SC + PMR treatment are distinct. Drs. Chen and Lejuez will review 20% of the audiotapes to maintain reliability. If therapist drift from the protocol is detected, the problem will be discussed in staff meetings and corrected through supervision.
Week 4, Week 8, and 3 month Follow Up
The Program Evaluation Form
Time Frame: Week 4, Week 8, and 3 month Follow Up
he Program Evaluation Form is an 8-item self-report measure assessing participants' perceptions of and satisfaction with the treatment services.
Week 4, Week 8, and 3 month Follow Up
Working Alliance Inventory (WAI)
Time Frame: Week 4, Week 8
he Working Alliance Inventory (WAI) (Horvath & Greenberg, 1989) will be used to assess therapeutic alliance. The WAI is a 36-item measure composed of items reflecting desirable aspects of the therapeutic relationship. Each item is assessed on a 7-point Likert scale ranging from 1 (never) to 7 (always), with higher scores indicating more positive therapeutic alliance.
Week 4, Week 8
RFB or MM Feedback and Quality Assessment
Time Frame: Weeks 1-8 and 3 month follow up
RFB or MM Feedback and Quality Assessment: BBMT participants will report daily quantity and quality of RFB or MM practice
Weeks 1-8 and 3 month follow up
Treatment Progress/Completion
Time Frame: Week 8
Treatment Progress/Completion: A checklist for the therapist to document the proportion of training components being delivered and practiced by the end of week 8 facilitation.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Maryland, College Park

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carl Lejuez, PhD, University of Maryland, College Park

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

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Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34AA022213-01A1 (U.S. NIH Grant/Contract)

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