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

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: NCT02527720
Recruitment Status : Completed
First Posted : August 19, 2015
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Carl W. Lejuez, University of Maryland, College Park

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Problem Drinking Behavioral: Mindfulness Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changing Impulsivity With Mindful Breathing Therapy to Reduce Problem Drinking
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : August 1, 2016
Actual Study Completion Date : December 1, 2016

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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.

  5. 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

  6. 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).

  7. 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.

  8. 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

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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): NCT02527720


Locations
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United States, Maryland
2103 Cole Field House
College Park, Maryland, United States, 20742
Sponsors and Collaborators
University of Maryland, College Park
Investigators
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Principal Investigator: Carl Lejuez, PhD University of Maryland, College Park
Publications:
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Responsible Party: Carl W. Lejuez, Professor, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT02527720    
Other Study ID Numbers: R34AA022213-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Keywords provided by Carl W. Lejuez, University of Maryland, College Park:
Mindfulness
Therapy
Problem Drinking
Breathing-based mindfulness training
Additional relevant MeSH terms:
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Respiratory Aspiration
Alcoholism
Impulsive Behavior
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders