Changing Impulsivity With Mindful Breathing Therapy to Reduce Problem Drinking

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2016-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Problem Drinking

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Mindfulness Therapy

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes