Changing Impulsivity With Mindful Breathing Therapy to Reduce Problem Drinking

NCT02527720 | Completed

• 1 other identifier: R34AA022213-01A1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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. 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. 2.to investigate the feasibility and preliminary efficacy of applying BBMT for reducing problem drinking with a pilot randomized controlled trial (RCT);
3. 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.

Conditions

Problem Drinking

Keywords

Mindfulness; Therapy; Problem Drinking; Breathing-based mindfulness training

Outcome Measures

Primary Outcomes (1)

• Changes in substance use utilizing the Timeline Follow Back from the baseline to 3 months

  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 Outcomes (18)

• Audit

  Baseline

• Readiness to Change

  Baseline , Week 4 , Week 8, and 3 month Follow Up

• Customary Drinking and Drug Use Record

  Baseline , Week 4 , Week 8, and 3 month Follow Up

• Barratt Impulsiveness Scale

  Baseline , Week 4 , Week 8, and 3 month Follow Up

• UPPS Impulsive Behavioral Scale

  Baseline , Week 4 , Week 8, and 3 month Follow Up

Study Arms (1)

Mindfulness Therapy

EXPERIMENTAL

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

Interventions

Mindfulness Therapy 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.

Mindfulness Therapy

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• UM College Park students aged 18-30
• AUDIT score of 8 or higher (Babor et al., 2004)
• 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)
• 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
• No plan to move away from the UM campus area for next 2 months

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, College Park: lead

Study Sites (1)

2103 Cole Field House

College Park, Maryland, 20742, United States

Location

Related Publications (8)

• Chen KW, Comerford A, Shinnick P, Ziedonis DM. Introducing qigong meditation into residential addiction treatment: a pilot study where gender makes a difference. J Altern Complement Med. 2010 Aug;16(8):875-82. doi: 10.1089/acm.2009.0443.

  PMID: 20649456 BACKGROUND

• Carroll, K. M., & Nuro, K. F. (2002). One size cannot fit all: A stage model for psychotherapy manual development. Clinical Psychology: Science and Practice, 9(4), 396-406.

  BACKGROUND

• Karavidas MK, Lehrer PM, Vaschillo E, Vaschillo B, Marin H, Buyske S, Malinovsky I, Radvanski D, Hassett A. Preliminary results of an open label study of heart rate variability biofeedback for the treatment of major depression. Appl Psychophysiol Biofeedback. 2007 Mar;32(1):19-30. doi: 10.1007/s10484-006-9029-z. Epub 2007 Mar 1.

  PMID: 17333315 BACKGROUND

• Lehrer PM, Vaschillo E, Vaschillo B. Resonant frequency biofeedback training to increase cardiac variability: rationale and manual for training. Appl Psychophysiol Biofeedback. 2000 Sep;25(3):177-91. doi: 10.1023/a:1009554825745.

  PMID: 10999236 BACKGROUND

• Schein MH, Gavish B, Herz M, Rosner-Kahana D, Naveh P, Knishkowy B, Zlotnikov E, Ben-Zvi N, Melmed RN. Treating hypertension with a device that slows and regularises breathing: a randomised, double-blind controlled study. J Hum Hypertens. 2001 Apr;15(4):271-8. doi: 10.1038/sj.jhh.1001148.

  PMID: 11319676 BACKGROUND

• Krueger, R. A. (1994). Focus groups: A practical guide for applied research. Sage

  BACKGROUND

• Krueger, R. A., & Casey, M. A. (2009). Focus groups: A practical guide for applied research (2 e.d.). Sage.

  BACKGROUND

• Strauss, A., & Corbin, J. M. (1997). Grounded theory in practice. Sage.

  BACKGROUND

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Carl Lejuez, PhD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: August 19, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 13, 2019

Record last verified: 2019-09

Locations

US (1)