Problem DrinkingBBMTNCT02527720
Changing Impulsivity With Mindful Breathing Therapy to Reduce Problem Drinking
A study testing Mindfulness Therapy in people with Problem Drinking, run by University of Maryland, College Park at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Problem Drinking
- What is being tested?
- Mindfulness Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to 1 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
- 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;
- to investigate the feasibility and preliminary efficacy of applying BBMT for reducing problem drinking with a pilot randomized controlled trial (RCT);
- 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.
Read the 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.
- Conditions
- Problem Drinking
- Being tested
- Mindfulness Therapy
- Keywords
- Mindfulness, Therapy, Problem Drinking, Breathing-based mindfulness training
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Mindfulness Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Weeks 1-8 and 3 month follow up
Secondary outcomes (18)
Audit
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
Measured: Baseline
Readiness to Change
Readiness to Change: Drug and Alcohol version of SOCRATES (Miller \& Tonigan, 1996) will be used to evaluate motivation for change
Measured: Baseline , Week 4 , Week 8, and 3 month Follow Up
Customary Drinking and Drug Use Record
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)
Measured: Baseline , Week 4 , Week 8, and 3 month Follow Up
Barratt Impulsiveness Scale
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.
Measured: Baseline , Week 4 , Week 8, and 3 month Follow Up
UPPS Impulsive Behavioral Scale
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
Measured: Baseline , Week 4 , Week 8, and 3 month Follow Up
Delay Discounting of Hypothetical Money Gains
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).
Measured: Baseline , Week 4 , Week 8, and 3 month Follow Up
Stop-Signal Task (SST)
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.
Measured: Baseline , Week 4 , Week 8, and 3 month Follow Up
Spielberger State-Trait Anxiety Inventory (STAI):
both trait and state anxiety will be measured monthly to monitor changes over time
Measured: Baseline , Week 4 , Week 8, and 3 month Follow Up
The Center for Epidemiological Studies Depression Scale (CES-D)
The Center for Epidemiological Studies Depression Scale (CES-D) (Radloff, 1977) is a 20-item self-report inventory measuring mood and symptoms of depression.
Measured: Baseline , Week 4 , Week 8, and 3 month Follow Up
Perceived Stress Scale
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
Measured: Baseline , Week 4 , Week 8, and 3 month Follow Up
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
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.
Measured: Baseline , Week 4 , Week 8, and 3 month Follow Up
Five-Facet Mindfulness Questionnaire
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.
Measured: Baseline , Week 4 , Week 8, and 3 month Follow Up
Perceived Quality of Life Measure
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.
Measured: Baseline , Week 4 , Week 8, and 3 month Follow Up
Therapist adherence and competence
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.
Measured: Week 4, Week 8, and 3 month Follow Up
The Program Evaluation Form
he Program Evaluation Form is an 8-item self-report measure assessing participants' perceptions of and satisfaction with the treatment services.
Measured: Week 4, Week 8, and 3 month Follow Up
Working Alliance Inventory (WAI)
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.
Measured: Week 4, Week 8
RFB or MM Feedback and Quality Assessment
RFB or MM Feedback and Quality Assessment: BBMT participants will report daily quantity and quality of RFB or MM practice
Measured: Weeks 1-8 and 3 month follow up
Treatment Progress/Completion
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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start1 Jun 2015
- Primary completion1 Aug 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Problem DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl W. Lejuez, University of Maryland, College Park
- Investigators
- Carl Lejuez, PhD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527720
- Sponsor's protocol ID
- R34AA022213-01A1
- Acronym
- BBMT
- Status last verified
- Sep 2019
- First submitted
- 12 Aug 2015
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20649456Carroll, 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.
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.
PubMed 17333315Lehrer 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.
PubMed 10999236Schein 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.
PubMed 11319676Krueger, R. A. (1994). Focus groups: A practical guide for applied research. Sage
Krueger, R. A., & Casey, M. A. (2009). Focus groups: A practical guide for applied research (2 e.d.). Sage.
Strauss, A., & Corbin, J. M. (1997). Grounded theory in practice. Sage.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Impulsivity With Mindful Breathing Therapy to Reduce Problem Drinking
- ClinicalTrials.gov ID
- NCT02527720
- Acronym / sponsor ID
- BBMT / R34AA022213-01A1
- Conditions
- Problem Drinking
- Keywords
- Mindfulness, Therapy, Problem Drinking, Breathing-based mindfulness training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- to investigate the feasibility and preliminary efficacy of applying BBMT for reducing problem drinking with a pilot randomized controlled trial (RCT);
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Therapy | Experimental | Behavioral: Mindfulness TherapyFor 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). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness TherapyBBMT 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. | Behavioural | Mindfulness Therapy |
Primary outcome
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)
18 secondary outcomes
Audit
Time frame: Baseline
Readiness to Change
Time frame: 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
Barratt Impulsiveness Scale
Time frame: 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
Delay Discounting of Hypothetical Money Gains
Time frame: 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
Spielberger State-Trait Anxiety Inventory (STAI):
Time frame: 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
Perceived Stress Scale
Time frame: 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
Five-Facet Mindfulness Questionnaire
Time frame: 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
Therapist adherence and competence
Time frame: Week 4, Week 8, and 3 month Follow Up
The Program Evaluation Form
Time frame: Week 4, Week 8, and 3 month Follow Up
Working Alliance Inventory (WAI)
Time frame: Week 4, Week 8
RFB or MM Feedback and Quality Assessment
Time frame: Weeks 1-8 and 3 month follow up
Treatment Progress/Completion
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Background: PubMed 20649456Chen 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.
- BackgroundCarroll, 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: PubMed 17333315Karavidas 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.
- Background: PubMed 10999236Lehrer 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.
- Background: PubMed 11319676Schein 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.
- BackgroundKrueger, R. A. (1994). Focus groups: A practical guide for applied research. Sage
- BackgroundKrueger, R. A., & Casey, M. A. (2009). Focus groups: A practical guide for applied research (2 e.d.). Sage.
- BackgroundStrauss, A., & Corbin, J. M. (1997). Grounded theory in practice. Sage.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Lejuez, PhD principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Therapy in people with Problem Drinking, run by University of Maryland, College Park at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02527720, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.