Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/17/2018 |
| Start Date: | November 22, 2016 |
| End Date: | August 27, 2018 |
Mindfulness-Based Intervention and Transcranial Direct Current Brain Stimulation to Reduce Heavy Drinking: Efficacy and Mechanisms of Change
Alcohol use disorder (AUD) impacts millions of Americans and is associated with significant
behavioral, social, economic, medical, and neurobiological dysfunction, yet current
behavioral treatments for AUD are only modestly effective. The proposed research will test
the efficacy of a novel behavioral intervention, which combines brain stimulation with
mindfulness-based relapse prevention, and is hypothesized to improve neural dysfunction and
ultimately lead to large effect size reductions in heavy drinking among individuals with AUD.
Given that mindfulness and brain stimulation are already available for "home use" there is
great potential for the ultimate dissemination of the intervention on a large scale, which
could have a significant impact on public health.
behavioral, social, economic, medical, and neurobiological dysfunction, yet current
behavioral treatments for AUD are only modestly effective. The proposed research will test
the efficacy of a novel behavioral intervention, which combines brain stimulation with
mindfulness-based relapse prevention, and is hypothesized to improve neural dysfunction and
ultimately lead to large effect size reductions in heavy drinking among individuals with AUD.
Given that mindfulness and brain stimulation are already available for "home use" there is
great potential for the ultimate dissemination of the intervention on a large scale, which
could have a significant impact on public health.
Heavy drinking (defined as 4+/5+ drinks per occasion for women/men) and alcohol use disorder
(AUD) are a significant public health problem. Modestly effective pharmacological and
psychosocial treatments for AUD exist, yet some heavy drinking (i.e., relapse) is the most
common outcome following AUD treatment. Continued development of innovative and efficacious
interventions that reduce heavy drinking and specifically target risk factors for heavy
drinking is thus clearly warranted. One novel intervention that has considerable promise for
reducing heavy drinking is mindfulness-based relapse prevention (MBRP). MBRP is a behavioral
intervention for substance use disorder that was designed to target experiences of craving
and other risk factors for heavy drinking. Based on the results of numerous studies, MBRP is
feasible and efficacious in the treatment of AUD. However the effect sizes of MBRP remain
small and many individuals struggle with engaging in the mindfulness practices early in
treatment. There is preliminary evidence that combining a non-invasive form of brain
stimulation, transcranial direct current stimulation (tDCS), may improve engagement with
mindfulness practices and lead to significant reductions in heavy drinking following
treatment. The goal of the proposed study is to examine the efficacy of a mindfulness + tDCS
intervention in reducing heavy drinking and impacting hypothesized mechanisms of behavior
change among individuals with AUD who are interested in reducing their heavy drinking. In the
proposed study, a research team with complementary expertise in AUD treatment,
mindfulness-based interventions, brain stimulation, and cognitive neuroscience will combine
self-report, behavioral, and neurophysiological data collection via electroencephalography
(EEG) to study the psychological and neurophysiological mechanisms of treatment efficacy
following a novel, promising intervention that combines brain stimulation with mindfulness
training. The mindfulness based intervention in combination with active tDCS is hypothesized
to lead to significant reductions in drinks per drinking day after 8 weeks of treatment and
these reductions will be maintained up to 2 months following treatment. Further, the effect
of active tDCS on drinks per drinking day at the 2 month follow-up will be mediated by
greater mindfulness, greater inhibitory control and reductions in craving and negative affect
during treatment and at the post-treatment assessment. Approximately 86 individuals meeting
criteria for AUD will be randomly assigned to 8 sessions of either MBRP combined with active
tDCS (up to 2.0 milliamp current) or MBRP combined with a sham tDCS (no current) control
condition. The proposed study will examine the efficacy (Primary Aim) and psychological and
neurophysiological mechanisms of treatment efficacy using behavioral measures and EEG
(Secondary Aim). In addition to addressing the question of whether adding active tDCS to MBRP
enhances efficacy, it will further examine issues of neurophysiological and behavioral
treatment mechanisms to better inform the design of a future large efficacy trial.
(AUD) are a significant public health problem. Modestly effective pharmacological and
psychosocial treatments for AUD exist, yet some heavy drinking (i.e., relapse) is the most
common outcome following AUD treatment. Continued development of innovative and efficacious
interventions that reduce heavy drinking and specifically target risk factors for heavy
drinking is thus clearly warranted. One novel intervention that has considerable promise for
reducing heavy drinking is mindfulness-based relapse prevention (MBRP). MBRP is a behavioral
intervention for substance use disorder that was designed to target experiences of craving
and other risk factors for heavy drinking. Based on the results of numerous studies, MBRP is
feasible and efficacious in the treatment of AUD. However the effect sizes of MBRP remain
small and many individuals struggle with engaging in the mindfulness practices early in
treatment. There is preliminary evidence that combining a non-invasive form of brain
stimulation, transcranial direct current stimulation (tDCS), may improve engagement with
mindfulness practices and lead to significant reductions in heavy drinking following
treatment. The goal of the proposed study is to examine the efficacy of a mindfulness + tDCS
intervention in reducing heavy drinking and impacting hypothesized mechanisms of behavior
change among individuals with AUD who are interested in reducing their heavy drinking. In the
proposed study, a research team with complementary expertise in AUD treatment,
mindfulness-based interventions, brain stimulation, and cognitive neuroscience will combine
self-report, behavioral, and neurophysiological data collection via electroencephalography
(EEG) to study the psychological and neurophysiological mechanisms of treatment efficacy
following a novel, promising intervention that combines brain stimulation with mindfulness
training. The mindfulness based intervention in combination with active tDCS is hypothesized
to lead to significant reductions in drinks per drinking day after 8 weeks of treatment and
these reductions will be maintained up to 2 months following treatment. Further, the effect
of active tDCS on drinks per drinking day at the 2 month follow-up will be mediated by
greater mindfulness, greater inhibitory control and reductions in craving and negative affect
during treatment and at the post-treatment assessment. Approximately 86 individuals meeting
criteria for AUD will be randomly assigned to 8 sessions of either MBRP combined with active
tDCS (up to 2.0 milliamp current) or MBRP combined with a sham tDCS (no current) control
condition. The proposed study will examine the efficacy (Primary Aim) and psychological and
neurophysiological mechanisms of treatment efficacy using behavioral measures and EEG
(Secondary Aim). In addition to addressing the question of whether adding active tDCS to MBRP
enhances efficacy, it will further examine issues of neurophysiological and behavioral
treatment mechanisms to better inform the design of a future large efficacy trial.
Inclusion Criteria:
1. interested in reducing alcohol drinking
2. right-handed
Exclusion Criteria:
1. lifetime diagnosis of schizophrenia or bipolar disorder or current substance use
disorder other than nicotine or marijuana
2. cardiac pacemaker
3. implantable defibrillator
4. metal objects in upper body that might interfere with tDCS, or that tDCS may interfere
with their function, including metal plates, screws and prosthetics in head, certain
older tattoos and permanent makeup using metal containing inks, aneurysm clips, neural
stimulators of any kind, ear implants, insulin pumps, drug infusion devices and dental
appliances
5. for females, pregnant or attempting to get pregnant
6. history of seizures or seizure disorder
7. allergic to latex, rubber, conductive medium like saline or electrode gel
8. if assigned to active tDCS and unable to tolerate 1.5 mA of tDCS during a baseline
stimulation session
We found this trial at
1
site
Click here to add this to my saved trials
