Alcohol Use Disorder (AUD)
Conditions
Keywords
alcohol use disorder, mindfulness-based intervention, neurofeedback, ventral striatum
Brief summary
The project is geared towards the understanding of how to increase cognitive control over cue reactivity and drug craving.
Detailed description
Project C04 aims at assessing the combined effect of two interventions targeting at reducing striatal cue reactivity and increasing cognitive control, namely mindfulness-based intervention and real-time fMRI neurofeedback. Firstly, the investigators will test whether a prior mindfulness-based intervention (WP1) is able to enhance the effect of rtfMRI NFB (WP2) and change the networks involved in regulation of cue reactivity by providing participants with explicit strategies. Secondly, the investigators will investigate whether this combined intervention leads to a better clinical outcome in terms of decreased heavy drinking days and a reduced sum of alcohol consumption three months later.
Interventions
BEHAVIORALTreatment as usual (TAU) and neurofeedback (NFB)
This group will receive Treatment as usual (TAU) and neurofeedback (NFB). During NFB, participants will be asked to regulate the signal from a target brain region during the presentation of alcohol cues. The ventral striatum was chosen as target region.
BEHAVIORALmindfulness-based relapse prevention (MBRP) and NFB
This group will receive MBRP and neurofeedback (NFB). MBRP consists of 5 extensive sessions of a specific manualized mindfulness-based intervention for alcohol dependent patients which will be carried out by trained psychologists and psychotherapists. During NFB, participants will be asked to regulate the signal from a target brain region during the presentation of alcohol cues. The ventral striatum was chosen as a target region.
BEHAVIORALTAU and sham NFB
This group will receive TAU and sham NFB. Sham NFB means that the signal displayed to the participant is based on activity in a control region, the auditory cortex, which is not involved in cue reactivity.
BEHAVIORALMBT and sham NFB
This group will receive MBRP and sham NFB. MBRP consists of 5 extensive sessions of a specific manualized mindfulness-based intervention for alcohol dependent patients which will be carried out by trained psychologists and psychotherapists. Sham NFB means that the signal displayed to the participant is based on activity in a control region, the auditory cortex, which is not involved in cue reactivity.
Sponsors
Central Institute of Mental Health, Mannheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The participants will be allocated to one of two NFB groups (real NFB or control group) in a double-blind procedure. Participants of both groups will be further sub-divided into a mindfulness-based relapse prevention (MBRP) and a TAU group (single-blind).
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* alcohol use disorder according to DSM-5 * ability to provide fully informed consent and to use self-rating scales * abstinent after detoxification for at least 5 days * sufficient understanding of the German language
Exclusion criteria
* lifetime history of DSM-5 bipolar, psychotic disorder, or substance dependence other than alcohol or nicotine dependence * current substance use other than nicotine and/or mild to moderate recreational use of cannabis as evidenced by positive urine test * current threshold DSM-5 diagnosis of any of the following disorders: current (hypo)manic episode, major depressive disorder, generalized anxiety disorder, PTSD, borderline personality disorder, or obsessive compulsive disorder * history of severe head trauma or other severe central neurological disorders (dementia, Parkinson's disease, multiple sclerosis) * pregnancy or nursing infants * use of medications or drugs known to interact with the CNS within the last 10 days, with testing at least four half-lives post last intake
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neural Level: Blood Oxygen Level Dependent Signal within the ventral striatum | 3 consecutive days within up to two weeks | Change of the ability to volitionally modulate brain activation to alcohol cues after training in the target area. |
| Clinical Level: Number of relapses | 3 months | MBT and NFB will each lead to a reduced number of relapses during three months after treatment in comparison to the combination of TAU and sham NFB. The combined intervention is expected to lead to a larger reduction compared to the other groups. The investigators expect a higher number of days until relapse, a lower number of heavy drinking days and a lower amount of alcohol consumed by the participants during the follow-up period showing similar group differences. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Form 90 (Miller, 1996) | up to two weeks | Primary dependent measure of alcohol consumption |
| Baratt Impulsiveness Scale (BIS-15) (Meule et al., 2011) | up to two weeks | Questionnaire assessing personality/behavioral construct of impulsivity. Scores range from 15 to 60. The BIS-15 has a four-point rating scale with a minimum value of 1 (1 = seldom/never) to a maximum of 4 (4 = almost always/always). Lower scores indicate less impulsivity and higher score mean more impulsivity. |
| Sensory Inventory (SI): self-assessment of sensory sensitivity for adults and adolescents (Zamoscik et al., 2017) | up to two weeks | Questionnaire on self-assessment of sensory sensitivity. Minimum value: 1 representing never. maximum value: 7 representing almost always. Higher scores indicate higher sensitivity for sensory influences. |
| General depression scale (german: Allgemeine Depressionsskala) (Radloff, 1977) | up to two weeks | Self-assessment of depressive symptoms. minimum: 0 representing seldom, maximum: 3 representing mostly. Higher scores indicate stronger depression. |
| Positive and Negative Affect Schedule (PANAS) (Watson et al., 1988) | up to two weeks. | measures mood/emotion. minimum: 1 representing not at all, maximum: 5 representing very much. Depending on the item, higher scores represent higher levels of positive affect and lower scores represent lower levels of negative affect. |
| Perceived Stress Scale (PSS) (Cohen et al., 1983) | up to two weeks | measures stress. minimum: 1 representing never. maximum: 5 representing quite often. Higher scores indicate higher levels of perceived stress. |
| Behavioral Inhibition/Approach System (BIS/BAS) (Carver & White, 1994) | up to two weeks | assessing individual differences in the sensitivity of the behavioral approach and the behavioral avoidance system. |
| Fagerström Test of Nicotine Dependence (Heatherton et al., 1991) | up to two weeks | assessing nicotine dependence |
| Visual Craving Scale | up to two weeks | Visual Analogue Scale for craving |
| Functional changes in brain networks | up to two weeks | Functional changes in brain networks related to cognitive control during cognitive task performance between baseline and post-neurofeedback fMRI sessions. |
| Dot-probe task with alcohol stimuli | Collected once during the baseline assessment | Change in attentional bias to alcohol-related cues. |
| Dimensional card sorting task (Zelazo, 2006) | Collected once during the baseline assessment | Neuropsychological test |
| Cue reactivity task (Vollstädt-Klein et al., 2011) | 2 timepoints: Before and after 2 weeks of neurofeedback. | fMRI task. Change in BOLD during cue reactivity task. |
| Alcohol Abstinence Self-Efficacy Scale (DiClemente et al., 1994) | 2 weeks | measure of craving. minimum: 1 representing not at all, maximum: 5 representing enormous. Higher scores indicate a high perceived temptation to drink. |
| Alcohol Urge Questionnaire (Bohn et al., 1995) | 2 weeks | measure of craving |
| Alcohol Dependence Scale (Ackermann et al., 1999) | 2 weeks | measure of craving. Range/response options vary depending on the question. Higher scores are predictive of DSM diagnosis of alcohol dependence. |
| German Inventory of Drinking Situations (DITS-40) (Victorio-Estrada, 1993) | 2 weeks | measure of craving. minimum: 0 representing never, maximum: 3 representing almost always. Higher scores indicate a higher frequency to drink. |
| Craving Automated Scale for Alcohol (CASA) (Vollstädt-Klein et al., 2015) | 2 weeks | measure of craving. minimum: 0 representing never, maximum: 5 representing always. Higher scores indicate automated craving. |
| Vocabulary test | Collected once during the baseline assessment | Neuropsychological test |
| Drinking type | up to two weeks | Short question on which kind of drinking type the participant identifies with the most |
Countries
Germany
Contacts
Primary ContactPeter Kirsch, Prof. Dr.
Backup ContactFalk Kiefer, Prof. Dr.
Outcome results
None listed