The project is geared towards the understanding of how to increase cognitive control over cue reactivity and drug craving.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
88
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.
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.
Klinische Psychologie + Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Wurttemberg, Germany
Neural Level: Blood Oxygen Level Dependent Signal within the ventral striatum
Change of the ability to volitionally modulate brain activation to alcohol cues after training in the target area.
Time frame: 3 consecutive days within up to two weeks
Clinical Level: Number of relapses
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.
Time frame: 3 months
Functional changes in brain networks
Functional changes in brain networks related to cognitive control during cognitive task performance between baseline and post-neurofeedback fMRI sessions.
Time frame: up to two weeks
Drinking type
Short question on which kind of drinking type the participant identifies with the most
Time frame: up to two weeks
Form 90 (Miller, 1996)
Primary dependent measure of alcohol consumption
Time frame: up to two weeks
Baratt Impulsiveness Scale (BIS-15) (Meule et al., 2011)
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.
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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.
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.
Time frame: up to two weeks
Sensory Inventory (SI): self-assessment of sensory sensitivity for adults and adolescents (Zamoscik et al., 2017)
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.
Time frame: up to two weeks
General depression scale (german: "Allgemeine Depressionsskala") (Radloff, 1977)
Self-assessment of depressive symptoms. minimum: 0 representing "seldom", maximum: 3 representing "mostly". Higher scores indicate stronger depression.
Time frame: up to two weeks
Positive and Negative Affect Schedule (PANAS) (Watson et al., 1988)
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.
Time frame: up to two weeks.
Perceived Stress Scale (PSS) (Cohen et al., 1983)
measures stress. minimum: 1 representing "never". maximum: 5 representing "quite often". Higher scores indicate higher levels of perceived stress.
Time frame: up to two weeks
Behavioral Inhibition/Approach System (BIS/BAS) (Carver & White, 1994)
assessing individual differences in the sensitivity of the behavioral approach and the behavioral avoidance system.
Time frame: up to two weeks
Fagerström Test of Nicotine Dependence (Heatherton et al., 1991)
assessing nicotine dependence
Time frame: up to two weeks
Visual Craving Scale
Visual Analogue Scale for craving
Time frame: up to two weeks
Vocabulary test
Neuropsychological test
Time frame: Collected once during the baseline assessment
Dot-probe task with alcohol stimuli
Change in attentional bias to alcohol-related cues.
Time frame: Collected once during the baseline assessment
Dimensional card sorting task (Zelazo, 2006)
Neuropsychological test
Time frame: Collected once during the baseline assessment
Cue reactivity task (Vollstädt-Klein et al., 2011)
fMRI task. Change in BOLD during cue reactivity task.
Time frame: 2 timepoints: Before and after 2 weeks of neurofeedback.
Alcohol Abstinence Self-Efficacy Scale (DiClemente et al., 1994)
measure of craving. minimum: 1 representing "not at all", maximum: 5 representing "enormous". Higher scores indicate a high perceived temptation to drink.
Time frame: 2 weeks
Alcohol Urge Questionnaire (Bohn et al., 1995)
measure of craving
Time frame: 2 weeks
Alcohol Dependence Scale (Ackermann et al., 1999)
measure of craving. Range/response options vary depending on the question. Higher scores are predictive of DSM diagnosis of alcohol dependence.
Time frame: 2 weeks
German Inventory of Drinking Situations (DITS-40) (Victorio-Estrada, 1993)
measure of craving. minimum: 0 representing "never", maximum: 3 representing "almost always". Higher scores indicate a higher frequency to drink.
Time frame: 2 weeks
Craving Automated Scale for Alcohol (CASA) (Vollstädt-Klein et al., 2015)
measure of craving. minimum: 0 representing "never", maximum: 5 representing "always". Higher scores indicate automated craving.
Time frame: 2 weeks