Modification of Cue Reactivity by Neurofeedback in Human Addiction
- Conditions
- Alcohol Use Disorder (AUD)
- Registration Number
- NCT04366505
- Lead Sponsor
- Central Institute of Mental Health, Mannheim
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 88
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Drinking type up to two weeks Short question on which kind of drinking type the participant identifies with the most
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.
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.
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
Vocabulary test Collected once during the baseline assessment Neuropsychological test
Dot-probe task with alcohol stimuli Collected once during the baseline assessment Change in attentional bias to alcohol-related cues.
Trial Locations
- Locations (1)
Klinische Psychologie + Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit
🇩🇪Mannheim, Baden-Württemberg, Germany
Klinische Psychologie + Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit🇩🇪Mannheim, Baden-Württemberg, Germany