Modification of Cue Reactivity by Neurofeedback in Human Addiction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alcohol Use Disorder (AUD)
- Sponsor
- Central Institute of Mental Health, Mannheim
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Neural Level: Blood Oxygen Level Dependent Signal within the ventral striatum
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Neural Level: Blood Oxygen Level Dependent Signal within the ventral striatum
Time Frame: 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
Time Frame: 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 Outcomes
- Functional changes in brain networks(up to two weeks)
- Drinking type(up to two weeks)
- Form 90 (Miller, 1996)(up to two weeks)
- Baratt Impulsiveness Scale (BIS-15) (Meule et al., 2011)(up to two weeks)
- Sensory Inventory (SI): self-assessment of sensory sensitivity for adults and adolescents (Zamoscik et al., 2017)(up to two weeks)
- General depression scale (german: "Allgemeine Depressionsskala") (Radloff, 1977)(up to two weeks)
- Positive and Negative Affect Schedule (PANAS) (Watson et al., 1988)(up to two weeks.)
- Perceived Stress Scale (PSS) (Cohen et al., 1983)(up to two weeks)
- Dimensional card sorting task (Zelazo, 2006)(Collected once during the baseline assessment)
- Cue reactivity task (Vollstädt-Klein et al., 2011)(2 timepoints: Before and after 2 weeks of neurofeedback.)
- Alcohol Abstinence Self-Efficacy Scale (DiClemente et al., 1994)(2 weeks)
- Alcohol Urge Questionnaire (Bohn et al., 1995)(2 weeks)
- Alcohol Dependence Scale (Ackermann et al., 1999)(2 weeks)
- German Inventory of Drinking Situations (DITS-40) (Victorio-Estrada, 1993)(2 weeks)
- Craving Automated Scale for Alcohol (CASA) (Vollstädt-Klein et al., 2015)(2 weeks)
- Behavioral Inhibition/Approach System (BIS/BAS) (Carver & White, 1994)(up to two weeks)
- Fagerström Test of Nicotine Dependence (Heatherton et al., 1991)(up to two weeks)
- Visual Craving Scale(up to two weeks)
- Vocabulary test(Collected once during the baseline assessment)
- Dot-probe task with alcohol stimuli(Collected once during the baseline assessment)