Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NFB + (MBRP) | Experimental | Neurofeedback (NFB) from target region or control region plus Mindfulness-based relapse prevention (for some) |
|
| TAU and sham NFB | Active Comparator | TAU + Neurofeedback (NFB) from control region |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment as usual (TAU) and neurofeedback (NFB) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to two weeks |
| Drinking type |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Kirsch, Prof. Dr. | Contact | +49-621/1703 | 6501 | peter.kirsch@zi-mannheim.de |
| Falk Kiefer, Prof. Dr. | Contact | +49-621/1703 | 3501 | falk.kiefer@zi-mannheim.de |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinische Psychologie + Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit | Mannheim | Baden-Wurttemberg | 68159 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7771669 | Background | Anton RF, Moak DH, Latham P. The Obsessive Compulsive Drinking Scale: a self-rated instrument for the quantification of thoughts about alcohol and drinking behavior. Alcohol Clin Exp Res. 1995 Feb;19(1):92-9. doi: 10.1111/j.1530-0277.1995.tb01475.x. | |
| 8189734 | Background | DiClemente CC, Carbonari JP, Montgomery RP, Hughes SO. The Alcohol Abstinence Self-Efficacy scale. J Stud Alcohol. 1994 Mar;55(2):141-8. doi: 10.15288/jsa.1994.55.141. |
Not provided
Not provided
Due to data protection rules, individual data cannot be shared. Cumulated data on the group level can be made available for meta-analyses on request.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D001521 | Behavior Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
|
| mindfulness-based relapse prevention (MBRP) and NFB | Behavioral | 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. |
|
| TAU and sham NFB | Behavioral | 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. |
|
| MBT and sham NFB | Behavioral | 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. |
|
Short question on which kind of drinking type the participant identifies with the most
| up to two weeks |
| Form 90 (Miller, 1996) | Primary dependent measure of alcohol consumption | 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. | 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. | 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. | 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. | 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. | 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. | up to two weeks |
| Fagerström Test of Nicotine Dependence (Heatherton et al., 1991) | assessing nicotine dependence | up to two weeks |
| Visual Craving Scale | Visual Analogue Scale for craving | up to two weeks |
| Vocabulary test | Neuropsychological test | Collected once during the baseline assessment |
| Dot-probe task with alcohol stimuli | Change in attentional bias to alcohol-related cues. | Collected once during the baseline assessment |
| Dimensional card sorting task (Zelazo, 2006) | Neuropsychological test | Collected once during the baseline assessment |
| Cue reactivity task (Vollstädt-Klein et al., 2011) | fMRI task. Change in BOLD during cue reactivity task. | 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. | 2 weeks |
| Alcohol Urge Questionnaire (Bohn et al., 1995) | measure of craving | 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. | 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. | 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. | 2 weeks |
| 7573780 | Background | Bohn MJ, Krahn DD, Staehler BA. Development and initial validation of a measure of drinking urges in abstinent alcoholics. Alcohol Clin Exp Res. 1995 Jun;19(3):600-6. doi: 10.1111/j.1530-0277.1995.tb01554.x. |
| 32546139 | Derived | Weiss F, Aslan A, Zhang J, Gerchen MF, Kiefer F, Kirsch P. Using mind control to modify cue-reactivity in AUD: the impact of mindfulness-based relapse prevention on real-time fMRI neurofeedback to modify cue-reactivity in alcohol use disorder: a randomized controlled trial. BMC Psychiatry. 2020 Jun 16;20(1):309. doi: 10.1186/s12888-020-02717-7. |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |