Back to resultsModification of Cue Reactivity by Neurofeedback in Human Addiction
Primary Purpose
Alcohol Use Disorder (AUD)
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Treatment as usual (TAU) and neurofeedback (NFB)
mindfulness-based relapse prevention (MBRP) and NFB
TAU and sham NFB
MBT and sham NFB
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder (AUD) focused on measuring alcohol use disorder, mindfulness-based intervention, neurofeedback, ventral striatum
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
Sites / Locations
- Klinische Psychologie + Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NFB + (MBRP)
TAU and sham NFB
Arm Description
Neurofeedback (NFB) from target region or control region plus Mindfulness-based relapse prevention (for some)
TAU + Neurofeedback (NFB) from control region
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Drinking type
Short question on which kind of drinking type the participant identifies with the most
Form 90 (Miller, 1996)
Primary dependent measure of alcohol consumption
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.
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.
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.
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.
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.
Behavioral Inhibition/Approach System (BIS/BAS) (Carver & White, 1994)
assessing individual differences in the sensitivity of the behavioral approach and the behavioral avoidance system.
Fagerström Test of Nicotine Dependence (Heatherton et al., 1991)
assessing nicotine dependence
Visual Craving Scale
Visual Analogue Scale for craving
Vocabulary test
Neuropsychological test
Dot-probe task with alcohol stimuli
Change in attentional bias to alcohol-related cues.
Dimensional card sorting task (Zelazo, 2006)
Neuropsychological test
Cue reactivity task (Vollstädt-Klein et al., 2011)
fMRI task. Change in BOLD during cue reactivity task.
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.
Alcohol Urge Questionnaire (Bohn et al., 1995)
measure of craving
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.
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.
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.
Full Information
NCT ID
NCT04366505
First Posted
March 30, 2020
Last Updated
April 26, 2021
Sponsor
Central Institute of Mental Health, Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT04366505
Brief Title
Modification of Cue Reactivity by Neurofeedback in Human Addiction
Official Title
Modification of Cue Reactivity by Neurofeedback in Human Addiction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Institute of Mental Health, Mannheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD)
Keywords
alcohol use disorder, mindfulness-based intervention, neurofeedback, ventral striatum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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).
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NFB + (MBRP)
Arm Type
Experimental
Arm Description
Neurofeedback (NFB) from target region or control region plus Mindfulness-based relapse prevention (for some)
Arm Title
TAU and sham NFB
Arm Type
Active Comparator
Arm Description
TAU + Neurofeedback (NFB) from control region
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (TAU) and neurofeedback (NFB)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
mindfulness-based relapse prevention (MBRP) and NFB
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TAU and sham NFB
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MBT and sham NFB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neural Level: Blood Oxygen Level Dependent Signal within the ventral striatum
Description
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
Title
Clinical Level: Number of relapses
Description
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
Secondary Outcome Measure Information:
Title
Functional changes in brain networks
Description
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
Title
Drinking type
Description
Short question on which kind of drinking type the participant identifies with the most
Time Frame
up to two weeks
Title
Form 90 (Miller, 1996)
Description
Primary dependent measure of alcohol consumption
Time Frame
up to two weeks
Title
Baratt Impulsiveness Scale (BIS-15) (Meule et al., 2011)
Description
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.
Time Frame
up to two weeks
Title
Sensory Inventory (SI): self-assessment of sensory sensitivity for adults and adolescents (Zamoscik et al., 2017)
Description
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
Title
General depression scale (german: "Allgemeine Depressionsskala") (Radloff, 1977)
Description
Self-assessment of depressive symptoms. minimum: 0 representing "seldom", maximum: 3 representing "mostly". Higher scores indicate stronger depression.
Time Frame
up to two weeks
Title
Positive and Negative Affect Schedule (PANAS) (Watson et al., 1988)
Description
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.
Title
Perceived Stress Scale (PSS) (Cohen et al., 1983)
Description
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
Title
Behavioral Inhibition/Approach System (BIS/BAS) (Carver & White, 1994)
Description
assessing individual differences in the sensitivity of the behavioral approach and the behavioral avoidance system.
Time Frame
up to two weeks
Title
Fagerström Test of Nicotine Dependence (Heatherton et al., 1991)
Description
assessing nicotine dependence
Time Frame
up to two weeks
Title
Visual Craving Scale
Description
Visual Analogue Scale for craving
Time Frame
up to two weeks
Title
Vocabulary test
Description
Neuropsychological test
Time Frame
Collected once during the baseline assessment
Title
Dot-probe task with alcohol stimuli
Description
Change in attentional bias to alcohol-related cues.
Time Frame
Collected once during the baseline assessment
Title
Dimensional card sorting task (Zelazo, 2006)
Description
Neuropsychological test
Time Frame
Collected once during the baseline assessment
Title
Cue reactivity task (Vollstädt-Klein et al., 2011)
Description
fMRI task. Change in BOLD during cue reactivity task.
Time Frame
2 timepoints: Before and after 2 weeks of neurofeedback.
Title
Alcohol Abstinence Self-Efficacy Scale (DiClemente et al., 1994)
Description
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
Title
Alcohol Urge Questionnaire (Bohn et al., 1995)
Description
measure of craving
Time Frame
2 weeks
Title
Alcohol Dependence Scale (Ackermann et al., 1999)
Description
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
Title
German Inventory of Drinking Situations (DITS-40) (Victorio-Estrada, 1993)
Description
measure of craving. minimum: 0 representing "never", maximum: 3 representing "almost always". Higher scores indicate a higher frequency to drink.
Time Frame
2 weeks
Title
Craving Automated Scale for Alcohol (CASA) (Vollstädt-Klein et al., 2015)
Description
measure of craving. minimum: 0 representing "never", maximum: 5 representing "always". Higher scores indicate automated craving.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Kirsch, Prof. Dr.
Phone
+49-621/1703
Ext
6501
Email
peter.kirsch@zi-mannheim.de
First Name & Middle Initial & Last Name or Official Title & Degree
Falk Kiefer, Prof. Dr.
Phone
+49-621/1703
Ext
3501
Email
falk.kiefer@zi-mannheim.de
Facility Information:
Facility Name
Klinische Psychologie + Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit
City
Mannheim
State/Province
Baden-Württemberg
ZIP/Postal Code
68159
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
7771669
Citation
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.
Results Reference
background
PubMed Identifier
8189734
Citation
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.
Results Reference
background
PubMed Identifier
7573780
Citation
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.
Results Reference
background
PubMed Identifier
32546139
Citation
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.
Results Reference
derived
Learn more about this trial
Modification of Cue Reactivity by Neurofeedback in Human Addiction
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