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Modification of Cue Reactivity by Neurofeedback in Human Addiction

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ClinicalTrials.gov Identifier: NCT04366505
Recruitment Status : Not yet recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder (AUD) Behavioral: Treatment as usual (TAU) and neurofeedback (NFB) Behavioral: mindfulness-based relapse prevention (MBRP) and NFB Behavioral: TAU and sham NFB Behavioral: MBT and sham NFB Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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).

Primary Purpose: Treatment
Official Title: Modification of Cue Reactivity by Neurofeedback in Human Addiction
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NFB + (MBRP)
Neurofeedback (NFB) from target region or control region plus Mindfulness-based relapse prevention (for some)
Behavioral: Treatment as usual (TAU) and neurofeedback (NFB)
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.

Behavioral: mindfulness-based relapse prevention (MBRP) and NFB
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.

Behavioral: MBT and sham NFB
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.

Active Comparator: TAU and sham NFB
TAU + Neurofeedback (NFB) from control region
Behavioral: TAU and sham NFB
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.




Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. Functional changes in brain networks [ Time Frame: up to two weeks ]
    Functional changes in brain networks related to cognitive control during cognitive task performance between baseline and post-neurofeedback fMRI sessions.

  2. Drinking type [ Time Frame: up to two weeks ]
    Short question on which kind of drinking type the participant identifies with the most

  3. Form 90 (Miller, 1996) [ Time Frame: up to two weeks ]
    Primary dependent measure of alcohol consumption

  4. Baratt Impulsiveness Scale (BIS-15) (Meule et al., 2011) [ Time Frame: up to two weeks ]
    Questionnaire assessing personality/behavioral construct of impulsivity

  5. Sensory Inventory (SI): self-assessment of sensory sensitivity for adults and adolescents (Zamoscik et al., 2017) [ Time Frame: 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.

  6. General depression scale (german: "Allgemeine Depressionsskala") (Radloff, 1977) [ Time Frame: up to two weeks ]
    Self-assessment of depressive symptoms. minimum: 0 representing "seldom", maximum: 3 representing "mostly". Higher scores indicate stronger depression.

  7. Positive and Negative Affect Schedule (PANAS) (Watson et al., 1988) [ Time Frame: 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.

  8. Perceived Stress Scale (PSS) (Cohen et al., 1983) [ Time Frame: up to two weeks ]
    measures stress. minimum: 1 representing "never". maximum: 5 representing "quite often". Higher scores indicate higher levels of perceived stress.

  9. Behavioral Inhibition/Approach System (BIS/BAS) (Carver & White, 1994) [ Time Frame: up to two weeks ]
    assessing individual differences in the sensitivity of the behavioral approach and the behavioral avoidance system.

  10. Fagerström Test of Nicotine Dependence (Heatherton et al., 1991) [ Time Frame: up to two weeks ]
    assessing nicotine dependence

  11. Visual Craving Scale [ Time Frame: up to two weeks ]
    Visual Analogue Scale for craving

  12. Vocabulary test [ Time Frame: Collected once during the baseline assessment ]
    Neuropsychological test

  13. Dot-probe task with alcohol stimuli [ Time Frame: Collected once during the baseline assessment ]
    Change in attentional bias to alcohol-related cues.

  14. Dimensional card sorting task (Zelazo, 2006) [ Time Frame: Collected once during the baseline assessment ]
    Neuropsychological test

  15. Cue reactivity task (Vollstädt-Klein et al., 2011) [ Time Frame: 2 timepoints: Before and after 2 weeks of neurofeedback. ]
    fMRI task. Change in BOLD during cue reactivity task.

  16. Alcohol Abstinence Self-Efficacy Scale (DiClemente et al., 1994) [ Time Frame: 2 weeks ]
    measure of craving. minimum: 1 representing "not at all", maximum: 5 representing "enormous". Higher scores indicate a high perceived temptation to drink.

  17. Alcohol Urge Questionnaire (Bohn et al., 1995) [ Time Frame: 2 weeks ]
    measure of craving

  18. Alcohol Dependence Scale (Ackermann et al., 1999) [ Time Frame: 2 weeks ]
    measure of craving. Range/response options vary depending on the question. Higher scores are predictive of DSM diagnosis of alcohol dependence.

  19. German Inventory of Drinking Situations (DITS-40) (Victorio-Estrada, 1993) [ Time Frame: 2 weeks ]
    measure of craving. minimum: 0 representing "never", maximum: 3 representing "almost always". Higher scores indicate a higher frequency to drink.

  20. Craving Automated Scale for Alcohol (CASA) (Vollstädt-Klein et al., 2015) [ Time Frame: 2 weeks ]
    measure of craving. minimum: 0 representing "never", maximum: 5 representing "always". Higher scores indicate automated craving.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366505


Contacts
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Contact: Peter Kirsch, Prof. Dr. +49-621/1703 ext 6501 peter.kirsch@zi-mannheim.de
Contact: Falk Kiefer, Prof. Dr. +49-621/1703 ext 3501 falk.kiefer@zi-mannheim.de

Locations
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Germany
Klinische Psychologie + Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Württemberg, Germany, 68159
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT04366505    
Other Study ID Numbers: TRR265 C04
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Institute of Mental Health, Mannheim:
alcohol use disorder
mindfulness-based intervention
neurofeedback
ventral striatum
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders