Modification of Cue Reactivity by Neurofeedback in Human Addiction

NCT04366505 | Unknown

• 1 other identifier: TRR265 C04
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The project is geared towards the understanding of how to increase cognitive control over cue reactivity and drug craving.

Conditions

Alcohol Use Disorder (AUD)

Keywords

alcohol use disorder; mindfulness-based intervention; neurofeedback; ventral striatum

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (20)

• 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

Study Arms (2)

NFB + (MBRP)

EXPERIMENTAL

Neurofeedback (NFB) from target region or control region plus Mindfulness-based relapse prevention (for some)

Behavioral: Treatment as usual (TAU) and neurofeedback (NFB); Behavioral: mindfulness-based relapse prevention (MBRP) and NFB; Behavioral: MBT and sham NFB

TAU and sham NFB

ACTIVE COMPARATOR

TAU + Neurofeedback (NFB) from control region

Behavioral: TAU and sham NFB

Interventions

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.

NFB + (MBRP)

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.

NFB + (MBRP)

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.

TAU and sham NFB

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.

NFB + (MBRP)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (1)

Klinische Psychologie + Klinik für Abhängiges Verhalten und Suchtmedizin, Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, 68159, Germany

Location

Related Publications (4)

• 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.

  PMID: 7771669 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.

  PMID: 8189734 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.

  PMID: 7573780 BACKGROUND

• 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.

  PMID: 32546139 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Therapeutics; Neurofeedback

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Central Study Contacts

Peter Kirsch, Prof. Dr.

CONTACT

+49-621/1703; peter.kirsch@zi-mannheim.de

Falk Kiefer, Prof. Dr.

CONTACT

+49-621/1703; falk.kiefer@zi-mannheim.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 29, 2020
• Study Start: July 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)