Using Neurofeedback to Understand the Relationship Between Stress and Alcohol Consumption

NCT06247306 | Recruiting

• 2 other identifiers: U1111-1302-2402TRR265-C04
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

In this research project, the aim is to discover the role specific brain networks play in the relationship between stress reactions and the desire for alcohol and alcohol consumption. To investigate this question, various brain imaging methods as well as cognitive tasks are combined. Various questionnaires are sampled and brain scans are conducted. Individuals interested in participating in the study have to fulfill certain criteria...

• no serious medical or mental health diagnosis
• problematic alcohol drinking habits
• interested in improving drinking habits ...and undergo various non-invasive procedures
• filling out several questionnaires concerning personality and habits
• undergoing a mental performance task while being in a brain scanner (MRI)
• attempting to regulate their own brain activity while lying in the MRI scanner
• filling out an electronic diary for 6 weeks - concerning daily mood, stress, and alcohol habits Participants will be randomly allocated to either one of 2 experimental groups. Both groups undergo the same tasks, receive the same instructions and only differ regarding some aspects of the brain self-regulation task .

Conditions

Alcohol Abuse; Craving; Psychosocial Stressor; Neural Stress Response

Keywords

functional Magnetic Resonance Imaging (fMRI); psychosocial stress; real-time fMRI neurofeedback (rtfMRI neurofeedback); problematic alcohol use; cortisol; Ecological momentary assessment (EMA)

Outcome Measures

Primary Outcomes (5)

• Neurofeedback/Stress-Regulation Parameters

  During neurofeedback runs, participants' activation changes in the region of interest (ROI) is sampled and compared to a previously determined baseline activation (localizer task). The ROI participants are tasked to regulate is the ACC. Successful regulation is characterized as significant increase (upregulation) of the ACC as compared to baseline activation.

  Assessed during each of the two neurofeedback runs, 9:30 minutes respectively

• Stress-induced neural activation

  Regional activation and network activation characterized during ScanSTRESS paradigm through means of contrast testing ("performance" condition vs "rest" condition)

  23 minutes - 2 runs lasting 11:20 minutes each

• Cortisol

  Cortisol will be assessed through saliva samples

  Three measurement time points: 1. T0: 10 minutes before the ScanStress Test 2. T1: 33 minutes after T0 (after the ScanStress Test) 3. T2: 52 minutes after T0 (after both fMRI paradigms -ScanStress & Neurofeedback)

• Craving

  Self-report assessment questionnaire, Craving Automated Scale for Alcohol (CAS-A, Vollstädt-Klein et. al., 2015),

  Three measurement time points: 1. T0: 10 minutes before the ScanStress Test 2. T1: 33 minutes after T0 (after the ScanStress Test) 3. T2: 52 minutes after T0 (after both fMRI paradigms -ScanStress & Neurofeedback)

• Ecological/electronic Momentary Assessment (movisensXS)

  Participants install the study app (movisensXS) on their mobile phones. During the six-week follow-up phase, data on daily stress experiences and alcohol consumption are collected through the study app. The study app assesses stress experiences, alcohol cravings, alcohol consumption, social interactions, health behavior, and coping with stress situations through short queries. The queries occur once daily at a random time between 10am and 8pm and last approximately 60 seconds. Participants can postpone the queries by up to 15 minutes or decline them altogether. Additionally, three extra queries regarding alcohol consumption are conducted once a week. During these queries, participants are asked to report their stress experiences, alcohol consumption, alcohol cravings, alcohol-related triggers, social interactions, coping with stress situations, health behavior (e.g., sleep duration), and goals related to alcohol consumption (duration of individual queries approx. 120 seconds.

  6 weeks starting from the conclusion of the neurofeedback intervention

Study Arms (2)

real-time fMRI neurofeedback (of the ACC)

EXPERIMENTAL

Participants are instructed to reduce their stress-response by attempts to upregulate the ACC activity contigent on real-time feedback.

Behavioral: ScanSTRESS fMRI-paradigm (Streit et al., 2014); Behavioral: real-time fMRI neurofeedback

Yoke-control group

SHAM COMPARATOR

Participants receive previously recorded feedback signal from other participants\' ACC activity instead of their own live ACC activity.

Behavioral: ScanSTRESS fMRI-paradigm (Streit et al., 2014); Behavioral: real-time fMRI neurofeedback

Interventions

ScanSTRESS fMRI-paradigm (Streit et al., 2014) BEHAVIORAL

The task is conducted within the MRI scanner and consists of two runs each lasting 11:20 mins., employs a block design and has two different conditions (performance, relaxation), as well as two different task within each condition. Participants undergo the following 2 tasks during the performance condition under time pressure: 1) serial subtraction, 2) a figure matching task. During the performance condition, all participants receive feedback (work faster, mistake, too slow) and are reprimanded concerning their performance. Two investigators in white coats observe the participants with critical facial expression, which is projected to participants through live-video feed during the tasks. The relaxation condition includes easy versions of arithmetic and figure matching task without time constrains or any type feedback on their performance. Performance and relaxation phases are appear in alternating order.

Yoke-control group; real-time fMRI neurofeedback (of the ACC)

real-time fMRI neurofeedback BEHAVIORAL

Two real-time fMRI neurofeedback sessions of 9:30 minutes each are conducted. During these sessions, the participants are instructed to regulate a feedback signal from the ACC. Participants are assigned to either the experimental or Yoke-control group through an automated double-blind procedure. In the neurofeedback sessions, participants in the experimental group receive a feedback signal indicating their current ACC activation. Participants in the control group receive the recorded feedback signal from another participant. The neurofeedback sessions follow a block structure with alternating feedback and rest periods. Before, between, and after the two sections of the fMRI examination, subjective stress levels and alcohol craving are assessed, and saliva samples are collected for cortisol level determination.

Yoke-control group; real-time fMRI neurofeedback (of the ACC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• Presence of 2 to a maximum of 5 criteria for alcohol use disorder according to DSM-5
• no clinical necessity for detoxification treatment
• participants may have a moderate cannabis use disorder and tobacco use disorder
• Capacity for consent and ability to use self-assessment scales
• Sufficient knowledge of German
• Willingness to use a mobile phone with Android operating system

You may not qualify if:

• Lifetime diagnosis of bipolar or psychotic disorder or a substance use disorder according to Diagnostical and Statistical Manual of Mental Disorders - 5 (DSM-5) that is not alcohol, cannabis, or tobacco use disorder
• Current substance use other than cannabis and tobacco
• Current diagnosis of one of the following conditions according to DSM-5: (hypo)manic episode, major depression, generalized anxiety disorder, post-traumatic stress disorder, 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 lactation
• Use of medications known to interact with the central nervous system within the last 10 days; testing at least four half-lives after the last dose
• Exercising the prerogative of the \"Right not to know\" in the context of incidental findings during an examination or investigation

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (1)

Central Institute of Mental Health - Department of Clinical Psychology

Mannheim, Baden-Wurttemberg, 68159, Germany

RECRUITING

Related Publications (16)

• Wolkowicz NR, Peltier MR, Wemm S, MacLean RR. Subjective stress and alcohol use among young adult and adult drinkers: Systematic review of studies using Intensive Longitudinal Designs. Drug Alcohol Depend Rep. 2022 Mar 11;3:100039. doi: 10.1016/j.dadr.2022.100039. eCollection 2022 Jun.

  PMID: 36845979 BACKGROUND

• Vollstadt-Klein S, Hermann D, Rabinstein J, Wichert S, Klein O, Ende G, Mann K. Increased activation of the ACC during a spatial working memory task in alcohol-dependence versus heavy social drinking. Alcohol Clin Exp Res. 2010 May;34(5):771-6. doi: 10.1111/j.1530-0277.2010.01149.x. Epub 2010 Mar 1.

  PMID: 20201927 BACKGROUND

• Vollstadt-Klein S, Lemenager T, Jorde A, Kiefer F, Nakovics H. Development and validation of the craving automated scale for alcohol. Alcohol Clin Exp Res. 2015 Feb;39(2):333-42. doi: 10.1111/acer.12636.

  PMID: 25684052 BACKGROUND

• Streit F, Haddad L, Paul T, Frank J, Schafer A, Nikitopoulos J, Akdeniz C, Lederbogen F, Treutlein J, Witt S, Meyer-Lindenberg A, Rietschel M, Kirsch P, Wust S. A functional variant in the neuropeptide S receptor 1 gene moderates the influence of urban upbringing on stress processing in the amygdala. Stress. 2014 Jul;17(4):352-61. doi: 10.3109/10253890.2014.921903. Epub 2014 Jun 16.

  PMID: 24800784 BACKGROUND

• Sinha R, Li CS. Imaging stress- and cue-induced drug and alcohol craving: association with relapse and clinical implications. Drug Alcohol Rev. 2007 Jan;26(1):25-31. doi: 10.1080/09595230601036960.

  PMID: 17364833 BACKGROUND

• Sinha R, Fox HC, Hong KA, Bergquist K, Bhagwagar Z, Siedlarz KM. Enhanced negative emotion and alcohol craving, and altered physiological responses following stress and cue exposure in alcohol dependent individuals. Neuropsychopharmacology. 2009 Apr;34(5):1198-208. doi: 10.1038/npp.2008.78. Epub 2008 Jun 18.

  PMID: 18563062 BACKGROUND

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  PMID: 23636842 BACKGROUND

• Seo D, Lacadie CM, Sinha R. Neural Correlates and Connectivity Underlying Stress-Related Impulse Control Difficulties in Alcoholism. Alcohol Clin Exp Res. 2016 Sep;40(9):1884-94. doi: 10.1111/acer.13166. Epub 2016 Aug 8.

  PMID: 27501356 BACKGROUND

• Koob GF, Le Moal M. Drug abuse: hedonic homeostatic dysregulation. Science. 1997 Oct 3;278(5335):52-8. doi: 10.1126/science.278.5335.52.

  PMID: 9311926 BACKGROUND

• Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.

  PMID: 8255414 BACKGROUND

• Cox WM, Klinger E. A motivational model of alcohol use. J Abnorm Psychol. 1988 May;97(2):168-80. doi: 10.1037//0021-843x.97.2.168. No abstract available.

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• Clay JM, Parker MO. The role of stress-reactivity, stress-recovery and risky decision-making in psychosocial stress-induced alcohol consumption in social drinkers. Psychopharmacology (Berl). 2018 Nov;235(11):3243-3257. doi: 10.1007/s00213-018-5027-0. Epub 2018 Sep 12.

  PMID: 30209533 BACKGROUND

• Clay JM, Adams C, Archer P, English M, Hyde A, Stafford LD, Parker MO. Psychosocial stress increases craving for alcohol in social drinkers: Effects of risk-taking. Drug Alcohol Depend. 2018 Apr 1;185:192-197. doi: 10.1016/j.drugalcdep.2017.12.021. Epub 2018 Feb 15.

  PMID: 29462766 BACKGROUND

• Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): an effective brief screening test for problem drinking. Ambulatory Care Quality Improvement Project (ACQUIP). Alcohol Use Disorders Identification Test. Arch Intern Med. 1998 Sep 14;158(16):1789-95. doi: 10.1001/archinte.158.16.1789.

  PMID: 9738608 BACKGROUND

• Blaine SK, Seo D, Sinha R. Peripheral and prefrontal stress system markers and risk of relapse in alcoholism. Addict Biol. 2017 Mar;22(2):468-478. doi: 10.1111/adb.12320. Epub 2015 Nov 5.

  PMID: 26537217 BACKGROUND

• Amlung M, MacKillop J. Understanding the effects of stress and alcohol cues on motivation for alcohol via behavioral economics. Alcohol Clin Exp Res. 2014 Jun;38(6):1780-9. doi: 10.1111/acer.12423. Epub 2014 May 30.

  PMID: 24890323 BACKGROUND

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

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

Study Officials

• Martin F Gerchen, PhD

  Central Institute of Mental Health

  PRINCIPAL INVESTIGATOR

• Peter Kirsch, Prof., PhD

  Central Institute of Mental Health

  PRINCIPAL INVESTIGATOR

• Falk Kiefer, MD, PhD

  Central Institute of Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina J Kempf, M. Sc.

CONTACT

+ 49/621-1703; nina.kempf@zi-mannheim.de

Lea Wazulin, M. Sc.

CONTACT

+49-621/1703; lea.wazulin@zi-mannheim.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Next to the investigator and participants, research assistants as well as medical technical radiology assistants (MTRAs) will be blinded to the conditions. Only after the 6-week long ecological momentary assessment is completed are participants as well as investigators, MTRAs and research assistants debriefed concerning the participants group assignment (experimental or Yoke-control group).
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Firstly,.all participants are assigned to either the experimental or the sham-control (Yoke-control) group through a fully automated, double-blind procedure. All participants undergo one neurofeedback (NFB) session with two runs à 9:30 mins. The NFB runs have a block structure with alternating periods/ blocks of self-regulation and rest. Participants of both groups receive the instruction to decrease their stress-response (thus, upregulating their ACC activity), through whichever strategy helps them to achieve this goal. The experimental group receives real-time fMRI feedback of their respective ACC activity. The sham-control group or Yoke-control group receives a previously acquired recording of the neurofeedback signal from a different participant instead of their own real-time ACC activity.

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: February 7, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The biomaterials will be destroyed immediately after the completion of the work. All other data will become available at the start of the study and will be deleted 10 years after the completion of the study. Data sharing will not be possible 10 years after completion of the study.

Locations

DE (1)