Using Neurofeedback to Understand the Relationship Between Stress and Alcohol Consumption (NeuStress)

January 30, 2024 updated by: Central Institute of Mental Health, Mannheim

Probing the Influence of Neural Stress Responses on Problematic Alcohol Use With Real-time fMRI Neurofeedback (C04)

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

While it is well known and long acknowledged in scientific research that stress and alcohol consumption are closely linked, the actual relationship is complex, and the underlying mechanisms are only partially understood. To investigate the effects of acute stress under controlled conditions, experimental procedures, stress tests, and related paradigms are often employed. Studies on alcohol addiction generally indicate an increase in acute cravings following the experimental induction of stress. Neurologically, acute stress induction is associated with activation changes in widespread networks. In particular, research employing stress tests found increased activations in striatum, thalamus and limbic areas and deactivations in anterior cingulate cortex (ACC) as well as ventromedial prefrontal cortex (vmPFC), areas often associated with emotion regulation during stress induction. Given their role in emotion regulation, deactivations in these areas could reflect a reduction in emotional control during acute stress. Deactivation of these areas during experimentally induced stress has also been linked to problematic alcohol consumption and increased alcohol cravings.

This study aims to elucidate how neurocognitive processes during stress influence alcohol cravings and consumption. To this end, participants with problematic alcohol consumption will be recruited. After having filled out various questionnaires pertaining to their biographical data, alcohol consumption and personality traits, participants will be experimentally stressed during a brain scan using functional Magnetic Resonance Imaging (fMRI). To reliably induce psychosocial stress, the ScanSTRESS test, a paradigm explicitly conceptualized for usage during MRI scanning, will be employed. Once the stress test is completed, participants will attempt to regulate their own neurological stress response through upregulation of the ACC using information about their current stress-induced brain activity (neurofeedback). Additionally, saliva samples will be regularly taken during the experiment to biologically observe the stress response through cortisol measurements. This will be followed by a 6-week follow-up phase, during which participants will be specifically asked about their alcohol cravings, alcohol consumption, and daily stress experiences.

By employing real-time fMRI neurofeedback, this study creates experimental conditions in which participants can self-regulate the neural stress response of the targeted brain network. Nonspecific effects of the neurofeedback paradigm are controlled using a sham condition (Yoke-control group). Participants are randomly assigned to either the control group or the real neurofeedback group (experimental group). This approach allows for the investigation of the neural self-regulation abilities of emotional control networks and their role in the connection between stress, alcohol cravings, and drinking behavior in real life.

In summary, this study aims to examine the relationship between the self-regulation abilities of neural stress responses and real-life drinking behavior.

Investigators hypothesize that 1) the stress experiment significantly increases acute self-reported stress in participants, 2) specifically stress-induced patterns of neural activity, namely increased striatal and thalamic activity as well as decreased ACC activity, predict alcohol cravings and consumption, 3) the experimental neurofeedback group exhibits higher ACC activity during brain self-regulation than the control group, 4) the experimental group shows lower alcohol craving/consumption during the follow-up phase.

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Baden-Württemberg
      • Mannheim, Baden-Württemberg, Germany, 68159
        • Central Institute of Mental Health - Department of Clinical Psychology
        • Contact:
        • Sub-Investigator:
          • Nina J Kempf, M. Sc.
        • Sub-Investigator:
          • Lea Wazulin, M. Sc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: real-time fMRI neurofeedback (of the ACC)
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)
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.
Behavioral: real-time fMRI neurofeedback

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.
Sham Comparator: Yoke-control group
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)
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.
Behavioral: real-time fMRI neurofeedback

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurofeedback/Stress-Regulation Parameters
Time Frame: Assessed during each of the two neurofeedback runs, 9:30 minutes respectively
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
Time Frame: 23 minutes - 2 runs lasting 11:20 minutes each
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
Time Frame: 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)
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
Time Frame: 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)
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)
Time Frame: 6 weeks starting from the conclusion of the neurofeedback intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Mental Health, Mannheim

Investigators

  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

January 13, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1302-2402
  • TRR265-C04 (Other Identifier: Deutsche Forschungsgemeinschaft)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There will be collaborative data processing, sharing of data and storage of data at different locations as specified below.

Research data will be stored on secure servers of the Center for Information Services and High-Performance Computing at the Dresden University of Technology (ZIH; Zellescher Weg 12, 01069 Dresden) and the ZI Mannheim. The data will be retained for 10 years after the completion or termination of the research project. Participants' data will be protected against unauthorized access, and anonymization will occur once the research purpose allows it. Data will be deleted at the latest after 10 years.

Coding method: Double coding, access by project staff, emergency decoding possible during the project duration (MRT scans).

Transfer of pseudonymized biomaterials/data to third parties: Name: Dresden University of Technology Address: Zellescher Weg 19, 01069 Dresden. There will be a transfer of pseudonymized saliva samples for cortisol level determination.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Craving

Clinical Trials on ScanSTRESS fMRI-paradigm (Streit et al., 2014)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe