NCT06247306

Using Neurofeedback to Understand the Relationship Between Stress and Alcohol Consumption

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Central Institute of Mental Health, Mannheim · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 .

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.

Conditions

• Alcohol Abuse
• Craving
• Psychosocial Stressor
• Neural Stress Response

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2024-02-07
• Last updated: 2025-01-23

Locations

1 site across 1 country: Germany