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

Central Institute of Mental Health, Mannheim

Status: Enrolling

Conditions: Neural Stress Response; Craving; Alcohol Abuse; Psychosocial Stressor

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06247306

U1111-1302-2402

TRR265-C04 (Other Identifier)

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

real-time fMRI neurofeedback (of the ACC)

Experimental group

Description:

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

Treatment:

Behavioral: real-time fMRI neurofeedback

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

Yoke-control group

Sham Comparator group

Description:

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

Treatment:

Behavioral: real-time fMRI neurofeedback

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