Alcohol Abuse, Craving, Neural Stress Response, Psychosocial Stressor
Conditions
Keywords
functional Magnetic Resonance Imaging (fMRI), psychosocial stress, real-time fMRI neurofeedback (rtfMRI neurofeedback), problematic alcohol use, cortisol, Ecological momentary assessment (EMA)
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 .
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.
Interventions
BEHAVIORALScanSTRESS 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.
BEHAVIORALreal-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.
Sponsors
Central Institute of Mental Health, Mannheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
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).
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurofeedback/Stress-Regulation Parameters | 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. |
| Stress-induced neural activation | 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) |
| Cortisol | 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 |
| Craving | 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), |
| Ecological/electronic Momentary Assessment (movisensXS) | 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. |
Countries
Germany
Contacts
Primary ContactNina J Kempf, M. Sc.
Backup ContactLea Wazulin, M. Sc.
Outcome results
None listed