Alcohol Abuse Clinical Trial
— NeuStressOfficial title:
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 .
Status | Not yet recruiting |
Enrollment | 102 |
Est. completion date | July 1, 2027 |
Est. primary completion date | December 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Central Institute of Mental Health - Department of Clinical Psychology | Mannheim | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
Central Institute of Mental Health, Mannheim |
Germany,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 |
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