Using Neurofeedback to Understand the Relationship Between Stress and Alcohol Consumption
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentral Institute of Mental Health, Mannheim
About this trial
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 .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
ScanSTRESS fMRI-paradigm (Streit et al., 2014)
BehavioralThe 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.
real-time fMRI neurofeedback
BehavioralTwo 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.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: real-time fMRI neurofeedback (of the ACC)Experimental treatment 2 interventions
Group B: Yoke-control groupSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Assessed during each of the two neurofeedback runs, 9:30 minutes respectively2
Stress-induced neural activation
Regional activation and network activation characterized during ScanSTRESS paradigm through means of contrast testing ("performance" condition vs "rest" condition)
Time frame
23 minutes - 2 runs lasting 11:20 minutes each3
Cortisol
Cortisol will be assessed through saliva samples
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)4
Craving
Self-report assessment questionnaire, Craving Automated Scale for Alcohol (CAS-A, Vollstädt-Klein et. al., 2015),
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov