RecruitingNot ApplicableNCT06247306

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)


Sponsor

Central Institute of Mental Health, Mannheim

Enrollment

102 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

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 .


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

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.


Locations(1)

Central Institute of Mental Health - Department of Clinical Psychology

Mannheim, Baden-Wurttemberg, Germany

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06247306


Related Trials