Using Neurofeedback to Understand the Relationship Between Stress and Alcohol Consumption

NCT06247306 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-01-23

No results posted yet for this study

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 .

Conditions

  • Alcohol Abuse
  • Craving
  • Psychosocial Stressor
  • Neural Stress Response

Interventions

BEHAVIORAL

ScanSTRESS 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.

BEHAVIORAL

real-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 & Collaborators

  • Central Institute of Mental Health, Mannheim

    lead OTHER

Principal Investigators

  • Martin F Gerchen, PhD · Central Institute of Mental Health

  • Peter Kirsch, Prof., PhD · Central Institute of Mental Health

  • Falk Kiefer, MD, PhD · Central Institute of Mental Health

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2026-12-01
Completion
2027-07-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06247306 on ClinicalTrials.gov