NCT04366505

Modification of Cue Reactivity by Neurofeedback in Human Addiction

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Central Institute of Mental Health, Mannheim · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The project is geared towards the understanding of how to increase cognitive control over cue reactivity and drug craving.

Detailed description

Project C04 aims at assessing the combined effect of two interventions targeting at reducing striatal cue reactivity and increasing cognitive control, namely mindfulness-based intervention and real-time fMRI neurofeedback. Firstly, the investigators will test whether a prior mindfulness-based intervention (WP1) is able to enhance the effect of rtfMRI NFB (WP2) and change the networks involved in regulation of cue reactivity by providing participants with explicit strategies. Secondly, the investigators will investigate whether this combined intervention leads to a better clinical outcome in terms of decreased heavy drinking days and a reduced sum of alcohol consumption three months later.

Conditions

• Alcohol Use Disorder (AUD)

Interventions

Type	Name	Description
BEHAVIORAL	Treatment as usual (TAU) and neurofeedback (NFB)	This group will receive Treatment as usual (TAU) and neurofeedback (NFB). During NFB, participants will be asked to regulate the signal from a target brain region during the presentation of alcohol cues. The ventral striatum was chosen as target region.
BEHAVIORAL	mindfulness-based relapse prevention (MBRP) and NFB	This group will receive MBRP and neurofeedback (NFB). MBRP consists of 5 extensive sessions of a specific manualized mindfulness-based intervention for alcohol dependent patients which will be carried out by trained psychologists and psychotherapists. During NFB, participants will be asked to regulate the signal from a target brain region during the presentation of alcohol cues. The ventral striatum was chosen as a target region.
BEHAVIORAL	TAU and sham NFB	This group will receive TAU and sham NFB. Sham NFB means that the signal displayed to the participant is based on activity in a control region, the auditory cortex, which is not involved in cue reactivity.
BEHAVIORAL	MBT and sham NFB	This group will receive MBRP and sham NFB. MBRP consists of 5 extensive sessions of a specific manualized mindfulness-based intervention for alcohol dependent patients which will be carried out by trained psychologists and psychotherapists. Sham NFB means that the signal displayed to the participant is based on activity in a control region, the auditory cortex, which is not involved in cue reactivity.

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2020-04-29
• Last updated: 2021-04-28

Locations

1 site across 1 country: Germany