Emotional Attention Bias Modification and Targeted Memory Reactivation in Alcohol Use Disorder

Augmentation of Emotional Attention Bias Modification With Targeted Memory Reactivation for Alcohol Use Disorder (AUD)

Through this protocol, researchers examine whether Targeted Memory Reactivation (TMR), a technique used to enhance memory, can augment the control of craving levels in patients with Alcohol Use Disorder by enhancing positive emotional attention bias modification.

Study Overview

• Status: Not yet recruiting
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Emotional Attention Bias Modification and Targeted memory reactivation during REM sleep; Behavioral: Emotional Attention Bias Modification

Detailed Description

This protocol uses TMR during REM sleep to strengthen associative memories generated by emotional attention bias modification (EABM), an effective treatment for controlling craving levels in patients with Alcohol Use Disorder (AUD). EABM involves exposure to negative emotional words (e.g., frustrated, inferior) associated with alcohol-related cues and positive emotional words (e.g., successful, confident) associated with healthy lifestyle cues. The goal is to reduce alcohol-related cue positive emotional attention bias (EABs). In EABM training, alcohol-related cues and healthy activity (e.g., exercising, reading, playing musical instruments) images are always paired with negative words and positive words, respectively. The TMR group receives the EABM protocol with auditory cue feedback (sound S1-Alcohol; sound S2-Healthy Life); the control group receives the EABM protocol without auditory cue feedback. All patients will perform EABM every evening and will be exposed to sounds S1 and S2 during REM sleep with a wireless headband, which automatically detects sleep stages. Clinical evaluation of the EAB and craving levels of AUD will be conducted before and after (with a 2-week follow-up). The investigators hypothesize that patients treated with EABM and who are exposed during REM sleep to a sound that had previously been associated with the new negative memory of alcohol and the positive memory of a healthy lifestyle (TMR group) will have more reduced EAB and craving levels compared to participants exposed to the same, but non-associated, sound during REM sleep (control group).

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Zhao, PhD; Phone Number: 021-54252689; Email: drminzhao@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18-55 years; Meets the diagnostic criteria for Alcohol Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (American Psychiatric Association, 2013); Alcohol withdrawal period of less than 6 months; Normal vision and hearing, or corrected to normal; Agrees to participate in the study and is able to cooperate to complete the experiment.

Exclusion Criteria:

• Acute alcohol withdrawal period: Clinical Institute Withdrawal Assessment for Alcohol Scale (CIWA-Ar) score ≥ 9; History of organic brain diseases or brain trauma; History of seizures, other neuropsychiatric disorders, or family history of psychiatric disorders; Presence of substance abuse/addiction other than alcohol (excluding nicotine addiction).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TMR group; Patients will receive a sound S1 and sound S2 while they generate a correct outcome of Emotional Attention Bias Modification(EABM). They will also receive the sound S1 and sound S2 during REM sleep.	Behavioral: Emotional Attention Bias Modification and Targeted memory reactivation during REM sleep; Emerging evidence shows that REM sleep is crucial for processing emotional memories and consolidating implicit memories. By using targeted memory reactivation (TMR), a known method where sound S1 and sound S2 are associated with a waking experience(i.e.negative emotional words is associated with alcohol-related cues and positive emotional words is associated with healthy lifestyle cues) and strengthened during REM sleep, the investigators aim to augment the control of craving levels in patients with Alcohol Use Disorder.
Active Comparator: Control group; Patients will not receive the sound S1 and sound S2 while they generate a correct outcome of Emotional Attention Bias Modification(EABM). During REM sleep, they will receive the same sound as the experimental group (S1 and S2) under the same conditions.	Behavioral: Emotional Attention Bias Modification; These patients will receive the treatment of emotional attention bias modification (EABM) without association with the sound S1 and sound S2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in behavioral indicators of positive emotional attention bias towards alcohol-related cues	Positive emotional attention bias is assessed through emotional attention bias under electroencephalogram recording, with the indicator being D scores calculated from the response time (D alcohol=RT (negative) - RT (positive) )/SD negative+positive).	baseline, 1 day after treatment, 2 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in behavioral indicators of positive emotional attention bias towards healthy activity cues	Positive emotional attention bias is assessed through emotional attention bias under electroencephalogram recording, with the indicator being D scores calculated from the response time (D health=RT (negative) - RT (positive) )/SD negative+positive).	baseline, 1 day after treatment, 2 weeks after treatment
Change of Craving assessed by Visual Analog Scale	evaluate all participants' craving for for methamphetamine assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 10, and higher values represent high level of craving.	baseline, 1 day after treatment, 2 weeks after treatment
Change of Craving assessed by Visual Analog Mood Scale	evaluate all participants' mood assessed by Visual Analog Scales (VAS). The scores ranges from 0 to 10, where 0 indicates the absence of the emotion and 10 indicates the emotion is extremely intense.	baseline, 1 day after treatment, 2 weeks after treatment

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Study Chair: MIn Zhao, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 8, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: MZhao-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No