Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Alcohol Dependence

Not Applicable

• Conditions: Alcohol Dependence

• Registration Number: NCT03910686
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

Alcohol dependence is one of most common substance dependence, which brings great burden on health worldwide. Alcohol dependence may lead to many serious diseases or consequences including cancer, cardiovascular diseases and accidents. Once alcohol dependence is developed, it will be difficult to recover and easy to relapse. Although many efforts had been made in the treatment of alcohol dependence, the annual recurrence of alcohol dependence with traditional therapies was over 45%. Repetitive transcranial magnetic stimulation (rTMS) on the dorsolateral prefrontal cortex (DLPFC) or cognitive behavioral therapy (CBT) each alone was reported to have some effect on preventing from relapse of alcohol dependence. In order to test whether combined therapy of high frequency rTMS (hf-rTMS) with CBT is better for preventing from relapse of alcohol dependence, we recruit patients with alcohol dependence to participate this study. The study is a factorial designed and the patients will be assigned into one of the following six groups randomly: (1) regular treatment (symptomatic treatment) with blank TMS; (2) regular treatment (RT) with blank TMS and CBT; (3) RT with right DLPFC hf-rTMS; (4) RT with right DLPFC hf-rTMS and CBT; (5) RT with left DLPFC hf-rTMS; (6) RT with left DLPFC hf-rTMS and CBT. TMS was given 5 days per week for total 2 weeks using uniform scheme (5 seconds of 10Hz stimulation per train, 30 trains per day with inter-train interval of 20 seconds). CBT will be given once per week for total 8 weeks. The patients will be followed up for 6 months. Recurrence of alcohol dependence, duration of abstention, alcohol intake, craving for alcohol and other cognitive psychological assessments will be recorded and compared among the 6 treatment groups and the efficacy of combined therapy of rTMS with CBT will be evaluated in our study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-10
• Study Start: 2019-06-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-22
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Diagnosis as alcohol dependence according to DSM-IV criteria
• No definite history of neurological diseases and psychological problems
• Volunteer to participate the study, cooperate to be followed up

Exclusion Criteria

• Acute withdrawal state and CIWA score > 9
• With other neurological diseases and psychological problems
• With ever brain trauma and damage
• With other psychological medications or other substance dependence
• With other contraindications to have transcranial magnetic stimulation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
The rate of relapse of alcohol dependence after discharge from hospital	6 month

Secondary Outcome Measures

Name	Time	Method
Alcohol intake	2 weeks, 1 month, 2 months, 3 months and 6 months	Diaries of alcohol intake in different time of the follow ups
Cognitive assessment	2 weeks, 1 month, 2 months, 3 months and 6 months	Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.
Duration of abstinence	6 months	The total time or period without any intake of alcohol during follow ups
Craving for alcohol	2 weeks, 1 month, 2 months, 3 months and 6 months	Craving assessment by Visual Analogue Scale (VAS) for alcohol desire ranging from 0 to 10. Higher score indicates more desire for alcohol.
Psychological assessment - Anxiety	2 weeks, 1 month, 2 months, 3 months and 6 months	Psychological assessment by Generalized Anxiety Disorder-7 (GAD-7) ranging from 0 to 21. Higher score indicates more severer anxiety.
Psychological assessment - Depression	2 weeks, 1 month, 2 months, 3 months and 6 months	Psychological assessment by Patient Health Questionnaire-9 (PHQ-9) ranging from 0 to 27. Higher score indicates more severer depression.
Psychological assessment - Sleep	2 weeks, 1 month, 2 months, 3 months and 6 months	Psychological assessment by Pittsburgh Sleep Quality Index (PSQI) ranging from 0 to 21. Higher score indicates worse sleep.

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China