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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe rate of relapse of alcohol dependence after discharge from hospital
Recurrence of alcohol dependence
Time frame: 1 month
The rate of relapse of alcohol dependence after discharge from hospital
Time frame: 2 month
The rate of relapse of alcohol dependence after discharge from hospital
Time frame: 3 month
The rate of relapse of alcohol dependence after discharge from hospital
Time frame: 6 month
Duration of abstinence
The total time or period without any intake of alcohol during follow ups
Time frame: 6 months
Alcohol intake
Diaries of alcohol intake in different time of the follow ups
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Craving for alcohol
Craving assessment for alcohol by Obsessive Compulsive Drinking Scale (OCDS) ranging from 0 to 40. Higher score of OCDS indicates more desire for alcohol.
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Craving for alcohol
Craving assessment by Visual Analogue Scale (VAS) for alcohol desire ranging from 0 to 10. Higher score indicates more desire for alcohol.
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Cognitive assessment
Cognitive assessment by Montreal Cognitive Assessment (MoCA) ranging from 0 to 30. Lower score indicates worse cognitive function.
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Psychological assessment - Anxiety
Psychological assessment by Generalized Anxiety Disorder-7 (GAD-7) ranging from 0 to 21. Higher score indicates more severer anxiety.
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Psychological assessment - Depression
Psychological assessment by Patient Health Questionnaire-9 (PHQ-9) ranging from 0 to 27. Higher score indicates more severer depression.
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
Psychological assessment - Sleep
Psychological assessment by Pittsburgh Sleep Quality Index (PSQI) ranging from 0 to 21. Higher score indicates worse sleep.
Time frame: 2 weeks, 1 month, 2 months, 3 months and 6 months
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