Efficacy of Repetitive Transcranial Magnetic Stimulation and Cognitive Behavioral Therapy on Alcohol Dependence
- Conditions
- Alcohol Dependence
- Interventions
- Combination Product: Transcranial magnetic stimulation and cognitive behavioral therapy
- Registration Number
- NCT03910686
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
- Arm && Interventions
Group Intervention Description RT with right DLPFC hf-rTMS Transcranial magnetic stimulation and cognitive behavioral therapy Regular treatment with right dorsolateral prefrontal cortex (DLPFC) high frequency repetitive transcranial magnetic stimulation (hf-rTMS) RT with right DLPFC hf-rTMS and CBT Transcranial magnetic stimulation and cognitive behavioral therapy Regular treatment with right DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT) Regular treatment (RT) with blank TMS and CBT Transcranial magnetic stimulation and cognitive behavioral therapy Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation and cognitive behavioral therapy Regular treatment (symptomatic treatment) with blank TMS Transcranial magnetic stimulation and cognitive behavioral therapy Regular treatment (symptomatic treatment) with blank transcranial magnetic stimulation RT with left DLPFC hf-rTMS Transcranial magnetic stimulation and cognitive behavioral therapy Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) RT with left DLPFC hf-rTMS and CBT Transcranial magnetic stimulation and cognitive behavioral therapy Regular treatment with left DLPFC high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and cognitive behavioral therapy (CBT)
- 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