The Effect of Mindfulness-based Relapse Prevention on Impulsive Control Circuit Among Methamphetamine Dependents
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|ClinicalTrials.gov Identifier: NCT03748875|
Recruitment Status : Unknown
Verified March 2019 by Shanghai Mental Health Center.
Recruitment status was: Not yet recruiting
First Posted : November 21, 2018
Last Update Posted : January 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Methamphetamine-dependence||Behavioral: mindfulness-based relapse prevention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of Mindfulness-based Relapse Prevention on Impulsive Control Circuit Among Methamphetamine Dependents|
|Estimated Study Start Date :||May 1, 2020|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Intervention group
an 8-session mindfulness-based relapse prevention program
Behavioral: mindfulness-based relapse prevention
mindfulness-based relapse prevention, 8 weeks
No Intervention: Control group
treatment as usual
- craving change [ Time Frame: change from baseline, 4，8，12，27and 52 weeks ]craving will be measured by visual analogue scale(VAS), participants specify their level of craving by indicating a position along a continuous line between two end-points, score ranges from 0 to 10, 0 refers to the lowest level of craving, 10 refers to the highest level of craving
- impulsiveness change [ Time Frame: baseline，4，8，12，27and 52 weeks ]impulsiveness will be measured by Barratt Impulsiveness Scale, the scale is a 30 item self-report measure, Rarely/Never = 1，Occasionally = 2，Often = 3，Almost Always/Always = 4. Assessment is indicated by the total score added together.
- functional connectivity change between prefrontal cortex and striatum [ Time Frame: baseline, 8 and 12weeks ]functional connectivity between prefrontal cortex and striatum will be measured by fMRI
- cognitive function improvement [ Time Frame: baseline，4，8，12，27and 52 weeks ]cognitive function improvement will be measured by Cogstate system
- depression level change [ Time Frame: baseline，4，8，12，27and 52 weeks ]depression level will be measured by patient health questionnaire-9(PHQ-9). The Patient Health Questionnaire (PHQ) is a multiple-choice self-report inventory, and The PHQ-9 is a tool specific to depression which has 9 items. Assessment is indicated by the total score, which made up by adding together the scores for the scale all seven items.System of scoring is Not at all (0 points),Several days (1 point) More than half the days (2 points) and Nearly every day (3 points).PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
- anxiety level change [ Time Frame: baseline，4，8，12，27and 52 weeks ]anxiety level will be measured by Generalized Anxiety Disorder(GAD-7). it has 7 items and measure severity of various signs of GAD according to reported response categories with assigned points. Assessment is indicated by the total score, which made up by adding together the scores for the scale all seven items.System of scoring is Not at all (0 points),Several days (1 point) More than half the days (2 points) and Nearly every day (3 points).
- addiction severity change [ Time Frame: baseline，4，8，12，27and 52 weeks ]addiction severity will be measured by addiction severity index(ASI). ASI is a semi-structured instrument used in face-to-face interviews conducted by clinicians, researchers or trained techniciansIt measures Medical issues relating to drug use, Employment/Support Status, Levels of Alcohol and Drug Use, Legal Issues Arising from Substance Abuse, Family/Social Factors and Psychiatric/Mental Health Status. Severity ratings are based on the following 10 point scale (0-9).0-1: No real problem, treatment not indicated, 2-3: Slight problem, treatment probably not necessary 4-5: Moderate problem, some treatment indicated 6-7: Considerable problem, treatment necessary 8-9: Extreme problem, treatment absolutely necessary
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748875
|Contact: Jiang DU, Doctorfirstname.lastname@example.org|