The Application of Cognitive Rehabilitation Therapy for Amphetamine-type Stimulants Addiction

Not Applicable

Completed

• Conditions: Amphetamine Addiction
• Interventions: Behavioral: cognitive function rehabilitation and bias modification

• Registration Number: NCT03318081
• Lead Sponsor: Shanghai Mental Health Center

Brief Summary

The computerized cognitive rehabilitation therapy will be used to treat amphetamine-type stimulant (ATS) addiction.

Detailed Description

The deficits in executive functions related to prefrontal-striatal circuits play a vital role in ATS addiction and relapse, and proposed computerized cognitive rehabilitation therapy as the novel interventions. Focused on evaluating and training executive functions including working memory, inhibitory control, cognitive flexibility, and congitive bias concerning prefrontal-striatal circuits, neuropsychological tests, electroencephalography tests, magnetic resonance spectroscopy (MRS) and functional MRI will be used to evaluate the therapeutic effect of ATS addiction treatment as well as investigate the mechanisms. The study will be very helpful to develop novel interventions in clinical practice and decrease ATS-related harm for both the patients and their families.

Study Timeline

• Study First Submitted: 2017-10-15
• Study First Submitted QC: 2017-10-18
• Study Start: 2017-10-20
• Study First Posted: 2017-10-23
• Primary Completion: 2017-12-31
• Study Completion: 2018-05-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. diagnosed MA dependence in accordance with the fourth edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (Association, 2000);
2. more than 9 years of education;
3. aged of 18-60 years old;
4. normal vision, audition and no color blindness;
5. receive no detoxification medications during treatment and
6. right handedness.

Exclusion Criteria

1. current medical diseases that required hospitalization or regular monitoring;
2. serious physical or neurological illness that required pharmacological treatment affecting cognitive function;
3. history of major psychiatric disorder such as bipolar disorder, schizophrenia, depression and disorders of high comorbidity with substance abuse/dependence;
4. neurological diseases such as stroke, seizure, migraine, head trauma
5. substance dependence other than nicotine, within the past 5 years;
6. intelligence quotient (IQ) <70.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cognitive bias modification group	cognitive function rehabilitation and bias modification	The main content of cognitive bias modification groups were changing ATS related attention bias, 45 minutes a day over 6 weeks period.
cognitive function rehabilitation group	cognitive function rehabilitation and bias modification	The main content of cognitive function rehabilitation esecutive function,including working memory,sustained attention, response inhibition function and cognitive flexibility, 45 minutes a day over 6 weeks period.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month , 3 month and 6 months	Baseline, 1 month, 3 month and 6 months	evaluate all participants' craving for ATS by Visual Analog Scales (VAS): The scores of the VAS were 0-10 points. 10 points reflect the highest level of individual's craving, and 0 point reflect no craving in patient.

Secondary Outcome Measures

Name	Time	Method
Changing of response inhibition ablility assessed by Balloon Analogue Risk Task (BART)	Baseline, 1 month, 3 month and 6 months	evaluate all participants' response inhibition function by Balloon Analogue Risk Task (BART): Several indices were computed to represent the behavioral performance, including the ratio of all pumps to numbers of win trials, the ratio of pumps to numbers in win trials, and the number of win trials. The higher values represent a worse outcome.
Number of participants who relapse	1 month, 3 month and 6 months	Follow up with patients after discharge, evaluate number of participants who relapse. The higher values represent a worse outcome.
Cognitive function assessed by CogState Battery (CSB)	Baseline, 1 month, 3 month and 6 months	evaluate all participants' cognitive function by the computerized CogState Battery (CSB) Chinese version: The five tasks listed below were examined. International shopping list task (ISLT, verbal learning and memory), the score is defined as the total number of correct responses. Continuous paired association learning task (CPAL) taps spatial working memory. Groton maze learning task (GML) taps problem solving/error monitoring. The scores of CPAL and GML tasks are the total number of errors. Social emotional cognition task (SEC, social cognition) asks the subjects to pick out the different facial expressions. Two back task (TWOB, working memory) requires subjects to decide whether a card is identical to the one shown just before. The scores of TWOB and SEC tasks are the proportion of correct responses, denoting the accuracy of performance. The higher values represent a better outcome in ISL, SEC and TWOB. The higher values represent a worse outcome in GML and CPAL.

Trial Locations

Locations (1)

Shanghai Compulsory Isolation Detoxification Center; 🇨🇳 Shanghai, China