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

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

Study Overview

• Status: Completed
• Conditions: Amphetamine Addiction
• Intervention / Treatment: Behavioral: cognitive function rehabilitation and bias modification

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Compulsory Isolation Detoxification Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: cognitive function rehabilitation group; 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.	Behavioral: cognitive function rehabilitation and bias modification; cognitive rehabilitation focus on the deficits executive funcitin and elevated cognitive bias
ACTIVE_COMPARATOR: cognitive bias modification group; The main content of cognitive bias modification groups were changing ATS related attention bias, 45 minutes a day over 6 weeks period.	Behavioral: cognitive function rehabilitation and bias modification; cognitive rehabilitation focus on the deficits executive funcitin and elevated cognitive bias
NO_INTERVENTION: control group; Participants only accept the regular scheduled in the compulsory isolated detoxification center

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 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.	Baseline, 1 month, 3 month and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function assessed by CogState Battery (CSB)	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.	Baseline, 1 month, 3 month and 6 months
Changing of response inhibition ablility assessed by Balloon Analogue Risk Task (BART)	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.	Baseline, 1 month, 3 month and 6 months
Number of participants who relapse	Follow up with patients after discharge, evaluate number of participants who relapse. The higher values represent a worse outcome.	1 month, 3 month and 6 months

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Zhao Min, PhD, MD, Shanghai Mental Health Center

Publications and helpful links

General Publications

• Zhu Y, Jiang H, Su H, Zhong N, Li R, Li X, Chen T, Tan H, Du J, Xu D, Yan H, Xu D, Zhao M. A Newly Designed Mobile-Based Computerized Cognitive Addiction Therapy App for the Improvement of Cognition Impairments and Risk Decision Making in Methamphetamine Use Disorder: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Jun 20;6(6):e10292. doi: 10.2196/10292.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2017
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): May 1, 2018

Study Registration Dates

• First Submitted: October 15, 2017
• First Submitted That Met QC Criteria: October 18, 2017
• First Posted (ACTUAL): October 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Amphetamine-type stimulants; prefrontal-striatal circuits; cognitive rehabilitation therapy
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Compulsive Behavior; Impulsive Behavior; Behavior, Addictive; Amphetamine-Related Disorders
• Other Study ID Numbers: MZhao-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No