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

Primary Purpose

Amphetamine Addiction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cognitive function rehabilitation and bias modification
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amphetamine Addiction focused on measuring Amphetamine-type stimulants, prefrontal-striatal circuits, cognitive rehabilitation therapy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shanghai Compulsory Isolation Detoxification Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

cognitive function rehabilitation group

cognitive bias modification group

control group

Arm Description

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.

The main content of cognitive bias modification groups were changing ATS related attention bias, 45 minutes a day over 6 weeks period.

Participants only accept the regular scheduled in the compulsory isolated detoxification center

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Number of participants who relapse
Follow up with patients after discharge, evaluate number of participants who relapse. The higher values represent a worse outcome.

Full Information

First Posted
October 15, 2017
Last Updated
January 8, 2020
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT03318081
Brief Title
The Application of Cognitive Rehabilitation Therapy for Amphetamine-type Stimulants Addiction
Official Title
The Application of Cognitive Rehabilitation Therapy for Amphetamine-type Stimulants Addiction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
May 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine Addiction
Keywords
Amphetamine-type stimulants, prefrontal-striatal circuits, cognitive rehabilitation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cognitive function rehabilitation group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
cognitive bias modification group
Arm Type
Active Comparator
Arm Description
The main content of cognitive bias modification groups were changing ATS related attention bias, 45 minutes a day over 6 weeks period.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Participants only accept the regular scheduled in the compulsory isolated detoxification center
Intervention Type
Behavioral
Intervention Name(s)
cognitive function rehabilitation and bias modification
Intervention Description
cognitive rehabilitation focus on the deficits executive funcitin and elevated cognitive bias
Primary Outcome Measure Information:
Title
Change from Baseline Craving for ATS assessed by Visual Analog Scales (VAS) at 1 month , 3 month and 6 months
Description
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.
Time Frame
Baseline, 1 month, 3 month and 6 months
Secondary Outcome Measure Information:
Title
Cognitive function assessed by CogState Battery (CSB)
Description
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.
Time Frame
Baseline, 1 month, 3 month and 6 months
Title
Changing of response inhibition ablility assessed by Balloon Analogue Risk Task (BART)
Description
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.
Time Frame
Baseline, 1 month, 3 month and 6 months
Title
Number of participants who relapse
Description
Follow up with patients after discharge, evaluate number of participants who relapse. The higher values represent a worse outcome.
Time Frame
1 month, 3 month and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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); more than 9 years of education; aged of 18-60 years old; normal vision, audition and no color blindness; receive no detoxification medications during treatment and right handedness. Exclusion Criteria: current medical diseases that required hospitalization or regular monitoring; serious physical or neurological illness that required pharmacological treatment affecting cognitive function; history of major psychiatric disorder such as bipolar disorder, schizophrenia, depression and disorders of high comorbidity with substance abuse/dependence; neurological diseases such as stroke, seizure, migraine, head trauma substance dependence other than nicotine, within the past 5 years; intelligence quotient (IQ) <70.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhao Min, PhD, MD
Organizational Affiliation
Shanghai Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Compulsory Isolation Detoxification Center
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29925497
Citation
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.
Results Reference
derived

Learn more about this trial

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

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