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Gamified Adaptive Approach Bias Modification on Individuals With Methamphetamine Use History

Primary Purpose

Addiction, Substance

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Static Approach Bias Modification
Adaptive Approach Bias Modification
Sponsored by
Adai Technology (Beijing) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Addiction, Substance

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: • having a history of methamphetamine use of at least one year Exclusion Criteria: could not fluently operate an Android or an iOS smartphone having mental health conditions other than MUD

Sites / Locations

  • Gao Ping Town Community Drug Rehabilitation Center
  • Han Zhou Street Community Drug Rehabilitation Center
  • Jin Lun Town Community Drug Rehabilitation Center
  • Jin Yan Street Community Drug Rehabilitation Center
  • Jin Yu Town Community Drug Rehabilitation Center
  • Lian Shan Town Community Drug Rehabilitation Center
  • Nan Feng Town Community Drug Rehabilitation Center
  • San Shui Town Community Drug Rehabilitation Center
  • Sanxingdui Town Community Drug Rehabilitation Center
  • SixTwentySix Service Center, Luo Cheng Street, Guanghan City
  • Xiang Yang Town Community Drug Rehabilitation Center
  • Xiao Han Town Community Drug Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Adaptive Approach Bias Modification

Static Approach Bias Modification

Control

Arm Description

Outcomes

Primary Outcome Measures

Cue induced craving for methamphetamine
The cue-induced craving was assessed by showing the participants images related to methamphetamine (methamphetamine crystals, powders, and paraphernalia) on a smartphone and asking them to rate their cravings on a 0-10 visual analog scale (0 being least craved and 10 being most craved).
Cue induced craving for methamphetamine
The cue-induced craving was assessed by showing the participants images related to methamphetamine (methamphetamine crystals, powders, and paraphernalia) on a smartphone and asking them to rate their cravings on a 0-10 visual analog scale (0 being least craved and 10 being most craved).
Cue induced craving for methamphetamine
The cue-induced craving was assessed by showing the participants images related to methamphetamine (methamphetamine crystals, powders, and paraphernalia) on a smartphone and asking them to rate their cravings on a 0-10 visual analog scale (0 being least craved and 10 being most craved).

Secondary Outcome Measures

Full Information

First Posted
March 6, 2023
Last Updated
July 17, 2023
Sponsor
Adai Technology (Beijing) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05794438
Brief Title
Gamified Adaptive Approach Bias Modification on Individuals With Methamphetamine Use History
Official Title
Gamified Adaptive Approach Bias Modification on Individuals With Methamphetamine Use History
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adai Technology (Beijing) Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
A randomized controlled trial will be conducted to investigate whether a proposed algorithm that adjusts the congruency ratio based on the user's performance and difficulty can enhance the effectiveness of approach bias modification. Methamphetamine users will be recruited and randomized into an algorithm group, a standard group, and a control group.
Detailed Description
To assess the efficacy of an adaptive approach bias modification (A-ApBM) paradigm with gamified designs and dynamic difficulty adjustments in reducing cue-induced craving in individuals with methamphetamine use history. DESIGN: Randomized controlled trial with three study groups: Adaptive ApBM (A-ApBM), Static ApBM (S-ApBM), and control. A-ApBM and S-ApBM groups engaged in ApBM training using a smartphone application for four weeks. A-ApBM used an adaptive algorithm to dynamically adjust the difficulty level based on individual performance, while S-ApBM had a static difficulty level. Cue-induced craving scores were assessed using a visual analog scale at baseline, post-intervention, and at week-16 follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Substance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adaptive Approach Bias Modification
Arm Type
Experimental
Arm Title
Static Approach Bias Modification
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Static Approach Bias Modification
Intervention Description
In the static approach bias modification, users were instructed to swipe upward when they see portrait format images and swipe downward when they see landscape format images. A shrinking animation comes after swiping upward to simulate the visual effect of moving away (approach), and a growing animation comes after swiping downward to simulate the visual effect of moving towards (avoidance). Two types of images, namely drug-related and non-drug-related, were used in the training. The drug-related images were related to methamphetamine (methamphetamine crystals, powders, and paraphernalia), and the non-drug-related images were related to healthy lifestyles (wealth, sports, gourmet, family activities, etc).
Intervention Type
Behavioral
Intervention Name(s)
Adaptive Approach Bias Modification
Intervention Description
In the adaptive approach bias modification, users were instructed to swipe upward when they see portrait format images and swipe downward when they see landscape format images. A shrinking animation comes after swiping upward to simulate the visual effect of moving away (approach), and a growing animation comes after swiping downward to simulate the visual effect of moving towards (avoidance). Two types of images, namely drug-related and non-drug-related, were used in the training. The drug-related images were related to methamphetamine (methamphetamine crystals, powders, and paraphernalia), and the non-drug-related images were related to healthy lifestyles (wealth, sports, gourmet, family activities, etc). An algorithm continuously monitors the performance of the user and adjusts the ratio of congruent and incongruent trials accordingly to attain a desired difficulty curve.
Primary Outcome Measure Information:
Title
Cue induced craving for methamphetamine
Description
The cue-induced craving was assessed by showing the participants images related to methamphetamine (methamphetamine crystals, powders, and paraphernalia) on a smartphone and asking them to rate their cravings on a 0-10 visual analog scale (0 being least craved and 10 being most craved).
Time Frame
Baseline
Title
Cue induced craving for methamphetamine
Description
The cue-induced craving was assessed by showing the participants images related to methamphetamine (methamphetamine crystals, powders, and paraphernalia) on a smartphone and asking them to rate their cravings on a 0-10 visual analog scale (0 being least craved and 10 being most craved).
Time Frame
Immediately Post-intervention
Title
Cue induced craving for methamphetamine
Description
The cue-induced craving was assessed by showing the participants images related to methamphetamine (methamphetamine crystals, powders, and paraphernalia) on a smartphone and asking them to rate their cravings on a 0-10 visual analog scale (0 being least craved and 10 being most craved).
Time Frame
16 week from baseline assesment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • having a history of methamphetamine use of at least one year Exclusion Criteria: could not fluently operate an Android or an iOS smartphone having mental health conditions other than MUD
Facility Information:
Facility Name
Gao Ping Town Community Drug Rehabilitation Center
City
Guanghan
State/Province
Sichuan
Country
China
Facility Name
Han Zhou Street Community Drug Rehabilitation Center
City
Guanghan
State/Province
Sichuan
Country
China
Facility Name
Jin Lun Town Community Drug Rehabilitation Center
City
Guanghan
State/Province
Sichuan
Country
China
Facility Name
Jin Yan Street Community Drug Rehabilitation Center
City
Guanghan
State/Province
Sichuan
Country
China
Facility Name
Jin Yu Town Community Drug Rehabilitation Center
City
Guanghan
State/Province
Sichuan
Country
China
Facility Name
Lian Shan Town Community Drug Rehabilitation Center
City
Guanghan
State/Province
Sichuan
Country
China
Facility Name
Nan Feng Town Community Drug Rehabilitation Center
City
Guanghan
State/Province
Sichuan
Country
China
Facility Name
San Shui Town Community Drug Rehabilitation Center
City
Guanghan
State/Province
Sichuan
Country
China
Facility Name
Sanxingdui Town Community Drug Rehabilitation Center
City
Guanghan
State/Province
Sichuan
Country
China
Facility Name
SixTwentySix Service Center, Luo Cheng Street, Guanghan City
City
Guanghan
State/Province
Sichuan
Country
China
Facility Name
Xiang Yang Town Community Drug Rehabilitation Center
City
Guanghan
State/Province
Sichuan
Country
China
Facility Name
Xiao Han Town Community Drug Rehabilitation Center
City
Guanghan
State/Province
Sichuan
Country
China

12. IPD Sharing Statement

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Gamified Adaptive Approach Bias Modification on Individuals With Methamphetamine Use History

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