Efficacy of Adaptive, Gamified Digital Therapeutics Intervention for Individuals With Methamphetamine Use Disorder in Community Rehabilitation

NCT07319325 | Completed

• 1 other identifier: JK2025
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy of a comprehensive, adaptive digital therapeutics (DTx) smartphone application compared to treatment as usual (TAu) for individuals with Methamphetamine Use Disorder (MUD) receiving community-based rehabilitation. The intervention integrates Internet-based Cognitive Behavioral Therapy (ICBT), adaptive Approach Bias Modification (A-ApBM), cognitive training, and contingency management. The primary hypothesis is that the DTx intervention will result in a greater reduction in cue-induced craving compared to standard community care.

Conditions

Methamphetamine Addiction

Keywords

Digital Therapeutics; Cognitive Bias Modification; Approach Bias Modification; Community Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Cue-Induced Craving Score

  Self-reported craving elicited by standardized methamphetamine-related images, measured using a Visual Analog Scale (VAS). Scores range from 0 to 100, with higher scores indicating higher craving. The outcome is defined as the change in score from Baseline to Week 8.

  Baseline and 8 Weeks (Post-intervention)

Study Arms (2)

Adaptive Digital Therapeutics (DTx)

EXPERIMENTAL

Participants receive access to WonderLab Harbor+ (Adaptive DTx), a smartphone application, for 8 weeks. They are instructed to complete one ICBT session per week (approx. 10 mins) and one Adaptive Approach Bias Modification (A-ApBM) session daily (approx. 3 mins). The app also includes cognitive training games and a rewards system (Contingency Management). This is provided in addition to standard community care.

Device: WonderLab Harbor+ (Adaptive DTx)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants receive standard care provided by the community rehabilitation centers, which consists of counseling sessions (in-person or telephone) delivered by social workers covering stress management, family issues, and craving suppression.

Behavioral: Standard Community Counseling

Interventions

WonderLab Harbor+ (Adaptive DTx) DEVICE

Participants receive access to a smartphone application for 8 weeks. They are instructed to complete one ICBT session per week (approx. 10 mins) and one Adaptive Approach Bias Modification (A-ApBM) session daily (approx. 3 mins). The app also includes cognitive training games and a rewards system (Contingency Management). This is provided in addition to standard community care.

Adaptive Digital Therapeutics (DTx)

Standard Community Counseling BEHAVIORAL

Participants receive standard care provided by the community rehabilitation centers, which consists of counseling sessions (in-person or telephone) delivered by social workers covering stress management, family issues, and craving suppression.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60 years.
• Currently enrolled in a community rehabilitation program.
• Ability to fluently operate a smartphone (Android or iOS).

You may not qualify if:

• Presence of a severe mental health condition (e.g., schizophrenia, bipolar I disorder) requiring acute psychiatric care.
• Inability to provide informed consent.

Sponsors & Collaborators

• Adai Technology (Beijing) Co., Ltd.: lead

Study Sites (1)

Community Rehabilitation Centers

Chengdu, Sichuan, China

Location

Related Publications (2)

• Zhang L, Li N, Li Y, Zhang T, Li D, Liu Y, Liu X, Hao W. Preliminary efficacy of a digital therapeutics smartphone application for methamphetamine use disorder: An experimental study. Front Psychiatry. 2022 Oct 19;13:1027695. doi: 10.3389/fpsyt.2022.1027695. eCollection 2022.

  PMID: 36339836 RESULT

• Shen D, Jiao J, Zhang L, Liu Y, Liu X, Li Y, Zhang T, Li D, Hao W. Gamified Adaptive Approach Bias Modification in Individuals With Methamphetamine Use History From Communities in Sichuan: Pilot Randomized Controlled Trial. JMIR Serious Games. 2025 Mar 10;13:e56978. doi: 10.2196/56978.

  PMID: 40063843 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 30, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE

Locations

CN (1)