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

NCT ID: NCT07319325

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-11-30

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.

Detailed Description

Methamphetamine Use Disorder (MUD) lacks effective pharmacotherapies, and traditional psychosocial interventions face scalability challenges in community settings. This pragmatic randomized controlled trial (RCT) aims to assess a smartphone-based digital therapeutic intervention designed to overcome these barriers.

Participants recruited from 12 community rehabilitation centers in Sichuan, China, are randomized 1:1 to either the DTx group or the Treatment as Usual (TAu) group.

The DTx group uses a smartphone application ("WonderLab Harbor+") for 8 weeks as an adjunct to standard care. The app includes:

1. Weekly Internet-based CBT sessions.

2. Daily Adaptive Approach Bias Modification (A-ApBM) training, which dynamically adjusts difficulty based on performance.

3. Gamified cognitive function training.

4. A contingency management system rewarding adherence.

The TAu group receives standard counseling services provided by community social workers. The primary outcome is the change in self-reported cue-induced craving from baseline to 8 weeks.

Conditions

Methamphetamine Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adaptive Digital Therapeutics (DTx)

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.

Group Type: EXPERIMENTAL

WonderLab Harbor+ (Adaptive DTx)

Intervention Type: 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.

Treatment as Usual (TAU)

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.

Group Type: ACTIVE_COMPARATOR

Standard Community Counseling

Intervention Type: 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.

Interventions

WonderLab Harbor+ (Adaptive DTx)

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.

Intervention Type: DEVICE

Standard Community Counseling

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Adai Technology (Beijing) Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Community Rehabilitation Centers

Chengdu, Sichuan, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 36339836 (View on PubMed)

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.

Reference Type: RESULT

PMID: 40063843 (View on PubMed)

Other Identifiers

JK2025

Identifier Type: -

Identifier Source: org_study_id