Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Rehabilitation Centers | Chengdu | Sichuan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36339836 | Result | 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. | |
| 40063843 | 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. |
Not provided
Not provided
De-identified individual participant data will be available upon reasonable request to the corresponding author.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|