Efficacy of an Adaptive, Gamified Digital Therapeutics Intervention for Individuals With Methamphetamine Use Disorder in Community Rehabilitation: A Pragmatic Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Change in Cue-Induced Craving Score
Overview
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:
- Weekly Internet-based CBT sessions.
- Daily Adaptive Approach Bias Modification (A-ApBM) training, which dynamically adjusts difficulty based on performance.
- Gamified cognitive function training.
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in Cue-Induced Craving Score
Time Frame: Baseline and 8 Weeks (Post-intervention)
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.
Secondary Outcomes
No secondary outcomes reported