Methamphetamine Addiction
Conditions
Keywords
Digital Therapeutics, Cognitive Bias Modification, Approach Bias Modification, Community Rehabilitation
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.
Interventions
DEVICEWonderLab 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.
BEHAVIORALStandard 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.
Sponsors
Adai Technology (Beijing) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cue-Induced Craving Score | 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. |
Countries
China
Outcome results
None listed