NCT05550493

Digital Therapeutics Smartphone Application for Methamphetamine Use Disorder

Preliminary Efficacy of a Digital Therapeutics Smartphone Application for Methamphetamine Use Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Adai Technology (Beijing) Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

One hundred participants were recruited and randomized into a digital therapeutics (DTx) group (n=52) and a treatment as usual (TAU) group (n=48). The DTx group used a smartphone application to deliver cognitive behavioral therapy, approach bias modification, cognitive training, and contingency management for eight weeks. The TAU group received counseling from social workers and psychoterapists. Cue-induced craving, cognitive functions, PHQ-9, and GAD-7 were measured at baseline and post-intervention.

Conditions

• Methamphetamine Abuse

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy	The cognitive behavioral therapy program consisted of eight interactive sessions, each requiring approximately 15 minutes to complete. Each ICBT session includes interactive multimedia modules (videos, pictures, and texts), the contents of which were based on the community reinforcement approach. The ICBT sessions covered the following topics: (1) introduction to digital therapeutics and CBT, (2) recognizing the triggers of craving, (3) coping with craving, (4) refusing skills/assertiveness, (5) problem-solving skills, (6) changing thoughts about drugs, (7) seemingly irrelevant decisions, and (8) HIV risks and prevention.
BEHAVIORAL	Counseling	Counseling provided by social workers and psychotherapists on topics including work, family, stress management, and drug craving suppression.
BEHAVIORAL	Approach Bias Modification	In an ApBM session, users were instructed to swipe upward (downward) when they saw portrait (landscape) format images. A shrinking (growing) animation comes after swiping upward (downward) to simulate the visual effect of moving away (moving towards). The images were related to methamphetamine usage (methamphetamine crystals, powders, and paraphernalia) or healthy lifestyles (wealth, sports, gourmet, family activities, etc.). Each ApBM session was composed of presenting each one of the healthy lifestyle (methamphetamine) cues 12 times in landscape (portrait) and once in portrait (landscape).
BEHAVIORAL	Cognitive Training	The DTx application incorporated a game-based cognitive function training module for improving working memory. In this game, a matrix of squares is displayed at the center of the screen. Between 3 and 5 target symbols are randomly placed in the matrix and displayed for 2 seconds. Next, the symbols disappear, and the matrix randomly rotates. The participants were asked to click the correct locations of the target symbols within the prescribed time limit. The game becomes more difficult as the size of the matrix, the number of target symbols, and the complexity of the matrix rotation change at each level. Each cognitive function training session lasted between 3 and 5 minutes.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-03-31
• Completion: 2022-05-01
• First posted: 2022-09-22
• Last updated: 2022-12-02

Locations

1 site across 1 country: China