Digital Therapeutics Smartphone Application for Methamphetamine Use Disorder
NCT05550493 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2022-12-02
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
- 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.
Sponsors & Collaborators
-
Huangshui Township Municipal Government, Shuangliu District, Chengdu, Sichuang
collaborator UNKNOWN -
Adai Technology (Beijing) Co., Ltd.
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-01
- Primary Completion
- 2021-03-31
- Completion
- 2022-05-01
Countries
- China
Study Locations
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