Skip to content

Digital Therapeutics Smartphone Application for Methamphetamine Use Disorder

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05550493
Enrollment
100
Registered
2022-09-22
Start date
2021-01-01
Completion date
2022-05-01
Last updated
2022-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methamphetamine Abuse

Brief 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.

Interventions

BEHAVIORALCounseling

Counseling provided by social workers and psychotherapists on topics including work, family, stress management, and drug craving suppression.

BEHAVIORALCognitive 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.

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).

BEHAVIORALCognitive 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

Huangshui Township Municipal Government, Shuangliu District, Chengdu, Sichuang
CollaboratorUNKNOWN
Adai Technology (Beijing) Co., Ltd.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* currently undergoing community-based rehabilitation were recruited voluntarily from four community * meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for methamphetamine dependence.

Exclusion criteria

* could not fluently operate an Android or an iOS smartphone * having mental health conditions other than MUD

Design outcomes

Primary

MeasureTime frameDescription
Cue induced craving for methamphetaminebaseline, pre-interventionThe cue-induced craving was assessed by showing the participants images related to methamphetamine (methamphetamine crystals, powders, and paraphernalia) on a smartphone and asking them to rate their cravings on a 0-10 visual analog scale (0 being least craved and 10 being most craved).
Cognitive Function Scorebaseline, pre-interventionWe use the Meaningless Figure Recognition Test (MFRT) to assess the cognitive function score. This test has eight blocks, and each block has two phases. In the first phase, the participant is presented with a series of meaningless figures one by one for three seconds. The participants were asked to memorize these figures. In the second phase, the previously presented meaningless figures and the same number of the novel meaningless figures are presented on one screen in random order. The participants were asked to recall their memory and click all the previously presented figures within 15 seconds. The correct rate of clicks is used for measuring the cognitive function scores.

Secondary

MeasureTime frameDescription
PHQ-9baseline, pre-interventionPatient Health Questionaire-9 administered on a smartphone
GAD-7baseline, pre-interventionGeneralized Anxiety Disorder 7-item administered on a smartphone

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026