Skip to main content
OpenTrials
Completed

NCT Number: NCT05550493

Digital Therapeutics Smartphone Application for Methamphetamine Use Disorder

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Methamphetamine Abuse

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huangshui Township Municipal Government

Chengdu, Sichuang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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.

Counseling

Behavioral

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

Approach Bias Modification

Behavioral

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).

Cognitive training

Behavioral

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.

Primary outcomes

  1. Cue induced craving for methamphetamine

    Time frame: baseline, pre-intervention

    The 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).

  2. Cue induced craving for methamphetamine

    Time frame: immediately after the intervetion

    The 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).

  3. Cognitive Function Score

    Time frame: baseline, pre-intervention

    We 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.

  4. Cognitive Function Score

    Time frame: immediately after the intervetion

    We 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 outcomes

  1. PHQ-9

    Time frame: baseline, pre-intervention

    Patient Health Questionaire-9 administered on a smartphone

  2. PHQ-9

    Time frame: immediately after the intervetion

    Patient Health Questionaire-9 administered on a smartphone

  3. GAD-7

    Time frame: baseline, pre-intervention

    Generalized Anxiety Disorder 7-item administered on a smartphone

  4. GAD-7

    Time frame: immediately after the intervetion

    Generalized Anxiety Disorder 7-item administered on a smartphone

Sponsors and collaborators

Lead sponsor

Adai Technology (Beijing) Co., Ltd.

Other

Collaborators

  • Huangshui Township Municipal Government, Shuangliu District, Chengdu, Sichuang

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Sep 22, 2022
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.