Digital Therapeutics Smartphone Application for Methamphetamine Use Disorder

Preliminary Efficacy of a 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.

Study Overview

• Status: Completed
• Conditions: Methamphetamine Abuse
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Behavioral: Approach Bias Modification; Behavioral: Cognitive Training; Behavioral: Counseling

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuang
    • Chengdu, Sichuang, China
      • Huangshui Township Municipal Government

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Therapeutics; The DTx group was asked to download and install a smartphone application (WonderLab Harbor) that incorporated Internet-based Cognitive Behavioral Therapy (ICBT), Approach Bias Modification (ApBM), cognitive function training, and Contingency Management (CM). During the 8-week treatment program, the participants in the DTx group were instructed to complete ICBT, cognitive trainings, and ApBM trainings. Reward points (which can be redeemed for cellphone plan credit) were rewarded following completing each task as part of the positive reinforcement following CM principles.	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: 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.
Active Comparator: Treatment as Usual; Upon enrollment, TAU participants were informed that they would receive weekly counseling sessions from a social worker for eight weeks. The counseling covered topics including work, family, stress management, and drug craving suppression.	Behavioral: Counseling; Counseling provided by social workers and psychotherapists on topics including work, family, stress management, and drug craving suppression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cue induced craving for methamphetamine	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).	baseline, pre-intervention
Cue induced craving for methamphetamine	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).	immediately after the intervetion
Cognitive Function Score	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.	baseline, pre-intervention
Cognitive Function Score	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.	immediately after the intervetion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ-9	Patient Health Questionaire-9 administered on a smartphone	baseline, pre-intervention
PHQ-9	Patient Health Questionaire-9 administered on a smartphone	immediately after the intervetion
GAD-7	Generalized Anxiety Disorder 7-item administered on a smartphone	baseline, pre-intervention
GAD-7	Generalized Anxiety Disorder 7-item administered on a smartphone	immediately after the intervetion

Collaborators and Investigators

• Sponsor: Adai Technology (Beijing) Co., Ltd.
• Collaborators: Huangshui Township Municipal Government, Shuangliu District, Chengdu, Sichuang

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: September 15, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Feidao

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No