Digital Therapeutics Smartphone Application for Methamphetamine Use Disorder

Not Applicable

Completed

• Conditions: Methamphetamine Abuse
• Interventions: Behavioral: Cognitive Behavioral Therapy; Behavioral: Counseling; Behavioral: Approach Bias Modification; Behavioral: Cognitive Training

• Registration Number: NCT05550493
• Lead Sponsor: Adai Technology (Beijing) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-03-31
• Study Completion: 2022-05-01
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-22
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Digital Therapeutics	Cognitive Behavioral Therapy	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.
Treatment as Usual	Counseling	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.
Digital Therapeutics	Approach Bias Modification	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.
Digital Therapeutics	Cognitive Training	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.

Primary Outcome Measures

Name	Time	Method
Cue induced craving for methamphetamine	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).
Cognitive Function Score	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 Outcome Measures

Name	Time	Method
PHQ-9	immediately after the intervetion	Patient Health Questionaire-9 administered on a smartphone
GAD-7	immediately after the intervetion	Generalized Anxiety Disorder 7-item administered on a smartphone

Trial Locations

Locations (1)

Huangshui Township Municipal Government; 🇨🇳 Chengdu, Sichuang, China