Digital Therapeutics Smartphone Application for Methamphetamine Use Disorder

Methamphetamine Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05550493
• Other study ID #: Feidao
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: November 2022
• Source: Adai Technology (Beijing) Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 1, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Methamphetamine Abuse

Intervention

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

Locations

Country	Name	City	State
China	Huangshui Township Municipal Government	Chengdu	Sichuang

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	PHQ-9	Patient Health Questionaire-9 administered on a smartphone	baseline, pre-intervention
Secondary	PHQ-9	Patient Health Questionaire-9 administered on a smartphone	immediately after the intervetion
Secondary	GAD-7	Generalized Anxiety Disorder 7-item administered on a smartphone	baseline, pre-intervention
Secondary	GAD-7	Generalized Anxiety Disorder 7-item administered on a smartphone	immediately after the intervetion