An interventional study of Cognitive Behavioral Therapy and Counseling in Methamphetamine Abuse, sponsored by Adai Technology (Beijing) Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-12-02.
Sponsored by Adai Technology (Beijing) Co., Ltd. · Not applicable, Interventional, and Treatment
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.
Adai Technology (Beijing) Co., Ltd. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
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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 · Behavioral: Approach Bias Modification · Behavioral: Cognitive Training
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
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 provided by social workers and psychotherapists on topics including work, family, stress management, and drug craving suppression.
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).
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.
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: immediately after the intervetion
PHQ-9
Patient Health Questionaire-9 administered on a smartphone
Time frame: baseline, pre-intervention
PHQ-9
Patient Health Questionaire-9 administered on a smartphone
Time frame: immediately after the intervetion
GAD-7
Generalized Anxiety Disorder 7-item administered on a smartphone
Time frame: baseline, pre-intervention
GAD-7
Generalized Anxiety Disorder 7-item administered on a smartphone
Time frame: immediately after the intervetion
Plan to share: No
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Adai Technology (Beijing) Co., Ltd.