None listed
Conditions
Interventions
Medical Device : The digital therapeutic device, referred to as D-STOP, which incorporates Cognitive Behavioral Therapy (CBT), will be provided only to the experimental group for a duration of 12 week
standard hospital-based care) plus the digital therapeutic device (D-STOP).
2. Control Group: Receives treatment as usual (TAU
standard hospital-based care) only.
Sponsors
Hallym University Medical Center- Chuncheon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 years or older 2. Individuals diagnosed with substance use disorders under ICD-10 codes F11, F12, F14, F15, or F19 3. Individuals with a drug abuse screening test score of 1 or higher at the time of screening 4. Individuals who meet the DSM-5 diagnostic criteria for substance use disorder within 30 days prior to screening 5. Individuals who have initiated or are receiving psychiatric treatment within 30 days prior to screening and plan to continue treatment for at least 3 months 6. Individuals with no difficulty in reading and writing Korean 7. Individuals with no difficulty in using a smartphone to operate a mobile application 8. Individuals who have been sufficiently informed about this clinical trial, fully understand it, voluntarily decide to participate, and provide written consent to comply with the precautions 9. Individuals with no history of dementia diagnosis 10. For women of childbearing potential, individuals who agree to use medically approved contraceptive methods during the clinical trial period 11. Individuals (or their legal representatives) who have received a detailed explanation of this clinical trial, fully understood it, and voluntarily decided to participate by providing written informed consent
Exclusion criteria
Exclusion criteria: 1. Participants with any severe, progressive, or unstable medical condition that may place the patient at risk. 2. Participants with neurological disorders that could account for cognitive impairment (e.g., post-traumatic conditions, Huntington’s disease, multiple sclerosis, cerebral palsy, encephalitis, meningitis, or other central nervous system disorders). 3. Participants with neurodegenerative diseases other than depression, or those with severe psychiatric symptoms that may interfere with cooperation during the trial. 4. Participants with uncontrolled seizure disorders at the time of screening. 5. Participants with a history of traumatic brain injury involving loss of consciousness longer than 1 hour or hospitalization within the past 3 years. 6. Participants with significant hearing or visual impairments that could interfere with the performance of study-related procedures. 7. Participants who do not possess a smartphone that meets the technical specifications required for installation of the investigational digital medical device. 8. Pregnant or breastfeeding women. 9. Participants who are currently enrolled in another clinical trial or have participated in another clinical trial within 30 days prior to screening. 10. Participants deemed by the investigator to be otherwise unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| abstinence success rate | — |
Secondary
| Measure | Time frame |
|---|---|
| abstinence success rate;treatment retention rate;total days of abstinence;Maximum number of consecutive abstinent days;University of rhode island change assessment - drug offender version(URICA-DO);korean hospital anxiety and depression scale(K-HADS);cognitive reappraisal questionnaire(CRQ);behavioral activation for depression scale(BADS);Adherence assessment;satisfaction assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactYong Chan Jeong
Hallym University Medical Center- Chuncheon
Outcome results
None listed