Mood DisordersNCT07455916
AI-Enabled Smartwatch for Medication Adherence in Outpatient Psychiatry
A study testing AI-enabled smartwatch in people with Mood Disorders and Medication Adherence, run by Wonkwang University Hospital at 1 site in South Korea.
Trial summary
Medication nonadherence remains difficult to measure objectively in psychiatric care. This completed, single-center exploratory randomized trial evaluated whether four weeks of AI-enabled smartwatch medication monitoring improved clinician-rated medication adherence compared with waitlist usual care in psychiatric… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Mood Disorders, Medication Adherence, Mental Disorders
- What is being tested?
- AI-enabled smartwatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Dec 2022to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12 years or older
- Receiving outpatient psychiatric care at Wonkwang University Hospital
- Receiving at least one regularly prescribed psychotropic medication
- Willing and able to wear the study smartwatch and complete the study assessments
- Able to provide written informed consent; for minors, written assent and written consent from a parent or legal guardian were required
Who cannot join
- Diagnosed congenital genetic disorder
- Clear history of acquired brain injury
- Seizure disorder or another neurological condition that could interfere with study participation
- Psychotic symptoms, aggression, or behavioral instability severe enough to prevent safe and stable smartwatch use or create a substantial risk of device damage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-Term Effects of an AI-Enabled Smartwatch on Medication Adherence in Adolescents and Young Adults With Mood Disorders: An Exploratory Randomized Controlled Trial
Medication nonadherence remains difficult to measure objectively in psychiatric care. This completed, single-center exploratory randomized trial evaluated whether four weeks of AI-enabled smartwatch medication monitoring improved clinician-rated medication adherence compared with waitlist usual care in psychiatric outpatients aged 12 years or older, predominantly adolescents and young adults with mood disorders.
Read the detailed description
This was a single-center, prospective, exploratory randomized controlled trial conducted in an outpatient psychiatric clinic. Participants aged 12 years or older were randomized 1:1 to an AI-enabled smartwatch medication-monitoring system or waitlist usual care for four weeks. Participants in both groups continued their usual psychiatric care, and no additional medication-adherence counseling was provided as part of the intervention.
Medication adherence was assessed at baseline and at Week 4 using the clinician-rated Korean Brief Adherence Rating Scale (K-BARS). The primary analysis compared the change in K-BARS score between the randomized groups. Control participants were offered the smartwatch for an additional four weeks after completing the randomized comparison period. Analyses of responder thresholds, device engagement, and the optional post-waitlist smartwatch period were exploratory.
The study was registered retrospectively after enrollment and study completion.
- Conditions
- Mood Disorders, Medication Adherence, Mental Disorders
- Being tested
- AI-enabled smartwatch
- Keywords
- psychiatry, medication adherence, wearable, smartwatch, randomized trial, artificial intelligence, digital health, young adult
- Medical subject headings
- Mood Disorders, Medication Adherence, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-enabled smartwatchDevice
The smartwatch was designed to detect medication-taking behavior using a built-in camera and electronic tags attached to medication containers. The camera remained inactive under ordinary conditions and captured a brief sequence only when container motion, ambient light, and close proximity between the watch and tag were detected concurrently. The captured sequence was processed by an artificial intelligence algorithm to classify whether a medication-taking event had occurred. Participants assigned to the intervention were instructed to wear the device for four weeks. The device provided monitoring only and delivered no reminders, alerts, counseling, or treatment recommendations.
| Study group | Role | What they receive |
|---|---|---|
| AI-enabled smartwatch | Experimental | Participants continued their usual psychiatric care and wore the AI-enabled smartwatch medication-monitoring system for four weeks. Electronic tags were attached to their active medication containers. The device did not provide medication reminders, adherence feedback, or additional counseling, and device-derived data were not returned to the treating clinician during the randomized comparison period. Receives: Device: AI-enabled smartwatch |
| Waitlist Usual Care | No intervention | Participants continued usual psychiatric care for four weeks without smartwatch monitoring or additional medication-adherence counseling. After completing the randomized comparison period, participants were offered optional use of the smartwatch for an additional four weeks. Data from this optional period were analyzed exploratorily. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Korean Brief Adherence Rating Scale Score at Week 4
Medication adherence was assessed using the clinician-rated Korean Brief Adherence Rating Scale (K-BARS). The clinician assessed the number of prescribed doses, the number of doses reportedly taken, and the frequency of missed doses over the preceding 28 days and integrated this information into a score ranging from 0% to 100%, with higher scores indicating greater medication adherence. For each participant, the change score was calculated as the Week 4 score minus the baseline score. The primary outcome was the difference in mean change score between the randomized groups.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start31 Dec 2022
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized 1:1 to the AI-enabled smartwatch intervention or waitlist usual care. The randomized comparison period lasted four weeks. At baseline, participants assigned to the intervention received smartwatch training, and electronic tags were attached to their active medication containers. Participants in both groups continued usual psychiatric care, with no additional medication-adherence counseling provided as part of the study. Medication adherence was assessed using the clinician-rated Korean Brief Adherence Rating Scale at baseline and Week 4. After completing the randomized comparison period, control participants were offered optional smartwatch monitoring for an additional four weeks; data from this optional period were analyzed exploratorily and were not part of the primary randomized comparison.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonkwang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Hoon Yoon, Wonkwang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455916
- Sponsor's protocol ID
- WKUH 2022-11-042
- Status last verified
- Aug 2026
- First submitted
- 25 Feb 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the participant consent documents did not include public or external sharing of de-identified individual-level data. Any future data sharing would require additional review and approval by the Institutional Review Board.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Effects of an AI-Enabled Smartwatch on Medication Adherence in Adolescents and Young Adults With Mood Disorders: An Exploratory Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07455916
- Acronym / sponsor ID
- WKUH 2022-11-042
- Conditions
- Mood Disorders, Medication Adherence, Mental Disorders
- Keywords
- psychiatry, medication adherence, wearable, smartwatch, randomized trial, artificial intelligence, digital health, young adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Wonkwang University HospitalUniversity, hospital or other
- Study start
- 31 Dec 2022 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Medication nonadherence remains difficult to measure objectively in psychiatric care. This completed, single-center exploratory randomized trial evaluated whether four weeks of AI-enabled smartwatch medication monitoring improved clinician-rated medication adherence compared with waitlist usual care in psychiatric outpatients aged 12 years or older, predominantly adolescents and young adults with mood disorders.
Detailed description
This was a single-center, prospective, exploratory randomized controlled trial conducted in an outpatient psychiatric clinic. Participants aged 12 years or older were randomized 1:1 to an AI-enabled smartwatch medication-monitoring system or waitlist usual care for four weeks. Participants in both groups continued their usual psychiatric care, and no additional medication-adherence counseling was provided as part of the intervention.
Medication adherence was assessed at baseline and at Week 4 using the clinician-rated Korean Brief Adherence Rating Scale (K-BARS). The primary analysis compared the change in K-BARS score between the randomized groups. Control participants were offered the smartwatch for an additional four weeks after completing the randomized comparison period. Analyses of responder thresholds, device engagement, and the optional post-waitlist smartwatch period were exploratory.
The study was registered retrospectively after enrollment and study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized 1:1 to the AI-enabled smartwatch intervention or waitlist usual care. The randomized comparison period lasted four weeks. At baseline, participants assigned to the intervention received smartwatch training, and electronic tags were attached to their active medication containers. Participants in both groups continued usual psychiatric care, with no additional medication-adherence counseling provided as part of the study. Medication adherence was assessed using the clinician-rated Korean Brief Adherence Rating Scale at baseline and Week 4. After completing the randomized comparison period, control participants were offered optional smartwatch monitoring for an additional four weeks; data from this optional period were analyzed exploratorily and were not part of the primary randomized comparison.
| Arm | Type | Receives |
|---|---|---|
| AI-enabled smartwatch | Experimental | Device: AI-enabled smartwatchParticipants continued their usual psychiatric care and wore the AI-enabled smartwatch medication-monitoring system for four weeks. Electronic tags were attached to their active medication containers. The device did not provide medication reminders, adherence feedback, or additional counseling, and device-derived data were not returned to the treating clinician during the randomized comparison period. |
| Waitlist Usual Care | No intervention | –Participants continued usual psychiatric care for four weeks without smartwatch monitoring or additional medication-adherence counseling. After completing the randomized comparison period, participants were offered optional use of the smartwatch for an additional four weeks. Data from this optional period were analyzed exploratorily. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 12 years or older
- Receiving outpatient psychiatric care at Wonkwang University Hospital
- Receiving at least one regularly prescribed psychotropic medication
- Willing and able to wear the study smartwatch and complete the study assessments
- Able to provide written informed consent; for minors, written assent and written consent from a parent or legal guardian were required
Key exclusion criteria (4 listed)
- Diagnosed congenital genetic disorder
- Clear history of acquired brain injury
- Seizure disorder or another neurological condition that could interfere with study participation
- Psychotic symptoms, aggression, or behavioral instability severe enough to prevent safe and stable smartwatch use or create a substantial risk of device damage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-enabled smartwatchThe smartwatch was designed to detect medication-taking behavior using a built-in camera and electronic tags attached to medication containers. The camera remained inactive under ordinary conditions and captured a brief sequence only when container motion, ambient light, and close proximity between the watch and tag were detected concurrently. The captured sequence was processed by an artificial intelligence algorithm to classify whether a medication-taking event had occurred. Participants assigned to the intervention were instructed to wear the device for four weeks. The device provided monitoring only and delivered no reminders, alerts, counseling, or treatment recommendations. | Device | AI-enabled smartwatch |
Primary outcome
Mean Change From Baseline in Korean Brief Adherence Rating Scale Score at Week 4
Time frame: Baseline and Week 4
Medication adherence was assessed using the clinician-rated Korean Brief Adherence Rating Scale (K-BARS). The clinician assessed the number of prescribed doses, the number of doses reportedly taken, and the frequency of missed doses over the preceding 28 days and integrated this information into a score ranging from 0% to 100%, with higher scores indicating greater medication adherence. For each participant, the change score was calculated as the Week 4 score minus the baseline score. The primary outcome was the difference in mean change score between the randomized groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the participant consent documents did not include public or external sharing of de-identified individual-level data. Any future data sharing would require additional review and approval by the Institutional Review Board.
Related trials for Mood Disorders
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-enabled smartwatch in people with Mood Disorders and Medication Adherence, run by Wonkwang University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Korean Brief Adherence Rating Scale Score at Week 4 (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.