Major Depressive DisorderASMA-DNCT05312203
Alleviating Stress by Mobile Application' for Depression
A study testing the App in people with Major Depressive Disorder, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
This study is a single-blind, multicenter, randomized, controlled crossover trial. The App, developed in South Korea, is an application that provides integrated interventions for stress reduction for the general population. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- the App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 May 2022to 31 Dec 2023
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between the ages of 19 and 65;
- Diagnosed with mild to moderate major depressive disorders in an expert interview evaluation according to the DSM-IV diagnostic criteria (Score of 7-24 on the Hamilton Rating Scale for Depression [HAM-D]);
- Stable medication for 28 days prior to study participation;
- Informed consent and voluntary participation.
Who cannot join
- Hard to use smart phone or unable to independently use Application;
- Diagnosed with severe major depressive disorder in an expert interview evaluation according to the DSM-5 diagnostic criteria (score of 25 or more on HAM-D);
- Severe mental disorders (current or in the past), including Major depressive disorder with psychotic features, bipolar affective disorder, personality disorder, obsessive compulsive disorder, autism spectrum disorder, substance use disorder;
- History of brain injury, epileptic seizures, intellectual disability, or cognitive disorders;
- History of severe physical disorders, including cancer, tuberculosis, severe cardiovascular disease, etc.
- Individuals participating in other cognitive behavioral therapy or activities related to stress relief
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Psychiatry, Korea University Guro Hospital
Seoul, Guro Gu, 08308
Junhyung Kim, MD, PhD, 010-9317-1776, jhcabilover@gmail.com
About this study
Official title: A Randomized Control Trial to Investigate the Effectiveness of Smart Mental Health Interventions for Stress Reduction(inMind) During the Pharmacological Treatment in Mild to Moderate Major Depressive Disorder.
This study is a single-blind, multicenter, randomized, controlled crossover trial. The App, developed in South Korea, is an application that provides integrated interventions for stress reduction for the general population. The App provides three contents based on MBSR, CBT, and relaxation sounds that are known to be effective in stress reduction ("Meditation category", "Cognitive approach", and "Relaxation Sound", respectively). Participants (n = 215) recruited via medical practitioner referral will be randomized to App first group (fAPP) or a waitlist crossover group (dAPP). Inclusion criteria are age 19-65; diagnosed with mild to moderate major depressive disorders (Score of 7-24 on the Hamilton Rating Scale for Depression); Stable medication for 28 days prior to study participation. The study was conducted over eight weeks, the fAPP group used The App for the first four weeks and the dAPP group for the next four weeks, and during all study periods, the participants received usual pharmacological treatment. Primary outcome measures are the Depression Anxiety Stress Scale-21. The analysis will use mixed-model repeated measures.
Read the detailed description
This study is a single-blind, multicenter, randomized, controlled crossover trial. All subjects who met the inclusion and exclusion criteria will be randomly assigned to the App first group (fAPP) and or a waitlist crossover group (dAPP). Due to the intervention's nature, this will be a single-blind study in which the results will be assessed blindly but participants will be aware of their group assignment. Participants assigned to fAPP group will use the App initially for 28 consecutive days (T1). During T1, participants assigned to the dAPP arm will maintain the usual treatment. After T1, during the next 28 consecutive days (T2) without washout period, dAPP will use the APP, and fAPP will only maintain the usual treatment. We assumed that there would be no carry-over effect as the App utilized in this study is not a curative treatment but rather a tool for relieving stress in patients with depression. Therefore, we decided to use a cross-over design without a wash-out period.
The three University Hospitals in the Republic of Korea participating in the study will recruit depressive patients for applying the App. The Korea University Guro Hospital and Korea University Anam Hospital are in the inner center of the Capital, and Korea University Ansan Hospital is in Ansan city, outskirts of the capital area. Each hospital is a general hospital, and the Korea University Guro Hospital will lead the ASMA-D study as. For patient recruitment, 96 patients (48 interventions and 48 controls) in the Korea University Guro Hospital and 60 patients (30 interventions and 30 controls) in each from Korea University Anam Hospital and Korea University Ansan Hospital will be expected.
Screening will begin for those who are interested in advertisements posted in the participating hospital among the depressive patients who visit the hospital. After interested patients will contact the research team. the patients will be screened for eligibility according to the above-described criteria by the psychiatrist. After eligibility is confirmed, details of study will be explained to potential participant. Once participant agrees to participate, Informed consent is obtained, patient is enrolled, and randomization only occurs after enrollment.
Successful volunteers will be randomly assigned to the fAPP of dAPP. Randomization is conducted using block randomization by each clinical center. To prevent bias towards one treatment group, eight patients will be configured in blocks and will be randomly assigned to groups fAPP and dAPP within each block. For consistent allocation, randomization will be done using a pre-built program. This program is created by Korea University Guro Hospital to blind the researcher from the information of assignment in advance.
Assessments are obtained clinician rating scale and self-rating scales during hospital visits. Assessments conducted at the hospital visit were acquired at the baseline (V0) and every two weeks (V1, V2, V3, and V4) during T1 and T2. The baseline assessments will be collected when participants are enrolled and include sociodemographic and clinical characteristics. All instruments have been translated to Korean with reliable psychometric properties. The data collection process implanted in the evaluation module of the mobile App will be activated through an ID issued after enrollment and randomization.
- Conditions
- Major Depressive Disorder
- Being tested
- the App
- Keywords
- Stress, Major depressive disorders, Mobile health, Mindfulness-based intervention, Cognitive-behavior therapy, Relaxation Therapy, Cost-effectiveness, Randomised controlled trial
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the AppOther
Also called Integrated mobile application for stress reduction, "inMind" (Demand, Republic of Korea, http://www.demand.co.kr)
The App provides content for mobile-based stress relief that can be used on most Android and iOS-based mobile devices. Content for stress relief consists of three modules; meditation, cognitive approach, and relaxation sounds. Additionally, the App includes the module for objective stress monitoring. The APP was originally designed and developed in Korean, but English, Chinese, and Japanese versions are also available. For use in the treatment environment, the manufacturer also provides a service that allows therapists to check their patients' application usage and their stress level measured by the stress monitoring module.
| Study group | Role | What they receive |
|---|---|---|
| the App first group (fAPP) | Other | Participants assigned to fAPP group will use the App initially for 28 consecutive days (T1). After T1, during the next 28 consecutive days (T2) without washout period, fAPP will only maintain the usual treatment. Receives: Other: the App |
| wait list crossover group (dAPP) | Other | During T1, participants assigned to the dAPP arm will maintain the usual treatment. After T1, during the next 28 consecutive days (T2) without washout period, dAPP will use the APP. Receives: Other: the App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression, Anxiety and Stress Scale (DASS-21)
DASS-21 is s a self-report measure of anxiety, depression and stress levels used in diverse settings developed by Lovibond [47]. The Korean version of DASS-21 was developed by Eun-Hyun Lee in 2018 [48]. This version was tested in Korean speaking samples and indicated that the items had been adequately and appropriately translated and adapted. Korean version of DASS-21 was tested in 481 Korean adults, the result showed that the Cronbach's α was 0.93.
Measured: Baseline / 2 week / 4 week / 6 week / 8 week
Secondary outcomes (5)
Change in Perceived stress scale (PSS)
The perceived stress scale (PSS) is used to measure the extent to which respondents feel that their stress is unpredictable, uncontrollable and overwhelming (e.g. In the last month, how often have you felt you were unable to control the important things in your life?) [49]. The validated Korean short version of the perceived stress scale (K-PSS) was used in the present study [50]. The K-PSS is a 10-item self-report questionnaire using a five-point Likert scale ranging from 0 (never) to 4 (very often). Total scores range from 0 to 40, with higher scores indicative of greater perceived stress (Cronbach's α = 0.819).
Measured: Baseline / 4 week / 8 week
Change in Posttraumatic embitterment disorders scale (PTED)
Post Traumatic Embitterment Disorder Self-Rating Scale (PTED Scale) is designed to assess the features of embitterment reactions to negative life events [51]. Consisting of 19 items, the PTED Scale asked participants to rate their reactions to each negative life event during recent years using a 5-point scale ranging from 0 (not true at all) to 4 (extremely true). A mean total score of 2.5 was used as a cut-off score to detect the clinically significant reactive embitterment [51]. The Korean version of the PTED Scale was translated and validated with good internal consistency (Cronbach's α = 0.962) [52].
Measured: Baseline / 4 week / 8 week
Change in 9-item Patient Health Questionnaire (PHQ-9)
The 9-item version of the Patient Health Questionnaire (PHQ-9) was developed from the historical Primary Care Evaluation of Mental Disorders (PRIME-MD), which was shortened to maximize clinical usefulness [53]. This measure has been widely used in primary care settings for psychiatric purposes, with major depression diagnosed if 5 or more of the 9 symptoms have been present more than half the days of the past 2 weeks, one of these symptoms being either depressed mood or anhedonia. Each item is rated on a scale from 0 to 3, and the total score can range from 0 to 27. The total scores of ≥5, ≥10 and ≥15 represent mild, moderate and severe levels of depression severity [54]. The Korean version of the PHQ-9 was translated and validated with good internal consistency (Cronbach's α = 0.86) [55].
Measured: Baseline / 2 week / 4 week / 6 week / 8 week
Change in Hamilton depression rating scale (HAM-D)
he Hamilton Depression Rating Scale (HAM-D) is an inventory of questions that is employed to detect and identify the intensity or severity of the signs and symptoms of depression in patients who have been diagnosed with clinical depression [56]. The 17-item version of the HAM-D is more commonly used than the 21-item version, which contains four additional items that measure symptoms related to depression, such as paranoia and obsession, rather than the severity of the depressive symptoms themselves. The Korean version of the HAM-D was translated and validated with good internal consistency (Cronbach's α = 0.76) [57].
Measured: Baseline / 2 week / 4 week / 6 week / 8 week
Intervention engagement
Activities on the application such as number of visits, time in-between logins and number of usages of each category, will be assessed through track and change functionalities (log files). Data on how patients use online modules (frequency, duration, order, completion), how they rate them and to what extent they adhere, will also be obtained through usage statistics on the App online server. All patient information from the server will be encrypted via Hypertext Transfer Protocol Secure which ensures no external parties are able to view it during transfer. Data access from server is also authenticated by a passphrase which is supplied from the Study coordinator, ensuring only the research assistants will be able to request and review patient data.
Measured: 4 week for fAPP 8 week for dAPP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start15 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a single-blind, multicenter, randomized, controlled crossover trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea
- Responsible party
- Principal investigator, Han, Chang Su, Korea University Guro Hospital
- Investigators
- Changsu Han, MD, PhD, Study chair, Department of Psychiatry, Korea University Guro Hospital, Korea University College of MedicineJunhyung Kim, MD, PhD, Principal investigator, Department of Psychiatry, Korea University Guro Hospital, Korea University College of MedicineCheolmin Shin, MD, PhD, Principal investigator, Department of Psychiatry, Korea University Ansan Hospital, Korea University College of MedicineKyu-Man Han, MD, PhD, Principal investigator, Department of Psychiatry, Korea University Anam Hospital, Korea University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312203
- Sponsor's protocol ID
- 2021GR0585
- Acronym
- ASMA-D
- Status last verified
- Nov 2023
- First submitted
- 23 Mar 2022
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and analyzed during the current study will be available from the corresponding author on reasonable request.
Publications
Kim J, Shin C, Han KM, Lee MS, Jeong HG, Pae CU, Patkar AA, Masand PM, Han C. Investigating the effectiveness of a smart mental health intervention (inMind) for stress reduction during pharmacological treatment for mild to moderate major depressive disorders: Study protocol for a randomized control trial. Front Psychiatry. 2023 Mar 14;14:1034246. doi: 10.3389/fpsyt.2023.1034246. eCollection 2023.
PubMed 36998625
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial to Investigate the Effectiveness of Smart Mental Health Interventions for Stress Reduction(inMind) During the Pharmacological Treatment in Mild to Moderate Major Depressive Disorder.
- ClinicalTrials.gov ID
- NCT05312203
- Acronym / sponsor ID
- ASMA-D / 2021GR0585
- Conditions
- Major Depressive Disorder
- Keywords
- Stress, Major depressive disorders, Mobile health, Mindfulness-based intervention, Cognitive-behavior therapy, Relaxation Therapy, Cost-effectiveness, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Ministry of Trade, Industry & Energy, Republic of Korea
- Study start
- 15 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Apr 2022 (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.
This study is a single-blind, multicenter, randomized, controlled crossover trial. The App, developed in South Korea, is an application that provides integrated interventions for stress reduction for the general population. The App provides three contents based on MBSR, CBT, and relaxation sounds that are known to be effective in stress reduction ("Meditation category", "Cognitive approach", and "Relaxation Sound", respectively). Participants (n = 215) recruited via medical practitioner referral will be randomized to App first group (fAPP) or a waitlist crossover group (dAPP). Inclusion criteria are age 19-65; diagnosed with mild to moderate major depressive disorders (Score of 7-24 on the Hamilton Rating Scale for Depression); Stable medication for 28 days prior to study participation. The study was conducted over eight weeks, the fAPP group used The App for the first four weeks and the dAPP group for the next four weeks, and during all study periods, the participants received usual pharmacological treatment. Primary outcome measures are the Depression Anxiety Stress Scale-21. The analysis will use mixed-model repeated measures.
Detailed description
This study is a single-blind, multicenter, randomized, controlled crossover trial. All subjects who met the inclusion and exclusion criteria will be randomly assigned to the App first group (fAPP) and or a waitlist crossover group (dAPP). Due to the intervention's nature, this will be a single-blind study in which the results will be assessed blindly but participants will be aware of their group assignment. Participants assigned to fAPP group will use the App initially for 28 consecutive days (T1). During T1, participants assigned to the dAPP arm will maintain the usual treatment. After T1, during the next 28 consecutive days (T2) without washout period, dAPP will use the APP, and fAPP will only maintain the usual treatment. We assumed that there would be no carry-over effect as the App utilized in this study is not a curative treatment but rather a tool for relieving stress in patients with depression. Therefore, we decided to use a cross-over design without a wash-out period.
The three University Hospitals in the Republic of Korea participating in the study will recruit depressive patients for applying the App. The Korea University Guro Hospital and Korea University Anam Hospital are in the inner center of the Capital, and Korea University Ansan Hospital is in Ansan city, outskirts of the capital area. Each hospital is a general hospital, and the Korea University Guro Hospital will lead the ASMA-D study as. For patient recruitment, 96 patients (48 interventions and 48 controls) in the Korea University Guro Hospital and 60 patients (30 interventions and 30 controls) in each from Korea University Anam Hospital and Korea University Ansan Hospital will be expected.
Screening will begin for those who are interested in advertisements posted in the participating hospital among the depressive patients who visit the hospital. After interested patients will contact the research team. the patients will be screened for eligibility according to the above-described criteria by the psychiatrist. After eligibility is confirmed, details of study will be explained to potential participant. Once participant agrees to participate, Informed consent is obtained, patient is enrolled, and randomization only occurs after enrollment.
Successful volunteers will be randomly assigned to the fAPP of dAPP. Randomization is conducted using block randomization by each clinical center. To prevent bias towards one treatment group, eight patients will be configured in blocks and will be randomly assigned to groups fAPP and dAPP within each block. For consistent allocation, randomization will be done using a pre-built program. This program is created by Korea University Guro Hospital to blind the researcher from the information of assignment in advance.
Assessments are obtained clinician rating scale and self-rating scales during hospital visits. Assessments conducted at the hospital visit were acquired at the baseline (V0) and every two weeks (V1, V2, V3, and V4) during T1 and T2. The baseline assessments will be collected when participants are enrolled and include sociodemographic and clinical characteristics. All instruments have been translated to Korean with reliable psychometric properties. The data collection process implanted in the evaluation module of the mobile App will be activated through an ID issued after enrollment and randomization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a single-blind, multicenter, randomized, controlled crossover trial.
| Arm | Type | Receives |
|---|---|---|
| the App first group (fAPP) | Other | Other: the AppParticipants assigned to fAPP group will use the App initially for 28 consecutive days (T1). After T1, during the next 28 consecutive days (T2) without washout period, fAPP will only maintain the usual treatment. |
| wait list crossover group (dAPP) | Other | Other: the AppDuring T1, participants assigned to the dAPP arm will maintain the usual treatment. After T1, during the next 28 consecutive days (T2) without washout period, dAPP will use the APP. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults between the ages of 19 and 65;
- Diagnosed with mild to moderate major depressive disorders in an expert interview evaluation according to the DSM-IV diagnostic criteria (Score of 7-24 on the Hamilton Rating Scale for Depression [HAM-D]);
- Stable medication for 28 days prior to study participation;
- Informed consent and voluntary participation.
Key exclusion criteria (6 listed)
- Hard to use smart phone or unable to independently use Application;
- Diagnosed with severe major depressive disorder in an expert interview evaluation according to the DSM-5 diagnostic criteria (score of 25 or more on HAM-D);
- Severe mental disorders (current or in the past), including Major depressive disorder with psychotic features, bipolar affective disorder, personality disorder, obsessive compulsive disorder, autism spectrum disorder, substance use disorder;
- History of brain injury, epileptic seizures, intellectual disability, or cognitive disorders;
- History of severe physical disorders, including cancer, tuberculosis, severe cardiovascular disease, etc.
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 |
|---|---|---|
| the AppAlso: Integrated mobile application for stress reduction, "inMind" (Demand, Republic of Korea, http://www.demand.co.kr)The App provides content for mobile-based stress relief that can be used on most Android and iOS-based mobile devices. Content for stress relief consists of three modules; meditation, cognitive approach, and relaxation sounds. Additionally, the App includes the module for objective stress monitoring. The APP was originally designed and developed in Korean, but English, Chinese, and Japanese versions are also available. For use in the treatment environment, the manufacturer also provides a service that allows therapists to check their patients' application usage and their stress level measured by the stress monitoring module. | Other | the App first group (fAPP), wait list crossover group (dAPP) |
Primary outcome
Change in Depression, Anxiety and Stress Scale (DASS-21)
Time frame: Baseline / 2 week / 4 week / 6 week / 8 week
DASS-21 is s a self-report measure of anxiety, depression and stress levels used in diverse settings developed by Lovibond [47]. The Korean version of DASS-21 was developed by Eun-Hyun Lee in 2018 [48]. This version was tested in Korean speaking samples and indicated that the items had been adequately and appropriately translated and adapted. Korean version of DASS-21 was tested in 481 Korean adults, the result showed that the Cronbach's α was 0.93.
5 secondary outcomes
Change in Perceived stress scale (PSS)
Time frame: Baseline / 4 week / 8 week
Change in Posttraumatic embitterment disorders scale (PTED)
Time frame: Baseline / 4 week / 8 week
Change in 9-item Patient Health Questionnaire (PHQ-9)
Time frame: Baseline / 2 week / 4 week / 6 week / 8 week
Change in Hamilton depression rating scale (HAM-D)
Time frame: Baseline / 2 week / 4 week / 6 week / 8 week
Intervention engagement
Time frame: 4 week for fAPP 8 week for dAPP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Derived from this study: PubMed 36998625Kim J, Shin C, Han KM, Lee MS, Jeong HG, Pae CU, Patkar AA, Masand PM, Han C. Investigating the effectiveness of a smart mental health intervention (inMind) for stress reduction during pharmacological treatment for mild to moderate major depressive disorders: Study protocol for a randomized control trial. Front Psychiatry. 2023 Mar 14;14:1034246. doi: 10.3389/fpsyt.2023.1034246. eCollection 2023.
- Individual participant dataSharing planned: Yes. The datasets used and analyzed during the current study will be available from the corresponding author on reasonable request.
Related trials for Major Depressive Disorder
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
RecruitingPhase 1
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
Healthy Volunteer, Major Depressive Disorder
Recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
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.
Changsu Han, MD, PhD study chair
Department of Psychiatry, Korea University Guro Hospital, Korea University College of Medicine
Junhyung Kim, MD, PhD principal investigator
Department of Psychiatry, Korea University Guro Hospital, Korea University College of Medicine
Cheolmin Shin, MD, PhD principal investigator
Department of Psychiatry, Korea University Ansan Hospital, Korea University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the App in people with Major Depressive Disorder, run by Korea University Guro 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junhyung Kim, MD, PhD (10-9317-1776 ext. 82, jhcabilover@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression, Anxiety and Stress Scale (DASS-21) (time frame: Baseline / 2 week / 4 week / 6 week / 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05312203, which also lists 1 linked publication.
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 2 Nov 2023.