Panic DisorderMeltzNCT07892885
A Clinical Trial to Evaluate the Efficacy and Safety of Meltz, a Digital Therapeutic Device, for Improving Panic Symptoms in Patients With Panic Disorder
A study testing Meltz in people with Panic Disorder and Agoraphobia, run by AIMNEXT.
Trial summary
i. This randomized clinical trial will evaluate the efficacy and safety of Meltz, a digital therapeutic device that provides cognitive behavioral therapy (CBT) for adults with panic disorder. ii. Participants will be randomly assigned to use either Meltz or a sham application. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Panic Disorder, Agoraphobia
- What is being tested?
- Meltz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female participants aged 19 years or older and under 65 years at the time of providing written informed consent.
- Participants who meet the DSM-5 diagnostic criteria for panic disorder or have a diagnosis corresponding to one or more of the following ICD-10 codes:
- F41.0: Panic disorder / panic attack / panic state F40.0: Agoraphobia / agoraphobia without a history of panic disorder / panic disorder with agoraphobia 3. Participants with a score on the Korean version of the Panic Disorder Severity Scale-Self Report (PDSS-SR) meeting the following criteria according to the presence or absence of agoraphobia: Without agoraphobia: ≥6 points With agoraphobia: ≥8 points 4. Participants who have no difficulty reading and writing Korean. 5. Participants who have no difficulty using a smartphone application. 6. Participants who, after receiving sufficient information about the clinical trial and fully understanding the information provided, voluntarily decide to participate, provide written informed consent, and agree to comply with the study requirements and instructions
Who cannot join
- -
- Participants who have any of the following psychiatric conditions at the time of providing written informed consent
- : Schizophrenia spectrum disorders, a manic episode, a major depressive episode, or substance use disorders
- Participants who have a lifetime history of any of the following psychiatric diagnoses as of the date of written informed consent
- : Schizophrenia spectrum disorders or substance use disorders
- However, participants with alcohol use disorder (AUD) may be included if the disorder is classified as mild according to the DSM-5 diagnostic criteria, they have no history of hospitalization or emergency department visits due to alcohol-related problems within the 3 months prior to providing written informed consent, and the investigator determines, based on medical judgment, that the condition would not interfere with the participant's ability to comply with the requirements of the clinical trial.
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- Participants who, at the time of providing written informed consent, have a medical condition that is uncontrolled or severe enough to require hospitalization.
- Participants who have attempted suicide within the 3 months prior to providing written informed consent and are assessed by a psychiatrist as being at high risk of suicide.
- Participants who have newly initiated another cognitive behavioral therapy (CBT) within the 3 months prior to providing written informed consent or who are currently receiving another CBT intervention, including CBT for panic disorder or any other condition.
- Participants with visual or hearing impairment, or cognitive impairment (e.g., intellectual disability or dementia).
- Participants who, within the 4 weeks prior to screening, have had a change in the type, dosage, or dosing regimen of any medication they are taking.
- However, participants meeting any of the following conditions may participate in the clinical trial:
- 4) Background therapy: Participants taking psychiatric medication for the management of panic symptoms may participate if the type, dosage, and dosing regimen of the medication have remained unchanged for at least 4 weeks prior to screening.
- 5) Pro re nata (PRN) medication: Participants using PRN medication for the relief of acute panic symptoms may participate even if there has been a change in the type, dosage, or dosing regimen of such PRN medication within the 4 weeks prior to screening.
- 6) Non-psychiatric medications:
- Medications for chronic medical conditions: Participants taking non-psychiatric medications for the treatment of underlying chronic medical conditions, such as hypertension, diabetes mellitus, or dyslipidemia, that are not expected to directly affect the assessment of panic symptoms may participate if the dosage and dosing regimen have remained unchanged for at least 4 weeks.
- Medications for transient symptoms: Participants who have taken short-term medications within the 4 weeks prior to screening for the relief of transient symptoms, such as a common cold, mild pain, or indigestion, that are not expected to directly affect the assessment of panic symptoms may participate.
- 8. Participants who, in the investigator's judgment, are considered unsuitable for participation in this clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Prospective, Randomized, Sham-controlled, Single-blind, Superiority, Pivotal Clinical Trial to Evaluate the Efficacy, Assessed by the Panic Disorder Severity Scale-Self Report, and Safety of the 'Meltz' Digital Therapeutics for Improving Panic Symptoms in Patients Diagnosed With Panic Disorder
- This randomized clinical trial will evaluate the efficacy and safety of Meltz, a digital therapeutic device that provides cognitive behavioral therapy (CBT) for adults with panic disorder. ii. Participants will be randomly assigned to use either Meltz or a sham application. Meltz provides personalized CBT for panic disorder through a smartphone application, while the sham application is similar in appearance and manner of use but does not provide the core therapeutic functions of Meltz. The treatment program is completed within 8 to 10 weeks depending on each participant's treatment progress. iii. This study will evaluate whether Meltz is more effective than the sham application in improving panic symptoms. The primary outcome is the change from baseline to Week 10 in the total score of the Panic Disorder Severity Scale-Self Report (PDSS-SR), a questionnaire used to assess the severity of panic disorder symptoms. The safety of Meltz will also be evaluated based on adverse events reported during the clinical trial.
- Conditions
- Panic Disorder, Agoraphobia
- Being tested
- Meltz, Sham Application
- Keywords
- Digital Therapeutics, Cognitive Behavioral Therapy, Digital Phenotyping, Personalized Intervention, Panic Symptoms, Agoraphobic Symptoms, Anxiety Symptoms
- Medical subject headings
- Panic Disorder, Agoraphobia, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeltzDevice
Meltz is a software-based digital therapeutic device that provides personalized cognitive behavioral therapy for panic disorder (CBT-P). The program includes psychoeducation, self-monitoring, cognitive restructuring, exposure to fear cues, modification of anxiety-maintaining behaviors, relaxation training, and relapse prevention. Meltz also provides educational content, real-time feedback, behavioral interventions, and push notifications to support treatment adherence.
Sham ApplicationDevice
The sham application is similar to Meltz in appearance and manner of use but does not provide the core therapeutic functions of Meltz. It does not provide CBT-P treatment content, personalized treatment recommendations based on treatment progress, real-life exposure training, or prediction checklist completion. It provides only management functions, including psychological questionnaires and mood and panic records.
| Study group | Role | What they receive |
|---|---|---|
| Meltz | Experimental | Participants assigned to the Meltz group use the Meltz digital therapeutic device. The program provides personalized cognitive behavioral therapy for panic disorder (CBT-P) through a smartphone application and is completed within 8 to 10 weeks depending on each participant's treatment progress. Receives: Device: Meltz |
| Sham Control | Sham comparator | An interventional study must have at least one arm with Arm Type other than Placebo Comparator or Sham Comparator. Receives: Device: Sham Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Panic Disorder Severity Scale-Self Report (PDSS-SR) Total Score at End of Treatment
The Panic Disorder Severity Scale-Self Report (PDSS-SR) is a 7-item self-report measure used by participants to assess the severity of panic disorder. Each item is rated from 0 to 4 based on experiences during the previous week, yielding a total score ranging from 0 to 28. Lower total scores indicate greater improvement or alleviation of panic symptoms.
Measured: Baseline and Week 10
Secondary outcomes (14)
Proportion of Participants with a ≥40% Reduction in PDSS-SR Total Score
The proportion of participants with a ≥40% reduction in the PDSS-SR total score from baseline at 10 weeks after application of the investigational or comparator device.
Measured: Baseline and Week 10
Proportion of Participants with a PDSS-SR Total Score ≤5
Proportion of Participants with a PDSS-SR Total Score ≤5 The proportion of participants with a PDSS-SR total score ≤5 at 10 weeks after application of the investigational or comparator device.
Measured: Week 10
Change in Panic Disorder Severity Scale (PDSS) Total Score
The PDSS consists of the same 7 items as the PDSS-SR but is administered by a clinician through a structured interview. Each item is rated from 0 to 4, yielding a total score ranging from 0 to 28. Lower total scores indicate improvement or alleviation of panic symptoms. The criteria for interpreting the total score are the same as those for the PDSS-SR.
Measured: Baseline and Week 10
Change in State-Trait Anxiety Inventory (STAI) State Anxiety Score
The State-Trait Anxiety Inventory (STAI) assesses anxiety in two dimensions: anxiety as a temporary emotional state (state anxiety, STAI-1) and anxiety as a persistent personality trait (trait anxiety, STAI-2). STAI-1 consists of 20 items, with a total score ranging from 20 to 80. Lower scores indicate improvement or alleviation of anxiety. Positively worded items (e.g., "I feel calm") are reverse-scored.
Measured: Baseline and Week 10
Change in State-Trait Anxiety Inventory (STAI) Trait Anxiety Score
The State-Trait Anxiety Inventory (STAI) assesses anxiety in two dimensions: anxiety as a temporary emotional state (state anxiety, STAI-1) and anxiety as a persistent personality trait (trait anxiety, STAI-2). STAI-2 consists of 20 items, with a total score ranging from 20 to 80. Lower scores indicate improvement or alleviation of anxiety. Positively worded items are reverse-scored.
Measured: Baseline and Week 10
Change in Agoraphobic Cognitions Questionnaire (ACQ) Score
The Agoraphobic Cognitions Questionnaire (ACQ) is a 14-item measure that assesses the frequency of catastrophic thoughts that spontaneously occur when a person feels anxious or tense. Each item is rated from 1 to 5 according to how often the thought occurs during an anxious state. Lower scores indicate a reduction in the frequency of catastrophic cognitions and improvement in cognitive symptoms.
Measured: Baseline and Week 10
Change in Albany Panic and Phobia Questionnaire (APPQ) Score
The Albany Panic and Phobia Questionnaire (APPQ) is a 27-item measure that assesses fear and avoidance related to panic- and phobia-related situations. Each item is rated from 0 to 8 according to the current level of fear and avoidance associated with the situation. The APPQ consists of three subscales: agoraphobia (14 items), social phobia (8 items), and interoceptive fear (5 items). Each subscale score is calculated by summing the corresponding item scores. Lower total and subscale scores indicate reduced fear and avoidance behavior and clinically meaningful improvement.
Measured: Baseline and Week 10
Change in Generalized Anxiety Disorder-7 (GAD-7) Total Score
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure that assesses the severity of generalized anxiety disorder and general anxiety symptoms. Each item is rated from 0 to 3 based on experiences during the previous 2 weeks, yielding a total score ranging from 0 to 21.
Measured: Baseline and Week 10
Change in Patient Health Questionnaire-9 (PHQ-9) Total Score
The Patient Health Questionnaire-9 (PHQ-9) is a self-report measure of the severity of depressive symptoms and assesses the nine symptoms of a depressive episode based on DSM diagnostic criteria. Each item is rated from 0 to 3 based on experiences during the previous 2 weeks, yielding a total score ranging from 0 to 27.
Measured: Baseline and Week 10
Change in EuroQol 5-Dimension Score
The EuroQol 5-Dimension (EQ-5D) is a self-report measure of health-related quality of life (HRQoL) consisting of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is assessed on five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems (levels 1-5).
Measured: Baseline and Week 10
Change in Clinical Global Impression-Severity (CGI-S) Score
The Clinical Global Impression-Severity (CGI-S) is a clinician-rated scale that assesses the severity of illness. Scores are rated as follows: 0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients.
Measured: Baseline and Week 10
Clinical Global Impression-Improvement (CGI-I) Score
The Clinical Global Impression-Improvement (CGI-I) is a clinician-rated scale that assesses overall change relative to baseline. No separate baseline CGI-I assessment is performed, and the CGI-I score is assessed at Week 10. Scores are rated as follows: 0 = Not assessed; 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse.
Measured: Week 10
Change in Panic Disorder Severity Scale-Self Report (PDSS-SR) Total Score at End of Study
The Panic Disorder Severity Scale-Self Report (PDSS-SR) is a 7-item self-report measure used by participants to assess the severity of panic disorder. Each item is rated from 0 to 4 based on experiences during the previous week, yielding a total score ranging from 0 to 28. Lower total scores indicate greater improvement or alleviation of panic symptoms.
Measured: Baseline and Week 18
Overall Cumulative Treatment Adherence
Adherence data are continuously collected and reviewed throughout the treatment period, and overall cumulative treatment adherence is calculated at Visit 6 using data accumulated from Visit 2 through Visit 6. For participants in the Meltz group, adherence is based on the number of completed treatment stages out of 77 total assigned stages. For participants in the sham control group, adherence is based on the number of days on which at least one mood or panic diary entry is completed during the period from Visit 2 through Visit 6
Measured: From treatment initiation (Visit 2) through Week 10 (Visit 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Panic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AIMNEXT
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Anam Hospital, Kangbuk Samsung Hospital, National Traffic Injury Rehabilitation Hospital, CHA University
- Responsible party
- Sponsor
- Investigators
- Cheolhyeon Cho, Principal investigator, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892885
- Sponsor's protocol ID
- AM-IS-06
- Other IDs
- Government
- Acronym
- Meltz
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Oromendia P, Orrego J, Bonillo A, Molinuevo B. Internet-based self-help treatment for panic disorder: a randomized controlled trial comparing mandatory versus optional complementary psychological support. Cogn Behav Ther. 2016 Jun;45(4):270-86. doi: 10.1080/16506073.2016.1163615. Epub 2016 Mar 23.
PubMed 27007256Allen AR, Newby JM, Mackenzie A, Smith J, Boulton M, Loughnan SA, Andrews G. Internet cognitive-behavioural treatment for panic disorder: randomised controlled trial and evidence of effectiveness in primary care. BJPsych Open. 2016 Mar 24;2(2):154-162. doi: 10.1192/bjpo.bp.115.001826. eCollection 2016 Mar.
PubMed 27703768Barlow DH, Gorman JM, Shear MK, Woods SW. Cognitive-behavioral therapy, imipramine, or their combination for panic disorder: A randomized controlled trial. JAMA. 2000 May 17;283(19):2529-36. doi: 10.1001/jama.283.19.2529.
PubMed 10815116Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. doi: 10.1016/0197-2456(89)90005-6.
PubMed 2691207Kim SH, Ahn J, Ock M, Shin S, Park J, Luo N, Jo MW. The EQ-5D-5L valuation study in Korea. Qual Life Res. 2016 Jul;25(7):1845-52. doi: 10.1007/s11136-015-1205-2. Epub 2016 Mar 10.
PubMed 2696100839. Kazantzis N, Whittington C, Dattilio F. Meta-Analysis of Homework Effects in Cognitive and Behavioral Therapy: A Replication and Extension. Clin Psychol Sci Prac. 2010;17(2):144-156.
Sandell R, Svensson M, Nilsson T, Johansson H, Viborg G, Perrin S. The POSE study - panic control treatment versus panic-focused psychodynamic psychotherapy under randomized and self-selection conditions: study protocol for a randomized controlled trial. Trials. 2015 Mar 31;16:130. doi: 10.1186/s13063-015-0656-7.
PubMed 2587306737. 서호석, 이재헌, 김민숙, 김민경. 공황장애의 한국형 최신 치료지침. J Korean Med Assoc. 2018;61(8):493-499.
Furukawa TA, Katherine Shear M, Barlow DH, Gorman JM, Woods SW, Money R, Etschel E, Engel RR, Leucht S. Evidence-based guidelines for interpretation of the Panic Disorder Severity Scale. Depress Anxiety. 2009;26(10):922-9. doi: 10.1002/da.20532.
PubMed 1900619834. 대한민국정부. 디지털의료제품법 (법률 제20331호). 2025.
33. Y Byeon, JY Lee. Current Status of Digital Therapeutic Devices in Cognitive Intervention in South Korea. J Cogn Interv Digital Health. 2025;4(1):11-19.
Carl JR, Miller CB, Henry AL, Davis ML, Stott R, Smits JAJ, Emsley R, Gu J, Shin O, Otto MW, Craske MG, Saunders KEA, Goodwin GM, Espie CA. Efficacy of digital cognitive behavioral therapy for moderate-to-severe symptoms of generalized anxiety disorder: A randomized controlled trial. Depress Anxiety. 2020 Dec;37(12):1168-1178. doi: 10.1002/da.23079. Epub 2020 Jul 29.
PubMed 32725848Sheikh JI, Leskin GA, Klein DF. Gender differences in panic disorder: findings from the National Comorbidity Survey. Am J Psychiatry. 2002 Jan;159(1):55-8. doi: 10.1176/appi.ajp.159.1.55.
PubMed 11772690Kim JE, Song IH, Lee SH. Gender Differences of Stressful Life Events, Coping Style, Symptom Severity, and Health-Related Quality of Life in Patients With Panic Disorder. J Nerv Ment Dis. 2017 Sep;205(9):714-719. doi: 10.1097/NMD.0000000000000696.
PubMed 2860931129. Doug-Woong Hahn, Chang Ho Lee, & Kyum Koo Chon. (1996). Korean Adaptation of Spielberger's STAI (K-STAI). The Korean Journal of Health Psychology, 1(1), 1-14.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Sham-controlled, Single-blind, Superiority, Pivotal Clinical Trial to Evaluate the Efficacy, Assessed by the Panic Disorder Severity Scale-Self Report, and Safety of the 'Meltz' Digital Therapeutics for Improving Panic Symptoms in Patients Diagnosed With Panic Disorder
- ClinicalTrials.gov ID
- NCT07892885
- Acronym / sponsor ID
- Meltz / AM-IS-06
- Conditions
- Panic Disorder, Agoraphobia
- Keywords
- Digital Therapeutics, Cognitive Behavioral Therapy, Digital Phenotyping, Personalized Intervention, Panic Symptoms, Agoraphobic Symptoms, Anxiety Symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AIMNEXTUniversity, hospital or other
- Collaborators
- Korea University Anam Hospital, Kangbuk Samsung Hospital, National Traffic Injury Rehabilitation Hospital, CHA University
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Oct 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.
- This randomized clinical trial will evaluate the efficacy and safety of Meltz, a digital therapeutic device that provides cognitive behavioral therapy (CBT) for adults with panic disorder. ii. Participants will be randomly assigned to use either Meltz or a sham application. Meltz provides personalized CBT for panic disorder through a smartphone application, while the sham application is similar in appearance and manner of use but does not provide the core therapeutic functions of Meltz. The treatment program is completed within 8 to 10 weeks depending on each participant's treatment progress. iii. This study will evaluate whether Meltz is more effective than the sham application in improving panic symptoms. The primary outcome is the change from baseline to Week 10 in the total score of the Panic Disorder Severity Scale-Self Report (PDSS-SR), a questionnaire used to assess the severity of panic disorder symptoms. The safety of Meltz will also be evaluated based on adverse events reported during the clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meltz | Experimental | Device: MeltzParticipants assigned to the Meltz group use the Meltz digital therapeutic device. The program provides personalized cognitive behavioral therapy for panic disorder (CBT-P) through a smartphone application and is completed within 8 to 10 weeks depending on each participant's treatment progress. |
| Sham Control | Sham comparator | Device: Sham ApplicationAn interventional study must have at least one arm with Arm Type other than Placebo Comparator or Sham Comparator. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female participants aged 19 years or older and under 65 years at the time of providing written informed consent.
- Participants who meet the DSM-5 diagnostic criteria for panic disorder or have a diagnosis corresponding to one or more of the following ICD-10 codes:
- F41.0: Panic disorder / panic attack / panic state F40.0: Agoraphobia / agoraphobia without a history of panic disorder / panic disorder with agoraphobia 3. Participants with a score on the Korean version of the Panic Disorder Severity Scale-Self Report (PDSS-SR) meeting the following criteria according to the presence or absence of agoraphobia: Without agoraphobia: ≥6 points With agoraphobia: ≥8 points 4. Participants who have no difficulty reading and writing Korean. 5. Participants who have no difficulty using a smartphone application. 6. Participants who, after receiving sufficient information about the clinical trial and fully understanding the information provided, voluntarily decide to participate, provide written informed consent, and agree to comply with the study requirements and instructions
Key exclusion criteria (18 listed)
- -
- Participants who have any of the following psychiatric conditions at the time of providing written informed consent
- : Schizophrenia spectrum disorders, a manic episode, a major depressive episode, or substance use disorders
- Participants who have a lifetime history of any of the following psychiatric diagnoses as of the date of written informed consent
- : Schizophrenia spectrum disorders or substance use disorders
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 |
|---|---|---|
| MeltzMeltz is a software-based digital therapeutic device that provides personalized cognitive behavioral therapy for panic disorder (CBT-P). The program includes psychoeducation, self-monitoring, cognitive restructuring, exposure to fear cues, modification of anxiety-maintaining behaviors, relaxation training, and relapse prevention. Meltz also provides educational content, real-time feedback, behavioral interventions, and push notifications to support treatment adherence. | Device | Meltz |
| Sham ApplicationThe sham application is similar to Meltz in appearance and manner of use but does not provide the core therapeutic functions of Meltz. It does not provide CBT-P treatment content, personalized treatment recommendations based on treatment progress, real-life exposure training, or prediction checklist completion. It provides only management functions, including psychological questionnaires and mood and panic records. | Device | Sham Control |
Primary outcome
Change in Panic Disorder Severity Scale-Self Report (PDSS-SR) Total Score at End of Treatment
Time frame: Baseline and Week 10
The Panic Disorder Severity Scale-Self Report (PDSS-SR) is a 7-item self-report measure used by participants to assess the severity of panic disorder. Each item is rated from 0 to 4 based on experiences during the previous week, yielding a total score ranging from 0 to 28. Lower total scores indicate greater improvement or alleviation of panic symptoms.
14 secondary outcomes
Proportion of Participants with a ≥40% Reduction in PDSS-SR Total Score
Time frame: Baseline and Week 10
Proportion of Participants with a PDSS-SR Total Score ≤5
Time frame: Week 10
Change in Panic Disorder Severity Scale (PDSS) Total Score
Time frame: Baseline and Week 10
Change in State-Trait Anxiety Inventory (STAI) State Anxiety Score
Time frame: Baseline and Week 10
Change in State-Trait Anxiety Inventory (STAI) Trait Anxiety Score
Time frame: Baseline and Week 10
Change in Agoraphobic Cognitions Questionnaire (ACQ) Score
Time frame: Baseline and Week 10
Change in Albany Panic and Phobia Questionnaire (APPQ) Score
Time frame: Baseline and Week 10
Change in Generalized Anxiety Disorder-7 (GAD-7) Total Score
Time frame: Baseline and Week 10
Change in Patient Health Questionnaire-9 (PHQ-9) Total Score
Time frame: Baseline and Week 10
Change in EuroQol 5-Dimension Score
Time frame: Baseline and Week 10
Change in Clinical Global Impression-Severity (CGI-S) Score
Time frame: Baseline and Week 10
Clinical Global Impression-Improvement (CGI-I) Score
Time frame: Week 10
Change in Panic Disorder Severity Scale-Self Report (PDSS-SR) Total Score at End of Study
Time frame: Baseline and Week 18
Overall Cumulative Treatment Adherence
Time frame: From treatment initiation (Visit 2) through Week 10 (Visit 6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 27007256Oromendia P, Orrego J, Bonillo A, Molinuevo B. Internet-based self-help treatment for panic disorder: a randomized controlled trial comparing mandatory versus optional complementary psychological support. Cogn Behav Ther. 2016 Jun;45(4):270-86. doi: 10.1080/16506073.2016.1163615. Epub 2016 Mar 23.
- Background: PubMed 27703768Allen AR, Newby JM, Mackenzie A, Smith J, Boulton M, Loughnan SA, Andrews G. Internet cognitive-behavioural treatment for panic disorder: randomised controlled trial and evidence of effectiveness in primary care. BJPsych Open. 2016 Mar 24;2(2):154-162. doi: 10.1192/bjpo.bp.115.001826. eCollection 2016 Mar.
- Background: PubMed 10815116Barlow DH, Gorman JM, Shear MK, Woods SW. Cognitive-behavioral therapy, imipramine, or their combination for panic disorder: A randomized controlled trial. JAMA. 2000 May 17;283(19):2529-36. doi: 10.1001/jama.283.19.2529.
- Background: PubMed 2691207Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989 Dec;10(4):407-15. doi: 10.1016/0197-2456(89)90005-6.
- Background: PubMed 26961008Kim SH, Ahn J, Ock M, Shin S, Park J, Luo N, Jo MW. The EQ-5D-5L valuation study in Korea. Qual Life Res. 2016 Jul;25(7):1845-52. doi: 10.1007/s11136-015-1205-2. Epub 2016 Mar 10.
- Background39. Kazantzis N, Whittington C, Dattilio F. Meta-Analysis of Homework Effects in Cognitive and Behavioral Therapy: A Replication and Extension. Clin Psychol Sci Prac. 2010;17(2):144-156.
- Background: PubMed 25873067Sandell R, Svensson M, Nilsson T, Johansson H, Viborg G, Perrin S. The POSE study - panic control treatment versus panic-focused psychodynamic psychotherapy under randomized and self-selection conditions: study protocol for a randomized controlled trial. Trials. 2015 Mar 31;16:130. doi: 10.1186/s13063-015-0656-7.
- Background37. 서호석, 이재헌, 김민숙, 김민경. 공황장애의 한국형 최신 치료지침. J Korean Med Assoc. 2018;61(8):493-499.
- Background: PubMed 19006198Furukawa TA, Katherine Shear M, Barlow DH, Gorman JM, Woods SW, Money R, Etschel E, Engel RR, Leucht S. Evidence-based guidelines for interpretation of the Panic Disorder Severity Scale. Depress Anxiety. 2009;26(10):922-9. doi: 10.1002/da.20532.
- Background34. 대한민국정부. 디지털의료제품법 (법률 제20331호). 2025.
- Background33. Y Byeon, JY Lee. Current Status of Digital Therapeutic Devices in Cognitive Intervention in South Korea. J Cogn Interv Digital Health. 2025;4(1):11-19.
- Background: PubMed 32725848Carl JR, Miller CB, Henry AL, Davis ML, Stott R, Smits JAJ, Emsley R, Gu J, Shin O, Otto MW, Craske MG, Saunders KEA, Goodwin GM, Espie CA. Efficacy of digital cognitive behavioral therapy for moderate-to-severe symptoms of generalized anxiety disorder: A randomized controlled trial. Depress Anxiety. 2020 Dec;37(12):1168-1178. doi: 10.1002/da.23079. Epub 2020 Jul 29.
- 35\. 대한디지털헬스학회. 디지털의료기기 허가 및 심사 가이드라인. 대한디지털헬스학회. Accessed April 21, 2026.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Cheolhyeon Cho principal investigator
Korea University Anam Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Meltz in people with Panic Disorder and Agoraphobia, run by AIMNEXT.
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 3 inclusion and 18 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: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheolhyeon Coordinating Investigator (82+02-920-5505, david0203@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Panic Disorder Severity Scale-Self Report (PDSS-SR) Total Score at End of Treatment (time frame: Baseline and Week 10). 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 NCT07892885, which also lists 42 linked publications.
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 23 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.