A Clinical Trial to Evaluate the Efficacy and Safety of Meltz, a Digital Therapeutic Device, for Improving Panic Symptoms in Patients With Panic Disorder

NCT07892885 | Not Yet Recruiting

• 2 other identifiers: AM-IS-06Government
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

Digital Therapeutics; Cognitive Behavioral Therapy; Digital Phenotyping; Personalized Intervention; Panic Symptoms; Agoraphobic Symptoms; Anxiety Symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 10

Secondary Outcomes (14)

• Proportion of Participants with a ≥40% Reduction in PDSS-SR Total Score

  Baseline and Week 10

• Proportion of Participants with a PDSS-SR Total Score ≤5

  Week 10

• Change in Panic Disorder Severity Scale (PDSS) Total Score

  Baseline and Week 10

• Change in State-Trait Anxiety Inventory (STAI) State Anxiety Score

  Baseline and Week 10

• Change in State-Trait Anxiety Inventory (STAI) Trait Anxiety Score

  Baseline and Week 10

Study Arms (2)

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.

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.

Device: Sham Application

Interventions

Meltz DEVICE

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.

Meltz

Sham Application DEVICE

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.

Sham Control

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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:
• \) 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.
• \) 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.
• \) 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.

Sponsors & Collaborators

• AIMNEXT: lead
• Korea University Anam Hospital: collaborator
• Kangbuk Samsung Hospital: collaborator
• National Traffic Injury Rehabilitation Hospital: collaborator
• CHA University: collaborator

Related Publications (42)

• 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.

  PMID: 27007256 BACKGROUND

• Allen 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.

  PMID: 27703768 BACKGROUND

• Barlow 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.

  PMID: 10815116 BACKGROUND

• Jaeschke 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.

  PMID: 2691207 BACKGROUND

• Kim 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.

  PMID: 26961008 BACKGROUND

• 39. 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

• 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.

  PMID: 25873067 BACKGROUND

• 37. 서호석, 이재헌, 김민숙, 김민경. 공황장애의 한국형 최신 치료지침. J Korean Med Assoc. 2018;61(8):493-499.

  BACKGROUND

• 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.

  PMID: 19006198 BACKGROUND

• 34. 대한민국정부. 디지털의료제품법 (법률 제20331호). 2025.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 32725848 BACKGROUND

• Sheikh 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.

  PMID: 11772690 BACKGROUND

• Kim 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.

  PMID: 28609311 BACKGROUND

• 29. 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.

  BACKGROUND

• 28. Spielberger, C. D., Gorsuch, R. L., & Lushene. R. E. (1970). Manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press.

  BACKGROUND

• 27. KIM, JI HAE; Jong-Chul Yang; Kim, Jung Bum; Ki-Young Lim; 이소영; 유범희. A Validation Study of Korean Albany Panic and Phobia Questionnaire (APPQ). JOURNAL OF THE KOREAN NEUROPSYCHIATRIC ASSOCIATION. 2004; 43(3) 329-336.

  BACKGROUND

• 26. Ho Taek Won, Hyun Soon Park, & Seok Man Kwon. (1995). A Study on the development of the Korean versions of Panic Scales. The Korean Journal of Clinical Psychology, 14(1), 95-110.

  BACKGROUND

• Chambless DL, Caputo GC, Bright P, Gallagher R. Assessment of fear of fear in agoraphobics: the body sensations questionnaire and the agoraphobic cognitions questionnaire. J Consult Clin Psychol. 1984 Dec;52(6):1090-7. doi: 10.1037//0022-006x.52.6.1090. No abstract available.

  PMID: 6520279 BACKGROUND

• 24. Guy, W. (1976). ECDEU assessment manual for psychopharmacology. US Department of Health, Education, and Welfare.

  BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• 21. Roy-Byrne, P. P., et al. (2005). Comorbidity of panic disorder with psychiatric and physical illnesses. The Journal of Clinical Psychiatry, 66(Suppl 4), 14-19.

  BACKGROUND

• Houck PR, Spiegel DA, Shear MK, Rucci P. Reliability of the self-report version of the panic disorder severity scale. Depress Anxiety. 2002;15(4):183-5. doi: 10.1002/da.10049.

  PMID: 12112724 BACKGROUND

• Shear MK, Brown TA, Barlow DH, Money R, Sholomskas DE, Woods SW, Gorman JM, Papp LA. Multicenter collaborative panic disorder severity scale. Am J Psychiatry. 1997 Nov;154(11):1571-5. doi: 10.1176/ajp.154.11.1571.

  PMID: 9356566 BACKGROUND

• Olthuis JV, Watt MC, Bailey K, Hayden JA, Stewart SH. Therapist-supported Internet cognitive behavioural therapy for anxiety disorders in adults. Cochrane Database Syst Rev. 2015 Mar 5;(3):CD011565. doi: 10.1002/14651858.CD011565.

  PMID: 25742186 BACKGROUND

• Katzman MA, Bleau P, Blier P, Chokka P, Kjernisted K, Van Ameringen M; Canadian Anxiety Guidelines Initiative Group on behalf of the Anxiety Disorders Association of Canada/Association Canadienne des troubles anxieux and McGill University; Antony MM, Bouchard S, Brunet A, Flament M, Grigoriadis S, Mendlowitz S, O'Connor K, Rabheru K, Richter PM, Robichaud M, Walker JR. Canadian clinical practice guidelines for the management of anxiety, posttraumatic stress and obsessive-compulsive disorders. BMC Psychiatry. 2014;14 Suppl 1(Suppl 1):S1. doi: 10.1186/1471-244X-14-S1-S1. Epub 2014 Jul 2.

  PMID: 25081580 BACKGROUND

• Baldwin DS, Anderson IM, Nutt DJ, Allgulander C, Bandelow B, den Boer JA, Christmas DM, Davies S, Fineberg N, Lidbetter N, Malizia A, McCrone P, Nabarro D, O'Neill C, Scott J, van der Wee N, Wittchen HU. Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: a revision of the 2005 guidelines from the British Association for Psychopharmacology. J Psychopharmacol. 2014 May;28(5):403-39. doi: 10.1177/0269881114525674. Epub 2014 Apr 8.

  PMID: 24713617 BACKGROUND

• Bos E, Preller KH, Kaur G, Malhotra P, Kharawala S, Motti D. Challenges With the Use of Digital Sham: Systematic Review and Recommendations. J Med Internet Res. 2023 Oct 24;25:e44764. doi: 10.2196/44764.

  PMID: 37874638 BACKGROUND

• Carlbring P, Andersson G, Cuijpers P, Riper H, Hedman-Lagerlof E. Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cogn Behav Ther. 2018 Jan;47(1):1-18. doi: 10.1080/16506073.2017.1401115. Epub 2017 Dec 7.

  PMID: 29215315 BACKGROUND

• Rozental A, Boettcher J, Andersson G, Schmidt B, Carlbring P. Negative effects of internet interventions: a qualitative content analysis of patients' experiences with treatments delivered online. Cogn Behav Ther. 2015;44(3):223-36. doi: 10.1080/16506073.2015.1008033. Epub 2015 Feb 23.

  PMID: 25705924 BACKGROUND

• 11. AIMneXt Co., Ltd. Clinical Study Report. A Multicenter, Prospective, Randomized, Single-blind, Exploratory Clinical Trial to Evaluate the Effectiveness of 'Meltz', a Digital Therapeutic, on Panic Symptoms in Patients with Panic Disorder. Protocol No. AM-IS-05. Seoul, Korea: AIMneXt Co., Ltd; 2026. Unpublished internal document.

  BACKGROUND

• 10. 식품의약품안전처. (2022). 공황장애 개선 디지털치료기기 안전성·성능 평가 및 임상시험계획서 작성 가이드라인(민원인 안내서).

  BACKGROUND

• Berger T, Urech A, Krieger T, Stolz T, Schulz A, Vincent A, Moser CT, Moritz S, Meyer B. Effects of a transdiagnostic unguided Internet intervention ('velibra') for anxiety disorders in primary care: results of a randomized controlled trial. Psychol Med. 2017 Jan;47(1):67-80. doi: 10.1017/S0033291716002270. Epub 2016 Sep 22.

  PMID: 27655039 BACKGROUND

• 8. Spies J, et al. (2024). A Smart Solution? Efficacy of a Self-Management Smartphone App for Panic Disorder and Agoraphobia. Cognitive Therapy and Research, 1-14.

  BACKGROUND

• Tolin DF, McGrath PB, Hale LR, Weiner DN, Gueorguieva R. A Multisite Benchmarking Trial of Capnometry Guided Respiratory Intervention for Panic Disorder in Naturalistic Treatment Settings. Appl Psychophysiol Biofeedback. 2017 Mar;42(1):51-58. doi: 10.1007/s10484-017-9354-4.

  PMID: 28194546 BACKGROUND

• Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS One. 2010 Oct 13;5(10):e13196. doi: 10.1371/journal.pone.0013196.

  PMID: 20967242 BACKGROUND

• 5. HJ Seo, KS Lee, SH Lee, et al. Recent Advances in Cognitive Behavioral Therapy for Panic Disorder. Anxiety and Mood. 2016;12(1):47-57

  BACKGROUND

• Kazdin AE. Addressing the treatment gap: A key challenge for extending evidence-based psychosocial interventions. Behav Res Ther. 2017 Jan;88:7-18. doi: 10.1016/j.brat.2016.06.004.

  PMID: 28110678 BACKGROUND

• Mitte K. A meta-analysis of the efficacy of psycho- and pharmacotherapy in panic disorder with and without agoraphobia. J Affect Disord. 2005 Sep;88(1):27-45. doi: 10.1016/j.jad.2005.05.003.

  PMID: 16005982 BACKGROUND

• 2. DW Black, JE Grant. DSM-5® Guidebook: The Essential Companion to the Diagnostic and Statistical Manual of Mental Disorders. American Psychiatric Pub. 2014

  BACKGROUND

• 1. MK Kim, JH Lee, M Gim, et al. Korean Guidelines for the Treatment of Panic Disorder 2018: Initial and Maintenance Treatment Strategies for the Phrmacological Treatment of Panic Disorder. Anxiety and Mood. 2018;14(2):53-62

  BACKGROUND

Related Links

• 35\. 대한디지털헬스학회. 디지털의료기기 허가 및 심사 가이드라인. 대한디지털헬스학회. Accessed April 21, 2026.

MeSH Terms

Conditions

Panic Disorder; Agoraphobia; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Study Officials

• Cheolhyeon Cho

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheolhyeon Coordinating Investigator

CONTACT

82+02-920-5505; david0203@gmail.com

Seulgi Clinical Research Coordinator

CONTACT

82+010-5190-5467; leeseulki625@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share