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Generalized Anxiety DisorderNCT06010654

Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder

A study testing Software as a Medical device in people with Generalized Anxiety Disorder, run by HAII corp.ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators propose to develop and adapt 'ANZEILAX' smartphone app specifically for individuals with Generalized anxiety disorder. The study will measure the therapeutic effects and safety of 'ANZEILAX' on symptoms of anxiety using pre- and post-treatment scores for generalized anxiety disorder and other… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Generalized Anxiety Disorder
What is being tested?
Software as a Medical device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteSouth Korea
Study dates
14 Aug 2023to 24 Jul 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • People can participate in this clinical trial only if following criteria are met.
  • Adults aged 19 years or older with a high school diploma or higher
  • Disease groups according to the criteria below:
  • A person diagnosed with Generalized Anxiety Disorder (DSM-5 (ICD-10) code: 300.02 (F41.1))
  • Those who are classified as moderate or severe with 10 points or more through GAD-7
  • Those taking prescription drugs related to generalized anxiety disorder
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  • A group of disorders with generalized anxiety disorder, or a group of disorders with worry that is a major symptom of generalized anxiety disorder in any of the following criteria:
  • Those suffering from other anxiety disorders such as panic disorder and social anxiety disorder
  • Those suffering from major depressive disorder accompanied by worry, the main symptom of generalized anxiety disorder
  • A person who fully understands the purpose, contents, and process of the clinical trial, agrees to participate, and signs the consent form in handwriting

Who cannot join

  • If any of the following criteria is applicable, the person cannot participate in this clinical trial.
  • Those who cannot read the consent form
  • Those who are inexperienced in using smartphones
  • In case of psychiatric symptoms or history (including schizophrenia, psychosis, bipolar disorder, epilepsy)
  • In case of brain damage, cognitive impairment, or neurological disease
  • In case of intellectual disability
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  • Having a substance and alcohol use disorder
  • Suicidal intent, suicidal ideation, or self-injurious behavior in the past 6 months
  • Receiving cognitive behavioral therapy for anxiety, depression or mood disorders, or participating in such therapy in the past 3 months
  • Those who are registered in other clinical studies
  • Other investigators judged that the conduct of this clinical trial was inappropriate

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yonsei University Health System, Gangnam Severance Hospital

    Seoul, 06273

Other trials in South Korea

About this study

Official title: A Single Blind, Parallel Arm, Single Institution Pivotal RCT to Test Safety and Efficacy of Digital Therapeutics 'ANZEILAX' for Managing Generalized Anxiety Disorder

The investigators propose to develop and adapt 'ANZEILAX' smartphone app specifically for individuals with Generalized anxiety disorder. The study will measure the therapeutic effects and safety of 'ANZEILAX' on symptoms of anxiety using pre- and post-treatment scores for generalized anxiety disorder and other physical, emotional, and cognitive symptoms of anxiety

Read the detailed description

Purpose: This study is designed to evaluate the safety and efficacy of ANZEILAX, a digital therapeutic intervention delivered via a smartphone application. The application incorporates Acceptance and Commitment Therapy (ACT), a type of cognitive behavioral therapy, and self-communicational techniques to treat Generalized Anxiety Disorder(GAD). The study amis to assess the effectiveness to thie digital therapeutic in reducing anxiety symptoms and improving overall mental health outcomes in individuals with GAD.

Study Population: The study will enroll adults aged 19 years older who have completed at least a high school education.

Study Duration: The intervention period will last for 10 weeks, followed by a follow-up visit at Week 15 to assess long-term outcomes and effects after the completion of the intervention.

Intervention: Participants will use the smartphone application for a period of 10 weeks. The application is recommended to be used twice daily, with a minimum required use of once per day. It can be used during flexible time periods, such as before sleep, after waking up, or at any other when the participant feels it is necessary. The application delivers Acceptance and Commitment Therapy(ACT). It also encourages self-referencing activities, which help participants focus on and reflects upon experiences associated with positive emotions. Additionally, the application promotes self-distancing techniques, helping participants to avoid excessive immersion in negative emotional experiences.

Being tested
Software as a Medical device
Medical subject headings
Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Software as a Medical deviceDevice

    Also called ANZEILAX

    The test device is a software medical device designed for the purpose of treating generalized anxiety disorder that provides self-talk training based on acceptance and commitment therapy (ACT). Use 2 sets per day for 10 weeks with generalized treatment of standard treatment method.

Study groups in NCT06010654
Study groupRoleWhat they receive
Experimental GroupExperimentalThe general treatment of the standard treatment method and the test device that provides self-talk training based on acceptance and commitment therapy (ACT) are used concurrently for 10 weeks.
Receives: Device: Software as a Medical device
Control GroupNo interventionTreatment as usual (TAU) is a standard treatment for 10 weeks, which is the clinical trial period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Generalized Anxiety Disorder-7

    The primary outcome will be measured using the Generalized Anxiety Disorder 7-item (GAD-7) scale, wich assesses the severity of generalized anxiety symptoms. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety. Anxiety severity is categorized into four levels: 0-4(minimal anxiety), 5-9 (mile anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety.)

    Measured: Measured at Baseline, Week 5, Week 10, and Week 15.

Secondary outcomes (5)

  1. Beck Anxiety Inventory

    The Beck Anxiety Inventory (BAI) is a 21-tem, self-report tool designed to measure the severity of anxiety symptoms. It includes items that assess cognitive, emotional, and physical aspects of anxiety. The BAI is specifically designed to differentiate betwwen symptoms of ansiety and depression, with a focus on physical symptoms typically assocaiated with anxiety.

    Measured: Measured at Baseline, Week 5, Week 10, and Week 15.

  2. Penn State Worry Questionnaire

    The Penn State Worry Questionnaire (PSWQ) is a self-report tool developed to assess the presence and severity of pathologicla worry. It is designed to identify excessive, uncontrollabel worry, a key feafure of generalized anxiety disorder.

    Measured: Measured at Baseline, Week 5, Week 10, and Week 15.

  3. Hospital Anxiety and Depression Scale

    The Hospital Anxiety and Depression Scale(HADS) is a self-report tool used to assess anxiety symptoms, focusing on both physical and emotional aspects of anxiety. It is specifically designed for use in hospital settings to evaluate both anxiety and depression in patients.

    Measured: Measured at Baseline, Week 5, Week 10, and Week 15.

  4. Treatment adherence

    During the clinical trial, Treatment As Usual (TAU) will vary depending on the severity of the participants' conditions, making it difficult to uniformly control across all subjects. Therefore, treatment adherence will be specifically assessed in the treatment group, where participants receive both TAU and ANZEILAX intervention. To evaluate adherence to the DTx, user log data from the DTx application will be collected and analyzed.

    Measured: Measured at Week 5 and Week 10

  5. Satisfaction evaluation

    Satisfaction with both Treatment As Usual (TAU) for anxiety and the digital therapeutic (DTx), ANZEILAX, will be assessed using two questions. The first question will ask participants to rate their satisfaction on a scale of 0 to 10, with 0 being "not satisfied" and 10 being "extremely satisfied." The second question will be an open-ended prompt asking participants to "write about their experiences during the treatment," allowing for qualitative feedback on their personal feelings and perceptions.

    Measured: Measured at Week 5 and Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2023
  2. Study start14 Aug 2023
  3. Primary completion24 Jul 2024
  4. Study completion24 Jul 2024

Resources

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
Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06010654
Sponsor's protocol ID
3-2023-0018
Status last verified
Sep 2024
First submitted
20 Aug 2023
Last updated
19 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park C, Song H, Kim H, Kim E, Jo HJ, Kim JJ, Lee JH, Kim J. Efficacy of a Smartphone-Based Digital Therapeutic (Anzeilax) in Generalized Anxiety Disorder: Randomized Controlled Trial. J Med Internet Res. 2025 Oct 14;27:e69981. doi: 10.2196/69981.

    PubMed 41086425

Questions about this trial

What is this clinical trial studying?

A study testing Software as a Medical device in people with Generalized Anxiety Disorder, run by HAII corp.ltd 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 10 inclusion and 11 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 19 Sep 2024. 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?

Generalized Anxiety Disorder-7 (time frame: Measured at Baseline, Week 5, Week 10, and Week 15.). 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 NCT06010654, 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 19 Sep 2024.

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