Alleviating Stress by Mobile Application' for Depression

NCT ID: NCT05312203

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2023-12-31

Brief 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. 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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

the App first group (fAPP)

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.

Group Type: OTHER

the App

Intervention Type: OTHER

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.

wait list crossover group (dAPP)

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.

Group Type: OTHER

the App

Intervention Type: OTHER

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.

Interventions

the App

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.

Intervention Type: OTHER

Other Intervention Names

Integrated mobile application for stress reduction; "inMind" (Demand, Republic of Korea, http://www.demand.co.kr)

Eligibility Criteria

Inclusion Criteria

1. Adults between the ages of 19 and 65;

2. 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]);

3. Stable medication for 28 days prior to study participation;

4. Informed consent and voluntary participation.

Exclusion Criteria

1. Hard to use smart phone or unable to independently use Application;

2. 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);

3. 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;

4. History of brain injury, epileptic seizures, intellectual disability, or cognitive disorders;

5. History of severe physical disorders, including cancer, tuberculosis, severe cardiovascular disease, etc.

6. Individuals participating in other cognitive behavioral therapy or activities related to stress relief

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Trade, Industry & Energy, Republic of Korea

OTHER_GOV

Sponsor Role: collaborator

Korea University Guro Hospital

OTHER

Sponsor Role: lead

Responsible Party

Han, Chang Su

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Changsu Han, MD, PhD

Role: STUDY_CHAIR

Department of Psychiatry, Korea University Guro Hospital, Korea University College of Medicine

Junhyung Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Korea University Guro Hospital, Korea University College of Medicine

Cheolmin Shin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Korea University Ansan Hospital, Korea University College of Medicine

Kyu-Man Han, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Korea University Anam Hospital, Korea University College of Medicine

Locations

Department of Psychiatry, Korea University Guro Hospital

Seoul, Guro Gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Junhyung Kim, MD, PhD

Role: CONTACT

jhcabilover@gmail.com

10-9317-1776 ext. 82

Facility Contacts

Junhyung Kim, MD, PhD

Role: primary

jhcabilover@gmail.com

010-9317-1776

References

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.

Reference Type: DERIVED

PMID: 36998625 (View on PubMed)

Other Identifiers

2021GR0585

Identifier Type: -

Identifier Source: org_study_id