Alleviating Stress by Mobile Application' for Depression

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.

Conditions

• Major Depressive Disorder

Interventions

OTHER

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.

Sponsors & Collaborators

• Ministry of Trade, Industry & Energy, Republic of Korea

  collaborator OTHER_GOV

• Korea University Guro Hospital

  lead OTHER

Principal Investigators

• Changsu Han, MD, PhD · Department of Psychiatry, Korea University Guro Hospital, Korea University College of Medicine

• Junhyung Kim, MD, PhD · Department of Psychiatry, Korea University Guro Hospital, Korea University College of Medicine

• Cheolmin Shin, MD, PhD · Department of Psychiatry, Korea University Ansan Hospital, Korea University College of Medicine

• Kyu-Man Han, MD, PhD · Department of Psychiatry, Korea University Anam Hospital, Korea University College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

19 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-15

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• South Korea

Study Locations