Alleviating Stress by Mobile Application' for Depression

NCT05312203 | Unknown

• 1 other identifier: 2021GR0585
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Stress; Major depressive disorders; Mobile health; Mindfulness-based intervention; Cognitive-behavior therapy; Relaxation Therapy; Cost-effectiveness; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in Depression, Anxiety and Stress Scale (DASS-21)

  DASS-21 is s a self-report measure of anxiety, depression and stress levels used in diverse settings developed by Lovibond \[47\]. The Korean version of DASS-21 was developed by Eun-Hyun Lee in 2018 \[48\]. This version was tested in Korean speaking samples and indicated that the items had been adequately and appropriately translated and adapted. Korean version of DASS-21 was tested in 481 Korean adults, the result showed that the Cronbach's α was 0.93.

  Baseline / 2 week / 4 week / 6 week / 8 week

Secondary Outcomes (5)

• Change in Perceived stress scale (PSS)

  Baseline / 4 week / 8 week

• Change in Posttraumatic embitterment disorders scale (PTED)

  Baseline / 4 week / 8 week

• Change in 9-item Patient Health Questionnaire (PHQ-9)

  Baseline / 2 week / 4 week / 6 week / 8 week

• Change in Hamilton depression rating scale (HAM-D)

  Baseline / 2 week / 4 week / 6 week / 8 week

• Intervention engagement

  4 week for fAPP 8 week for dAPP

Study Arms (2)

the App first group (fAPP)

OTHER

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.

Other: the App

wait list crossover group (dAPP)

OTHER

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.

Other: the App

Interventions

the App 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.

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

the App first group (fAPP); wait list crossover group (dAPP)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults between the ages of 19 and 65;
• 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 \[HAM-D\]);
• Stable medication for 28 days prior to study participation;
• Informed consent and voluntary participation.

You may not qualify if:

• Hard to use smart phone or unable to independently use Application;
• 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);
• 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;
• History of brain injury, epileptic seizures, intellectual disability, or cognitive disorders;
• History of severe physical disorders, including cancer, tuberculosis, severe cardiovascular disease, etc.
• Individuals participating in other cognitive behavioral therapy or activities related to stress relief

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Ministry of Trade, Industry & Energy, Republic of Korea: collaborator

Study Sites (1)

Department of Psychiatry, Korea University Guro Hospital

Seoul, Guro Gu, 08308, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 36998625 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Changsu Han, MD, PhD

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

  STUDY CHAIR

• Junhyung Kim, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Cheolmin Shin, MD, PhD

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

  PRINCIPAL INVESTIGATOR

• Kyu-Man Han, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junhyung Kim, MD, PhD

CONTACT

10-9317-1776; jhcabilover@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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. Most of the assessments are self-rated, and the clinician rating, HAM-D, will be assessed by an independent blinded evaluator not participating in the assignment and care providing.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a single-blind, multicenter, randomized, controlled crossover trial.

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 5, 2022
• Study Start: May 15, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The time when all research processes have been completed and the relevant results are published.

Locations

KR (1)