Examining the safety and effectiveness of mental health care apps for young people with depressive symptoms

JRCT ID: jRCT1030240118

Registered date:27/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Depressive symptoms
• Date of first enrollment: 28/05/2024
• Target sample size: 134
• Study type: Interventional

Intervention(s)

App Intervention Group: Participants in this group are assigned to use the 'SELF MIND' app daily for a duration of four weeks. 'SELF MIND' has been developed by Self Co., Ltd. Its primary function includes AI-driven counseling for mental health, stress level assessment and visualization, a diary feature, and providing mental health information. The initial usage of the 'SELF MIND' app requires approximately 15 minutes, with subsequent uses around 5 minutes.

Control Group: Participants in this group are assigned to use a lifestyle recording tool, designed specifically for this study, on a daily basis for four weeks. Each session with this tool takes around 5 minutes.

Outcome(s)

• Primary Outcome: Patient Health Questionnaire-9

Secondary Outcome

Ten Item Personality Inventory (TIPI-J)
Resilience Scale (RS-14)
PERMA Profiler
Mobile App Rating Scale (MARS)
Implementation Outcome Scales for Digital Mental Health (iOSDMH) for USERs

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 30age old

Include criteria

Age and Educational Status: Participants must be 18 years old or older, with the exception of high school students, who are not eligible.

Depressive Symptomatology: Participants should exhibit depressive symptoms, ranging from mild to moderate severity, as indicated by scores of 5 to 14 on the Patient Health Questionnaire-9 (PHQ-9).

Participant's smartphone: Participants must own and have access to an iPhone.

Educational Institution Affiliation: Participants should be affiliated with one of the following campuses in Kanagawa or Tokyo: Yokohama City University, Kanagawa University, Kanagawa Prefectural Health and Welfare University, Yokohama National University, Chuo University, or Keio University.

Consent to Participate: Participants must provide informed electronic consent (eConsent) prior to participating in this study

Exclude criteria

Psychiatric Treatment History: Individuals currently receiving treatment at medical institutions for mental health issues, as well as those who have received such treatment in the past.

Prior Experience with Test Equipment Apps: Individuals who have prior experience using any application in the capacity of test equipment.

PHQ-9 Specific Criteria: Individuals scoring 3 points on item 9 of the Patient Health Questionnaire-9 (PHQ-9).

Exclusion by Psychiatrist's Judgment: Individuals deemed inappropriate as study participants based on the clinical discretion of a psychiatrist.

Related Information

• Primary Sponsor: Ide Keiko
• Source(s) of Monetary Support: Japan Science and Technology Agency (JST)