Evaluation of the Prevention Effectiveness of an Online CBT Program for Employees

UMIN ID: UMIN000055673

Registered date:01/10/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Well-being of workers
• Date of first enrollment: 2024/10/01
• Target sample size: 62
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: The primary outcome measure will be psychological well-being, assessed using the Psychological Well-Being Scale short-form (Iwano et al., 2015). Measurements will be taken at the start of the online CBT program and then at 3, 6, and 9 months after the program begins. Each measurement will be considered valid if it is conducted within a 2-week period before or after the scheduled time.
• Secondary Outcome: The following secondary outcome measures will be assessed at 0, 3, 6, and 9 months after the start of the online CBT program. The assessment period will be considered valid for a duration of two weeks before and after each assessment point. Additionally, "Program Satisfaction" and "Program Practicality" will be assessed only at 3 months after the program's start, while "Dropout" and "Safety Assessment Items" will be measured at each session. Measures to be assessed: Psychological distress (K6, Kessler et al., 2002) Presenteeism (WHO-HPQ, Kessler et al., 2003) Absence from work or resignation due to mental health reasons Program Satisfaction Program Practicality Dropout Safety Assessment Items

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: - Individuals who were found to have suicidal thoughts during the program - Individuals who do not have normal visual or auditory functions - Individuals who are not Japanese speakers

Related Information

• Primary Sponsor: Lezily, Inc.
• Source(s) of Monetary Support: Lezily, Inc.
• Secondary ID(s): G24153-2