Effectiveness and Cost Effectiveness of OkeyMind for Social Anxiety-Driven Depression Among Youth
NCT Number: NCT06490315
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression|Social Anxiety
Interventions: BEHAVIORAL: OkeyMind intervention|BEHAVIORAL: Wait-list control
Sponsor: Hong Kong Shue Yan University
Sex: ALL
Age: ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-09-30
Completion Date: 2026-05-01
Locations: Hong Kong Shue Yan University, Hong Kong, HKG, Hong Kong

Summary:
This randomized controlled trial aims to evaluate the effectiveness and cost-effectiveness of a mobile-based psychoeducation program (OkeyMind) in mitigating symptoms associated with social anxiety-driven depression among youth.

Participants will be recruited and screened onsite and then randomized to the intervention group and the waiting list control group. The intervention group will receive a one-month mobile psychoeducation program (OkeyMind), which includes both psychoeducation and meditation components, with all content fully automated. The waiting list control group will receive the same intervention after 3 months. Participants will be followed up at three time-points: baseline, 1 month, and 3 months Results: We will recruit 180 participants, with 90 in each group. The primary effectiveness outcomes are the scores of SPIN and PHQ-9, and the cost-effectiveness outcomes is measured by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L).

This research evaluates the effectiveness and cost-effectiveness of OkeyMind, a mobile-based psychoeducation program for youth with social anxiety-driven depression. OkeyMind might be a promising strategy for combating social anxiety, especially in low- and middle-income countries with limited medical resources. By leveraging mobile technology, it aims to provide accessible, cost-effective mental health support, improving outcomes on a broader scale.

Primary Outcome Measures: Social Phobia Inventory, Developed by Connor et al. in 2000, SPIN is a brief self-report tool consisting of 17 items that assess fear, avoidance, and physiological discomfort in social situations. It is specifically designed for use with social anxiety disorder. A cut-off value of 19 is used to distinguish between clients with and without social phobia., 3 months|Patient Health Questionnaire-9, The Patient Health Questionnaire-9 (PHQ-9) is widely used to screen for the presence and severity of depression, monitor the severity of depression over time, and assist with the diagnosis of depression. Each of the nine items is scored from 0 (not at all) to 3 (nearly every day), with a total score ranging from 0 to 27. Higher scores indicate more severe depressive symptoms. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively., 3 months
Secondary Outcome Measures: EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), EQ-5D-5L is an established tool for assessing the general health status of individuals across a wide array of health conditions and treatments. It measures health outcomes in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-level scale, from no problems (level 1) to extreme problems (level 5), facilitating a comprehensive evaluation of a patient's health-related quality of life. The total score is derived by converting the individual dimension scores into a single summary index value, reflecting the overall health status, with higher scores indicating better health outcomes., 3 months