Viewing Study NCT06490315



Ignite Creation Date: 2024-07-17 @ 11:45 AM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06490315
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-07-08
First Post: 2024-06-29

Brief Title: Effectiveness and Cost Effectiveness of OkeyMind for Social Anxiety-Driven Depression Among Youth
Sponsor: Hong Kong Shue Yan University
Organization: Hong Kong Shue Yan University

Study Overview

Official Title: Effectiveness and Cost Effectiveness of a Mobile Psychoeducation Program OkeyMind for Social Anxiety-Driven Depression Among Youth A Randomized Controlled Trial
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: Background Social anxiety-driven depression is increasingly prevalent among youths leading to social withdrawal and isolation which heighten depression risk eHealth interventions have shown promise in improving access and engagement offering anonymity broader accessibility and personalized treatment features However the effectiveness and cost-effectiveness of eHealth methods for young individuals dealing with social anxiety-driven depression remain unexplored

Objective 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

Methods Participants will be recruited and screened onsite and then randomized to the intervention group and the waiting list control group Eligible participants are youths aged 18 to 25 years with moderate or above depression Patient Health Questionnaire-9 PHQ-9gt9 mild or above social phobia Social Phobia Inventory SPINgt19 and a smartphone with WeChat installed 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 Participant recruitment will begin before January 2025 The first follow-up assessment will conclude by March 2025 and data analysis will be finalized by early 2026 Results will be expected around May 2026

Conclusions 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None