Effectiveness and Cost Effectiveness of OkeyMind for Social Anxiety Among Youth

September 8, 2025 updated by: Wang Yizhou, Hong Kong Shue Yan University

Effectiveness and Cost Effectiveness of a Mobile Psychoeducation Program (OkeyMind) for Social Anxiety Among Youth: A Randomized Controlled Trial

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 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: The investigators 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. 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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Background: Social anxiety 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 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-9)>9), mild or above social phobia [Social Phobia Inventory (SPIN)>19], 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: The investigators 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 May 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. 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 Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong, HKG
        • Hong Kong Shue Yan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. youths aged between 15 and 24 years old;
  2. exhibiting mild or above social phobia (i.e. Social Phobia Inventory score ≥ 25);
  3. having a smartphone with WeChat installed and basic internet literacy

Exclusion Criteria:

  1. unable to attempt a baseline assessment (e.g., due to being unpermitted to leave a psychiatric ward);
  2. currently receiving another intensive psychological intervention;
  3. currently holding active suicidal plan;
  4. currently diagnosed with psychological disorders (e.g., schizophrenia, bipolar disorder, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention 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.
Behavioral: OkeyMind intervention
The intervention group will receive a one-month mobile psychoeducation program (OkeyMind), which includes both psychoeducation and meditation components, with all content fully automated.
Experimental: Waiting list control group
Participants in the waiting list control group will withhold access to the OkeyMind intervention until after the 3-month follow-up assessment.
Behavioral: Wait-list control
Participants in the waiting list control group will withhold access to the OkeyMind intervention until after the 3-month follow-up assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Phobia Inventory
Time Frame: 3 months
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
Time Frame: 3 months
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

Outcome Measure
Measure Description
Time Frame
EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Time Frame: 3 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Shue Yan University

Investigators

  • Principal Investigator: Yizhou Wang, PhD, Hong Kong Shue Yan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Actual)

August 5, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

June 29, 2024

First Submitted That Met QC Criteria

June 29, 2024

First Posted (Actual)

July 8, 2024

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OkeyMind intervention

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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