Effectiveness and Cost Effectiveness of OkeyMind for Social Anxiety Among Youth

NCT06490315 | Enrolling By Invitation

• 1 other identifier: OkeyMind intervention
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Depression; Social Anxiety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

  3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Waiting list control group

EXPERIMENTAL

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

Interventions

OkeyMind intervention BEHAVIORAL

The intervention group will receive a one-month mobile psychoeducation program (OkeyMind), which includes both psychoeducation and meditation components, with all content fully automated.

Intervention group

Wait-list control BEHAVIORAL

Participants in the waiting list control group will withhold access to the OkeyMind intervention until after the 3-month follow-up assessment.

Waiting list control group

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hong Kong Shue Yan University: lead

Study Sites (1)

Hong Kong Shue Yan University

Hong Kong, Hong Kong, HKG, Hong Kong

Location

Related Publications (1)

• Wang YZ, Zhou DR, Ng SM, Wang BB, Feng YY, Weng X. Effectiveness and Cost-Effectiveness of a Mobile Psychoeducation Program (OkeyMind) for Social Anxiety Symptoms Among Youths: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jul 14;14:e64518. doi: 10.2196/64518.

  PMID: 40658950 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Yizhou Wang, PhD

  Hong Kong Shue Yan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 8, 2024
• Study Start: September 27, 2024
• Primary Completion: August 5, 2025
• Study Completion: May 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)