Effectiveness and Cost Effectiveness of OkeyMind for Social Anxiety Among Youth

NCT ID: NCT06490315

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-27

Study Completion Date

2026-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression Social Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

OkeyMind intervention

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Wait-list control

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.).
Minimum Eligible Age

15 Years

Maximum Eligible Age

24 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hong Kong Shue Yan University

OTHER

Sponsor Role lead

Responsible Party

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Wang Yizhou

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yizhou Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Shue Yan University

Locations

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Hong Kong Shue Yan University

Hong Kong, Hong Kong, Hong Kong

Site Status

Countries

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Hong Kong

References

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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.

Reference Type DERIVED
PMID: 40658950 (View on PubMed)

Other Identifiers

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OkeyMind intervention

Identifier Type: -

Identifier Source: org_study_id

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