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Enrolling by invitation NCT06490315

Effectiveness and Cost Effectiveness of OkeyMind for Social Anxiety Among Youth

No phase Interventional Depression Social Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OkeyMind intervention, Wait-list control.
Who it may be relevant to
Registry conditions: Depression, Social Anxiety. Basic parameters: 15 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Social Phobia Inventory [Time frame: 3 months]
  • Patient Health Questionnaire-9 [Time frame: 3 months]
Secondary outcome measures (1)
  • EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Hong Kong Shue Yan University — Hong Kong

Publications

  • 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

Identifiers

NCT: NCT06490315 · OkeyMind intervention

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗