Clinical trial NCT06490315: Effectiveness and Cost Effectiveness of OkeyMind for Social Anxiety Among Youth
Official title: Effectiveness and Cost Effectiveness of a Mobile Psychoeducation Program (OkeyMind) for Social Anxiety Among Youth: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression
Social Anxiety
Lead sponsor: Hong Kong Shue Yan University
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 180
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)\&gt;9), mild or above social phobia \[Social Phobia Inventory (SPIN)\&gt;19\], 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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Social Phobia Inventory
timeFrame: 3 months
measure: Patient Health Questionnaire-9
timeFrame: 3 months
Secondary outcomes:
measure: EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
timeFrame: 3 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong Shue Yan University
Study officials:
affiliation: Hong Kong Shue Yan University
name: Yizhou Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: