The Gather: Town Gaming Intervention for Depression Management

Gamification Clinical Trial

Official title:

The Gather: Town Gaming Intervention for Depression Management Among Pregnant Adolescents in Thailand: A Mixed Methods Study Protocol

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06468020
• Other study ID #: The Gather.town gaming
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Est. completion date: January 2026

Study information

• Verified date: June 2024
• Source: National Taiwan University
• Contact: Chotip Phonkusol
• Phone: 0905085846
• Email: d10426011[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim This study aims to explore the experience of depression among pregnant adolescents in Thailand and assess the effectiveness of the Gather.town gaming intervention for relieving depressive symptoms.

Methods The study will adopt an exploratory sequential mixed-methods design. It comprises two phases: a qualitative and a quantitative sub-study to answer the research questions.

Phase one is a qualitative sub-study to gain a comprehensive understanding of the experiences of pregnant adolescents with depression and their perceptions of interventions for relieving depressive symptoms. This sub-study will conduct in-depth interviews and content analysis with 20 pregnant adolescents selected through purposive sampling from an antenatal care clinic. The interview results will be used to develop the Gather.town gaming intervention for depression management.

Phase two is a quantitative sub-study conducted through a quasi-experimental design with 64 participants, divided into an intervention group of 32 and a control group of 32. Convenience and snowball sampling will be performed. The effect of the oGBL intervention will be evaluated on the primary outcome of depression symptoms/levels and secondary outcomes including knowledge of depression, coping skills, perceived social support, and help-seeking attitudes. Initial feedback from users on the Gather.town gaming intervention will also be examined. Data will be collected using self-report questionnaires and open-ended questions. Assessments will be conducted at four time points: baseline, after the intervention, and at the 1-month and 3-month follow-ups. Descriptive statistics, Chi-square tests, and ANCOVA will be used for data analysis. Finally, data from the qualitative and quantitative sub-studies will be merged to interpret the effects of the Gather.town gaming intervention for depression management among Thai pregnant adolescents.

Description:

Measurement

1. The pretest-posttest questionnaires 1.1 The sociodemographic data form The researcher developed this form based on the literature review, which consisted of 11 questions regarding age, education status, spouse's age, spouse's education, employment status, monthly income, family type, marital status, gestational age, number of pregnancies, and pregnancy planning.

1.2 The Center for Epidemiological Studies Depression Scale (CES-D) will be used to evaluate the inclusion criteria for the participants and assess current depressive symptoms. The scale contains 20 items asking about symptoms associated with depression. Each item focuses on the affective component of depressed mood (e.g., feelings of failure, guilt, hopelessness). Respondents rate how often they experienced each of the symptoms in the past week on a 4-point Likert scale ranging from none of the time (0) to all of the time (3). The total possible score is 0-60 points: a score between 0 and 15 indicates no depression, 16 to 20 is mild, 21 to 30 is moderate, and 31 or greater is severe depression. This sub-study will use the CES-D (Thai version). The Cronbach's alpha internal consistency coefficient of the scale was reported to be 0.85.

1.3 The 5-item Brief Symptom Rating Scale (BSRS-5) is commonly used for screening psychological disorders. It consists of 5 self-rated items measuring brief psychological symptoms, including insomnia, anxiety, hostility, depression, and inferiority. Each item is rated on a Likert scale ranging from 0 (not at all) to 4 (extremely). A total score on the BSRS-5 of more than 15 indicates severe mental distress; scores between 10 and 14 indicate moderate distress, scores between 6 and 9 indicate mild distress, and scores lower than 6 indicate normal status. The scale has a Cronbach's alpha coefficient ranging from 0.77 to 0.90. In this sub-study, the researcher will translate the scale into Thai and have it back-translated by two experts proficient in both English and Thai.

1.4 The Depression Literacy Questionnaire (D-Lit) evaluates individual knowledge of depression. The questionnaire consists of 22 items regarding the signs, symptoms, and treatments of depression. Respondents can answer each item with one of three options: "true," "false," and "do not know." Each correct response receives one point. Higher scores indicate greater knowledge of depression. In this sub-study, the researcher will use the Thai version. The Thai version contains 21 items; one question from the original version was excluded as it was not culturally appropriate within the Thai context. The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.74.

1.5 The Brief COPE is an abbreviated version of the COPE and was created for use in time-limited settings. It is a questionnaire designed to assess a broad range of coping strategies. There are 28 items representing 14 types of coping strategies: active coping (items 2 and 7), planning (items 14 and 25), positive reframing (items 12 and 17), acceptance (items 20 and 24), humor (items 18 and 28), religion (items 22 and 27), using emotional support (items 5 and 15), using instrumental support (items 10 and 23), self-distraction (items 1 and 19), denial (items 3 and 8), venting (items 9 and 21), substance use (items 4 and 11), behavioral disengagement (items 6 and 16), and self-blame (items 13 and 26). Items are rated on a 4-point Likert scale ranging from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot). A higher total score demonstrates the application of coping strategies. This sub-study will use the Brief COPE (Thai version). The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.70 in total.

1.6 The Multi-dimensional Scale of Perceived Social Support (MSPSS) is a brief and easy-to-use scale used to measure an individual's perceived social support from three sources: significant others, friends, and family. The scale consists of 12 items, with four items each representing support from a significant other (items 1, 2, 5, and 10), family (items 3, 4, 8, and 11), and friends (items 6, 7, 9, and 12). Each item is scored on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). A high total score indicates a high level of perceived social support. This sub-study will use the MSPSS Thai version. The Cronbach's alpha internal consistency coefficient of the scale was found to be 0.90 in total, and 0.88, 0.91, and 0.92, respectively, for the family, friends, and significant other dimensions.

1.7 The Attitudes Toward Seeking Professional Psychological Help Scale-Short Form (ATSPPH-SF) measures attitudes toward seeking mental health care from professionals. This sub-study will use the ATSPPH-SF (Thai version). The scale is an abbreviated 10-item version. Items are answered using a 4-point Likert scale ranging from 0 (disagree) to 3 (agree). Higher total scores indicate more positive attitudes toward seeking help from a professional. The questionnaire demonstrated good overall internal consistency (α = 0.84).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: January 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 19 Years

Eligibility

Inclusion Criteria:

For participants:

1. pregnant adolescents aged 15 to 19 years

2. having a score of 16-20 on the Thai version of the Center for Epidemiological Studies-Depression Scale (CES-D)

3. being able to speak and understand the Thai language

4. willing to participate in the study

Exclusion Criteria:

For participants:

1. having a diagnosis of a psychiatric disorder

Related Conditions & MeSH terms

• Depression
• Gamification

Intervention

Other:
• The Gather.town gaming intervention
The online game-based learning intervention (oGBL): The investigator will develop the oGBL intervention based on Rational Emotive Behavior Therapy (REBT), which consists of 5 sessions and plays a game through the Gather.Town platform.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in depression levels, as measured by the Likert scale of the 5-item Brief Symptom Rating Scale (BSRS-5)	Scores are measured on a Likert scale ranging from 0 to 4. The total score ranges from 0 to 20, with scores more than 15 indicating severe mental distress, scores between 10 and 14 indicating moderate distress, scores between 6 and 9 indicating mild distress, and scores lower than 6 indicating normal status.	Baseline, immediately after the intervention, and at the 1-month and 3-month follow-ups
Secondary	Change from baseline in the knowledge of depression, as measured by a true or false questionnaire of the Depression Literacy Questionnaire (D-Lit)	Scores are measured using a true or false questionnaire, with one point awarded for each correct answer. The score ranges from 0 to 22, with higher scores indicating greater knowledge.	Baseline, immediately after the intervention, and at the 1-month and 3-month follow-ups
Secondary	Change from baseline in the coping skills, as measured by the Likert scale of the Brief COPE	Scores are measured on a Likert scale ranging from 1 to 4. The total score ranges from 1 to 112, with higher scores indicating greater use of coping strategies.	Baseline, immediately after the intervention, and at the 1-month and 3-month follow-ups
Secondary	Change from baseline in the individual's perceived social support, as measured by the Likert scale of the Multi-dimensional Scale of Perceived Social Support (MDPSS)	cores are measured on a Likert scale ranging from 1 to 7. The total score ranges from 1 to 84, with a high total score indicating a high level of perceived social support.	Baseline, immediately after the intervention, and at the 1-month and 3-month follow-ups
Secondary	Change from baseline in attitudes toward seeking mental health care from professionals, as measured by the Likert scale of the Attitudes Toward Seeking Professional Psychological Help Scale-Short Form (ATSPPH-SF).	Scores are measured on a Likert scale ranging from 0 to 3. The total score ranges from 0 to 30, with higher total scores indicating more positive attitudes about seeking help from a professional.	Baseline, immediately after the intervention, and at the 1-month and 3-month follow-ups