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

Status Not yet recruiting

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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Depression
• Gamification

• NCT number: NCT06468020
• Study type: Interventional
• Source: National Taiwan University
• Contact: Chotip Phonkusol
• Phone: 0905085846
• Email: d10426011@ntu.edu.tw
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2024
• Completion date: January 2026