Efficacy of Cognitive Behavioral Therapy With Local Wisdom and Web-Based Counseling on Generalized Anxiety Disorders and Functional Gastrointestinal Disorders in Adolescent College Girls: Protocol for a Randomized Controlled Trial
Authors: Ardi Zadrian , Eseadi Chiedu , Yuniarti Elsa , Yendi Frischa Meivilona , Murni Arina Widya 
Published: August 2023

Background
The high academic demands experienced by students will often have an impact on the quality of their mental and physical health. The most common health problems reported are gastrointestinal disorders. This condition tends to manifest in the emergence of generalized anxiety disorders (GADs) and reduces the quality of life and productivity. The population that experiences this disorder the most is female adolescents, and this condition occurs in both South African and Indonesian populations. The use of drugs, especially benzodiazepines, often causes psychological conditions as side effects. For this reason, it is necessary to have a solution in the form of a targeted and efficient approach to reduce psychological symptoms that arise from functional gastrointestinal disorders (FGIDs) in the form of anxiety.

Objective
The purpose of this study is to produce and implement a counseling intervention model to assist female students with GADs caused by FGID factors using an approach combining cognitive behavioral therapy (CBT), web-based counseling, and local wisdom in Indonesian and South African populations.

Methods
The research subjects will comprise 118 female adolescent students from Indonesia and 118 female adolescent students from South Africa, making a total sample of 236 participants, and the study will use a prospective, parallel randomized controlled trial design. The recruitment process will begin in July 2023, and the trial will begin in August 2023. The posttest assessment data gathering will take place by November 2023. Questionnaires that will be used in this study include the Functional Gastrointestinal Disorder Checklist (FGI-Checklist) to collect data related to FGIDs and the Generalized Anxiety Disorder 7-item (GAD-7) to measure the anxiety conditions experienced by respondents.

Results
By adopting the intention-to-treat principle, there will be significant mean changes in GAD scores and FGID scores after exposure to this combined approach in the Indonesian and South African populations. Implementing this comprehensive intervention will improve the students’ psychological symptoms related to FGIDs and ultimately enhance their overall well-being.

Conclusions
This study will develop and implement a model of counseling intervention for female students with GADs obtained from FGIDs using a combination approach to CBT, web-based counseling, and local wisdom in both the Indonesian and South African populations. The trial findings will contribute to our understanding of the effects of CBT combined with local wisdom and web-based counseling approaches that mental health counselors can use to treat GAD-affected adolescent girls who have FGIDs.

Trial Registration
UMIN Clinical Trial Registry UMIN000051386; https://tinyurl.com/yjwz8kht

International Registered Report Identifier (IRRID)
PRR1-10.2196/50316