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IRCT20250311065031N1 IRCT 2025-05-13 Iran University of Medical Sciences "Effect of unified transdiagnostic group therapy in adolescents with functional gastrointestinal disorders" Comparing the effectiveness of unified transdiagnostic versus cognitive behavioral group therapy on treatment outcomes in adolescents with functional gastrointestinal disorders and determination of the mechanisms of change 2025-06-22 anticipated 30 Complete https://irct.ir/trial/82575 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization is used to allocate participants to treatment groups. This method allows each individual in the study to be assigned to one of the treatment groups randomly and without bias. To generate random allocations, a table of random numbers is used. This table contains randomly generated numbers that are employed to assign each participant to one of the groups. All randomization steps are carefully documented and recorded to maintain transparency in the allocation process and ensure traceability, Blinding description: In this study, a three-blinded method is used to prevent bias and enhance the validity of the results. In this trial, all stages of blinding are carefully implemented to ensure that none of the individuals involved in the study can influence the results. These individuals include: the participants of the study, who are unaware of the type of intervention they are receiving; the outcome assessors, who collect the data related to the treatment outcome variables; and the data analysts, who analyze the collected data. Outcome assessors will be individuals outside the research team who will administer the questionnaires to participants during post-test, pre-test, and follow-up stages. The person responsible for delivering the intervention will not be involved in this process. These individuals will possess at least a master's degree and will receive sufficient information regarding the tools used and the procedures for their administration. Participants, who are randomly assigned to either the experimental or control group, will only be informed about their group allocation and will not be provided with any additional details about the research. Data analysts will receive the coded dataset files without knowledge of participants' names or group assignments, with groups coded as 1 and 2. 3 functional gastrointestinal disorders. Intervention 1: Intervention group: In this study, the adolescent group therapy protocol (UP-A) designed by Ehrenreich (2018) is used. This therapeutic protocol consists of eight modules with flexibility in the number of sessions, targeting key aspects of emotional processing, regulation, and emotional experiences. It includes present-moment emotional awareness, cognitive flexibility, emotional avoidance, emotion-driven behaviors, awareness and tolerance of bodily feelings, and both endogenous and situational emotional exposure. In this protocol, sessions with parents are held to encourage their participation in the treatment. The number of sessions in the present study is 10 to 12 sessions. Intervention 2: Control group: In this study, a cognitive-behavioral therapy protocol for anxiety in adolescents is used, with session topics including assessment and identification of anxiety problems and setting treatment goals, cognitive skills training (cognitive techniques such as identifying negative thoughts and challenging them), behavioral skills training (including exposure therapy, where adolescents gradually face fearful situations), real-life practice (where adolescents are encouraged to apply the skills learned in real-life situations and review their progress), and parental involvement (including sessions to educate parents on how to support their child). The number of sessions in the present study is 10 to 12 sessions. Yes - There is a plan to make this available What will be shared: The SPSS file contains participant information in the form of defined codes, as well as the variables related to the research and their scoring in the data file When: Year 2026 To whom: Researchers and academic institutions for use in scientific studies Conditions: Submission of logical and scientific requests by individuals whose identities are known Where to obtain: Ensiyeh najjari email: ensiyehnajjary@gmail .com How to obtain: Researchers who submit their requests with logical and scientific reasons, including supplementary analyses, advanced data analyses, or data aggregation in the form of a meta-analysis, can contact me via email (ensiyehnajjary@gmail.com) to introduce themselves and specify the objectives of their study. After receiving the request, the data will be provided to them within two to three weeks. Comments:
public Ensiyeh najjari
Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran 14
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 86701 ensiyehnajjary@gmail.com Iran University of Medical Sciences scientific Ghazaleh Zargarinejad
Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran 14
Tehran Iran (Islamic Republic of) 1445613111 +98 21 8670 6001 zargarinejad.gh@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of at least one functional gastrointestinal disorder by a pediatric gastroenterologist based on the ROME diagnostic criteria Age range of 12 to 18 years Currently enrolled in an educational level appropriate for their age If a comorbid diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) is made, the adolescent must be receiving pharmacological treatment for symptoms At least one parent must be able to participate in the parent-specific sections of the therapeutic program 12 years 18 years Both Concurrent diagnosis of Autism Spectrum Disorder or Bipolar Disorder Requirement to initiate pharmacotherapy for emotional disorders (if pharmacological treatment is stabilized, it does not preclude entry into therapy) Simultaneous participation in other psychological treatments Students from special education schools K58-K59 Irritable bowel syndrome - Other functional intestinal disorders Treatment - Other Treatment - Other Intervention group: In this study, the adolescent group therapy protocol (UP-A) designed by Ehrenreich (2018) is used. This therapeutic protocol consists of eight modules with flexibility in the number of sessions, targeting key aspects of emotional processing, regulation, and emotional experiences. It includes present-moment emotional awareness, cognitive flexibility, emotional avoidance, emotion-driven behaviors, awareness and tolerance of bodily feelings, and both endogenous and situational emotional exposure. In this protocol, sessions with parents are held to encourage their participation in the treatment. The number of sessions in the present study is 10 to 12 sessions Control group: In this study, a cognitive-behavioral therapy protocol for anxiety in adolescents is used, with session topics including assessment and identification of anxiety problems and setting treatment goals, cognitive skills training (cognitive techniques such as identifying negative thoughts and challenging them), behavioral skills training (including exposure therapy, where adolescents gradually face fearful situations), real-life practice (where adolescents are encouraged to apply the skills learned in real-life situations and review their progress), and parental involvement (including sessions to educate parents on how to support their child). The number of sessions in the present study is 10 to 12 sessions Functional Gastrointestinal Disorders: These disorders typically include symptoms such as abdominal pain, bloating, changes in bowel habits (such as diarrhea or constipation), and discomfort in the digestive area. Timepoint: One week before the pre-test and one week after the post-test, and three months after the intervention (follow-up). Method of measurement: Gastrointestinal Symptoms Rating Scale. Anxiety Symptoms: Anxiety is described as "a feeling of tension and worry" that may be associated with specific behaviors such as avoiding stressful situations and fear. These feelings and behaviors can become disruptive patterns, especially if their intensity and duration negatively affect an individual’s daily functioning. Timepoint: One week before the pre-test and one week after the post-test, and three months after the intervention (follow-up). Method of measurement: the Screen for Child Anxiety Related Emotional Disorders. Quality of Life: Quality of life is typically regarded as a multidimensional concept that encompasses various aspects, including physical health, mental health, social interactions, and environmental influences. Timepoint: One week before the pre-test and one week after the post-test, and three months after the intervention (follow-up). Method of measurement: Pediatric Quality of Life Inventory TM 4.0. Emotion Regulation: Emotion regulation refers to the processes that individuals use to manage and control their emotions, which include identifying, assessing, and modifying feelings in a way that aids adaptation and improves an individual's quality of life. Timepoint: One week before the pre-test and one week after the post-test, and three months after the intervention (follow-up). Method of measurement: Emotion Regulation Questionnaire for Children and Adolescents. Iran University of Medical Sciences Approved 2025-02-23 Research Ethics Committees of Iran University of Medical Sciences Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran 14 Tehran Tehran Iran (Islamic Republic of)