UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051386 |
|---|---|
| Receipt number | R000058622 |
| Scientific Title | Development of a Counseling Intervention Model for Adolescent Girls with Functional Gastrointestinal Disorders (FGIDs) and Generalized Anxiety Disorder (GAD) based on Cognitive Behavior Therapy Approaches, Online Counseling, and Local Wisdom: A Cross-Cultural Study of Indonesian and South African Students. |
| Date of disclosure of the study information | 2023/06/20 |
| Last modified on | 2023/06/27 16:31:49 |
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Basic information
Public title
Development of a Counseling Intervention Model for Adolescent Girls with Functional Gastrointestinal Disorders (FGIDs) and Generalized Anxiety Disorder (GAD) based on Cognitive Behavior Therapy Approaches, Online Counseling, and Local Wisdom: A Cross-Cultural Study of Indonesian and South African Students.
Acronym
CBT with LW & OC for GAD and FGIDs
Scientific Title
Development of a Counseling Intervention Model for Adolescent Girls with Functional Gastrointestinal Disorders (FGIDs) and Generalized Anxiety Disorder (GAD) based on Cognitive Behavior Therapy Approaches, Online Counseling, and Local Wisdom: A Cross-Cultural Study of Indonesian and South African Students.
Scientific Title:Acronym
CBT with LW & OC for GAD and FGIDs
Region
| Asia(except Japan) | Africa |
Condition
Condition
Generalized Anxiety Disorders and Functional Gastrointestinal Disorders
Classification by specialty
| Medicine in general | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to produce and implement a counseling intervention model for assisting female students with generalized anxiety disorders (GAD) obtained from Functional Gastrointestinal Disorders (FGIDs) factors using a combination approach to cognitive behavior therapy (CBT), online counseling, and local wisdom in Indonesian and South African populations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Generalized Anxiety Disorder 7-item
Pretest and Posttest
Key secondary outcomes
Functional Gastrointestinal (FGI) Disorder Checklist
Pretest and Posttest
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A 16-session CBT manual incorporating online counseling techniques and principles and local wisdom approaches to the treatment of GAD among adolescent college girls with FGID symptoms will be developed by the research team for this study. The research team will adapt evidence-based techniques and procedures from existing CBT intervention manuals for GAD and FGID treatments with a focus on cultural components, traditions and values and/or local wisdom, and online counseling techniques, and processes to address GAD and FGID symptoms among adolescent college girls. Each online session for the treatment group as well as the usual care session for the control group in each country (study site) is expected to last for 90 minutes each; once a week for four months.
Interventions/Control_2
To assess the efficacy of CBT combined with local wisdom and online counseling approaches, we used the usual care as a comparison group. This study defines usual care as whichever treatment for GAD and FGIDs adolescents receive from their regular healthcare providers or therapists.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 17 | years-old | >= |
Gender
Female
Key inclusion criteria
To be considered eligible, participants must: (i) be between the ages of 15 and 17 years; (ii) be suffering from moderate to severe GAD and FGID symptoms at baseline, (iii) speak and understand English to a reasonable level; (iv) be willing to take part in the online CBT program or attend the usual care program; (v) have been taking continuous doses of anxiety medications for at least two months before the commencement of the program; (vi) have a smartphone or tablet device that is capable of running Whatsapp, Zoom, and/or the Konselo counseling app and have access to the internet, which is necessary to participate in the program sessions; and (vii) demonstrate the ability to commit to the expectations of the trial.
Key exclusion criteria
Some conditions will exclude participants from the study: (i) participants who cannot answer questions in the assessment tools on their own with a reasonable degree of English; (ii) participants affected by psychiatric or medical comorbidities that would severely impact their ability to participate or adhere to the program schedule; (iii) persons who are currently receiving CBT treatment; (iv) individuals who have practiced meditation regularly or previously; (v) a lack of internet access or the inability to use a device that is capable of connecting to the internet; (vi) inability to commit to the expectations of the trial.
Target sample size
236
Research contact person
Name of lead principal investigator
| 1st name | Zadrian |
| Middle name | |
| Last name | Ardi |
Organization
Universitas Negeri Padang
Division name
Department of Guidance & Counseling
Zip code
25131
Address
Jl. Prof Dr. Hamka, Kampus UNP Air Tawar, Padang City, West Sumatra Province, Indonesia
TEL
+6285274030264
zadrian@fip.unp.ac.id
Public contact
Name of contact person
| 1st name | Zadrian |
| Middle name | |
| Last name | Ardi |
Organization
Universitas Negeri Padang
Division name
Department of Guidance & Counseling
Zip code
25131
Address
Jl. Prof Dr. Hamka, Kampus UNP Air Tawar, Padang City, West Sumatra Province, Indonesia
TEL
+6285274030264
Homepage URL
https://unp.ac.id/
zadrian@fip.unp.ac.id
Sponsor or person
Institute
Otusum Consult Training & Services
Institute
Department
Personal name
Funding Source
Organization
The authors would like to thank Program Dana Abadi Perguruan Tinggi WCU UNP for funding this work with a contract number: 4938/UN35.13/KP/2022
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Indonesia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ministry of Health of Republic of Indonesia
Address
Jl H.R.Rasuna Said Blok X.5 Kav. 4-9, Blok A, Lt.6 Jakarta 12950
Tel
0215201587
pusdatin@kemkes.go.id
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 20 | Day |
Last modified on
| 2023 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058622
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| Registered date | File name |
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