- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06171516
Internet-based Cognitive Behavioral Therapy for Individuals With Gambling Disorder in Indonesia (ICBT)
Internet-based Cognitive Behavioral Therapy for Individuals With Gambling Disorder in Indonesia: a Pilot and Feasibility Study
Gambling disorder (GD) has become a wide concern in Indonesia, as many negative consequences aroused from this psychiatric condition. Prompt treatment with appropriate method of delivery is required to achieve optimal outcome in GD patients. This study aims to determine the effectiveness and feasibility of internet-based cognitive behavioral therapy (iCBT) in treating GD.
This non-randomised pilot and feasibility study will recruit 20 people with GD. All participants will receive the iCBT intervention through self-learning videos and guided weekly group sessions. The effectiveness of the intervention will be assessed at baseline (week 0), post-treatment completion (week 10), and 6 weeks post-treatment (week 16).
Expanded access of the iCBT module will not be available until after the study completion.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- be aged 18-59 years old;
- be screened as probable pathological gambler based on South Oaks Gambling Screen (SOGS);
- have access to electronic devices (ie, smartphone, mobile tablet, personal computer) with internet connection;
- be proficient in Indonesian language;
- have agreed to take part in the study by filling out the informed consent form.
Exclusion Criteria:
- have severe mental disorders or intellectual disabilities;
- have extreme agitation that hinder instrument fill out and adequate cognitive behavior therapy participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Internet-based Cognitive Behavioral Therapy
10 guided therapy sessions (once-weekly) with each session lasting 20 minutes.
|
All participants will undergo 10 guided therapy sessions (once-weekly) with each session lasting 20 minutes.
The therapy module will be given as an online self-learning source via videos in a website specifically developed for this training.
The videos will divide the module content into several parts with each video lasting about 10 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gambling symptom severity
Time Frame: G-SAS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
|
a decrease in Gambling Symptom Assessment Scale (G-SAS) score
|
G-SAS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
|
|
Problem gambling severity
Time Frame: PGSI will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
|
a decrease in Problem Gambling Severity Index score
|
PGSI will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
|
|
Gambling urges
Time Frame: GUS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
|
a decrease in Gambling Urge Scale (GUS) score
|
GUS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
|
|
Gambling-related cognitive distortions
Time Frame: GRCS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
|
a decrease in Gambling Related Cognitions Scale (GRCS) score
|
GRCS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nonspecific psychological distress
Time Frame: SRQ-20 will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
|
a decrease in Self Rating Questionnaire-20 (SRQ-20) score
|
SRQ-20 will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
|
|
Subjective quality of life
Time Frame: WHOQOL-BREF will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
|
an increase in World Health Organization Quality-of-Life Scale (WHOQOL-BREF) score
|
WHOQOL-BREF will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KET-992-2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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