GamblingICBTNCT06171516
Internet-based Cognitive Behavioral Therapy for Individuals With Gambling Disorder in Indonesia
A study testing iCBT in people with Gambling, run by Universitas Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Gambling
- What is being tested?
- iCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- have severe mental disorders or intellectual disabilities;
- have extreme agitation that hinder instrument fill out and adequate cognitive behavior therapy participation.
About this study
Official title: 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.
- Conditions
- Gambling
- Being tested
- iCBT
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based Cognitive Behavioral Therapy | Experimental | 10 guided therapy sessions (once-weekly) with each session lasting 20 minutes. Receives: Behavioral: iCBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gambling symptom severity
a decrease in Gambling Symptom Assessment Scale (G-SAS) score
Measured: G-SAS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
Problem gambling severity
a decrease in Problem Gambling Severity Index score
Measured: PGSI will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
Gambling urges
a decrease in Gambling Urge Scale (GUS) score
Measured: GUS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
Gambling-related cognitive distortions
a decrease in Gambling Related Cognitions Scale (GRCS) score
Measured: GRCS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
Secondary outcomes (2)
Nonspecific psychological distress
a decrease in Self Rating Questionnaire-20 (SRQ-20) score
Measured: SRQ-20 will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
Subjective quality of life
an increase in World Health Organization Quality-of-Life Scale (WHOQOL-BREF) score
Measured: WHOQOL-BREF will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study startAug 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GamblingStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Flinders University
- Responsible party
- Principal investigator, Kristiana Siste, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171516
- Sponsor's protocol ID
- KET-992-2023
- Acronym
- ICBT
- Status last verified
- Jul 2024
- First submitted
- 6 Dec 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavioral Therapy for Individuals With Gambling Disorder in Indonesia: a Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT06171516
- Acronym / sponsor ID
- ICBT / KET-992-2023
- Conditions
- Gambling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Flinders University
- Study start
- Aug 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-based Cognitive Behavioral Therapy | Experimental | Behavioral: iCBT10 guided therapy sessions (once-weekly) with each session lasting 20 minutes. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- have severe mental disorders or intellectual disabilities;
- have extreme agitation that hinder instrument fill out and adequate cognitive behavior therapy participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCBTAll 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. | Behavioural | Internet-based Cognitive Behavioral Therapy |
Primary outcome
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
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
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
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
2 secondary outcomes
Nonspecific psychological distress
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
Related trials for Gambling
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 2
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
Gambling Disorder
Recruiting
Digital Cognitive Behavioral Therapy for Gambling Disorder
Gambling Disorder, Gambling
RecruitingObservational study
Is Craving a Central Criterion for Diagnosing a Behavioral Addiction?
Addictive Behaviors, Internet Addiction Disorder
Not yet recruiting
COMpulsive Gambling: Efficacy of DEEP Transcranial Magnetic Stimulation With H7 COIL
Gambling Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing iCBT in people with Gambling, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gambling symptom severity (time frame: G-SAS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.