Gambling DisorderIndo CHIPNCT07863440
Digital Cognitive Behavioral Therapy for Gambling Disorder
A study testing Digital Cognitive Behavioral Therapy for Gambling Disorder, Digital Family Intervention for Gambling-Related Harms and Face-to-Face Cognitive Behavioral Therapy for Gambling Disorder in people with Gambling Disorder and Gambling, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary clinical effects of digital cognitive behavioral therapy (CBT) for adults with gambling disorder involving online gambling in Indonesia. Twenty patient-family dyads will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gambling Disorder, Gambling
- What is being tested?
- Digital Cognitive Behavioral Therapy for Gambling Disorder, Digital Family Intervention for Gambling-Related Harms and Face-to-Face Cognitive Behavioral Therapy for Gambling Disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- Nov 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 59 years.
- Positive screening for gambling problems using the validated Indonesian version of the South Oaks Gambling Screen (SOGS), with a score of 5 or higher.
- Diagnosis of gambling disorder according to ICD-11 criteria confirmed through a psychiatric interview conducted by an addiction psychiatrist.
- Willing and able to provide written informed consent.
- Has one eligible affected family member who is willing to participate and provide written informed consent.
- Has access to the internet and a smartphone capable of accessing the digital intervention.
Show all 11Show fewer
- 18 years or older.
- Willing and able to provide written informed consent.
- Is the parent, spouse, or sibling of the participating patient with gambling disorder.
- Accompanies the patient during treatment and is affected by the patient's gambling behavior.
- Has access to the internet and a smartphone capable of accessing the digital intervention.
Who cannot join
- No history of gambling during the previous 6 months.
- History of a neuropsychiatric disorder that would interfere with study participation.
- Severe mental disorder or intellectual disability preventing adequate completion of study assessments or participation in CBT.
- Severe agitation preventing adequate participation in CBT.
- Previous pharmacological or non-pharmacological treatment specifically for gambling disorder (treatment-naive).
- The associated patient withdraws from the study or otherwise becomes ineligible for continued study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
dr. Cipto Mangunkusumo General Hospital
Jakarta Pusat, Jakarta Special Capital Region, 10430
Kristiana Siste, MD, PhD, +62 87782516771, ksiste@yahoo.com
About this study
Official title: Digital Cognitive Behavioral Therapy Versus Face-to-Face Cognitive Behavioral Therapy for Gambling Disorder: A Pilot Randomized Controlled Feasibility Trial
This pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary clinical effects of digital cognitive behavioral therapy (CBT) for adults with gambling disorder involving online gambling in Indonesia. Twenty patient-family dyads will be enrolled. Patients with gambling disorder will be randomized to receive either 12 sessions of digital CBT or 12 individualized face-to-face CBT sessions over approximately 6 weeks. Family members in the digital arm will receive six digital family-intervention sessions over 3 weeks, while family members in the comparator arm will receive the same six-session intervention in printed format. Gambling-related symptoms, urges, cognitions, psychological symptoms, depression, sleep quality, coping, readiness to change, and family-related outcomes will be assessed during treatment. Feasibility and acceptability of the digital interventions will also be evaluated.
Read the detailed description
Gambling disorder is associated with substantial psychological, social, financial, and family-related harms. Although cognitive behavioral therapy (CBT) is an established psychological treatment for gambling problems, access to regular face-to-face treatment may be limited. Digital delivery may provide a scalable treatment option while maintaining structured therapeutic support.
This study is a two-arm pilot randomized controlled feasibility trial conducted at the Integrated Outpatient Addiction Clinic of Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia. Twenty patient-family dyads, comprising 20 patients and 20 affected family members, will be enrolled. Patients aged 18 to 59 years with gambling disorder confirmed according to ICD-11 criteria will be randomized in a 1:1 ratio to digital CBT or individualized face-to-face CBT. The participating family member will follow the patient's treatment allocation and receive the corresponding digital or printed family intervention.
Patients assigned to digital CBT will complete 12 smartphone-based CBT sessions over 6 weeks, with two sessions unlocked each week. Sessions include video-based therapeutic content, structured worksheets, and therapeutic assignments that can be completed at the participant's convenience. Patients will meet with an addiction psychiatrist once every 2 weeks, for a total of three meetings, to review completed sessions and assignments and reinforce therapeutic strategies. Family members in this arm will complete six digital family-intervention sessions over 3 weeks, with two sessions released each week. They will meet with an addiction psychiatrist twice, once after Session 4 and again approximately 1 week after completing Session 6.
Patients assigned to the active comparator will receive 12 individualized face-to-face CBT sessions delivered by an addiction psychiatrist twice weekly over 6 weeks. Family members in this arm will receive the same six-session family-intervention content provided to the digital family group, but in printed format, and will complete two sessions per week over 3 weeks with the corresponding worksheets and assessments.
Clinically indicated pharmacological treatment may continue during the study in both groups. Feasibility and acceptability of the digital interventions will be evaluated among participants assigned to the digital arm. Patient clinical outcomes and family-related outcomes will be assessed at baseline, during treatment, and following completion of the respective interventions.
- Conditions
- Gambling Disorder, Gambling
- Being tested
- Digital Cognitive Behavioral Therapy for Gambling Disorder, Digital Family Intervention for Gambling-Related Harms, Face-to-Face Cognitive Behavioral Therapy for Gambling Disorder, Printed Family Intervention for Gambling-Related Harms
- Keywords
- Online gambling, Internet gambling, Gambling Addiction, Cognitive Behavioral Therapy, Digital CBT, Internet-Based CBT, Behavioral Addiction, Gambling Harms, Family, Affected Others
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Cognitive Behavioral Therapy for Gambling DisorderBehavioural
Also called Digital CBT
A therapist-supported digital CBT intervention for gambling disorder delivered through a smartphone-accessible platform. Patients complete 12 digital CBT sessions over 6 weeks, with two sessions released each week. Sessions consist of video-based therapeutic content, structured worksheets, and therapeutic assignments and may be completed at a time chosen by the participant. Patients also meet with an addiction psychiatrist once every 2 weeks, for a total of three meetings, to review completed session content and assignments, address difficulties encountered during treatment, and reinforce therapeutic strategies.
Digital Family Intervention for Gambling-Related HarmsBehavioural
Also called Digital Family Module
A six-session digital intervention for family members affected by the participating patient's gambling behavior. Two sessions are released each week over 3 weeks and may be completed using a smartphone at the family member's convenience. Sessions include video-based therapeutic content, structured assessments, and worksheets addressing gambling-related harms and coping strategies. Family members meet with an addiction psychiatrist twice, once after completion of Session 4 and again approximately 1 week after completion of Session 6, to review the intervention material and discuss difficulties encountered.
Face-to-Face Cognitive Behavioral Therapy for Gambling DisorderBehavioural
Also called Face-to-Face CBT
Individualized face-to-face CBT for gambling disorder delivered by an addiction psychiatrist twice weekly over 6 weeks, for a total of 12 sessions. Each session lasts approximately 30 to 45 minutes. Treatment addresses gambling-related triggers and urges, gambling-related cognitions and behaviors, coping strategies, alternative behaviors, cognitive restructuring, financial management, relationship difficulties, emotional regulation, and relapse prevention.
Printed Family Intervention for Gambling-Related HarmsBehavioural
Also called Printed Family Module
A six-session printed intervention for family members affected by the participating patient's gambling behavior. The therapeutic content corresponds to the family intervention delivered digitally in the experimental arm but is provided in printed format. Family members complete two sessions per week over 3 weeks, together with the corresponding therapeutic content, structured assessments, and worksheets.
| Study group | Role | What they receive |
|---|---|---|
| Digital CBT and Digital Family Intervention | Experimental | Patients receive 12 digital cognitive behavioral therapy (CBT) sessions over 6 weeks, with two smartphone-based sessions unlocked each week. Sessions include video-based therapeutic content, structured worksheets, and therapeutic assignments and may be completed at the participant's convenience. Patients meet with an addiction psychiatrist once every 2 weeks, for a total of three meetings, to review completed sessions and assignments, discuss difficulties, and reinforce therapeutic strategies.
Participating family members receive six digital family-intervention sessions over 3 weeks, with two sessions unlocked each week. Family sessions include video-based therapeutic content and worksheets addressing gambling-related harms and coping strategies. Family members meet with an addiction psychiatrist twice, once after Session 4 and again approximately 1 week after completing Session 6. Receives: Behavioral: Digital Cognitive Behavioral Therapy for Gambling Disorder; Behavioral: Digital Family Intervention for Gambling-Related Harms |
| Face-to-Face CBT and Family Intervention | Active comparator | Patients receive 12 individualized face-to-face cognitive behavioral therapy (CBT) sessions for gambling disorder, delivered by an addiction psychiatrist twice weekly over 6 weeks. Each session lasts approximately 30 to 45 minutes and addresses gambling triggers and urges, gambling-related cognitions and behaviors, coping strategies, alternative behaviors, cognitive restructuring, financial management, relationship difficulties, emotional regulation, and relapse prevention.
Participating family members receive the same six-session family-intervention content used in the digital arm, but in printed format. Family members complete two printed sessions per week over 3 weeks, including the corresponding therapeutic content, structured assessments, and worksheets. The printed format provides the same core family-intervention content while differing only in delivery format from the digital family intervention. Receives: Behavioral: Face-to-Face Cognitive Behavioral Therapy for Gambling Disorder; Behavioral: Printed Family Intervention for Gambling-Related Harms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Digital CBT Sessions by Patients
Feasibility of the digital CBT intervention will be assessed in patients assigned to the digital CBT arm as the number and proportion of patients who complete at least 80% of the 12 prescribed digital CBT sessions. Completion of at least 10 of 12 sessions will be considered intervention completion.
Measured: From initiation of the digital intervention through Week 6
Completion of Digital Family Intervention Sessions
Feasibility of the digital family intervention will be assessed among family members assigned to the digital intervention arm as the number and proportion who complete at least 80% of the six prescribed digital sessions. Completion of at least five of six sessions will be considered intervention completion.
Measured: From initiation of the digital family intervention through Week 3
Overall Satisfaction With Digital CBT
Overall acceptability of digital CBT will be assessed after completion of the intervention using the overall satisfaction item from a study-specific acceptability questionnaire. Patients rate their overall satisfaction with digital CBT on a 4-point Likert-type scale from 0 (not at all) to 3 (very much), with higher scores indicating greater satisfaction and acceptability. Additional questionnaire items assess perceived usefulness, suitability of digital CBT as an alternative or adjunct to face-to-face treatment, willingness to recommend the intervention, and intervention-related problems or adverse experiences.
Measured: Immediately after completion of Digital CBT Session 12, approximately Week 6
Overall Satisfaction With the Digital Family Intervention
Overall acceptability of the digital family intervention will be assessed after completion of the intervention using the overall satisfaction item from a study-specific acceptability questionnaire. Family members rate their overall satisfaction with the digital intervention on a 4-point Likert-type scale from 0 (not at all) to 3 (very much), with higher scores indicating greater satisfaction and acceptability. Additional questionnaire items assess perceived usefulness, suitability of the digital intervention as an alternative or adjunct to face-to-face care, willingness to recommend the intervention, and intervention-related problems or adverse experiences.
Measured: Immediately after completion of Family Session 6, approximately Week 3
Secondary outcomes (12)
Change in Gambling Symptom Assessment Scale (G-SAS) Score
The G-SAS is a 12-item self-report measure assessing gambling symptom severity during the previous week, including gambling urges, gambling-related thoughts and behaviors, anticipatory excitement, emotional distress, and gambling-related personal problems. Total scores range from 0 to 48, with higher scores indicating greater gambling symptom severity. Change in G-SAS score will be assessed across the three study assessments.
Measured: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Problem Gambling Severity Index (PGSI) Score
The PGSI is a 9-item self-report measure assessing problematic gambling behavior and gambling-related adverse consequences. Items are summed to produce a total score ranging from 0 to 27, with higher scores indicating greater problem gambling severity. Change in PGSI score will be assessed across the three study assessments.
Measured: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Gambling Urge Scale (GUS) Score
The GUS is a 6-item self-report measure assessing the intensity of current urges to gamble. In the study version, each item is rated from 0 to 7, producing a possible total score from 0 to 42. Higher scores indicate stronger gambling urges. Change in GUS score will be assessed across the three study assessments.
Measured: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Gambling Related Cognitions Scale (GRCS) Score
The GRCS is a 23-item self-report measure assessing gambling-related cognitive distortions across five domains: gambling expectancies, illusion of control, predictive control, inability to stop gambling, and interpretative bias. In the study version, each item is rated from 0 to 7, producing a total possible score from 0 to 161 when summed. Higher scores indicate greater endorsement of gambling-related cognitive distortions. Change in GRCS score will be assessed across the three study assessments.
Measured: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Self-Reporting Questionnaire-20 (SRQ-20) Score
The SRQ-20 is a 20-item self-report screening measure developed by the World Health Organization to assess symptoms of common mental disorders and general psychological distress. Items are scored as present or absent, producing a total score from 0 to 20. Higher scores indicate greater psychological symptom burden. Change in SRQ-20 score will be assessed across the three study assessments
Measured: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Patient Health Questionnaire-9 (PHQ-9) Score
The PHQ-9 is a 9-item self-report measure assessing depressive symptoms during the previous 2 weeks. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. Change in PHQ-9 score will be assessed across the three study assessments.
Measured: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) Score
The PSQI is a self-report measure assessing sleep quality and sleep disturbances during the previous month. Seven component scores are summed to produce a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. Change in global PSQI score will be assessed across the three study assessments
Measured: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Brief COPE Subscale Scores
The Brief COPE is a 28-item self-report measure assessing 14 coping strategies, with two items representing each strategy. Each item is rated from 1 to 4, and each two-item subscale therefore ranges from 2 to 8. Higher subscale scores indicate greater use of the corresponding coping strategy. Because the instrument assesses both adaptive and maladaptive coping strategies, higher scores do not uniformly indicate a better or worse outcome. Changes in the 14 individual coping subscale scores will be assessed across the three study assessments.
Measured: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in University of Rhode Island Change Assessment (URICA) Readiness to Change Score
The URICA is a 32-item self-report measure assessing readiness for behavioral change across four stages: precontemplation, contemplation, action, and maintenance. Each stage is represented by eight items rated from 1 (strongly disagree) to 5 (strongly agree). Mean scores are calculated for each subscale. An overall Readiness to Change score is calculated as the sum of the mean Contemplation, Action, and Maintenance scores minus the mean Precontemplation score (C + A + M - PC). The resulting score ranges from -2 to 14, with higher scores indicating greater readiness to change. Change in the URICA Readiness to Change score will be assessed across the three study assessments.
Measured: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Gambling Harms Scale for Affected Others (GHS-20-AO) Score
The GHS-20-AO is a 20-item self-report measure assessing harms experienced by an affected other as a result of another person's gambling, including financial, emotional, and social harms. Each item is scored 0 (No) or 1 (Yes), producing a total score ranging from 0 to 20. Higher scores indicate greater gambling-related harm experienced by the family member. Change in GHS-20-AO score will be assessed across the three family assessments.
Measured: Baseline, after Family Session 4 (approximately Week 2), and after Family Session 6 (approximately Week 3)
Change in 5-Step Method Family Member Questionnaire (5SM-FMQ) Scores
The 5SM-FMQ is a 33-item self-report measure assessing four domains relevant to affected family members: impact, physical and psychological symptoms, coping, and social support. The Total Impact scale contains six items scored from 0 to 3, giving a range of 0 to 18, with higher scores indicating greater adverse impact. The Total Symptoms scale contains six items scored from 0 to 2, giving a range of 0 to 12, with higher scores indicating greater symptom burden. Coping and support items are scored from 0 to 3, with higher scores indicating greater use or experience of the corresponding coping or support construct; therefore, direction of improvement differs across these subscales. Changes in the prespecified 5SM-FMQ scores will be assessed across the three family assessments.
Measured: Baseline, after Family Session 4 (approximately Week 2), and after Family Session 6 (approximately Week 3)
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Domain Scores
The WHOQOL-BREF is a 26-item self-report measure assessing quality of life across four domains: physical health, psychological health, social relationships, and environment. Domain scores will be calculated according to the WHO scoring procedure and transformed to a 0 to 100 scale. Higher scores indicate better quality of life. Changes in each of the four domain scores will be assessed across the three family assessments.
Measured: Baseline, after Family Session 4 (approximately Week 2), and after Family Session 6 (approximately Week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Twenty patient-family dyads will be enrolled. Patients with gambling disorder will be randomized in a 1:1 ratio to digital cognitive behavioral therapy (CBT) or face-to-face CBT. The participating family member will follow the patient's treatment allocation and receive the corresponding digital or printed family intervention. Each patient-family dyad will remain in its assigned treatment arm throughout the intervention period.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristiana Siste, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863440
- Sponsor's protocol ID
- KET-607-2026
- Acronym
- Indo CHIP
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Cognitive Behavioral Therapy Versus Face-to-Face Cognitive Behavioral Therapy for Gambling Disorder: A Pilot Randomized Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT07863440
- Acronym / sponsor ID
- Indo CHIP / KET-607-2026
- Conditions
- Gambling Disorder, Gambling
- Keywords
- Online gambling, Internet gambling, Gambling Addiction, Cognitive Behavioral Therapy, Digital CBT, Internet-Based CBT, Behavioral Addiction, Gambling Harms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 7 Oct 2026 (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.
This pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary clinical effects of digital cognitive behavioral therapy (CBT) for adults with gambling disorder involving online gambling in Indonesia. Twenty patient-family dyads will be enrolled. Patients with gambling disorder will be randomized to receive either 12 sessions of digital CBT or 12 individualized face-to-face CBT sessions over approximately 6 weeks. Family members in the digital arm will receive six digital family-intervention sessions over 3 weeks, while family members in the comparator arm will receive the same six-session intervention in printed format. Gambling-related symptoms, urges, cognitions, psychological symptoms, depression, sleep quality, coping, readiness to change, and family-related outcomes will be assessed during treatment. Feasibility and acceptability of the digital interventions will also be evaluated.
Detailed description
Gambling disorder is associated with substantial psychological, social, financial, and family-related harms. Although cognitive behavioral therapy (CBT) is an established psychological treatment for gambling problems, access to regular face-to-face treatment may be limited. Digital delivery may provide a scalable treatment option while maintaining structured therapeutic support.
This study is a two-arm pilot randomized controlled feasibility trial conducted at the Integrated Outpatient Addiction Clinic of Dr. Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia. Twenty patient-family dyads, comprising 20 patients and 20 affected family members, will be enrolled. Patients aged 18 to 59 years with gambling disorder confirmed according to ICD-11 criteria will be randomized in a 1:1 ratio to digital CBT or individualized face-to-face CBT. The participating family member will follow the patient's treatment allocation and receive the corresponding digital or printed family intervention.
Patients assigned to digital CBT will complete 12 smartphone-based CBT sessions over 6 weeks, with two sessions unlocked each week. Sessions include video-based therapeutic content, structured worksheets, and therapeutic assignments that can be completed at the participant's convenience. Patients will meet with an addiction psychiatrist once every 2 weeks, for a total of three meetings, to review completed sessions and assignments and reinforce therapeutic strategies. Family members in this arm will complete six digital family-intervention sessions over 3 weeks, with two sessions released each week. They will meet with an addiction psychiatrist twice, once after Session 4 and again approximately 1 week after completing Session 6.
Patients assigned to the active comparator will receive 12 individualized face-to-face CBT sessions delivered by an addiction psychiatrist twice weekly over 6 weeks. Family members in this arm will receive the same six-session family-intervention content provided to the digital family group, but in printed format, and will complete two sessions per week over 3 weeks with the corresponding worksheets and assessments.
Clinically indicated pharmacological treatment may continue during the study in both groups. Feasibility and acceptability of the digital interventions will be evaluated among participants assigned to the digital arm. Patient clinical outcomes and family-related outcomes will be assessed at baseline, during treatment, and following completion of the respective interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Twenty patient-family dyads will be enrolled. Patients with gambling disorder will be randomized in a 1:1 ratio to digital cognitive behavioral therapy (CBT) or face-to-face CBT. The participating family member will follow the patient's treatment allocation and receive the corresponding digital or printed family intervention. Each patient-family dyad will remain in its assigned treatment arm throughout the intervention period.
| Arm | Type | Receives |
|---|---|---|
| Digital CBT and Digital Family Intervention | Experimental | Behavioral: Digital Cognitive Behavioral Therapy for Gambling Disorder, Behavioral: Digital Family Intervention for Gambling-Related HarmsPatients receive 12 digital cognitive behavioral therapy (CBT) sessions over 6 weeks, with two smartphone-based sessions unlocked each week. Sessions include video-based therapeutic content, structured worksheets, and therapeutic assignments and may be completed at the participant's convenience. Patients meet with an addiction psychiatrist once every 2 weeks, for a total of three meetings, to review completed sessions and assignments, discuss difficulties, and reinforce therapeutic strategies. Participating family members receive six digital family-intervention sessions over 3 weeks, with two sessions unlocked each week. Family sessions include video-based therapeutic content and worksheets addressing gambling-related harms and coping strategies. Family members meet with an addiction psychiatrist twice, once after Session 4 and again approximately 1 week after completing Session 6. |
| Face-to-Face CBT and Family Intervention | Active comparator | Behavioral: Face-to-Face Cognitive Behavioral Therapy for Gambling Disorder, Behavioral: Printed Family Intervention for Gambling-Related HarmsPatients receive 12 individualized face-to-face cognitive behavioral therapy (CBT) sessions for gambling disorder, delivered by an addiction psychiatrist twice weekly over 6 weeks. Each session lasts approximately 30 to 45 minutes and addresses gambling triggers and urges, gambling-related cognitions and behaviors, coping strategies, alternative behaviors, cognitive restructuring, financial management, relationship difficulties, emotional regulation, and relapse prevention. Participating family members receive the same six-session family-intervention content used in the digital arm, but in printed format. Family members complete two printed sessions per week over 3 weeks, including the corresponding therapeutic content, structured assessments, and worksheets. The printed format provides the same core family-intervention content while differing only in delivery format from the digital family intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 to 59 years.
- Positive screening for gambling problems using the validated Indonesian version of the South Oaks Gambling Screen (SOGS), with a score of 5 or higher.
- Diagnosis of gambling disorder according to ICD-11 criteria confirmed through a psychiatric interview conducted by an addiction psychiatrist.
- Willing and able to provide written informed consent.
- Has one eligible affected family member who is willing to participate and provide written informed consent.
Key exclusion criteria (6 listed)
- No history of gambling during the previous 6 months.
- History of a neuropsychiatric disorder that would interfere with study participation.
- Severe mental disorder or intellectual disability preventing adequate completion of study assessments or participation in CBT.
- Severe agitation preventing adequate participation in CBT.
- Previous pharmacological or non-pharmacological treatment specifically for gambling disorder (treatment-naive).
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 |
|---|---|---|
| Digital Cognitive Behavioral Therapy for Gambling DisorderAlso: Digital CBTA therapist-supported digital CBT intervention for gambling disorder delivered through a smartphone-accessible platform. Patients complete 12 digital CBT sessions over 6 weeks, with two sessions released each week. Sessions consist of video-based therapeutic content, structured worksheets, and therapeutic assignments and may be completed at a time chosen by the participant. Patients also meet with an addiction psychiatrist once every 2 weeks, for a total of three meetings, to review completed session content and assignments, address difficulties encountered during treatment, and reinforce therapeutic strategies. | Behavioural | Digital CBT and Digital Family Intervention |
| Digital Family Intervention for Gambling-Related HarmsAlso: Digital Family ModuleA six-session digital intervention for family members affected by the participating patient's gambling behavior. Two sessions are released each week over 3 weeks and may be completed using a smartphone at the family member's convenience. Sessions include video-based therapeutic content, structured assessments, and worksheets addressing gambling-related harms and coping strategies. Family members meet with an addiction psychiatrist twice, once after completion of Session 4 and again approximately 1 week after completion of Session 6, to review the intervention material and discuss difficulties encountered. | Behavioural | Digital CBT and Digital Family Intervention |
| Face-to-Face Cognitive Behavioral Therapy for Gambling DisorderAlso: Face-to-Face CBTIndividualized face-to-face CBT for gambling disorder delivered by an addiction psychiatrist twice weekly over 6 weeks, for a total of 12 sessions. Each session lasts approximately 30 to 45 minutes. Treatment addresses gambling-related triggers and urges, gambling-related cognitions and behaviors, coping strategies, alternative behaviors, cognitive restructuring, financial management, relationship difficulties, emotional regulation, and relapse prevention. | Behavioural | Face-to-Face CBT and Family Intervention |
| Printed Family Intervention for Gambling-Related HarmsAlso: Printed Family ModuleA six-session printed intervention for family members affected by the participating patient's gambling behavior. The therapeutic content corresponds to the family intervention delivered digitally in the experimental arm but is provided in printed format. Family members complete two sessions per week over 3 weeks, together with the corresponding therapeutic content, structured assessments, and worksheets. | Behavioural | Face-to-Face CBT and Family Intervention |
Primary outcome
Completion of Digital CBT Sessions by Patients
Time frame: From initiation of the digital intervention through Week 6
Feasibility of the digital CBT intervention will be assessed in patients assigned to the digital CBT arm as the number and proportion of patients who complete at least 80% of the 12 prescribed digital CBT sessions. Completion of at least 10 of 12 sessions will be considered intervention completion.
Completion of Digital Family Intervention Sessions
Time frame: From initiation of the digital family intervention through Week 3
Feasibility of the digital family intervention will be assessed among family members assigned to the digital intervention arm as the number and proportion who complete at least 80% of the six prescribed digital sessions. Completion of at least five of six sessions will be considered intervention completion.
Overall Satisfaction With Digital CBT
Time frame: Immediately after completion of Digital CBT Session 12, approximately Week 6
Overall acceptability of digital CBT will be assessed after completion of the intervention using the overall satisfaction item from a study-specific acceptability questionnaire. Patients rate their overall satisfaction with digital CBT on a 4-point Likert-type scale from 0 (not at all) to 3 (very much), with higher scores indicating greater satisfaction and acceptability. Additional questionnaire items assess perceived usefulness, suitability of digital CBT as an alternative or adjunct to face-to-face treatment, willingness to recommend the intervention, and intervention-related problems or adverse experiences.
Overall Satisfaction With the Digital Family Intervention
Time frame: Immediately after completion of Family Session 6, approximately Week 3
Overall acceptability of the digital family intervention will be assessed after completion of the intervention using the overall satisfaction item from a study-specific acceptability questionnaire. Family members rate their overall satisfaction with the digital intervention on a 4-point Likert-type scale from 0 (not at all) to 3 (very much), with higher scores indicating greater satisfaction and acceptability. Additional questionnaire items assess perceived usefulness, suitability of the digital intervention as an alternative or adjunct to face-to-face care, willingness to recommend the intervention, and intervention-related problems or adverse experiences.
12 secondary outcomes
Change in Gambling Symptom Assessment Scale (G-SAS) Score
Time frame: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Problem Gambling Severity Index (PGSI) Score
Time frame: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Gambling Urge Scale (GUS) Score
Time frame: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Gambling Related Cognitions Scale (GRCS) Score
Time frame: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Self-Reporting Questionnaire-20 (SRQ-20) Score
Time frame: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Brief COPE Subscale Scores
Time frame: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in University of Rhode Island Change Assessment (URICA) Readiness to Change Score
Time frame: Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
Change in Gambling Harms Scale for Affected Others (GHS-20-AO) Score
Time frame: Baseline, after Family Session 4 (approximately Week 2), and after Family Session 6 (approximately Week 3)
Change in 5-Step Method Family Member Questionnaire (5SM-FMQ) Scores
Time frame: Baseline, after Family Session 4 (approximately Week 2), and after Family Session 6 (approximately Week 3)
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Domain Scores
Time frame: Baseline, after Family Session 4 (approximately Week 2), and after Family Session 6 (approximately Week 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Gambling Disorder
RecruitingPhase 2
Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study
Gambling Disorder
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
Not yet recruiting
QAIAx (AIhealth4U) - AI Smart Health Cities: Microcity Enclave Program (Quantum AI/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)
Asperger's Disorder, Asperger Disorder
Recruiting
Efficacy and Safety of Combo-stim Deep Brain Stimulation for Treatment-refractory Mental Disorders
Deep Brain Stimulation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Cognitive Behavioral Therapy for Gambling Disorder, Digital Family Intervention for Gambling-Related Harms and Face-to-Face Cognitive Behavioral Therapy for Gambling Disorder in people with Gambling Disorder and Gambling, run by Universitas Indonesia at 1 site in 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 11 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristiana Siste, MD, PhD (+62 87782516771, ksiste@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Digital CBT Sessions by Patients (time frame: From initiation of the digital intervention through Week 6). 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 15 Oct 2026.