[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659334":3},{"organization":4,"outcomesModule":7,"designInfo":73,"detailedDescription":85,"studyPopulation":78,"armGroups":86,"interventions":101,"overallOfficials":78,"centralContacts":127,"locations":133,"responsibleParty":150,"collaborators":78,"id":154,"slug":155,"hasResults":156,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":156,"sex":162,"minAge":163,"maxAge":78,"enrollmentInfo":164,"targetDuration":78,"studyType":167,"phases":168,"briefSummary":170,"conditions":171,"keywords":174,"overallStatus":136,"whyStopped":78,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},{"fullName":5,"class":6},"Universitas Indonesia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":64},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"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.","From initiation of the digital intervention through Week 6",{"measure":14,"description":15,"timeFrame":16},"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.","From initiation of the digital family intervention through Week 3",{"measure":18,"description":19,"timeFrame":20},"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.","Immediately after completion of Digital CBT Session 12, approximately Week 6",{"measure":22,"description":23,"timeFrame":24},"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.","Immediately after completion of Family Session 6, approximately Week 3",[26,30,33,36,39,42,45,48,51,54,58,61],{"measure":27,"description":28,"timeFrame":29},"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.","Baseline, after Session 6, and after Session 12; up to approximately 6 weeks",{"measure":31,"description":32,"timeFrame":29},"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.",{"measure":34,"description":35,"timeFrame":29},"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.",{"measure":37,"description":38,"timeFrame":29},"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.",{"measure":40,"description":41,"timeFrame":29},"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",{"measure":43,"description":44,"timeFrame":29},"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.",{"measure":46,"description":47,"timeFrame":29},"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",{"measure":49,"description":50,"timeFrame":29},"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.",{"measure":52,"description":53,"timeFrame":29},"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.",{"measure":55,"description":56,"timeFrame":57},"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.","Baseline, after Family Session 4 (approximately Week 2), and after Family Session 6 (approximately Week 3)",{"measure":59,"description":60,"timeFrame":57},"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.",{"measure":62,"description":63,"timeFrame":57},"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.",[65,69],{"measure":66,"description":67,"timeFrame":68},"Session-Level Acceptability of Digital CBT","After each digital CBT session, patients complete a study-specific acceptability questionnaire consisting of three items assessing: (1) overall usefulness of the session, (2) helpfulness of the session in addressing their gambling disorder, and (3) anticipated use of what was learned in daily life. Each item is rated on a 4-point Likert-type scale from 0 (not at all) to 3 (very much), with higher scores indicating greater session-level acceptability. An optional free-text item allows additional comments or suggestions. Items will be evaluated individually.","After each of the 12 digital CBT sessions, from Week 1 through Week 6",{"measure":70,"description":71,"timeFrame":72},"Session-Level Acceptability of the Digital Family Intervention","After each digital family-intervention session, family members complete a study-specific acceptability questionnaire consisting of three items assessing: (1) overall usefulness of the session, (2) helpfulness of the session in addressing the family member's gambling-related problems and their impact, and (3) anticipated use of what was learned in daily life. Each item is rated on a 4-point Likert-type scale from 0 (not at all) to 3 (very much), with higher scores indicating greater session-level acceptability. An optional free-text item allows additional comments or suggestions. Items will be evaluated individually.","After each of the 6 digital family-intervention sessions, from Week 1 through Week 3",{"allocation":74,"interventionModel":75,"interventionModelDescription":76,"primaryPurpose":77,"observationalModel":78,"timePerspective":78,"maskingInfo":79},"RANDOMIZED","PARALLEL","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.","TREATMENT",null,{"masking":80,"maskingDescription":81,"whoMasked":82},"DOUBLE","Participants are not informed of the existence or identity of the alternative treatment condition and are not informed of their randomized study-arm designation or the comparative study hypothesis. However, because of the nature of the interventions, participants are aware of the treatment modality they receive, and treating addiction psychiatrists are aware of the modality they deliver. Randomization and allocation are performed by a separate study team member. Outcome data are analyzed by a statistician who is masked to treatment allocation and receives treatment groups identified only by coded labels (Group A and B). The treatment-code key is withheld until completion of the prespecified analyses.",[83,84],"PARTICIPANT","OUTCOMES_ASSESSOR","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.\n\nThis 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.\n\nPatients 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.\n\nPatients 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.\n\nClinically 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.",[87,94],{"label":88,"type":89,"description":90,"interventionNames":91},"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.\n\nParticipating 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.",[92,93],"Behavioral: Digital Cognitive Behavioral Therapy for Gambling Disorder","Behavioral: Digital Family Intervention for Gambling-Related Harms",{"label":95,"type":96,"description":97,"interventionNames":98},"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.\n\nParticipating 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.",[99,100],"Behavioral: Face-to-Face Cognitive Behavioral Therapy for Gambling Disorder","Behavioral: Printed Family Intervention for Gambling-Related Harms",[102,109,115,121],{"type":103,"name":104,"description":105,"armGroupLabels":106,"otherNames":107},"BEHAVIORAL","Digital Cognitive Behavioral Therapy for Gambling Disorder","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.",[88],[108],"Digital CBT",{"type":103,"name":110,"description":111,"armGroupLabels":112,"otherNames":113},"Digital Family Intervention for Gambling-Related Harms","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.",[88],[114],"Digital Family Module",{"type":103,"name":116,"description":117,"armGroupLabels":118,"otherNames":119},"Face-to-Face Cognitive Behavioral Therapy for Gambling Disorder","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.",[95],[120],"Face-to-Face CBT",{"type":103,"name":122,"description":123,"armGroupLabels":124,"otherNames":125},"Printed Family Intervention for Gambling-Related Harms","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.",[95],[126],"Printed Family Module",[128],{"name":129,"role":130,"phone":131,"phoneExt":78,"email":132},"Kristiana Siste, MD, PhD","CONTACT","+62 87782516771","ksiste@yahoo.com",[134],{"facility":135,"status":136,"city":137,"state":138,"zip":139,"country":140,"countryCode":141,"cosmosGeoPoint":142,"geoPoint":147,"contacts":148},"dr. Cipto Mangunkusumo General Hospital","RECRUITING","Jakarta Pusat","Jakarta Special Capital Region","10430","Indonesia","ID",{"type":143,"coordinates":144},"Point",[145,146],106.8223,-6.1818,{"lat":146,"lon":145},[149],{"name":129,"role":130,"phone":131,"phoneExt":78,"email":132},{"type":151,"investigatorFullName":152,"investigatorTitle":153,"investigatorAffiliation":5,"oldNameTitle":78,"oldOrganization":78},"PRINCIPAL_INVESTIGATOR","Kristiana Siste","Dr. dr. Kristiana Siste, Sp.KJ(K) - Head of Department of Psychiatry, Cipto Mangunkusumo General Hospital","100659334","digital-cognitive-behavioral-therapy-for-gambling-disorder-a-pilot-randomized-controlled-trial-100659334",false,"NCT07863440","Digital Cognitive Behavioral Therapy for Gambling Disorder: A Pilot Randomized Controlled Trial","Digital Cognitive Behavioral Therapy Versus Face-to-Face Cognitive Behavioral Therapy for Gambling Disorder: A Pilot Randomized Controlled Feasibility Trial","Indo CHIP","Inclusion Criteria for Patients With Gambling Disorder:\n\n* Aged 18 to 59 years.\n* Positive screening for gambling problems using the validated Indonesian version of the South Oaks Gambling Screen (SOGS), with a score of 5 or higher.\n* Diagnosis of gambling disorder according to ICD-11 criteria confirmed through a psychiatric interview conducted by an addiction psychiatrist.\n* Willing and able to provide written informed consent.\n* Has one eligible affected family member who is willing to participate and provide written informed consent.\n* Has access to the internet and a smartphone capable of accessing the digital intervention.\n\nExclusion Criteria for Patients With Gambling Disorder:\n\n* No history of gambling during the previous 6 months.\n* History of a neuropsychiatric disorder that would interfere with study participation.\n* Severe mental disorder or intellectual disability preventing adequate completion of study assessments or participation in CBT.\n* Severe agitation preventing adequate participation in CBT.\n* Previous pharmacological or non-pharmacological treatment specifically for gambling disorder (treatment-naive).\n\nInclusion Criteria for Participating Family Members:\n\n* 18 years or older.\n* Willing and able to provide written informed consent.\n* Is the parent, spouse, or sibling of the participating patient with gambling disorder.\n* Accompanies the patient during treatment and is affected by the patient's gambling behavior.\n* Has access to the internet and a smartphone capable of accessing the digital intervention.\n\nExclusion Criteria for Participating Family Members:\n\n• The associated patient withdraws from the study or otherwise becomes ineligible for continued study participation.","ALL","18 Years",{"count":165,"type":166},40,"ESTIMATED","INTERVENTIONAL",[169],"NA","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.",[172,173],"Gambling Disorder","Gambling",[175,176,177,178,108,179,180,181,182,183],"Online gambling","Internet gambling","Gambling Addiction","Cognitive Behavioral Therapy","Internet-Based CBT","Behavioral Addiction","Gambling Harms","Family","Affected Others","2026-10-02",{"date":186,"type":187},"2026-10-07","ACTUAL",{"date":189,"type":166},"2026-11",{"date":191,"type":166},"2027-02",{"name":5,"class":6},1]