Digital Cognitive Behavioral Therapy for Gambling Disorder: A Pilot Randomized Controlled Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitas Indonesia

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Digital Cognitive Behavioral Therapy for Gambling Disorder

    Behavioral

    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 Harms

    Behavioral

    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 Disorder

    Behavioral

    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 Harms

    Behavioral

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Digital CBT and Digital Family InterventionExperimental treatment 2 interventions
Group B: Face-to-Face CBT and Family InterventionActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
From initiation of the digital intervention through Week 6
2

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.

Time frame
From initiation of the digital family intervention through Week 3
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.

Time frame
Immediately after completion of Digital CBT Session 12, approximately Week 6
4

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.

Time frame
Immediately after completion of Family Session 6, approximately Week 3

Secondary outcomes

1

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.

Time frame
Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
2

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.

Time frame
Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
3

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.

Time frame
Baseline, after Session 6, and after Session 12; up to approximately 6 weeks
4

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.

Time frame
Baseline, after Session 6, and after Session 12; up to approximately 6 weeks

Other outcomes

1

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.

Time frame
After each of the 12 digital CBT sessions, from Week 1 through Week 6
2

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.

Time frame
After each of the 6 digital family-intervention sessions, from Week 1 through Week 3

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