NCT06171516

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

December 6, 2023

Last Update Submit

July 10, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Gambling symptom severity

    a decrease in Gambling Symptom Assessment Scale (G-SAS) score

    G-SAS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)

  • Problem gambling severity

    a decrease in Problem Gambling Severity Index score

    PGSI will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)

  • Gambling urges

    a decrease in Gambling Urge Scale (GUS) score

    GUS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)

  • Gambling-related cognitive distortions

    a decrease in Gambling Related Cognitions Scale (GRCS) score

    GRCS will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)

Secondary Outcomes (2)

  • Nonspecific psychological distress

    SRQ-20 will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)

  • Subjective quality of life

    WHOQOL-BREF will be assessed at baseline (week 0), post-treatment (week 6), and follow-up (week 16)

Study Arms (1)

Internet-based Cognitive Behavioral Therapy

EXPERIMENTAL

10 guided therapy sessions (once-weekly) with each session lasting 20 minutes.

Behavioral: iCBT

Interventions

iCBTBEHAVIORAL

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.

Internet-based Cognitive Behavioral Therapy

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • have severe mental disorders or intellectual disabilities;
  • have extreme agitation that hinder instrument fill out and adequate cognitive behavior therapy participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. dr. Kristiana Siste, SpKJ(K) - Head of Department of Psychiatry, Faculty of Medicine, Indonesia University

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

August 1, 2024

Primary Completion

November 1, 2024

Study Completion

January 1, 2025

Last Updated

July 11, 2024

Record last verified: 2024-07