Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Behavioral Therapy (CBT) for Gambling Disorder

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorIndonesia University

About this trial

Treatment options for gambling disorder (GD) remain limited, with no pharmacotherapy proven effective. As of date, cognitive behavioral therapy (CBT) is the preferred therapy for GD, but the improvements often require months to show, highlighting the need for a more comprehensive therapy. Repetitive transcranial magnetic stimulation (rTMS) is a promising treatment modality in alleviating craving. Studies have shown potential benefit of combining both CBT and rTMS in substance addiction, but not in GD. Thus, this study aims to determine the feasibility and efficacy of rTMS and CBT combination therapy in the management of GD in Indonesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with pathological gambling (SOGS score ≥ 5)

Subjects aged 18-70 years old

Subjects who understand Bahasa Indonesia

Subjects who agree to participate and receive treatment

Disqualifiers

Subjects with history of psychotic disorder and personality disorder according to ICD-11

Subjects with severe neurological disorder comorbidities, which cause seizure or loss of consciousness

Subjects with intellectual disability

Subjects with history of neurostimulation

Trial design

Design model

Single group

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

    Device

    an open arm study of 10 gambling disorder subjects will be conducted to determine the efficacy and feasibility of a multimodalistic therapy of rTMS and Cognitive Behavioral Therapy (CBT) for gambling disorder in Indonesia.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: rTMS and CBTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Improvement in pathological gambling score

South Oaks Gambling Screen (SOGS), Indonesian version, with minimum score of 0 and maximum score of 20. A score of 0-2 indicates no pathological gambling; a score of 3-4 indicates problems with gambling, and a score of 5 or more indicates that the subject is a probable pathological gambler. Lower score indicates a better outcome.

Time frame
Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
2

Improvement in gambling symptoms severity

Gambling Symptoms Assessment Scale (G-SAS), Indonesian version, with minimum score of 0 and maximum score of 48. Interpretations: Mild (8-20), Moderate (21-30), Severe (31-40), and Extreme (41-48). Lower score indicates a better outcome.

Time frame
Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
3

Improvement in gambling urge

Gambling Urge Scale (GUS), Indonesian version, with minimum score of 0 and maximum score of 42. Lower score indicates a better outcome.

Time frame
Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
4

Improvement in gambling related cognitive distortions

Gambling Related Cognitions Scale (GRCS), Indonesian version, with 5 cognitive distortion domains. Lower score indicates a better outcome.

Time frame
Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention

Secondary outcomes

1

Improvement in gambling-related cognitive functions

Creyos (formerly Cambridge Brain Sciences, CBS), measures 12 domains of cognitive function with the subject results compared with their respective average age results in percentile. A higher percentile is a better outcome.

Time frame
Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention
2

Improvement in depression symptoms

Beck Depression Inventory-II (BDI II), measures severity of depression symptoms, with minimum score of 0 and maximum score of 63. Interpretation: (1) minimal (0-13), (2) mild (14-19), (3) moderate (20-28), and (4) severe (29-63). Lower score indicates a better outcome.

Time frame
Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention
3

Improvement in self-reported psychological distress

20-item Self-Reporting Questionnaire (SRQ-20), Indonesian version, measures non-specific psychological distress. Score range 0-20, with scores \>10 classified as mental distress. Lower score indicates a better outcome.

Time frame
Baseline (week 0), post-intervention (week 6), follow up at 3 months and 6 months after intervention
4

Improvement of overall severity of illness

Clinical Global Impression (CGI), measure overall severity of illness and improvement observed by the clinician. Lower score indicates a better outcome.

Time frame
Baseline (week 0), interim assessment (week 3), post-intervention (week 6), follow up at 3 months and 6 months after intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Indonesia University

Lead sponsor

Radboud University Medical Center

Collaborator

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