iCBT for GD and Comorbidities - a Pilot

Study Overview
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Brief Summary
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The study is a pilot study (Total N=30), with at pre, weekly during treatment, post and at three-month follow-up.

Detailed Description
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Recruitment will be done through online advertisement via social media and gambling-related websites. Participants will self-referred to the study via a study dedicated website (www.spelstudien.se). Login to a treatment platform will be verified using double authentication (detailed description of the online platform is provided in the application to the Swedish Ethical Review Authority). Written information about the study will be provided on the web page. Consent will be done online, with the possibility for participants to download study information and consent. Consenting participants will start a screening procedure. After screening, participants will be contacted for a telephone assessment with a clinical psychologist. During this interview, participants will be assessed for GD with a diagnostic interview, as well as the inclusion criteria for utilization of Spelpaus. If meeting criteria for the study, participants will be referred to the baseline/ pre-measures - which will start with an additional informed consent for the treatment phase and the iCBT. Inclusion will be done after the completion of the informed consent and baseline/pre-measures. After that, participant will get access to the iCBT.

Official Title
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Internet-based Cognitive Behavioral Therapy for Gambling Disorder and and Comorbidities - a Pilot Study

Conditions
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Gambling Disorder, Comorbidities and Coexisting Conditions

Intervention / Treatment
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* Behavioral: iCBT for Gambling Disorder and psychiatric comorbidities


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Screen positive for GD, as measured with the Gambling Disorder Identification Test (total score ≥20 GDIT). Fulfilling GD, assessed according to the Structured Clinical Interview for Gambling Disorder (SCI-GD). Utilization of Spelpaus (3 months from treatment start). ≥18 years of age. Able to provide digital informed consent. Classified within pathways 2 or 3, as measured with the Gambling pathways Questionnaire (GPQ). Screen positive for at least one common mental diagnosis in addition to GD, assessed according to the Web Screening Questionnaire (WSQ). Exclusion Criteria: Other ongoing psychological treatment for GD. Severe depression, screened according to the Montgomery Åsberg Depression Rating Scale (total score >34 MADRS-S). Suicidality, screening of ≥4 points on item 9 of the MADRS-S

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based iCBT targeting Gambling Disorder and comorbidities<br>An 8 module internet-based iCBT program targeting Gambling Disorder and comorbidities, administered with treatment support. | Behavioral: iCBT for Gambling Disorder and psychiatric comorbidities<br>* The iCBT, is based on the gambling pathways model. As a clinical conceptualization, the treatment build on loss of control, but also include additional interventions (e.g., emotion regulation and impulse control) targeting the etiological co-morbidity factors in the pathways model for emotionally vulnerable and impulsive gamblers (pathways subtypes 2 and 3).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Gambling Symptom Assessment Scale | Primary outcome will be gambling symptoms, measured with the the Gambling Symptom Assessment Scale. Minimum score is 0 and maximum score is 48, with higher scores indicated higher frequency of gambling symptoms. | Six months after treatment cessation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The TimeLine Followback for gambling | Gambling behavior (days per week gambled) will be measured with a self-report item adapted from the TimeLine Followback for gambling. | Six months after treatment cessation | 
| The Generalized Anxiety Disorder 7-itemscale | Anxiety symptoms will be measured by the Generalized Anxiety Disorder 7-itemscale. | Six months after treatment cessation | 
| The Patient Health Questionnaire | Depressive symptoms will be measured with the The Patient Health Questionnaire. | Six months after treatment cessation | 
| The Alcohol Use Disorders Identification Test | Alcohol problems will be measured with the Alcohol Use Disorders Identification Test. | Six months after treatment cessation | 
| The Drug Use Disorders Identification Test | Drug problems will be measured with the Drug Use Disorders Identification Test. | Six months after treatment cessation |