Internet-CBT for Gambling Disorder - a Randomized Controlled Trial

Study Overview
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Brief Summary
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The study is a randomized controlled trial (Total N=150; each condition n=75) of internet-based cognitive behavioral therapy (iCBT), with measures at pre, weekly during treatment, post, three and at six month follow-up. Participants will be assigned to either standard iCBT and Spelpaus (treatment condition), or Spelpaus only (control condition).

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 be randomized to iCBT and Spelpaus (treatment condition), or Spelpaus only (control condition). Randomization will be conducted by a third party using a true random service, https://random.org. Participants assigned to the control condition in the randomized controlled trial will receive a voucher of total 1000 Swedish Krona's when completing the post and follow up measures. Participants assigned to the control condition in the randomized controlled trial will receive a voucher of total 1000 Swedish Krona's when completing the post and follow up measures.

Official Title
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Internet-based Cognitive Behavioral Treatment for Gambling Disorder - a Randomized Controlled Trial

Conditions
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Gambling Disorder

Intervention / Treatment
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* Behavioral: Internet-based cognitive behavioral therapy (iCBT)


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. 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned to either standard iCBT and Spelpaus (treatment condition), or Spelpaus only (control condition).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based cognitive behavioral therapy (iCBT)<br>An 8-module internet-delivered cognitive behavioral therapy program. Participants receiving treatment will simultaneously use Spelpaus - a self-exclusion gambling service. | Behavioral: Internet-based cognitive behavioral therapy (iCBT)<br>* The treatment is a newly developed iCBT 8 module program, with interventions targeting gambling-related loss of control, through 4 clinical processes: Gambling triggers, Gambling-related anticipation, the Gambling zone and Chasing behaviors. The treatment will be delivered with therapist support.<br>|
| No Intervention: Spelpaus (gambling self-exclusion)<br>Spelpaus only - a self-exclusion gambling service. | |

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. | 6 month 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. | 6 month after treatment cessation | 
| The Generalized Anxiety Disorder 7-itemscale | Anxiety symptoms will be measured by the Generalized Anxiety Disorder 7-itemscale. | 6 month after treatment cessation | 
| The Patient Health Questionnaire | Depressive symptoms will be measured with the The Patient Health Questionnaire. | 6 month after treatment cessation | 
| The Alcohol Use Disorders Identification Test | Alcohol problems will be measured with the Alcohol Use Disorders Identification Test. | 6 month after treatment cessation | 
| The Drug Use Disorders Identification Test | Drug problems will be measured with the Drug Use Disorders Identification Test. | 6 month after treatment cessation |