iCBT for GD and Comorbidities - a Pilot

Not Applicable

Recruiting

• Conditions: Comorbidities and Coexisting Conditions; Gambling Disorder
• Interventions: Behavioral: iCBT for Gambling Disorder and psychiatric comorbidities

• Registration Number: NCT06107621
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-08-30
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-30
• Study Start: 2023-12-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet-based iCBT targeting Gambling Disorder and comorbidities	iCBT for Gambling Disorder and psychiatric comorbidities	An 8 module internet-based iCBT program targeting Gambling Disorder and comorbidities, administered with treatment support.

Primary Outcome Measures

Name	Time	Method
The Gambling Symptom Assessment Scale	Six months after treatment cessation	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre for psychiatry research; 🇸🇪 Stockholm, Sweden