Internet-CBT for Gambling Disorder - a Randomized Controlled Trial

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

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).

Study Overview

• Status: Recruiting
• Conditions: Gambling Disorder
• Intervention / Treatment: Behavioral: Internet-based cognitive behavioral therapy (iCBT)

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olof Molander, PhD; Phone Number: 0700011241; Email: olof.molander@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 116 30
    • Recruiting
    • Centre for psychiatry research
    • Contact: Olof Molander; Phone Number: 0700011241; Email: olof.molander@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based cognitive behavioral therapy (iCBT); 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); 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.
No Intervention: "Spelpaus" (gambling self-exclusion); "Spelpaus" only - a self-exclusion gambling service.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Deakin University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Gambling
• Other Study ID Numbers: Dnr 2023-01075-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No