iCBT for GD and Comorbidities - a Pilot

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

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

Study Overview

• Status: Recruiting
• Conditions: Gambling Disorder; Comorbidities and Coexisting Conditions
• Intervention / Treatment: Behavioral: iCBT for Gambling Disorder and psychiatric comorbidities

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olof Molander; 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.
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Internet-based iCBT targeting Gambling Disorder and comorbidities; An 8 module internet-based iCBT program targeting Gambling Disorder and comorbidities, administered with treatment support.

Behavioral: iCBT for Gambling Disorder and psychiatric comorbidities; 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).

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.	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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Deakin University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 30, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 30, 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 2023-01074-01

Drug and device information, study documents

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