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Internet-CBT for Gambling Disorder - a Randomized Controlled Trial

Primary Purpose

Gambling Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet-based cognitive behavioral therapy (iCBT)
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gambling Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Internet-based cognitive behavioral therapy (iCBT)

    "Spelpaus" (gambling self-exclusion)

    Arm Description

    An 8-module internet-delivered cognitive behavioral therapy program. Participants receiving treatment will simultaneously use "Spelpaus" - a self-exclusion gambling service.

    "Spelpaus" only - a self-exclusion gambling service.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 29, 2023
    Last Updated
    October 24, 2023
    Sponsor
    Karolinska Institutet
    Collaborators
    Deakin University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06099522
    Brief Title
    Internet-CBT for Gambling Disorder - a Randomized Controlled Trial
    Official Title
    Internet-based Cognitive Behavioral Treatment for Gambling Disorder - a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    June 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet
    Collaborators
    Deakin University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gambling Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be assigned to either standard iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Internet-based cognitive behavioral therapy (iCBT)
    Arm Type
    Experimental
    Arm Description
    An 8-module internet-delivered cognitive behavioral therapy program. Participants receiving treatment will simultaneously use "Spelpaus" - a self-exclusion gambling service.
    Arm Title
    "Spelpaus" (gambling self-exclusion)
    Arm Type
    No Intervention
    Arm Description
    "Spelpaus" only - a self-exclusion gambling service.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Internet-based cognitive behavioral therapy (iCBT)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The Gambling Symptom Assessment Scale
    Description
    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.
    Time Frame
    6 month after treatment cessation
    Secondary Outcome Measure Information:
    Title
    The TimeLine Followback for gambling
    Description
    Gambling behavior (days per week gambled) will be measured with a self-report item adapted from the TimeLine Followback for gambling.
    Time Frame
    6 month after treatment cessation
    Title
    The Generalized Anxiety Disorder 7-itemscale
    Description
    Anxiety symptoms will be measured by the Generalized Anxiety Disorder 7-itemscale.
    Time Frame
    6 month after treatment cessation
    Title
    The Patient Health Questionnaire
    Description
    Depressive symptoms will be measured with the The Patient Health Questionnaire.
    Time Frame
    6 month after treatment cessation
    Title
    The Alcohol Use Disorders Identification Test
    Description
    Alcohol problems will be measured with the Alcohol Use Disorders Identification Test.
    Time Frame
    6 month after treatment cessation
    Title
    The Drug Use Disorders Identification Test
    Description
    Drug problems will be measured with the Drug Use Disorders Identification Test.
    Time Frame
    6 month after treatment cessation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Olof Molander, PhD
    Phone
    0700011241
    Email
    olof.molander@ki.se

    12. IPD Sharing Statement

    Learn more about this trial

    Internet-CBT for Gambling Disorder - a Randomized Controlled Trial

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