iCBT for GD and Comorbidities - a Pilot

March 6, 2024 updated by: Olof Molander, Karolinska Institutet

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Stockholm, Sweden, 116 30
        • Recruiting
        • Centre for Psychiatry Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
Six months after treatment cessation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The TimeLine Followback for gambling
Time Frame: 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.
Six months after treatment cessation
The Generalized Anxiety Disorder 7-itemscale
Time Frame: Six months after treatment cessation
Anxiety symptoms will be measured by the Generalized Anxiety Disorder 7-itemscale.
Six months after treatment cessation
The Patient Health Questionnaire
Time Frame: Six months after treatment cessation
Depressive symptoms will be measured with the The Patient Health Questionnaire.
Six months after treatment cessation
The Alcohol Use Disorders Identification Test
Time Frame: Six months after treatment cessation
Alcohol problems will be measured with the Alcohol Use Disorders Identification Test.
Six months after treatment cessation
The Drug Use Disorders Identification Test
Time Frame: Six months after treatment cessation
Drug problems will be measured with the Drug Use Disorders Identification Test.
Six months after treatment cessation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Deakin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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