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Clinical Trials/NCT06107621
NCT06107621RecruitingNot Applicable

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

Karolinska Institutet2 sites in 1 country30 target enrollmentStarted: December 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
2
Primary Endpoint
The Gambling Symptom Assessment Scale

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Internet-based iCBT targeting Gambling Disorder and comorbidities

Experimental

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

Intervention: iCBT for Gambling Disorder and psychiatric comorbidities (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • The Generalized Anxiety Disorder 7-itemscale(Six months after treatment cessation)
  • The TimeLine Followback for gambling(Six months after treatment cessation)
  • The Patient Health Questionnaire(Six months after treatment cessation)
  • The Alcohol Use Disorders Identification Test(Six months after treatment cessation)
  • The Drug Use Disorders Identification Test(Six months after treatment cessation)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Olof Molander

Principal Investigator

Karolinska Institutet

Study Sites (2)

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