ClinicalTrials.gg
RecruitingNCT06107621Updated Mar 8, 2024

iCBT for GD and Comorbidities - a Pilot

An interventional study of iCBT for Gambling Disorder and psychiatric comorbidities in Gambling Disorder and Comorbidities and Coexisting Conditions, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-08.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Gambling Disorder
  • Comorbidities and Coexisting Conditions

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03

In context

Gambling

158 studies on the registry are indexed under Gambling; 42 are open to participants now.

This study's planned enrollment of 30 is below the median of 66 across 128 interventional studies indexed under Gambling.

Browse Gambling studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioraliCBT 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Six months after treatment cessation

Secondary outcomes

  1. 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.

    Time frame: Six months after treatment cessation

  2. The Generalized Anxiety Disorder 7-itemscale

    Anxiety symptoms will be measured by the Generalized Anxiety Disorder 7-itemscale.

    Time frame: Six months after treatment cessation

  3. The Patient Health Questionnaire

    Depressive symptoms will be measured with the The Patient Health Questionnaire.

    Time frame: Six months after treatment cessation

  4. The Alcohol Use Disorders Identification Test

    Alcohol problems will be measured with the Alcohol Use Disorders Identification Test.

    Time frame: Six months after treatment cessation

  5. The Drug Use Disorders Identification Test

    Drug problems will be measured with the Drug Use Disorders Identification Test.

    Time frame: Six months after treatment cessation

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06107621
Collaborators
Deakin University
Responsible party
Olof Molander (Principal Investigator, Karolinska Institutet) — Principal investigator
First posted
Oct 30, 2023
Start date
Dec 1, 2023
Primary completion
Jun 1, 2024 (estimated)
Completion
Jun 1, 2024 (estimated)
Last update
Mar 8, 2024

Study contacts

Olof Molander
Contact
olof.molander@ki.se
0700011241

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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