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Internet-CBT for Gambling Disorder - a Randomized Controlled Trial

Internet-based Cognitive Behavioral Treatment for Gambling Disorder - a Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06099522
Enrollment
150
Registered
2023-10-25
Start date
2024-01-15
Completion date
2025-06-01
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gambling Disorder

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.

Interventions

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.

Sponsors

Deakin University
CollaboratorOTHER
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants will be assigned to either standard iCBT and Spelpaus (treatment condition), or Spelpaus only (control condition).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

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

Design outcomes

Primary

MeasureTime frameDescription
The Gambling Symptom Assessment Scale6 month after treatment cessationPrimary 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

MeasureTime frameDescription
The TimeLine Followback for gambling6 month after treatment cessationGambling 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-itemscale6 month after treatment cessationAnxiety symptoms will be measured by the Generalized Anxiety Disorder 7-itemscale.
The Patient Health Questionnaire6 month after treatment cessationDepressive symptoms will be measured with the The Patient Health Questionnaire.
The Alcohol Use Disorders Identification Test6 month after treatment cessationAlcohol problems will be measured with the Alcohol Use Disorders Identification Test.
The Drug Use Disorders Identification Test6 month after treatment cessationDrug problems will be measured with the Drug Use Disorders Identification Test.

Countries

Sweden

Contacts

Primary ContactOlof Molander, PhD
olof.molander@ki.se0700011241

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026