Clinical trial NCT06099522: 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
Overall status: RECRUITING
Phase: NA
Conditions: Gambling Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Deakin University
First posted: 2023-10-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to either standard iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Gambling Symptom Assessment Scale
timeFrame: 6 month after treatment cessation
Secondary outcomes:
measure: The TimeLine Followback for gambling
timeFrame: 6 month after treatment cessation
measure: The Generalized Anxiety Disorder 7-itemscale
timeFrame: 6 month after treatment cessation
measure: The Patient Health Questionnaire
timeFrame: 6 month after treatment cessation
measure: The Alcohol Use Disorders Identification Test
timeFrame: 6 month after treatment cessation
measure: The Drug Use Disorders Identification Test
timeFrame: 6 month after treatment cessation
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Centre for psychiatry research
Study officials:
References: