Internet-CBT for Gambling Disorder - a Randomized Controlled Trial

Gambling Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06099522
• Other study ID #: Dnr 2023-01075-01
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Olof Molander, PhD
• Phone: 0700011241
• Email: olof.molander[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gambling
• Gambling Disorder

Intervention

Behavioral:
• Internet-based cognitive behavioral therapy (iCBT)
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.

Locations

Country	Name	City	State
Sweden	Centre for psychiatry research	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Deakin University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 month after treatment cessation
Secondary	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.	6 month after treatment cessation
Secondary	The Generalized Anxiety Disorder 7-itemscale	Anxiety symptoms will be measured by the Generalized Anxiety Disorder 7-itemscale.	6 month after treatment cessation
Secondary	The Patient Health Questionnaire	Depressive symptoms will be measured with the The Patient Health Questionnaire.	6 month after treatment cessation
Secondary	The Alcohol Use Disorders Identification Test	Alcohol problems will be measured with the Alcohol Use Disorders Identification Test.	6 month after treatment cessation
Secondary	The Drug Use Disorders Identification Test	Drug problems will be measured with the Drug Use Disorders Identification Test.	6 month after treatment cessation