Internet-CBT for Gambling Disorder - a Randomized Controlled Trial

NCT06099522 | Recruiting

• 1 other identifier: Dnr 2023-01075-01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Gambling Disorder

Outcome Measures

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.

  6 month after treatment cessation

Secondary Outcomes (5)

• The TimeLine Followback for gambling

  6 month after treatment cessation

• The Generalized Anxiety Disorder 7-itemscale

  6 month after treatment cessation

• The Patient Health Questionnaire

  6 month after treatment cessation

• The Alcohol Use Disorders Identification Test

  6 month after treatment cessation

• The Drug Use Disorders Identification Test

  6 month after treatment cessation

Study Arms (2)

Internet-based cognitive behavioral therapy (iCBT)

EXPERIMENTAL

An 8-module internet-delivered cognitive behavioral therapy program. Participants receiving treatment will simultaneously use "Spelpaus" - a self-exclusion gambling service.

Behavioral: Internet-based cognitive behavioral therapy (iCBT)

"Spelpaus" (gambling self-exclusion)

NO INTERVENTION

"Spelpaus" only - a self-exclusion gambling service.

Interventions

Internet-based cognitive behavioral therapy (iCBT) BEHAVIORAL

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.

Internet-based cognitive behavioral therapy (iCBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Deakin University: collaborator

Study Sites (1)

Centre for psychiatry research

Stockholm, 116 30, Sweden

RECRUITING

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-Taking; Behavior; Disruptive, Impulse Control, and Conduct Disorders; Mental Disorders

Central Study Contacts

Olof Molander, PhD

CONTACT

0700011241; olof.molander@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: October 25, 2023
• Study Start: January 15, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

SE (1)