Internet-CBT for Gambling Disorder - a Randomized Controlled Trial

Sponsor
Karolinska Institutet (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06099522
Collaborator
Deakin University (Other)
150
2
19

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Internet-based cognitive behavioral therapy (iCBT)
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be assigned to either standard iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition).Participants will be assigned to either standard iCBT and "Spelpaus" (treatment condition), or "Spelpaus" only (control condition).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Internet-based Cognitive Behavioral Treatment for Gambling Disorder - a Randomized Controlled Trial
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Internet-based cognitive behavioral therapy (iCBT)

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)
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.

No Intervention: "Spelpaus" (gambling self-exclusion)

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

Outcome Measures

Primary Outcome Measures

  1. The Gambling Symptom Assessment Scale [6 month after treatment cessation]

    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.

Secondary Outcome Measures

  1. The TimeLine Followback for gambling [6 month after treatment cessation]

    Gambling behavior (days per week gambled) will be measured with a self-report item adapted from the TimeLine Followback for gambling.

  2. The Generalized Anxiety Disorder 7-itemscale [6 month after treatment cessation]

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

  3. The Patient Health Questionnaire [6 month after treatment cessation]

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

  4. The Alcohol Use Disorders Identification Test [6 month after treatment cessation]

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

  5. The Drug Use Disorders Identification Test [6 month after treatment cessation]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Karolinska Institutet
  • Deakin University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Olof Molander, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT06099522
Other Study ID Numbers:
  • Dnr 2023-01075-01
First Posted:
Oct 25, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2023