iCBT for GD and Comorbidities - a Pilot

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06107621
• Collaborator: Deakin University (Other)
• Enrollment: 30
• Arm: 1
• Anticipated Duration (Months): 7

Study Details

Study Description

Brief Summary

The study is a pilot study (Total N=30), with at pre, weekly during treatment, post and at three-month follow-up.

Condition or Disease	Intervention/Treatment	Phase
Gambling Disorder; Comorbidities and Coexisting Conditions	Behavioral: iCBT for Gambling Disorder and psychiatric comorbidities	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 get access to the iCBT.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Internet-based Cognitive Behavioral Therapy for Gambling Disorder and and Comorbidities - a Pilot Study
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Internet-based iCBT targeting Gambling Disorder and comorbidities An 8 module internet-based iCBT program targeting Gambling Disorder and comorbidities, administered with treatment support.

Behavioral: iCBT for Gambling Disorder and psychiatric comorbidities; The iCBT, is based on the gambling pathways model. As a clinical conceptualization, the treatment build on loss of control, but also include additional interventions (e.g., emotion regulation and impulse control) targeting the etiological co-morbidity factors in the pathways model for emotionally vulnerable and impulsive gamblers (pathways subtypes 2 and 3).

Outcome Measures

Primary Outcome Measures

1. The Gambling Symptom Assessment Scale [Six months 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 [Six months 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 [Six months after treatment cessation]

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

3. The Patient Health Questionnaire [Six months after treatment cessation]

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

4. The Alcohol Use Disorders Identification Test [Six months after treatment cessation]

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

5. The Drug Use Disorders Identification Test [Six months 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.

• Classified within pathways 2 or 3, as measured with the Gambling pathways Questionnaire (GPQ).

• Screen positive for at least one common mental diagnosis in addition to GD, assessed according to the Web Screening Questionnaire (WSQ).

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: NCT06107621
• Other Study ID Numbers: Dnr 2023-01074-01
• First Posted: Oct 30, 2023
• Last Update Posted: Oct 30, 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: Gambling

Study Results

No Results Posted as of Oct 30, 2023