iCBT for GD and Comorbidities - a Pilot

NCT06107621 | Recruiting

• 1 other identifier: Dnr 2023-01074-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gambling Disorder; Comorbidities and Coexisting Conditions

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.

  Six months after treatment cessation

Secondary Outcomes (5)

• The TimeLine Followback for gambling

  Six months after treatment cessation

• The Generalized Anxiety Disorder 7-itemscale

  Six months after treatment cessation

• The Patient Health Questionnaire

  Six months after treatment cessation

• The Alcohol Use Disorders Identification Test

  Six months after treatment cessation

• The Drug Use Disorders Identification Test

  Six months after treatment cessation

Study Arms (1)

Internet-based iCBT targeting Gambling Disorder and comorbidities

EXPERIMENTAL

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

Behavioral: iCBT for Gambling Disorder and psychiatric comorbidities

Interventions

iCBT for Gambling Disorder and psychiatric comorbidities BEHAVIORAL

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).

Internet-based iCBT targeting Gambling Disorder and comorbidities

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.
• 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).

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

CONTACT

0700011241; olof.molander@ki.se

Study Design

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

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: October 30, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

SE (1)