ICBTG in Routine Care (iCBTG)

December 11, 2021 updated by: Anne H Berman, Karolinska Institutet

Implementation of Internet-based Cognitive Behavior Therapy for Problem Gambling in Routine Addiction Care: A Feasibility Study

Problem gambling (PG) is a major public health concern worldwide. As awareness of PG has risen, treatment demand is increasing, and internet interventions is a promising alternative for providing fast, evidence-based treatment at scale, to a low cost. This article presents the protocol of an open label, uncontrolled pilot and feasibility trial of a novel internet-delivered cognitive behavioral treatment, conducted in regular addiction care with adult treatment-seeking patients (max N=25) with problematic gambling. Weekly measures of gambling symptoms and gambling will serve as outcome measures. Study results will further guide the development of the intervention and its implementation into regular addiction care.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Stockholm, Sweden, 117 61
        • eStöd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • being at least 18 years old
  • living in Sweden
  • being able to read and write Swedish.
  • having a total score of >= 3 on the Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001)
  • having the ability to work with online treatment material by themselves (with support from a therapist)

Exclusion criteria:

  • fulfilling criteria for ongoing manic episode
  • currently undergoing a parallel CBT treatment for Gambling Disorder or problem gambling.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: iCBT for Gambling Disorder
Treatment will consist of a 1+10 module internet delivered CBT program targeting problem gambling, newly developed. A bottom-up procedure was used to develop the treatment protocol, inspired by Clark's (2004) method for developing novel CBT treatments. We developed a clinical model delineating what factors contribute to the persistence of problem gambling behavior, and aligned these with targeted treatment interventions; based on behavioral upon research on the learning and maintenance processes of gambling behavior (Ramnerö et al, in press), theoretical models of gambling and comorbidity (Blaszczynski & Nower, 2002); as well as qualitative interviews with treatment seeking gamblers with or without comorbidity.
A newly developed iCBT protocol targeting problem gambling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Gambling Symptom Assessment Scale (G-SAS)
Time Frame: Past 7 days
Gambling symptoms
Past 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Gambling Time Line Follow Back (TLFB-G)
Time Frame: Past 7 days
Gambling behavior
Past 7 days
The 9-item Patient Health Questionnaire (PHQ-9
Time Frame: Past 2 weeks
Depressive symptoms
Past 2 weeks
The 7-item Generalised Anxiety Disorder scale (GAD-7)
Time Frame: Past 2 weeks
Anxiety symptoms
Past 2 weeks
The Alcohol Use Disorders Identification Test (AUDIT)
Time Frame: Past 12 months
Alcohol use
Past 12 months
The Drug Use Disorders Identification Test (DUDIT)
Time Frame: Past 12 months
Drug use
Past 12 months
the 26-item World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time Frame: Past 2 weeks
Quality of life
Past 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Philip H Lindner, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 4, 2019

Primary Completion (ACTUAL)

February 9, 2021

Study Completion (ACTUAL)

February 9, 2021

Study Registration Dates

First Submitted

April 28, 2019

First Submitted That Met QC Criteria

May 9, 2019

First Posted (ACTUAL)

May 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2022

Last Update Submitted That Met QC Criteria

December 11, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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