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ICBTG in Routine Care (iCBTG)

Primary Purpose

Problem Gambling, Gambling Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
iCBT
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Problem Gambling focused on measuring Internet intervention, Gambling Disorder, Cognitive-behavioral therapy, Psychiatric comorbidity, Regular addiction care, Problem gambling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • eStöd

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iCBT for Gambling Disorder

Arm Description

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.

Outcomes

Primary Outcome Measures

The Gambling Symptom Assessment Scale (G-SAS)
Gambling symptoms

Secondary Outcome Measures

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

Full Information

First Posted
April 28, 2019
Last Updated
December 11, 2021
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03946098
Brief Title
ICBTG in Routine Care
Acronym
iCBTG
Official Title
Implementation of Internet-based Cognitive Behavior Therapy for Problem Gambling in Routine Addiction Care: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
February 9, 2021 (Actual)
Study Completion Date
February 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Problem Gambling, Gambling Disorder
Keywords
Internet intervention, Gambling Disorder, Cognitive-behavioral therapy, Psychiatric comorbidity, Regular addiction care, Problem gambling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iCBT for Gambling Disorder
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
iCBT
Intervention Description
A newly developed iCBT protocol targeting problem gambling.
Primary Outcome Measure Information:
Title
The Gambling Symptom Assessment Scale (G-SAS)
Description
Gambling symptoms
Time Frame
Past 7 days
Secondary Outcome Measure Information:
Title
The Gambling Time Line Follow Back (TLFB-G)
Description
Gambling behavior
Time Frame
Past 7 days
Title
The 9-item Patient Health Questionnaire (PHQ-9
Description
Depressive symptoms
Time Frame
Past 2 weeks
Title
The 7-item Generalised Anxiety Disorder scale (GAD-7)
Description
Anxiety symptoms
Time Frame
Past 2 weeks
Title
The Alcohol Use Disorders Identification Test (AUDIT)
Description
Alcohol use
Time Frame
Past 12 months
Title
The Drug Use Disorders Identification Test (DUDIT)
Description
Drug use
Time Frame
Past 12 months
Title
the 26-item World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Description
Quality of life
Time Frame
Past 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip H Lindner, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Chair
Facility Information:
Facility Name
eStöd
City
Stockholm
ZIP/Postal Code
117 61
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32699645
Citation
Molander O, Lindner P, Ramnero J, Bjureberg J, Carlbring P, Berman AH. Internet-based cognitive behavior therapy for problem gambling in routine care: protocol for a non-randomized pilot and feasibility trial. Pilot Feasibility Stud. 2020 Jul 21;6:106. doi: 10.1186/s40814-020-00647-5. eCollection 2020.
Results Reference
derived

Learn more about this trial

ICBTG in Routine Care

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