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Trial record 3 of 5 for:    Gambling Disorder | Sweden

iCBT for Problem Gambling: Protocol for an Open Feasibility Trial (iCBTPG)

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ClinicalTrials.gov Identifier: NCT03946098
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Anne H Berman, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Problem Gambling Gambling Disorder Behavioral: iCBT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Cognitive Behavior Therapy for Gambling Disorder and Psychiatric Comorbidities: Protocol for an Open Feasibility Trial
Actual Study Start Date : January 18, 2020
Estimated Primary Completion Date : December 24, 2020
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


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.
Behavioral: iCBT
A newly developed iCBT protocol targeting problem gambling.




Primary Outcome Measures :
  1. The Gambling Symptom Assessment Scale (G-SAS) [ Time Frame: Past 7 days ]
    Gambling symptoms


Secondary Outcome Measures :
  1. The Gambling Time Line Follow Back (TLFB-G) [ Time Frame: Past 7 days ]
    Gambling behavior

  2. The 9-item Patient Health Questionnaire (PHQ-9 [ Time Frame: Past 2 weeks ]
    Depressive symptoms

  3. The 7-item Generalised Anxiety Disorder scale (GAD-7) [ Time Frame: Past 2 weeks ]
    Anxiety symptoms

  4. The Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Past 12 months ]
    Alcohol use

  5. The Drug Use Disorders Identification Test (DUDIT) [ Time Frame: Past 12 months ]
    Drug use

  6. the 26-item World Health Organization Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: Past 2 weeks ]
    Quality of life



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946098


Contacts
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Contact: Philip Lindner, PhD +46704522587 philip.lindner@ki.se
Contact: Anne H Berman, PhD +46704245360 anne.h.berman@ki.se

Locations
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Sweden
eStöd Recruiting
Stockholm, Sweden, 117 61
Contact: Olof C Molander, MCs    0700011241    olof.molander@ki.se   
Contact: Philip Lindner, PhD    ‭070-300 59 07‬    philip.lindner@ki.se   
Sub-Investigator: Olof Molander, MSc         
Principal Investigator: Philip Lindner, PhD         
Principal Investigator: Anne H Berman, PhD         
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Study Chair: Philip H Lindner, PhD Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anne H Berman, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03946098    
Other Study ID Numbers: 2019-0428
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne H Berman, Karolinska Institutet:
Internet intervention
Gambling Disorder
Cognitive-behavioral therapy
Psychiatric comorbidity
Regular addiction care
Problem gambling
Additional relevant MeSH terms:
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Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders