iCBTG: ICBTG in Routine Care

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT03946098
Collaborator
(none)
23
1
1
16.2
1.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: iCBT
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Implementation of Internet-based Cognitive Behavior Therapy for Problem Gambling in Routine Addiction Care: A Feasibility Study
Actual Study Start Date :
Oct 4, 2019
Actual Primary Completion Date :
Feb 9, 2021
Actual Study Completion Date :
Feb 9, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The Gambling Symptom Assessment Scale (G-SAS) [Past 7 days]

    Gambling symptoms

Secondary Outcome Measures

  1. The Gambling Time Line Follow Back (TLFB-G) [Past 7 days]

    Gambling behavior

  2. The 9-item Patient Health Questionnaire (PHQ-9 [Past 2 weeks]

    Depressive symptoms

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

    Anxiety symptoms

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

    Alcohol use

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

    Drug use

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

    Quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 eStöd Stockholm Sweden 117 61

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anne H Berman, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT03946098
Other Study ID Numbers:
  • 2019-0428
First Posted:
May 10, 2019
Last Update Posted:
Jan 3, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anne H Berman, Associate professor, Karolinska Institutet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 3, 2022