Internet Based Self-help for Problem Gambling Concerned Significant Others

January 25, 2024 updated by: Anders Nilsson, Karolinska Institutet
The project aims to evaluate a brief online self-help intervention for Concerned Significant Others of individuals with Problem Gambling. The intervention consists of five modules with texts, films and exercises and is compared to a waiting list.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

170

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 Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • No treatment related to the gambling during the past 3 months for the CSO
  • The CSO is at least 18 years old
  • The CSO can read and answer questions in Swedish.
  • The CSO is assessed as a non-problem gambler according to the Gambling Disorder Identification Test.

Exclusion Criteria:

  • Displaying symptoms of severe psychiatric disorders such as psychosis or bipolar disease deemed to needed other treatment options.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Behavioral: Web-based self-help
Web-based self-help with 5 modules, lasting 5 weeks.
No Intervention: Waitlist
Waitlist, participants will be included after 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kessler-9
Time Frame: At baseline and post treatment (5-7 weeks after inclusion) and again 3, 6, and 12 months following treatment completion
Mental health
At baseline and post treatment (5-7 weeks after inclusion) and again 3, 6, and 12 months following treatment completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9
Time Frame: At baseline and post treatment (5-7 weeks after baseline) and again 3, 6, and 12 months following treatment completion
Depressive symptoms
At baseline and post treatment (5-7 weeks after baseline) and again 3, 6, and 12 months following treatment completion
Generalized Anxiety Disorder 7-item scale
Time Frame: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Anxiety symptoms
At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Relationship Assessment Scale
Time Frame: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Relationship satisfaction
At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Family Member Impact Scale
Time Frame: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Gambling-related family stress
At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Coping Questionnaire
Time Frame: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Coping
At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Brunnsviken Brief Quality of life quality scale
Time Frame: At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Quality of life
At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Collaborators

The National Gambling Helpline Sweden

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-04225-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared upon reasonable request.

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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