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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06230809
Other study ID # 2023-04225-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date June 1, 2025

Study information

Verified date January 2024
Source Karolinska Institutet
Contact Anders Nilsson
Phone +46702235492
Email anders.nilsson.2@ki.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 170
Est. completion date June 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Web-based self-help
Web-based self-help with 5 modules, lasting 5 weeks.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Karolinska Institutet The National Gambling Helpline Sweden

Outcome

Type Measure Description Time frame Safety issue
Primary Kessler-9 Mental health At baseline and post treatment (5-7 weeks after inclusion) and again 3, 6, and 12 months following treatment completion
Secondary Patient Health Questionnaire-9 Depressive symptoms At baseline and post treatment (5-7 weeks after baseline) and again 3, 6, and 12 months following treatment completion
Secondary Generalized Anxiety Disorder 7-item scale Anxiety symptoms At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Secondary Relationship Assessment Scale Relationship satisfaction At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Secondary Family Member Impact Scale Gambling-related family stress At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Secondary Coping Questionnaire Coping At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
Secondary Brunnsviken Brief Quality of life quality scale Quality of life At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion
See also
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