NCT06230809

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

10 months

First QC Date

October 2, 2023

Last Update Submit

January 25, 2024

Conditions

Keywords

concerned significant others

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Patient Health Questionnaire-9

    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

    At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion

  • Relationship Assessment Scale

    At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion

  • Family Member Impact Scale

    At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion

  • Coping Questionnaire

    At baseline and post treatment (5-7 weeks after inclusion), and again 3, 6, and 12 months following treatment completion

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL
Behavioral: Web-based self-help

Waitlist

NO INTERVENTION

Waitlist, participants will be included after 8 weeks.

Interventions

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

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 2, 2023

First Posted

January 30, 2024

Study Start

March 1, 2024

Primary Completion

December 31, 2024

Study Completion

June 1, 2025

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

IPD will be shared upon reasonable request.