Internet Based Self-help for Problem Gambling Concerned S... | NCT06230809

Studies
Internet Based Self-help for Problem Gambling Concerned Significant Others

NCT06230809

Sponsor

Karolinska Institutet

Status

Unknown status

Last Update Posted

Jan 30, 2024Actual

Enrollment

170Estimated

Phase

Not Applicable

Conditions

Problem Gambling

Interventions

Web-based self-help

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Estimated

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Jun 1, 2025Estimated

First Submitted Date

Oct 2, 2023

First Submission Date that Met QC Criteria

Jan 25, 2024

First Posted Date

Jan 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2024

Last Update Posted Date

Jan 30, 2024Actual

Name	Class
The National Gambling Helpline Sweden	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental		Behavioral: Web-based self-help
Waitlist	No Intervention	Waitlist, participants will be included after 8 weeks.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Web-based self-help	Behavioral	Web-based self-help with 5 modules, lasting 5 weeks.	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Generalized Anxiety Disorder 7-item scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anders Nilsson	Contact	+46702235492		anders.nilsson.2@ki.se

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

IPD will be shared upon reasonable request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided