ClinicalTrials.gg
Not yet recruitingNCT06230809Updated Jan 30, 2024

Internet Based Self-help for Problem Gambling Concerned Significant Others

An interventional study of Web-based self-help in Problem Gambling, sponsored by Karolinska Institutet. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Problem Gambling

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Keywords

  • concerned significant others
03

In context

Gambling

158 studies on the registry are indexed under Gambling; 42 are open to participants now.

This study's planned enrollment of 170 is above the median of 66 across 128 interventional studies indexed under Gambling.

Browse Gambling studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Displaying symptoms of severe psychiatric disorders such as psychosis or bipolar disease deemed to needed other treatment options.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
170 participants (estimated)

Study arms

  • Experimental
    Intervention

    Behavioral: Web-based self-help

  • No intervention
    Waitlist

    Waitlist, participants will be included after 8 weeks.

Interventions

  • BehavioralWeb-based self-help

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

06

What researchers measure

Primary outcomes

  1. Kessler-9

    Mental health

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

Secondary outcomes

  1. Patient Health Questionnaire-9

    Depressive symptoms

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

  2. Generalized Anxiety Disorder 7-item scale

    Anxiety symptoms

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

  3. Relationship Assessment Scale

    Relationship satisfaction

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

  4. Family Member Impact Scale

    Gambling-related family stress

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

  5. Coping Questionnaire

    Coping

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

  6. Brunnsviken Brief Quality of life quality scale

    Quality of life

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — IPD will be shared upon reasonable request.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Mar 2024; primary completion for Dec 2024, 9 months later.

Of 47 non-industry interventional studies with no phase under Gambling, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 9 months is below that.

Counting every sponsor, half of 47 studies reached it within 16 months; a quarter within 10 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2023
First posted
Jan 30, 2024
StartEst.
Mar 1, 2024
Primary completionEst.
Dec 31, 2024
CompletionEst.
Jun 1, 2025
Last update
Jan 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06230809
Collaborators
The National Gambling Helpline Sweden
Responsible party
Anders Nilsson (PhD, Karolinska Institutet) — Principal investigator
First posted
Jan 30, 2024
Start date
Mar 1, 2024 (estimated)
Primary completion
Dec 31, 2024 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Jan 30, 2024

Study contacts

Anders Nilsson
Contact
anders.nilsson.2@ki.se
+46702235492

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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