ClinicalTrials.gg
CompletedNCT03725735Updated Mar 18, 2025

Emotion Regulation Group Treatment for Gambling Disorder - a Pilot Trial

An interventional study of CBT for problem gambling with emotion regulation in Gambling Disorder, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-03-18.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 14 studies in Gambling with a site in Sweden — 3 open to participants now, 4 under way, none of them phase 3. Gambling · Sweden.

Enrollment
9th of 10
27 · median 80
Started
2018
the only one that year
No phase
10 of 14
3 open now
Registered
4th of 14
by date
Lead sponsor
6 of 14
Karolinska Institutet

Among the 14 studies in Gambling with a site in Sweden, this one is the 9th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2018, is one of 10 with no phase, and was the 4th registered.

Gambling

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

Browse Gambling studies →

Open to participants now

3 of the 14 studies in Gambling with a site in Sweden are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Sweden have not opened yet or have stopped. Only those recruiting at a site in Sweden →

Who these studies take

Of the 24 Gambling studies recruiting now, 14 (58%) set no upper age limit and 10 (42%) stop at 75 or younger; 1 takes children under 18; 5 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · no healthy volunteers.

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02

Study summary

Group cognitive behavioral therapy for Gambling Disorder (GD) with a focus on emotion regulation - A pilot study This pilot study will evaluate the feasibility and possible effectiveness of a novel treatment protocol developed within the research group including emotion regulation techniques for the treatment of GD.

Read the detailed description

The manual is based on principles from so called third wave cognitive behavioral therapy, which differs from current treatment within standard care in that focus is more on emotion regulation techniques. The treatment consists of an 8- session program delivered by weekly sessions. The study is an open trial in order to evaluate the possible benefit of components of emotion regulation in treating gambling disorder (GD). Participants with psychiatric comorbidities will be included and symptoms of comorbidities will be measured as secondary outcomes.

Once included in the study the participant will be measured weekly on symptoms of gambling disorder.

By increasing competencies in emotion regulation (such as active problem solving, acceptance and reappraisal of events in order to change their emotional impact) the hypothesis is that the participants will improve on measures of symptoms of GD as well as gambling expenditure in terms of time and money.

03

Conditions studied

  • Gambling Disorder

Keywords

  • Gambling disorder
  • psychiatric comorbidities
  • emotion regulation
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Gambling Disorder according to DSM 5

Exclusion criteria

Exclusion Criteria:

  • Unable to speak and read Swedish
  • Symptoms of manic episode
  • Severe psychiatric condition in need of urgent care
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    CBT for PG with emotion regulation

    A new treatment protocol for problem gamblers, CBT for problem gambling with emotion regulation, has a focus on emotion regulation, a component that has been lacking in current published research.

    Behavioral: CBT for problem gambling with emotion regulation

Interventions

  • BehavioralCBT for problem gambling with emotion regulation

    CBT group treatment for problem gambling with emotion regulation focus, with 8 sessions.

06

What researchers measure

Primary outcomes

  1. Change in gambling symptoms

    Change in gambling symptoms will be measured by Gambling symptoms assessment scale (G-SAS) - a 12-item scale measuring symtoms of gambling disorder within the last week. Maximum score 48. Higher scores indicating more severe problems.

    Time frame: Pre-treatment up to 12-month followup.

  2. Change in gambling expenditure

    Change in time and money spent on gambling, per week

    Time frame: Pre-treatment up to 12-month followup.

Secondary outcomes

  1. Symptoms of depression

    Patient health questionnaire, PHQ-9 - measuring symtoms of depression with the last 2 weeks. Maximum score: 27. Higher scores indicating more severe problems.

    Time frame: PHQ-9 will be administered: assessment prior to treatment, weekly measures during the 8 weeks of treatment, at treatment termination and 3, 6 and 12 months after treatment termination.

  2. Symptoms of anxiety

    Generalized Anxiety Disorder 7 item, GAD-7.Maximum score: 21. Higher scores indicating more severe problems

    Time frame: GAD- 7 will be administered: assessment prior to treatment, weekly measures during the 8 weeks of treatment, at treatment termination and 3, 6 and 12 months after treatment termination.

  3. WHOQOL-Bref

    Measures quality of life in four domains (psychological, social, environmental and physical)

    Time frame: WHOQOL-Bref will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.

Other outcomes

  1. Gambling Urges

    Gambling Urge Scale, 6 item - measuring gambling urges. Maximun score of 18. Higher score = stronger urges.

    Time frame: will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.

  2. Craving experiences

    Craving experiences questionnaire for gambling (CEQ-G)- measuring gambling cravings in terms of frequency and intensity within the last week. 16 item scores from 0-10. Maximum score of 160. Higher scores = more strong and/or intense cravings.

    Time frame: CEQ-G will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.

  3. Alcohol consumption

    Alcohol Use Disorder Identification Test, AUDIT

    Time frame: AUDIT will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.

  4. Drug consumption

    Drug Use Disorder Identification Test, DUDIT

    Time frame: DUDIT will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.

  5. Increased competencies in Emotion Regulation

    Difficulties in Emotion Regulation Scale, DERS- 16

    Time frame: DERS - 16 will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.

  6. Increased psychological flexibility

    Acceptance and Action Questionnaire - AAQ - II - a measure of psychological flexibility and acceptance which will be analysed as mediator in treatment. 6 items, maximum score of 42. Higher scores indicating more inflexibility and experiential avoidance.

    Time frame: AAQ-II will be administered: assessment prior to treatment, weekly measures during the 8 weeks of treatment, at treatment termination and 3, 6 and 12 months after treatment termination.

07

Study locations

1 site
  • Center for Psychiatry Research, Karolinska Institutet
    Stockholm, Sweden
08

References and documents

Publications

  • Mansson V, Molander O, Carlbring P, Rosendahl I, Berman AH. Emotion regulation-enhanced group treatment for gambling disorder: a non-randomized pilot trial. BMC Psychiatry. 2022 Jan 6;22(1):16. doi: 10.1186/s12888-021-03630-3. PubMed 34991511 ↗
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

Ran from Oct 2018 to primary completion in Dec 2019, 14 months.

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 14 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
Aug 21, 2018
First posted
Oct 31, 2018
StartActual
Oct 30, 2018
Primary completionActual
Dec 31, 2019
CompletionActual
Dec 31, 2019
Last update
Mar 18, 2025
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 Mar 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03725735
Responsible party
Anne H Berman (associate Professor, Karolinska Institutet) — Principal investigator
First posted
Oct 31, 2018
Start date
Oct 30, 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Mar 18, 2025

Study contacts

Anne H Berman, PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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