NCT03725735

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

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

August 21, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

August 21, 2018

Last Update Submit

March 13, 2025

Conditions

Gambling Disorder

Keywords

Gambling disorderpsychiatric comorbiditiesemotion regulation

Outcome Measures

Primary Outcomes (2)

  • 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.

    Pre-treatment up to 12-month followup.

  • Change in gambling expenditure

    Change in time and money spent on gambling, per week

    Pre-treatment up to 12-month followup.

Secondary Outcomes (3)

  • Symptoms of depression

    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.

  • Symptoms of anxiety

    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.

  • WHOQOL-Bref

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

Other Outcomes (6)

  • Gambling Urges

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

  • Craving experiences

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

  • Alcohol consumption

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

  • +3 more other outcomes

Study Arms (1)

CBT for PG with emotion regulation

EXPERIMENTAL

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

CBT for problem gambling with emotion regulationBEHAVIORAL

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

CBT for PG with emotion regulation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gambling Disorder according to DSM 5

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Psychiatry Research, Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 34991511BACKGROUND

MeSH Terms

Conditions

GamblingEmotional Regulation

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental DisordersSelf-ControlSocial Behavior

Study Officials

  • Anne H Berman, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate Professor

Study Record Dates

First Submitted

August 21, 2018

First Posted

October 31, 2018

Study Start

October 30, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations

SE(1)