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Emotion Regulation Group Treatment for Gambling Disorder - a Pilot Trial

Primary Purpose

Gambling Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CBT for problem gambling with emotion regulation
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gambling Disorder focused on measuring Gambling disorder, psychiatric comorbidities, emotion regulation

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Gambling Disorder according to DSM 5

Exclusion Criteria:

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

Sites / Locations

  • Magnus Huss kliniken

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT for PG with emotion regulation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Change in gambling expenditure
Change in time and money spent on gambling, per week

Secondary Outcome Measures

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.
Symptoms of anxiety
Generalized Anxiety Disorder 7 item, GAD-7.Maximum score: 21. Higher scores indicating more severe problems
WHOQOL-Bref
Measures quality of life in four domains (psychological, social, environmental and physical)

Full Information

First Posted
August 21, 2018
Last Updated
September 1, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT03725735
Brief Title
Emotion Regulation Group Treatment for Gambling Disorder - a Pilot Trial
Official Title
Group Cognitive Behavioral Therapy for Problem Gambling With a Focus on Emotion Regulation - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling Disorder
Keywords
Gambling disorder, psychiatric comorbidities, emotion regulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open label pilot study
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT for PG with emotion regulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT for problem gambling with emotion regulation
Intervention Description
CBT group treatment for problem gambling with emotion regulation focus, with 8 sessions.
Primary Outcome Measure Information:
Title
Change in gambling symptoms
Description
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.
Title
Change in gambling expenditure
Description
Change in time and money spent on gambling, per week
Time Frame
Pre-treatment up to 12-month followup.
Secondary Outcome Measure Information:
Title
Symptoms of depression
Description
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.
Title
Symptoms of anxiety
Description
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.
Title
WHOQOL-Bref
Description
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 Pre-specified Outcome Measures:
Title
Gambling Urges
Description
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.
Title
Craving experiences
Description
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.
Title
Alcohol consumption
Description
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.
Title
Drug consumption
Description
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.
Title
Increased competencies in Emotion Regulation
Description
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.
Title
Increased psychological flexibility
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gambling Disorder according to DSM 5 Exclusion Criteria: Unable to speak and read Swedish Symptoms of manic episode Severe psychiatric condition in need of urgent care
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne H Berman, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magnus Huss kliniken
City
Stockholm
State/Province
Gävlegatan 22
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
34991511
Citation
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. Erratum In: BMC Psychiatry. 2023 Aug 23;23(1):619.
Results Reference
derived

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Emotion Regulation Group Treatment for Gambling Disorder - a Pilot Trial

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