- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03725735
Emotion Regulation Group Treatment for Gambling Disorder - a Pilot Trial
Group Cognitive Behavioral Therapy for Problem Gambling With a Focus on Emotion Regulation - A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gävlegatan 22
-
Stockholm, Gävlegatan 22, Sweden
- Magnus Huss kliniken
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
CBT group treatment for problem gambling with emotion regulation focus, with 8 sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in gambling symptoms
Time Frame: Pre-treatment up to 12-month followup.
|
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
Time Frame: Pre-treatment up to 12-month followup.
|
Change in time and money spent on gambling, per week
|
Pre-treatment up to 12-month followup.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms of depression
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.
|
Patient health questionnaire, PHQ-9 - measuring symtoms of depression with the last 2 weeks.
Maximum score: 27.
Higher scores indicating more severe problems.
|
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
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.
|
Generalized Anxiety Disorder 7 item, GAD-7.Maximum score: 21.
Higher scores indicating more severe problems
|
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
Time Frame: WHOQOL-Bref will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
|
Measures quality of life in four domains (psychological, social, environmental and physical)
|
WHOQOL-Bref will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gambling Urges
Time Frame: will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
|
Gambling Urge Scale, 6 item - measuring gambling urges.
Maximun score of 18. Higher score = stronger urges.
|
will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
|
Craving experiences
Time Frame: CEQ-G will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
|
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.
|
CEQ-G will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
|
Alcohol consumption
Time Frame: AUDIT will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
|
Alcohol Use Disorder Identification Test, AUDIT
|
AUDIT will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
|
Drug consumption
Time Frame: DUDIT will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
|
Drug Use Disorder Identification Test, DUDIT
|
DUDIT will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
|
Increased competencies in Emotion Regulation
Time Frame: DERS - 16 will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
|
Difficulties in Emotion Regulation Scale, DERS- 16
|
DERS - 16 will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
|
Increased psychological flexibility
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.
|
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.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne H Berman, PhD, Karolinska Institutet
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/1479-31/1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gambling Disorder
-
Université Catholique de LouvainCentre Hospitalier Universitaire Vaudois; Cliniques universitaires Saint-Luc-... and other collaboratorsUnknownCraving | Gambling | Gambling Disorder | Gambling, Pathological | Gambling ProblemSwitzerland
-
Region SkaneLund UniversityRecruitingGambling Disorder | Problem GamblingSweden
-
Universitat Jaume INot yet recruitingGambling Disorder | Problem GamblingSpain
-
University of ChicagoCompleted
-
ITAB - Institute for Advanced Biomedical TechnologiesNot yet recruitingAccelerated rTMS in Gambling Disorder: a Multicentric, Randomized, Sham-controlled Trial (arTMSinGD)Gambling | Gambling Disorder | Gambling, Pathological | Gambling Problem
-
Karolinska InstitutetCompleted
-
Finnish Institute for Health and WelfareUnknownNaloxone | Gambling Disorder | Opioid Antagonist | Pathological GamblingFinland
-
Region SkaneRecruitingGambling Disorder | Gaming DisorderSweden
-
Indonesia UniversityRadboud University Medical CenterNot yet recruiting
-
Karolinska InstitutetDeakin UniversityRecruiting
Clinical Trials on CBT for problem gambling with emotion regulation
-
Arizona State UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and other collaboratorsCompletedRheumatoid ArthritisUnited States
-
University of BergenHaukeland University HospitalRecruitingAttention Deficit Hyperactivity DisorderNorway
-
University of WindsorUniversity of Manitoba; Treatment Innovations; Manitoba Gambling Research ProgramCompletedPosttraumatic Stress Disorder | Gambling Disorder | Trauma, Psychological | Problem GamblingUnited States
-
Karolinska InstitutetCompletedNonsuicidal Self-InjurySweden
-
Memorial Sloan Kettering Cancer CenterColumbia University; University of Michigan; University of Aarhus; University of...RecruitingCancer Patients | Family CaregiversUnited States
-
Karolinska InstitutetCompletedNonsuicidal Self-InjurySweden
-
Philipps University Marburg Medical CenterUnknownSomatic Symptom Disorder (DSM-5)Germany
-
Philipps University Marburg Medical CenterGerman Research Foundation; University of Giessen; Universitätsklinikum Hamburg-Eppendorf and other collaboratorsCompletedSomatic Symptom Disorder (DSM-V)Germany
-
Memorial Sloan Kettering Cancer CenterWeill Medical College of Cornell University; Hunter College of City University...Completed
-
University Hospital, AngersNot yet recruiting