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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03725735
Other study ID # 2017/1479-31/1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 30, 2018
Est. completion date December 31, 2019

Study information

Verified date September 2020
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Sweden Magnus Huss kliniken Stockholm Gävlegatan 22

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other Gambling Urges 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.
Other 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. CEQ-G will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
Other Alcohol consumption 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.
Other Drug consumption 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.
Other Increased competencies in Emotion Regulation 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.
Other 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. 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.
Primary 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.
Primary Change in gambling expenditure Change in time and money spent on gambling, per week Pre-treatment up to 12-month followup.
Secondary 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. 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.
Secondary Symptoms of anxiety 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.
Secondary WHOQOL-Bref 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.
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