Clinical trial NCT03725735: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gambling Disorder
Keywords: Gambling disorder
psychiatric comorbidities
emotion regulation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label pilot study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in gambling symptoms
timeFrame: Pre-treatment up to 12-month followup.
measure: Change in gambling expenditure
timeFrame: Pre-treatment up to 12-month followup.
Secondary outcomes:
measure: Symptoms of depression
timeFrame: 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.
measure: Symptoms of anxiety
timeFrame: 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.
measure: WHOQOL-Bref
timeFrame: WHOQOL-Bref will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
Other outcomes:
measure: Gambling Urges
timeFrame: will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
measure: Craving experiences
timeFrame: CEQ-G will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
measure: Alcohol consumption
timeFrame: AUDIT will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
measure: Drug consumption
timeFrame: DUDIT will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
measure: Increased competencies in Emotion Regulation
timeFrame: DERS - 16 will be administered: assessment prior to treatment, at treatment termination and 3, 6 and 12 months after treatment termination.
measure: Increased psychological flexibility
timeFrame: 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.
Locations:
city: Stockholm
country: Sweden
facility: Center for Psychiatry Research, Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Anne H Berman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.