Clinical trial NCT04609007: The Effect of a Brief Intervention for Problem Gamblers
Official title: The Effect of a Brief Intervention for Problem Gamblers - a Randomized Controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gambling Problem
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A pragmatic randomized pilot trial primarily examining the feasibility of a brief therapist guided online self-help program based on Cognitive behavioral therapy (CBT). Participants will be randomized to either a treatment as usual condition (TAU) or to TAU plus CBT.

Detailed description: The current study is a pragmatic randomized pilot trial examining the feasibility and effects of a brief therapist guided online self-help program based on Cognitive behavioral therapy (CBT) . Participants will be randomized to either a treatment as usual condition (TAU) or to TAU plus CBT.

Participants will be recruited via the Swedish national gambling helpline. After assessment for eligibility participants will be randomized, using block randomization to ensure balanced groups, to either TAU or TAU+CBT.

The participants will be measured; at baseline, weekly during the intervention (6 weeks), immediately after the intervention and at 6 weeks after treatment termination. Informed consent will be collected prior any data collection.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* Experiencing gambling problems (PGSI ≥ 3 p)
* Good enough knowledge in Swedish
* Access to a smart phone or computer with internet connection

Exclusion Criteria:

* Being involved in another treatment study the previous 3 months
* Other concurrent treatment for gambling problems
* Being on a non-stable pharmacological treatment for any psychiatric condition
* Severe depression defined as a PHQ-9 score of 20 points or more

Primary outcomes:
measure: Retention at the end of the study
timeFrame: 6-weeks after the intervention
measure: Time for execution of the study
timeFrame: from the date of the first included participant to the last included, assessed up to 52 weeks
measure: Participant rated satisfaction with the treatment protocol
timeFrame: measured in conjunction with each online treatment module for up to six weeks (at four occasions)
measure: Participant rated satisfaction with the treatment at large
timeFrame: immediately after the intervention.
Secondary outcomes:
measure: Timeline follow-back, days gambling and net losses due to gambling
timeFrame: At baseline, weekly during the intervention, immediately after the intervention and at the 6-weeks follow-up
measure: Problem Gambling Severity Index (PGSI)
timeFrame: At baseline and at the 6-weeks follow-up
measure: National Opinion Research Center Diagnostic and Statistical Manual of Mental Disorders-IV Screen for Gambling (NODS)
timeFrame: At baseline, immediately after the intervention and at the 6-weeks follow-up
measure: Alcohol Use Disorders Identification Consumption (AUDIT-C)
timeFrame: At baseline, immediately after the intervention and at the 6-weeks follow-up
measure: Drug Use Disorders Identification Test Consumption (DUDIT-C)
timeFrame: At baseline, immediately after the intervention and at the 6-weeks follow-up
measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
timeFrame: At baseline, immediately after the intervention and at the 6-weeks follow-up
measure: Gambling Abstinence Self-Efficacy Scale (GASS)
timeFrame: At baseline, immediately after the intervention and at the 6-weeks follow-up
measure: Gambling Urges Scale (GUS)
timeFrame: At baseline, immediately after the intervention and at the 6-weeks follow-up
measure: Consumption Screen for Problematic Gambling (CSPG)
timeFrame: At baseline
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: At baseline, immediately after the intervention and at the 6-weeks follow-up
measure: World Health Organization Quality of Life Instruments (WHOQOL-BREF)
timeFrame: At baseline, immediately after the intervention and at the 6-weeks follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholm Center for Psychiatry Research
Study officials:
affiliation: Karolinska Institutet
name: Clara Hellner, Professor
role: PRINCIPAL_INVESTIGATOR
References: