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Clinical Trials/NCT04609007
NCT04609007
Completed
Not Applicable

The Effect of a Brief Intervention for Problem Gamblers - a Randomized Controlled

Karolinska Institutet1 site in 1 country36 target enrollmentMarch 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gambling Problem
Sponsor
Karolinska Institutet
Enrollment
36
Locations
1
Primary Endpoint
Participant rated satisfaction with the treatment at large
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
March 2015
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Clara Hellner Gumpert

Professor

Karolinska Institutet

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

Outcomes

Primary Outcomes

Participant rated satisfaction with the treatment at large

Time Frame: immediately after the intervention.

Participant rated satisfaction with the treatment at large will be measured immediately after the intervention using 12 items on a VAS scale ranging from 1 (not at all) to 10 (very). Item 8 answers "yes" or "no" and item 9 is a free-text entry only available if item 8 answers "yes". Items 1- 4 and items 10-12 captures satisfaction with the program and items 5 - 9 captures satisfaction with the therapist.

Participant rated satisfaction with the treatment protocol

Time Frame: measured in conjunction with each online treatment module for up to six weeks (at four occasions)

Participant rated satisfaction with the treatment protocol will be measured using three items at the end of each online treatment module. The items are measured on a VAS scale ranging from 1-5 (1= not at all, 5 = very). Item 1) "How helpful do you think the content of this module has been?" Item 2) "How well does the content of the module fit the problems you experience and want help with?" Item 3) "What grade from 1 to 5 would you give this module?

Retention at the end of the study

Time Frame: 6-weeks after the intervention

Retention, defined as proportion of participants who fill out the last follow-up survey

Time for execution of the study

Time Frame: from the date of the first included participant to the last included, assessed up to 52 weeks

Time for execution of the study as measured by the time from the first included participant to the last included,

Secondary Outcomes

  • Timeline follow-back, days gambling and net losses due to gambling(At baseline, weekly during the intervention, immediately after the intervention and at the 6-weeks follow-up)
  • Drug Use Disorders Identification Test Consumption (DUDIT-C)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
  • Problem Gambling Severity Index (PGSI)(At baseline and at the 6-weeks follow-up)
  • National Opinion Research Center Diagnostic and Statistical Manual of Mental Disorders-IV Screen for Gambling (NODS)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
  • Generalised Anxiety Disorder 7-item scale (GAD-7)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
  • Alcohol Use Disorders Identification Consumption (AUDIT-C)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
  • Consumption Screen for Problematic Gambling (CSPG)(At baseline)
  • Patient Health Questionnaire-9 (PHQ-9)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
  • Gambling Abstinence Self-Efficacy Scale (GASS)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
  • World Health Organization Quality of Life Instruments (WHOQOL-BREF)(At baseline, immediately after the intervention and at the 6-weeks follow-up)
  • Gambling Urges Scale (GUS)(At baseline, immediately after the intervention and at the 6-weeks follow-up)

Study Sites (1)

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