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Completed

NCT Number: NCT04609007

The Effect of a Brief Intervention for Problem Gamblers

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.

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Key information

Conditions

Gambling Problem

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stockholm Center for Psychiatry Research

Stockholm, 11364, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Behavioral

A brief 4 sessions online CBT program with therapist support.

Regular help-line telephone counselling

Behavioral

A single session of telephone counselling with a help-line counsellor

Primary outcomes

  1. 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

  2. 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,

  3. 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?

  4. 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.

Secondary outcomes

  1. Timeline follow-back, days gambling and net losses due to gambling

    Time frame: At baseline, weekly during the intervention, immediately after the intervention and at the 6-weeks follow-up

    A calendar function where gamblers registers days gambling and nett losses due to gambling.

  2. Problem Gambling Severity Index (PGSI)

    Time frame: At baseline and at the 6-weeks follow-up

    An instrument measuring level of gambling problems using 9 items on a 4 levels Likert-scale, 0 p (never) to 3 p (always), with a total score ranging from 0 to 27 p. Scoring 5 points or more indicates problem gambling.

  3. National Opinion Research Center Diagnostic and Statistical Manual of Mental Disorders-IV Screen for Gambling (NODS)

    Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up

    An instrument measuring measuring gambling disorder. The instrument consists of 17 items which are market "yes" or "no" and yields a total score of 10 points. Five points or more indicates a pathological gambler.

  4. Alcohol Use Disorders Identification Consumption (AUDIT-C)

    Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up

    An instrument which measures alcohol consumption in the general population. The instrument consists of 3 questions ranging from 0 to 4 with a total score of 0-12 points. A total score of ≥ 6 p indicates alcohol problems in men and ≥ 4 p in women

  5. Drug Use Disorders Identification Test Consumption (DUDIT-C)

    Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up

    An instrument consisting of 3 items measuring illicit drug consumption.

  6. Generalised Anxiety Disorder 7-item scale (GAD-7)

    Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up

    An instrument measuring anxiety consisting of 7 items with a total score ranging from 0 to 21 points where 15 or more points indicates severe anxiety.

  7. Gambling Abstinence Self-Efficacy Scale (GASS)

    Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up

    An instrument measuring self efficacy in gambling situations. The instrument consists of 21 items scored 0 to 5 points, yielding a total score of 0 - 105 points.

  8. Gambling Urges Scale (GUS)

    Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up

    An instrument measuring gambling urges. The instrument consists of 6 items on a Likert-scale 0 to 7, yielding a total score ranging from 0 - 42 points. A higher total score indicates more gambling urges.

  9. Consumption Screen for Problematic Gambling (CSPG)

    Time frame: At baseline

    An instrument measuring consumption of gambling the previous year. The instrument consists of three items yielding a total score ranging from 0-13 points. Four or more points indicates gambling problems

  10. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up

    A nine items instrument measuring depression ranging from 0 to 27 points. Twenty points or more indicates severe depression

  11. World Health Organization Quality of Life Instruments (WHOQOL-BREF)

    Time frame: At baseline, immediately after the intervention and at the 6-weeks follow-up

    A 26 items instrument developed by the World Health Organisation measuring quality of life. Items are scored 1-5 points, yielding a total score ranging from 26 - 130 p.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 30, 2020
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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