The Effect of a Brief Intervention for Problem Gamblers

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT04609007
Collaborator
(none)
36
1
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive behavioral therapy (CBT)
  • Behavioral: Regular help-line telephone counselling
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of a Brief Intervention for Problem Gamblers - a Randomized Controlled
Actual Study Start Date :
Mar 1, 2015
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment as usual

The TAU condition consists of a single session of regular help-line telephone counselling

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

Experimental: Cognitive behavioral therapy

The experimental condition consists of a single session of regular help-line telephone counselling plus four therapist guided online CBT sessions.

Behavioral: Cognitive behavioral therapy (CBT)
A brief 4 sessions online CBT program with therapist support.

Outcome Measures

Primary Outcome Measures

  1. Retention at the end of the study [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 [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 [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 [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 Outcome Measures

  1. 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]

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

  2. Problem Gambling Severity Index (PGSI) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stockholm Center for Psychiatry Research Stockholm Sweden 11364

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

  • Principal Investigator: Clara Hellner, Professor, Karolinska Institutet

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Clara Hellner Gumpert, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT04609007
Other Study ID Numbers:
  • 2017/1063-31
First Posted:
Oct 30, 2020
Last Update Posted:
Oct 30, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 30, 2020