The Effect of a Brief Intervention for Problem Gamblers

Karolinska Institutet36 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Gambling Problem

Interventions

Cognitive behavioral therapy (CBT)BEHAVIORAL

A brief 4 sessions online CBT program with therapist support.

Regular help-line telephone counsellingBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stockholm Center for Psychiatry Research

Stockholm, Sweden

Outcomes

Primary Outcomes

Retention at the end of the study

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

Time frame: 6-weeks after the intervention

Time for execution of the study

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

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

Participant rated satisfaction with the treatment protocol

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?

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

Participant rated satisfaction with the treatment at large

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.

Time frame: immediately after the intervention.

Secondary Outcomes

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

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

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

Data from ClinicalTrials.gov

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Problem Gambling Severity Index (PGSI)

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.

Time frame: 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)

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.