Internet Based Cognitive Behavior Therapy for Concerned Significant Others of Problem Gamblers

February 15, 2021 updated by: Per Carlbring, Stockholm University

Internet Based Cognitive-behavioral Therapy for Concerned Significant Others of Problem Gamblers: a Randomized Wait-list Controlled Trial

BACKGROUND: About 2.3 % of the adult population in Sweden is considered to be problem gamblers, and it is estimated that only 5 % of them seek treatment. Problem gambling can have devastating effects on the economy, health and relationship, both for the problem gambler and their concerned significant other (CSO). No empirically supported program exists for the CSOs of problem gamblers. Consequently, the aim of this study is to develop and evaluate a program aimed at CSOs of treatment refusing problem gamblers. The program will be based on principles from cognitive behavioral therapy and motivational interviewing. In order to benefit as many CSOs as possible, the program will be delivered via the Internet with therapist support via email and telephone.

METHODS/DESIGN: This will be a randomized wait-list controlled internet-delivered trial. A cognitive behavioral-therapy program for the concerned significant others (CSOs) of problem gamblers (PGs) will be developed and evaluated. The participants will work through 8 modules over 10 weeks in a secure online environment, and receive support via text messages and over telephone. 150 CSOs over 18 years of age will be included. Measures will be taken at baseline 3, 6 and 12 months. Primary outcomes concern gambling-related harm and motivating the PG to seek treatment. Secondary outcomes are CSO's feelings of depression, anxiety, relationship satisfaction and quality of life.

HYPOTHESIS: The investigators hypothesize: 1) that the CBT-CSO group will lead to a reduction in gambling related harm experienced by the CSO, 2) the CBT-CSO program will reduce the CSO's anxiety and depressive feelings, 3) the CBT-CSO program will decrease the amount of time and money the problem gambler spend on gambling, 4) the CBT-CSO program will increase the CSO's relationship satisfaction with the problem gambler.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Stockholm University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The CSO and the gambler are at least 18 years old,
  • The CSO is a parent, child, sibling, friend or partner of the gambler.
  • The CSO must have had a relationship with the gambler for at least 3 months.
  • Neither the CSO nor the gambler has had any treatment in the past 3 months (that is related to gambling).
  • The gambler is currently refusing help.
  • The CSO is able to read and answer questions in Swedish, and is willing to talk to a counselor each week.
  • The gambler is a problem gambler according to Problem Gambling Severity Index, as rated by the CSO.
  • The CSO must agree to have their telephone calls recorded.

Exclusion Criteria:

  • Presence of psychotic- or bipolar disorder in the CSO or gambler.
  • CSO meets PGSI criteria for ongoing problem gambling.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CBT-CSO

The CBT-CSO program will be based on concepts from cognitive-behavioral therapy and motivational interviewing, and is specifically developed for use with CSOs of treatment refusing problem gamblers. The program resembles the community reinforcement and family training approach that has been successfully used with CSOs of substance abusers.

The program will be given as guided self-help with guidance given via email and telephone. There are 8 modules, which all contain homework exercises and about 5-10 pages of text.
Behavioral: CBT-CSO
Internet-delivered cognitive-behavioral therapy for CSO's of treatment refusing problem gamblers
NO_INTERVENTION: Wait-list
The participants allocated to the control condition will be put on a waiting list and offered the CBT-CSO program after 10 weeks. The CSOs will receive information about available treatment options-in their area and web-based-for the problem gambler.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Inventory of Consequences Scale for the Gambler and CSO
Time Frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
9-item Patient Health Questionnaire (PHQ-9)
Time Frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
The Generalised Anxiety Disorder 7-item (GAD-7)
Time Frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
Relationship Assessment Scale (generic version)
Time Frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
WHO Quality of Life Questionnaire-Bref
Time Frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
Timeline followback method
Time Frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
CSOs will be asked to report the amount of money spent on gambling by the identified problem gambler.
Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
Treatment engagement
Time Frame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
CSO will be asked to report if and when the identified problem gambler enter treatment. "Entering treatment" is defined as attending at least 1 session or calling the National Gambling Helpline
Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stockholm University

Collaborators

Karolinska Institutet
Linkoeping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2015

Primary Completion (ACTUAL)

August 20, 2018

Study Completion (ACTUAL)

August 20, 2018

Study Registration Dates

First Submitted

September 18, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (ESTIMATE)

September 26, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBT-CSO-Gambling

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: awtg7
    Information comments: The trial's outcome data and scripts are available for download: https://osf.io/awtg7/

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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