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GamblingNCT02250586

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

A study testing CBT-CSO in people with Gambling, run by Stockholm University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gambling
What is being tested?
CBT-CSO
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteSweden
Study dates
1 Mar 2015to 20 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Stockholm University

    Stockholm

Other trials in Sweden

About this study

Official title: 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.

Conditions
Gambling
Being tested
CBT-CSO
Keywords
concerned significant other, internet-delivered cognitive-behavioral therapy,, treatment-refusing problem gambler
Medical subject headings
Gambling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT-CSOBehavioural

    Internet-delivered cognitive-behavioral therapy for CSO's of treatment refusing problem gamblers

Study groups in NCT02250586
Study groupRoleWhat they receive
CBT-CSOExperimentalThe 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.
Receives: Behavioral: CBT-CSO
Wait-listNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Inventory of Consequences Scale for the Gambler and CSO

    Measured: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.

Secondary outcomes (6)

  1. 9-item Patient Health Questionnaire (PHQ-9)

    Measured: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.

  2. The Generalised Anxiety Disorder 7-item (GAD-7)

    Measured: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.

  3. Relationship Assessment Scale (generic version)

    Measured: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.

  4. WHO Quality of Life Questionnaire-Bref

    Measured: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.

  5. Timeline followback method

    CSOs will be asked to report the amount of money spent on gambling by the identified problem gambler.

    Measured: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.

  6. Treatment engagement

    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

    Measured: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2014 (estimated)
  2. Study start1 Mar 2015
  3. Primary completion20 Aug 2018
  4. Study completion20 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02250586
Sponsor's protocol ID
CBT-CSO-Gambling
Status last verified
Feb 2021
First submitted
18 Sep 2014
Last updated
17 Feb 2021
Results posted
No
Data monitoring committee
No

Publications

  • Magnusson K, Nilsson A, Hellner Gumpert C, Andersson G, Carlbring P. Internet-delivered cognitive-behavioural therapy for concerned significant others of people with problem gambling: study protocol for a randomised wait-list controlled trial. BMJ Open. 2015 Dec 9;5(12):e008724. doi: 10.1136/bmjopen-2015-008724.

    PubMed 26656017

  • Magnusson K, Nilsson A, Andersson G, Hellner C, Carlbring P. Internet-delivered cognitive-behavioral therapy for significant others of treatment-refusing problem gamblers: A randomized wait-list controlled trial. J Consult Clin Psychol. 2019 Sep;87(9):802-814. doi: 10.1037/ccp0000425.

    PubMed 31403816

Questions about this trial

What is this clinical trial studying?

A study testing CBT-CSO in people with Gambling, run by Stockholm University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02250586, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.

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