NCT02250586

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2018

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

3.5 years

First QC Date

September 18, 2014

Last Update Submit

February 15, 2021

Conditions

Keywords

concerned significant otherinternet-delivered cognitive-behavioral therapy,treatment-refusing problem gambler

Outcome Measures

Primary Outcomes (1)

  • Inventory of Consequences Scale for the Gambler and CSO

    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)

  • 9-item Patient Health Questionnaire (PHQ-9)

    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)

    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)

    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

    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

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

  • +1 more secondary outcomes

Study Arms (2)

CBT-CSO

EXPERIMENTAL

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

Wait-list

NO INTERVENTION

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.

Interventions

CBT-CSOBEHAVIORAL

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

CBT-CSO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockholm University

Stockholm, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 26656017BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 18, 2014

First Posted

September 26, 2014

Study Start

March 1, 2015

Primary Completion

August 20, 2018

Study Completion

August 20, 2018

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations