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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02250586
Other study ID # CBT-CSO-Gambling
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2015
Est. completion date August 20, 2018

Study information

Verified date February 2021
Source Stockholm University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 20, 2018
Est. primary completion date August 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Sweden Stockholm University Stockholm

Sponsors (3)

Lead Sponsor Collaborator
Stockholm University Karolinska Institutet, Linkoeping University

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary Timeline followback method 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.
Secondary 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 Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
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