Clinical trial NCT02250586: Internet Based Cognitive Behavior Therapy for Concerned Significant Others of Problem Gamblers
Official title: Internet Based Cognitive-behavioral Therapy for Concerned Significant Others of Problem Gamblers: a Randomized Wait-list Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gambling
Keywords: concerned significant other
internet-delivered cognitive-behavioral therapy,
treatment-refusing problem gambler
Lead sponsor: Stockholm University
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Linkoeping University
First posted: 2014-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Inventory of Consequences Scale for the Gambler and CSO
timeFrame: 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:
measure: 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: The Generalised Anxiety Disorder 7-item (GAD-7)
timeFrame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: Relationship Assessment Scale (generic version)
timeFrame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: WHO Quality of Life Questionnaire-Bref
timeFrame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: Timeline followback method
timeFrame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
measure: Treatment engagement
timeFrame: Change from baseline at: [1] end of treatment period; follow-ups at [2] month 6 and [3] month 12 after the treatment period.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholm University
Study officials:
References:
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.
citation: 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.