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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01743092
Other study ID # 153-2012
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 2, 2012
Last updated May 21, 2015
Start date November 2012
Est. completion date August 2015

Study information

Verified date May 2015
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

Research specific to women's gambling treatment needs is limited but suggests a critical need for women sensitive options and reduced barriers to access. This pilot will test the effectiveness of a Tutorial Workbook (TW) both as a self-help tool and used in combination with a webinar. Ontario women(n=48) over the age of 19, with gambling concerns, will be recruited through flyers, on-line and newspaper ads and randomly assigned to one of two groups: (a) TW or (b) TWW (TW plus Webinar). All will complete questionnaires addressing gambling behaviours, personal history and mood states prior to and after the 12 week study. Groups (a) and (b) will also provide feedback on the TW's content and relevance. Group (b) will, in addition, provide feedback on the Webinar Group. TW and TWW will be valuable additions to current treatments, of special importance to reduce barriers for women. The study will contribute to best practices in developing web-based treatments.


Description:

Most gambling specific research involves men yet findings are typically generalized to women, a shortcoming addressed in the literature. Women are underrepresented in treatment. A previous study (Boughton and Brewster, 2002) with 365 Ontario women not in treatment, explored barriers and treatment needs. Many respondents indicated that women-only groups and self-help materials would be of value. Using web-based resources to increase treatment options has merit in a growing technological age. This study will introduce two unique forms of treatment, a women friendly tutorial workbook developed specifically to address issues commonly underlying women's gambling and a webinar based group facilitated by a gambling clinician. Group support has been demonstrated to be highly beneficial for women in reducing isolation and shame. The research will assist in developing Best Practices in the problem gambling field, especially for women, a neglected and vulnerable group.

There are two questions:

1. First, to what extent is the Tutorial Workbook effective by itself as a treatment option in helping women make changes to their gambling.

2. What extent is the addition of the webinar discussion group option an incremental benefit to the participant in helping women make changes to their gambling.

Web based therapy has proven effective in the treatment of addiction and mental health issues but more research is needed to assess its efficacy for problem gambling. Self-help tools have been demonstrated as effective in reducing gambling but no women specific tools are available. Evidence of the effectiveness of the TW and TWW treatment options will reduce barriers for hard to serve populations of women and expand options for clinical programs to meet the needs of women unable to attend face to face programs. The TW attends to the unique issues and treatment/support needs of women with gambling concerns.

Ultimately the TW materials, once fully developed, can be made available to the general public as an online tool, used to assist n providing telephone counselling, individually or in a group (Webinar) format or be made available as a self-help paper based utorial workbook.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 48
Est. completion date August 2015
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- pathological gamblers

- not currently in formal gambling specific treatment

- English proficiency (reading, writing and speech)

- access to private computer and phone

- sufficient computer skills to engage in webinar

- able to fully commit to time demands of weekly participation

Exclusion Criteria:

- active psychosis

- unstable mood disorders

- emotion dysregulation

- extreme social anxiety

- cognitive challenges in reading

- not proficient in in English (reading, writing and speech)

- suicidal behaviours

- current problems with drugs/ alcohol abuse

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Webinar
Some clients will receive a webinar as part of their treatment.
Tutuorial workbook
A work book about their addiciton

Locations

Country Name City State
Canada Problem Gambling Treatment Service Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gambling Behaviours Questionnaire (unpublished) The questionnaire asks the client about their involvement and spending on 16 different forms of gambling. The intended outcome would be reduced gambling behaviours 12 weeks No
Secondary Motivation to gamble (unpublished) This is a three part questionnaire that asks the client about their motivation to gamble (Boughton, & Brewster, 2002). Part 1 convers INCENTIVES TO GAMBLE, part 2 coverss URGES TO GAMBLE OR KEEP GAMBLING, and part three covers DRAWBACKS TO GAMBLING. The expected outcome would be reduced motivation to gamble. In particular a reduction in their feelings about incentives and urges to gamble and an increase in their awareness of drawbacks to gambling.
Boughton, R. & Brewster, J. (2002). Voices of women who gamble in Ontario: A survey of women's gambling,, barriers to treatment and treatment service needs. Report to Ontario Ministry of Health and Long Term Care. Retrieved from http://www.gamblingresearch.org/download.sz/voicesofwomen%20Boughton%20(1).pdf
?docid=1524
12 weeks No
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