Testing Resources: Manual and Webinar Guided Treatment vs. Manual Guided Treatment

• Sponsor: Centre for Addiction and Mental Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT01743092
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pathological Gambling	Behavioral: Webinar; Behavioral: Tutuorial workbook	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Meeting the Unique Treatment Needs of Female Gamblers: A Workbook and Webinar Effectiveness Pilot Study
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Tutorial Workbook Tutorial Workbook Group only receives a Tutorial Workbook Group	Behavioral: Tutuorial workbook; A work book about their addiciton
Experimental: Tutorial Workbook Group plus webinar Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.	Behavioral: Webinar; Some clients will receive a webinar as part of their treatment.; Other Names: online discussion ; Behavioral: Tutuorial workbook; A work book about their addiciton

Outcome Measures

Primary Outcome Measures

1. Perceived Stress Scale [12 weeks]

   The questionnaire asks the client about their perceived stress. The Perceived Stress Scale (Cohen, S., Kamarck, T., and Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 386-396. December 1983) is a scale developed to measure the degree to which situations in one's life are appraised as stressful. Psychological stress has been defined as the extent to which persons perceive (appraise) that their demands exceed their ability to cope. The PSS has become one of the most widely used psychological instruments for measuring nonspecific perceived stress. The scale has ten questions asking respondents to circle a number between 0 and 4. (0 the feelings and thoughts during the last month: 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. The range of possible score is from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered to be indicative of high stress levels.

Secondary Outcome Measures

1. DASS Depression [12 weeks]

   The Depression, Anxiety and Stress Scale (DASS 21) is a 21 item self-report questionnaire developed by Lovibond, S.H. & Lovibond, P.F. (1995, Manual for the Depression Anxiety Stress Scales, 2nd. Ed., Sydney: Psychology Foundation). The range of total scores for each subscale is from 0 to 21. Higher values represent a worse outcome. Depression Normal 0-4 Mild 5-6 Moderate 7-10 Severe 11-13 Extremely Severe 14+ Anxiety Normal 0-3 Mild 4-5 Moderate 6-7 Severe 8-9 Extremely Severe 10+ Stress Normal 0-7 Mild 8-9 Moderate 10-12 Severe 13-16 Extremely Severe 17+

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Problem Gambling Treatment Service	Toronto	Ontario	Canada	M5S 2S1

Sponsors and Collaborators

• Centre for Addiction and Mental Health

Investigators

• Principal Investigator: Nigel E Turner, Ph.D., Centre for Addiction and Mental Health

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Website for the Problem Gambling Institute of Ontario and CAMH's problem gambling service

Publications

None provided.

• Responsible Party: Nigel Turner, Independent Scientist, Centre for Addiction and Mental Health
• ClinicalTrials.gov Identifier: NCT01743092
• Other Study ID Numbers: 153-2012
• First Posted: Dec 6, 2012
• Last Update Posted: Apr 1, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Nigel Turner, Independent Scientist, Centre for Addiction and Mental Health: Pathological gambling; treatment; online counselling; webinar; workbook
• Additional relevant MeSH terms: Gambling

Study Results

Participant Flow

Arm/Group Title	Tutorial Workbook	Tutorial Workbook Group Plus Webinar
Arm/Group Description	Tutorial Workbook Group only receives a Tutorial Workbook Group Tutuorial workbook: A work book about their addiciton	Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource. Webinar: Some clients will receive a webinar as part of their treatment. Tutuorial workbook: A work book about their addiciton
Period Title: Overall Study
STARTED	33	26
COMPLETED	19	11
NOT COMPLETED	14	15

Baseline Characteristics

Arm/Group Title	Tutorial Workbook	Tutorial Workbook Group Plus Webinar	Total
Arm/Group Description	Tutorial Workbook Group only receives a Tutorial Workbook Group Tutuorial workbook: A work book about their addiciton	Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource. Webinar: Some clients will receive a webinar as part of their treatment. Tutuorial workbook: A work book about their addiciton	Total of all reporting groups
Overall Participants	33	26	59
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	51	56	53
Sex: Female, Male (Count of Participants)
Female	33 100%	26 100%	59 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
white / european	22 66.7%	22 84.6%	44 74.6%
other	11 33.3%	4 15.4%	15 25.4%
Region of Enrollment (participants) [Number]
Canada	33 100%	26 100%	59 100%

Outcome Measures

1. Primary Outcome

Title	Perceived Stress Scale
Description	The questionnaire asks the client about their perceived stress. The Perceived Stress Scale (Cohen, S., Kamarck, T., and Mermelstein, R. (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 386-396. December 1983) is a scale developed to measure the degree to which situations in one's life are appraised as stressful. Psychological stress has been defined as the extent to which persons perceive (appraise) that their demands exceed their ability to cope. The PSS has become one of the most widely used psychological instruments for measuring nonspecific perceived stress. The scale has ten questions asking respondents to circle a number between 0 and 4. (0 the feelings and thoughts during the last month: 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. The range of possible score is from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered to be indicative of high stress levels.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The number of data points in this analysis equals the number who completed the study, minus 2. There were 2 missing data points in this analysis because two people did not complete the questionnaire.

Arm/Group Title	Tutorial Workbook	Tutorial Workbook Group Plus Webinar
Arm/Group Description	Tutorial Workbook Group only receives a Tutorial Workbook Group Tutuorial workbook: A work book about their addiciton	Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource. Webinar: Some clients will receive a webinar as part of their treatment. Tutuorial workbook: A work book about their addiciton
Measure Participants	17	11
Mean (Standard Deviation) [units on a scale]	15.2 (7.9)	14.5 (7.1)

2. Secondary Outcome

Title	DASS Depression
Description	The Depression, Anxiety and Stress Scale (DASS 21) is a 21 item self-report questionnaire developed by Lovibond, S.H. & Lovibond, P.F. (1995, Manual for the Depression Anxiety Stress Scales, 2nd. Ed., Sydney: Psychology Foundation). The range of total scores for each subscale is from 0 to 21. Higher values represent a worse outcome. Depression Normal 0-4 Mild 5-6 Moderate 7-10 Severe 11-13 Extremely Severe 14+ Anxiety Normal 0-3 Mild 4-5 Moderate 6-7 Severe 8-9 Extremely Severe 10+ Stress Normal 0-7 Mild 8-9 Moderate 10-12 Severe 13-16 Extremely Severe 17+
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The number of data points in this analysis equals the number who completed the study.

Arm/Group Title	Tutorial Workbook	Tutorial Workbook Group Plus Webinar
Arm/Group Description	Tutorial Workbook Group only receives a Tutorial Workbook Group Tutuorial workbook: A work book about their addiciton	Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource. Webinar: Some clients will receive a webinar as part of their treatment. Tutuorial workbook: A work book about their addiciton
Measure Participants	19	11
depression	4.3 (4.2)	3.5 (6.2)
anxiety	3.8 (4.9)	2.4 (3.3)
Stress	3.6 (4.0)	5.7 (4.9)

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	No adverse reactions were reported.
Arm/Group Title	Tutorial Workbook		Tutorial Workbook Group Plus Webinar
Arm/Group Description	Tutorial Workbook Group only receives a Tutorial Workbook Group Tutuorial workbook: A work book about their addiciton		Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource. Webinar: Some clients will receive a webinar as part of their treatment. Tutuorial workbook: A work book about their addiciton
All Cause Mortality
	Tutorial Workbook		Tutorial Workbook Group Plus Webinar
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Tutorial Workbook		Tutorial Workbook Group Plus Webinar
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Tutorial Workbook		Tutorial Workbook Group Plus Webinar
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/26 (0%)

Limitations/Caveats

The samples were recruited by advertisements and thus were not a true random sample of the population.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.