A Virtual Arm to Stop Smoking

• ClinicalTrials.gov Identifier: NCT00639093
• Recruitment Status: Completed
• First Posted: March 19, 2008
• Results First Posted: July 31, 2009
• Last Update Posted: July 2, 2012
• Sponsor: Universite du Quebec en Outaouais
• Information provided by (Responsible Party): Stephane Bouchard, Universite du Quebec en Outaouais

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cigarette Smoking
• Interventions: Behavioral: psychoeducational / motivational combined with crushing; Behavioral: psychoeducational / motivational combined with control
• Enrollment: 91

Participant Flow

Recruitment Details	Medical clinic in the province of Quebec.
Pre-assignment Details

Arm/Group Title	VR - Cigarettes	VR - Balls (Control)
Arm/Group Description	All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR). During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer).	All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR). During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer).
Period Title: Overall Study
Started	45 [1]	46 [2]
Completed	45 [1]	46 [2]
Not Completed	0	0
[1] 45; [2] 46

Baseline Characteristics

Arm/Group Title		VR - Cigarettes	VR - Balls (Control)	Total
Arm/Group Description		All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR). During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer).	All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR). During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer).	Total of all reporting groups
Overall Number of Baseline Participants		45	46	91
Baseline Analysis Population Description		[Not Specified]
Age, Categorical [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants	46 participants	91 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	45 100.0%	46 100.0%	91 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
		[1] Measure Description: Aged above 18.
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	45 participants	46 participants	91 participants
	Female	25 55.6%	26 56.5%	51 56.0%
	Male	20 44.4%	20 43.5%	40 44.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Canada	Number Analyzed	45 participants	46 participants	91 participants
		45	46	91
Nicotine addiction [1]; Measure Type: Number; Unit of measure: Participants
	Number Analyzed	45 participants	46 participants	91 participants
		45	46	91
		[1] Measure Description: As stated in the Eligibility Criteria, participants had to be smokers (10 cigarettes per day minimum) wanting but incapable to quit.

Outcome Measures

1. Primary Outcome

Title	Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples.
Description	Participants completed a daily diary to record the number cigarettes smoked during the day. No cigarette smoked during 7 days = abstinence. To be counted as real abstinence, the participant had to smoke zero cigarettes during four weeks and confirmed by zero nicoting in the unrine sample. Six measurement times were used to assess if zero cigarettes has been smoked in the last 4 weeks prior to the study (Week 1), during the first four weeks (Week 4 measurement point) and so on for a blok of four weeks ending at each measurement point (e.g., four weeks before the 12-month follow-up).
Time Frame	Weeks 1, 4, 6, 12, 24 and 12-month follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VR - Cigarettes	VR - Balls (Control)
Arm/Group Description:	All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR). During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer).	All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR). During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer).
Overall Number of Participants Analyzed	45	46
Measure Type: Number; Unit of Measure: participants
	45	46

2. Secondary Outcome

Title	Tiffany's Urge to Smoke Questionnaire
Description	[Not Specified]
Time Frame	Weeks 1, 4, 6, 12, 24 and 12-month follow-up

Outcome Measure Data Not Reported

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	VR - Cigarettes	VR - Balls (Control)
Arm/Group Description	All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR). During the immersions in VR, 45 of the participants will use a virtual reality arm to catch and crush virtual cigarettes (on a computer).	All participants will receive an eight-session psychoeducational and motivational program. During the first four weeks, all participants will be immersed in virtual reality (VR). During the immersions in VR, the 45 participants in the control condition will use a virtual reality arm to catch and crush virtual fruits (on a computer).
All-Cause Mortality
	VR - Cigarettes	VR - Balls (Control)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	VR - Cigarettes	VR - Balls (Control)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/45 (0.00%)	0/46 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	VR - Cigarettes	VR - Balls (Control)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/45 (0.00%)	0/46 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

Results Point of Contact

• Name/Title: Benoît Girard
• Organization: GRAP, Clinique de Psychologie au Travail
• Phone: 418-542-2030
• EMail: g.r.a.p@videotron.ca

Publications:

Girard, B., & Turcotte, V. (2007). A virtual arm to stop smoking, a perceptual learning experiment. In N. Appel & H. Hoffman (Chairs), Addictions. Symposium presented at the Cybertherapy 12 Conference, in June in Washington, D.C.

Martin RA, Rohsenow DJ, MacKinnon SV, Abrams DB, Monti PM. Correlates of motivation to quit smoking among alcohol dependent patients in residential treatment. Drug Alcohol Depend. 2006 Jun 9;83(1):73-8. doi: 10.1016/j.drugalcdep.2005.10.013. Epub 2005 Nov 28.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Girard B, Turcotte V, Bouchard S, Girard B. Crushing virtual cigarettes reduces tobacco addiction and treatment discontinuation. Cyberpsychol Behav. 2009 Oct;12(5):477-83. doi: 10.1089/cpb.2009.0118.

• Responsible Party: Stephane Bouchard, Universite du Quebec en Outaouais
• ClinicalTrials.gov Identifier: NCT00639093
• Other Study ID Numbers: GRAP-CRC-cyberpsychologie
• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Results First Submitted: July 30, 2009
• Results First Posted: July 31, 2009
• Last Update Posted: July 2, 2012