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 Description

Brief Summary:

The investigators reported in a pilot study presented at last year's Cybertherapy Conference (Girard & Turcotte, 2007) that using an action-cue exposure strategy in virtual reality (ACE-VR; crushing virtual cigarettes) might be useful in the treatment of tobacco addiction.

The investigators are pursuing research in this area with a randomized control trial based on 90 smokers who will receive a brief psychosocial smoking cessation program (25 people are enrolled so far and we expect to finish the study before the conference). During the first four weeks of an eight-session psychoeducational and motivational program, all participants will be immersed in VR. During the immersions in VR, 45 of the participants will use a virtual arm to catch and crush virtual cigarettes. The other half of the sample will use the virtual arm to catch virtual fruits (control condition).

The smoking frequency, and abstinence, will be assessed with a daily diary and exhaled carbon monoxide tests (the CO2 tests will provide an objective confirmation of the abstinence reported in the diaries). The success the program will be compared based on the number of subjects who quitted or reduced their smoking frequency. The severity of addiction will be assessed with two questionnaires, the Fagerstrom and the Horn tests. Craving and withdrawal effects will be measured with the Minnesota Nicotine Withdrawal Scale (MNWS) and the Brief Questionnaire of Smoking Urges (QSU-Brief) at the baseline and at the visits from weeks 1 through 4, 6, 12 and at the end of the program. Before the VR immersion, the Immersive Tendencies Questionnaire will be administered and after each VR session participants will fill two questionnaires addressing presence and cybersickness. The comparative impact of both treatments will be tested with repeated measures ANOVAs (and planned contrasts) with sufficient power to detect medium effect sizes.

The main goal of our study is show that crushing virtual cigarettes can boost the impact of a behavioural program dedicated to cigarette addiction.

Condition or disease	Intervention/treatment	Phase
Cigarette Smoking	Behavioral: psychoeducational / motivational combined with crushing; Behavioral: psychoeducational / motivational combined with control	Not Applicable

Detailed Description:

A detailed description is available, in French, by contacting stephane.bouchard@uqo.ca.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Virtual Arm to Stop Smoking. A Comparative Study
• Study Start Date: March 2008
• Actual Primary Completion Date: June 2008
• Actual Study Completion Date: June 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; 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).	Behavioral: psychoeducational / motivational combined with crushing; 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).
Active Comparator: 2; 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).	Behavioral: psychoeducational / motivational combined with control; 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).

Outcome Measures

Primary Outcome Measures :

1. Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples. [ Time Frame: Weeks 1, 4, 6, 12, 24 and 12-month follow-up ]

   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).

Secondary Outcome Measures :

1. Tiffany's Urge to Smoke Questionnaire [ Time Frame: Weeks 1, 4, 6, 12, 24 and 12-month follow-up ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• adult smoker
• aged 18 - 65
• willing to stop smoking
• at least 10 cigarettes per day in the last year

Exclusion Criteria:

• receiving concomitant treatment for smoking (e.g., patches or varenicline)
• weight problems : Body Mass Index < 15 kg or > 45.5 kg
• suffering from a mental disorder, such as major depression, schizophrenia, etc.

Contacts and Locations

Locations

Canada, Quebec

GRAP - Clinique de psychologie au travail

Jonquière, Quebec, Canada, G7X 0A4

Sponsors and Collaborators

Universite du Quebec en Outaouais

Investigators

• Principal Investigator: Benoit Girard, M.D.; G.R.A.P.
• Study Chair: Stephane Bouchard, Ph.D.; U.Q.O.

More Information

Additional Information:

Click here for more information about this study about the virtual arm 

Click here for more information about clinical applications of virtual reality 

For more information about using VR to treat smoking 

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, Professor, Universite du Quebec en Outaouais
• ClinicalTrials.gov Identifier: NCT00639093
• Other Study ID Numbers: GRAP-CRC-cyberpsychologie
• First Posted: March 19, 2008
• Results First Posted: July 31, 2009
• Last Update Posted: July 2, 2012
• Last Verified: June 2012

Keywords provided by Stephane Bouchard, Universite du Quebec en Outaouais:

cigarette smoking; psychoeducational and motivational program; virtual reality