An interventional study of psychoeducational / motivational combined with crushing and psychoeducational / motivational combined with control in Cigarette Smoking, sponsored by Universite du Quebec en Outaouais. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-02.
Sponsored by Universite du Quebec en Outaouais · Not applicable, Interventional, and Treatment
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.
A detailed description is available, in French, by contacting stephane.bouchard@uqo.ca.
132 studies on the registry are indexed under Cigarette Smoking; 60 are open to participants now.
This study's enrollment of 91 is close to the median of 94 across 114 interventional studies indexed under Cigarette Smoking.
Browse Cigarette Smoking studies →Universite du Quebec en Outaouais is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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, 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, 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).
Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples.
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
Tiffany's Urge to Smoke Questionnaire
Time frame: Weeks 1, 4, 6, 12, 24 and 12-month follow-up
Medical clinic in the province of Quebec.
| Milestone | VR - Cigarettes | VR - Balls (Control) |
|---|---|---|
| Started | 45 | 46 |
| Completed | 45 | 46 |
| Not completed | 0 | 0 |
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).
| participants | VR - Cigarettes | VR - Balls (Control) |
|---|---|---|
| Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples. | 45 | 46 |
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VR - Cigarettes | — | 0/45 (0%) | 0/45 (0%) |
| VR - Balls (Control) | — | 0/46 (0%) | 0/46 (0%) |
| Age, Categorical(Participants) | VR - Cigarettes | VR - Balls (Control) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 45 | 46 | 91 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | VR - Cigarettes | VR - Balls (Control) | Total |
|---|---|---|---|
| Female | 25 | 26 | 51 |
| Male | 20 | 20 | 40 |
| Region of Enrollment(participants) | VR - Cigarettes | VR - Balls (Control) | Total |
|---|---|---|---|
| Canada | 45 | 46 | 91 |
| Nicotine addiction(Participants) | VR - Cigarettes | VR - Balls (Control) | Total |
|---|---|---|---|
| Number | 45 | 46 | 91 |
The record gives a start of Mar 2008, a primary completion of Jun 2008 and a completion of Jun 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2009, 1 year 1 month after primary completion.
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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Universite du Quebec en Outaouais