Cigarette Smoking
Conditions
Keywords
cigarette smoking, psychoeducational and motivational program, virtual reality
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.
Detailed description
A detailed description is available, in French, by contacting stephane.bouchard@uqo.ca.
Interventions
BEHAVIORALpsychoeducational / 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).
BEHAVIORALpsychoeducational / 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).
Sponsors
Universite du Quebec en Outaouais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples. | 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
| Measure | Time frame |
|---|---|
| Tiffany's Urge to Smoke Questionnaire | Weeks 1, 4, 6, 12, 24 and 12-month follow-up |
Countries
Canada
Participant flow
Recruitment details
Medical clinic in the province of Quebec.
Participants by arm
| Arm | Count |
|---|---|
| VR - Cigarettes 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). | 45 |
| VR - Balls (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). | 46 |
| Total | 91 |
Baseline characteristics
| Characteristic | VR - Cigarettes | VR - Balls (Control) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 46 Participants | 91 Participants |
| Nicotine addiction | 45 Participants | 46 Participants | 91 Participants |
| Region of Enrollment Canada | 45 participants | 46 participants | 91 participants |
| Sex: Female, Male Female | 25 Participants | 26 Participants | 51 Participants |
| Sex: Female, Male Male | 20 Participants | 20 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 46 |
| serious Total, serious adverse events | 0 / 45 | 0 / 46 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VR - Cigarettes | Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples. | 45 participants |
| VR - Balls (Control) | Self-report Measure of Abstinence in the Last 7 Days, Averaged Over Four Weeks, and Confirmed by Urine Samples. | 46 participants |
Secondary
Tiffany's Urge to Smoke Questionnaire
Time frame: Weeks 1, 4, 6, 12, 24 and 12-month follow-up