A Virtual Arm to Stop Smoking

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephane Bouchard, Universite du Quebec en Outaouais
ClinicalTrials.gov Identifier:
NCT00639093
First received: March 12, 2008
Last updated: June 25, 2012
Last verified: June 2012
  Purpose

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 Intervention
Cigarette Smoking
Behavioral: psychoeducational / motivational combined with crushing
Behavioral: psychoeducational / motivational combined with control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Virtual Arm to Stop Smoking. A Comparative Study

Resource links provided by NLM:


Further study details as provided by Universite du Quebec en Outaouais:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • Tiffany's Urge to Smoke Questionnaire [ Time Frame: Weeks 1, 4, 6, 12, 24 and 12-month follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 91
Study Start Date: March 2008
Study Completion Date: June 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639093

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:
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephane Bouchard, Professor, Universite du Quebec en Outaouais
ClinicalTrials.gov Identifier: NCT00639093     History of Changes
Other Study ID Numbers: GRAP-CRC-cyberpsychologie
Study First Received: March 12, 2008
Results First Received: July 30, 2009
Last Updated: June 25, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Universite du Quebec en Outaouais:
cigarette smoking
psychoeducational and motivational program
virtual reality

ClinicalTrials.gov processed this record on August 19, 2014