Smoking Cessation Clinical Trial
Official title:
A Randomized Controlled Trial of Smoking Interventions in Women
NCT number | NCT03749382 |
Other study ID # | 0245 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 10, 2019 |
Est. completion date | August 20, 2020 |
Verified date | September 2020 |
Source | Manchester Metropolitan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a randomised controlled trial (RCT) designed to test two tailored conditions of
an appearance-based intervention for smoking in female smokers, compared to a control group
administered a general stop smoking intervention.
The intervention delivery is being tested to assess whether the level of physiological
arousal evoked by the intervention and the instruction type has an influence on the outcome
measures. To do this one condition will receive the intervention with a neutral instruction
and the other the intervention with additional instructions, measures of physiological stress
reactivity will be used to measure level of stress evoked by the intervention and delivery.
Status | Completed |
Enrollment | 70 |
Est. completion date | August 20, 2020 |
Est. primary completion date | August 20, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Female - Aged 18-55 - Smoke at least 1 cigarette a week Exclusion Criteria: - Non-smokers - Self-reported appearance related mental health issue |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Brooks Building | Manchester |
Lead Sponsor | Collaborator |
---|---|
Manchester Metropolitan University |
United Kingdom,
Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. Review. — View Citation
Borrelli B, Mermelstein R. The role of weight concern and self-efficacy in smoking cessation and weight gain among smokers in a clinic-based cessation program. Addict Behav. 1998 Sep-Oct;23(5):609-22. — View Citation
Cash, T. F. (2016) 'Multidimensional Body-Self Relations Questionnaire (MBSRQ).' In Wade, T. (ed.) Encyclopedia of Feeding and Eating Disorders. Singapore: Springer Singapore, pp. 1-4.
DiClemente CC, Prochaska JO, Fairhurst SK, Velicer WF, Velasquez MM, Rossi JS. The process of smoking cessation: an analysis of precontemplation, contemplation, and preparation stages of change. J Consult Clin Psychol. 1991 Apr;59(2):295-304. — View Citation
Flett K, Clark-Carter D, Grogan S, Davey R. How effective are physical appearance interventions in changing smoking perceptions, attitudes and behaviours? A systematic review. Tob Control. 2013 Mar;22(2):74-9. doi: 10.1136/tobaccocontrol-2011-050236. Epub 2012 May 9. Review. — View Citation
Flett K, Grogan S, Clark-Carter D, Gough B, Conner M. Male smokers' experiences of an appearance-focused facial-ageing intervention. J Health Psychol. 2017 Mar;22(4):422-433. doi: 10.1177/1359105315603477. Epub 2016 Jul 10. — View Citation
Grogan S, Flett K, Clark-Carter D, Conner M, Davey R, Richardson D, Rajaratnam G. A randomized controlled trial of an appearance-related smoking intervention. Health Psychol. 2011 Nov;30(6):805-9. doi: 10.1037/a0024745. Epub 2011 Jul 18. — View Citation
Grogan S, Flett K, Clark-Carter D, Gough B, Davey R, Richardson D, Rajaratnam G. Women smokers' experiences of an age-appearance anti-smoking intervention: a qualitative study. Br J Health Psychol. 2011 Nov;16(4):675-89. doi: 10.1348/2044-8287.002006. Epub 2010 Dec 6. — View Citation
Gupta SK. Intention-to-treat concept: A review. Perspect Clin Res. 2011 Jul;2(3):109-12. doi: 10.4103/2229-3485.83221. — View Citation
Koh JS, Kang H, Choi SW, Kim HO. Cigarette smoking associated with premature facial wrinkling: image analysis of facial skin replicas. Int J Dermatol. 2002 Jan;41(1):21-7. — View Citation
Strathman, A., Gleicher, F., Boninger, D. S. and Edwards, C. S. (1994) 'The consideration of future consequences: Weighing immediate and distant outcomes of behavior.' Journal of Personality and Social Psychology, 66(4) pp. 742-752.
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Smoking Intentions | Smoking Intentions, which are intentions the participant has to quit smoking are measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Three items are each asked on a 13-point scale producing a combined score between 0-39. The score from each individual item is then averaged together to create a total score for smoking intentions. The higher the averaged score the more intention the participant has to quit smoking.The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011). | Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention. | |
Secondary | Change in Smoking Attitudes | Smoking Attitudes, is the attitude a participant has to smoking cessation, measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Four items are each asked on a 13-point scale producing a score between 0-52. Scores from individual items are then averaged together to create a total score for Smoking Attitudes. The higher the averaged score the more positive the participants attitude is to smoking cessation. The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011). | Measures obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention. | |
Secondary | Change in Smoking Subjective Norms | Smoking Subjective Norms, is the perceived social pressure the participant feels to stop smoking, measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Three items are each asked on a 13-point scale producing a combined score between 0-39. Scores from each individual item is then averaged together to create a total score for Smoking Subjective Norms. The higher the averaged score the more the participants feels it socially acceptable to quit smoking .The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011). | Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention. | |
Secondary | Change in Smoking Perceived Behavioural Control | Smoking Subjective Perceived Behavioural Control, is the Perceived Control the participant has over their own smoking behaviour, measured via self-report as part of the Smoking Questionnaire (Grogan et al., 2011) based on the theory of planned behaviour construct (Ajzen, 1991). Four items are each asked on a 13-point scale producing a combined score between 0-52. Scores from each individual item is then averaged together to create a total score for Smoking Perceived Behavioural Control. The higher the averaged score the more control a participants feels they have over their own smoking behaviour. The scale has previously been used in similar appearance-based interventions for smoking research (Grogan et al., 2011). | Measure obtained pre-intervention, immediately after the intervention and again at 1, 3 and 6 months post-intervention. | |
Secondary | Change in Nicotine dependence | Nicotine dependence as measured by the Fagerstrom test for nicotine dependence (Heatherton et al.,1991) a validated instrument that determines the extent to which participants are physically addicted to nicotine. The measure includes six items that are summed to create a score between 0-10. Higher scores equate to a higher dependence to nicotine. | Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention. | |
Secondary | Change in Self-reported smoking behaviour | Participants report the amount of cigarettes smoked each day for the week prior to each measurement time point, the cigarettes consumed on each day are summed to create a total cigarette consumption score for the week. The measure is administered to the participant as part of the Smoking Questionnaire (Grogan et al., 2011). | Measure obtained pre-intervention and again at 1, 3 and 6 months post-intervention. |
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