Smoking Cessation Clinical Trial
Official title:
A Randomized Controlled Trial of Smoking Interventions in Women
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.
Background
Despite health-related smoking cessation campaigns, still one in five of adults in the UK
smokes and it is estimated that half of all regular smokers will eventually die from
smoking-related diseases. Innovative smoking cessation campaigns are needed to reach the
remaining smoker population and prevent smoking-related diseases.
Smoking interventions have previously focused on smoking impact on health. However, besides
health-related diseases, smoking causes aging effects to the skin and recent research
suggests that smoking interventions based on threats to appearance may be more effective.
Further research using an age-appearance facial morphing intervention for smoking, which
shows women realistic images of the effects of smoking on their own face, research found that
female smokers aged 18-34 reported increased motivation to quit after the intervention.
Quantitative results from a randomised control trial support the interventions effectiveness
.
The previous research on appearance-based interventions for smoking show promising results
however these studies had report small sample sizes and differences in the age range of
participants. Additionally, previous research has focused on the primary outcome measures of
smoking including smoking cognitions, behaviours and CO readings and have not investigated
further moderating variables such as, anxiety, depression, appearance orientation and stage
of change.
In previous research participants have consistently reported a 'shock' reaction, and findings
from a pilot and feasibility study (unpublished) suggest that this 'shock' reaction as
measured by physiological reactivity to the intervention could mediate smoking outcomes.
Therefore, the present research proposes to assess facial morphing intervention effectiveness
in relation to individual's physiological shock reactions to viewing the morphed images and
moderator variables in a large sample of women across a broad age range.
Objectives:
Primary Objectives- To assess effectiveness of an appearance-based intervention on smoking
outcomes in a female population (18-55 years old) immediately after the intervention session
and at 1, 3 and 6 months post intervention session. In addition to compare the results to
that of a standard stop smoking intervention.
An additional primary objective will be to compare the primary outcome measures for both
appearance-based intervention instruction conditions (neutral vs additional) immediately
after the intervention and at 1, 3 and 6 months after to assess which instruction type is
more effective in reducing smoking behaviour.
Other objectives-
1. Investigate the mediating effects of physiological arousal [measured during the
intervention by electro dermal activity and beats per a minute (BPM, derived from pulse
rate)] on the intervention efficacy as measured by the primary and secondary outcome
measures.
2. Investigate the impact of moderating variables on the primary outcome measures.
Measures
Outcome measures -
1. The primary outcomes will be smoking intentions measured pre, immediately after and at
1, 3 and 6 months post intervention.
2. Secondary outcome measures will be smoking cognitions (attitudes, subjective norms and
perceived behavioural control), nicotine dependence and self-reported smoking behaviour
measured pre, immediately after and at 1, 3 and 6 month post the intervention.
Participants:
Current female smokers aged 18-55 will be recruited and randomised into one of three
conditions. (1) Appearance-based intervention neutral, (2) Appearance-based intervention
additional instructions, (3) Control general stop smoking intervention. Participants are
eligible to take part if they are a female between the ages of 18-55 and that they smoke at
least one cigarette a week. Participants are informed to withhold from taking part if they
have any mental health issues that may be affected by appearance-based imagery.
Randomisation will be achieved through using SPSS (V25) to create two sets of randomisation
one for participants over the age of 35 and another for women under the age 35 to allow an
equal distribution of ages into each condition.
Protocol:
At the start of the intervention session participants will be asked to provide informed
consent, immediately after electrodes and a light sensor will be placed on the participants
non-dominant hand. Participants are then asked to fill in a self-report questionnaire
including demographic questions and stress confounders, smoking behaviour, cognitions and
quit attempts, levels of anxiety and depression, how much they consider their future
consequences and how they view their appearance.
Participants in the two appearance-based interventions groups will then have a photo taken of
their face and aged with the effects of smoking in a range of morphing sequences and then
given a general stop smoking booklet alternatively participants allocated to the control
condition will be asked to only read a general stop smoking intervention booklet. All three
conditions will then be asked to provide carbon monoxide breath reading using a hand held
battery operated device. The participants smoking cognitions and behaviours will then be
measured again immediately and longer term at 1, 3 and 6 months post intervention.
Sample size calculation:
In a previous randomized controlled trial (RCT) on an appearance-based intervention for
female smokers , 35 women were allocated to one of two conditions (control group or
intervention) with a reported effect size of d=.63 for nicotine dependence at 4 weeks
post-intervention. Based on previous research and to account for a 30% dropout at six-month
follow up 50 participants per group is required in the current study. Additionally, an a
priori power analysis has been conducted using GPower which supports the specified number of
participants per group. Specifically, to obtain a medium effect of .25 and a power of .80 at
alpha .05, a total sample of 158 is required (52 per group).
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