Testing Smoking Interventions in Women
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): AprilAge- facial morphing appearance based intervention for smoking
Intervention type(s): Other
Intervention description(s): Appearance-based intervention: The intervention is a software that ages an individual's face with and without the effects of smoking. Participants have their photo taken on a laptop webcam, they are then asked to report their age and ethnicity in order to calibrate the software, the participants picture is then matched to a stock image. The participants will see two images on the screen, on the left is there face aged without the effects of smoking and one the right aged with the effects of smoking. Participants will be led through a series of morphing sequences (1-5). In-between each of the morphing sequences (Morph1 to Morph5) the participant will be asked to comment on the differences they can see between the two images.
General stop smoking intervention: The General stop smoking intervention comes in the form of a NHS stop smoking information leaflet. The participants will be given the leaflet on a laptop screen and asked to read through the whole document.
Other intervention name(s): Appearance-based intervention; Appearance orientated intervention; Internet-based Photo aging intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Smoking; Tobacco; Cessation; Intervention