A RCT of a digital CBT app for smoking cessation v1

  • Research type

    Research Study

  • Full title

    Randomised controlled trial assessing efficacy of a novel cognitive behavioral therapy app for smoking cessation

  • IRAS ID

    252163

  • Contact name

    Yusuf Sherwani

  • Contact email

    yusuf@digithera.ai

  • Sponsor organisation

    Digital Therapeutics Inc.

  • ISRCTN Number

    ISRCTN00000000

  • Duration of Study in the UK

    1 years, 9 months, 1 days

  • Research summary

    Summary of Research
    Smoking continues to be the largest cause of preventable death and disease across the world. Therefore, providing effective treatment to help smokers quit is a major albeit elusive public health goal. The most effective way to help people quit smoking is using medications (i.e. nicotine replacement therapy, NRT) together with high intensity behavioural support. However, behavioural therapy offered on the NHS is low intensity, and is only being accessed by 5.9% of smokers looking to quit.

    In this study we will test a mobile app that delivers high intensity behavioural support to smokers looking to quit. The form of therapy delivered is cognitive behavioural therapy (CBT), which works by changing the way one thinks, and therefore, how one behaves, in challenging situations. More than 500,000 users have already downloaded the app over the past year, and we have published three pilot studies using results from this programme (PMID: 29907557, 29669708, 27777216). However, its efficacy has thus far not been tested in a randomised controlled trial.

    The aim of this study is to investigate the efficacy of this novel digital CBT mobile app in helping individuals to quit smoking, compared to a control group receiving “very brief advice” (https://www.nice.org.uk/guidance/ng92/chapter/recommendations#very-brief-advice). Eligible participants will attend an initial meeting for consent and baseline questionnaires. They then receive the intervention and are monitored for smoking status and secondary outcomes at 4 weeks, 26 weeks, and 52 weeks after their quit date. Each participant will also be offered free NRT.

    Summary of Results
    The hypothesis that the treatment (Quit Genius) condition would yield higher rates of self-reported 7-day abstinence across the 52-week post-quit period, compared to the control condition was partially supported.

    Those in the treatment arm were 55% more likely to self-report seven-day abstinence at 4-weeks post- quit date compared to those in the control group. The treatment condition had a 44.5% quit rate vs 28.3% in the control condition.

    The treatment condition also produced significantly higher self-reported 7-day PPA rates at week 26, relative to the control group (p<0.01), though this effect did not hold at 52 weeks (p>0.05).

  • REC name

    HSC REC A

  • REC reference

    18/NI/0171

  • Date of REC Opinion

    11 Sep 2018

  • REC opinion

    Favourable Opinion