Pilot Trial of Mindfulness-Integrated Cognitive Behavioural Therapy for Adults with Attention-Deficit Hyperactivity Disorder and Depression and/or Anxiety

Name / Overview. This study aims to measure feasibility, acceptability, and potential efficacy for mindfulness-integrated cognitive behavioural therapy (MiCBT) for treating symptoms of depression, anxiety, emotion dysregulation, and ADHD behavioural symptoms in adults with diagnosed ADHD. MiCBT is a transdiagnostic therapy which blends meditation-based mindfulness training with elements of cognitive behavioural therapy. More information on this therapy can be found at mindfulness.net.au or through the Treatment Manual (Cayman et al., 2018). What. This trial will offer a slightly modified version of the traditional MiCBT therapy, using the same materials as published in the treatment manual (Cayoun et al., 2018). In discussion with the founder of the therapy, Dr. Bruno Cayoun, we have received permission modify delivery for adults with ADHD in these ways: 1) we are extending the duration from 10 weeks to 12, so that we can move slower at times if needed and offer more support; 2) we will offer 1:1 support via phone consultation mid-way though delivery to add further support; 3) we will allow the daily meditation durations to be slightly less (e.g., when a guided meditation runs for 13 minutes and asks participants to continue on in silence, these participants will be told that any additional un-guided time is entirely optional). The therapy consists of at-home meditations with audio guides to be practised twice daily as far as possible. It also includes weekly group sessions held face-to-face to help introduce, practise, support, and troubleshoot the meditation practice, as well as to introduce and support participants through integrated components from cognitive behavioural therapy. Sessions will generally follow this agenda: 1) to review the previous week's meditation practice, sharing experiences and responding to questions or concerns that arise; 2) introducing the next week's theoretical component (e.g., what is mindfulness) and the rationale for the next meditation practice; 3) guiding participants through the new meditation practice; 4) addressing any questions / concerns and supporting them to be able to follow that week's meditation practice. In the first week, participants use progressive muscle relaxation as a way to relax their bodies and experiment with how to make time for meditation, so that by week 2, when the begin mindfulness meditations, they feel more confident about their habits. Meditations then progress with: Week 2, mindfulness of breath; Week 3, introduction to body scanning; Week 4, body scanning with objective descriptions of sensations; Week 5, symmetrical scanning; Week 6, additional practice of symmetrical scanning and individual support offered; Week 7, partial sweeping; Week 8, sweeping en mass; Week 9, transversal scanning; Week 10, additional practice of transversal scanning; Week 11, sweeping in depth; Week 12, loving kindness. Who. All therapy sessions, individual consultation, and administration of measures will be conducted by Denise Goggin, a registered clinical psychologist registrar with training and professional experience delivering a range of therapies including CBT and MiCBT, as well as experiencing delivering therapy and assessments to adults with ADHD, depression, and anxiety. All treatment delivery and assessment administration will be performed with appropriate supervision in place for any incident to review and suggest procedures. A supervisory group will meet monthly throughout the trial, and within 24-48 hours of any incident to review and suggest procedures to ensure safety and well-being of all participants. How and Where. Delivery of the 12 group sessions will be done weekly and face-to-face, with a duration of 2.5 hours per session. Materials for the therapy will be provided as printed handouts, as well as through free access to the MiCBT app. The researchers will have no ability to access any participant data on the app. The use of this tool is to also provide the materials, including the audio guides for meditations, in one place for ease of use and engagement. All administration of assessments will be done through a trained clinician with appropriate instructions. This may be the treating clinician, though will be a registered and trained psychologist who is not the treating clinician for the post-treatment qualitative interview so as to avoid biased responses. When and How Much. There will be 12 consecutive weeks of therapy provided. Each week will have 1 face-to-face session lasting 2.5 hours, including short breaks. Participants are asked to practice guided meditations twice per day with each meditation lasting around 20 minutes. Participants will be asked to return for follow-up assessments three months following treatment. This means the trial will last 6 months (3 months therapy and 3 months for the follow-up assessment). Tailoring. This treatment is not going to be personalised as it aims to measure feasibility, acceptability, and potential efficacy for the treatment as adapted for use with an adult ADHD population. Modifications. All materials will be from the traditional MiCBT treatment manual, including all handouts and audio guides. However, the traditional MiCBT program has been adapted for this delivery by extending the number of weeks, offering 1:1 support mid-way through delivery , and allowing for some meditation times to be reduced. How Well. Adherence to group sessions will be tracked by recording attendance. Adherence to daily meditation practice will be tracked through written practice logs recorded by the participants. For those participants using the MiCBT app, their practice will be automatically tracked by the app, and they will be asked to transfer this to a written record for the researchers. For those who choose not to use the app, but the emailed link to the audio guide, they will record their meditations on the written log on a daily basis. Meditation logs will track frequency, duration, and perceived engagement with the meditation for each practice. Participants who do not attend a group session or stop practising meditations at home will be consulted about their desire to continue and offered support if they would like to re-engage. Participants are informed at the start through both verbal and written form that they are free to stop at any time, without consequence, and without needing to provide a reason. They are also informed that if they stop meditations, they will be considered as having dropped out from the trial, though they can continue to attend the sessions if beneficial. Any participants who develop physical or mental health concerns that make participation in the group unrealistic will be counselled by the treating clinician, including a throrough risk assessment with relevant supports and referrals provided.