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Table 4 Summary of the main changes to the intervention following facilitator and participant feedback

From: Development of an education and self-management intervention for chronic headache – CHESS trial (Chronic Headache Education and Self-management Study)

Collated feedback summary Changes to the intervention
Facilitators for the main randomised controlled trial During the feasibility phase it had been difficult for the lay facilitators to commit to running groups due to their own chronic headaches. This was collaboratively discussed and there was agreement to use an AHP who is registered with an appropriate regulatory body rather than a lay facilitator for the main RCT.
Length of the course The original 2.5 days was challenging for participants due to work and family commitments. For this reason the half day follow-up was removed. We felt confident that any issues could be raised during the one to one session and subsequent telephone follow-up. The content due to be covered on the follow-up day was merged into day two of the course. This was possible as other topics had been removed and/or revised. The fourth group was run using this two day format.
Timing of the sessions Originally we had planned to run the two days consecutively, with the follow-up day approximately two weeks later. Two groups were run using this format but participants struggled with some experiencing headaches. The third group was run using a weekly format with one day delivered each week with the follow-up day two weeks after the second group session. In between the second full day and follow-up session, participants had their one to one consultation with the nurse.
Merging of topics related to unhelpful thinking patterns and reframing negative thoughts to positive thoughts Facilitators found these session difficult to facilitate as they felt disjointed. By merging the sessions it allowed more clarity on the importance of recognising unhelpful thought patterns and subsequently using questions to challenge them and look for more helpful alternatives.
Merging physical activity as a topic into lifestyle factors Physical activity was included as a separate topic, however it fitted better under the theme of lifestyle factors therefore this topic was integrated into this section.
Removal of session on emerging and complementary treatments The nurses felt this session was difficult to deliver because of the level of knowledge required and the questions presented to them. For this reason, as well as our understanding that most of these treatments would not be readily available on the NHS we decided to remove this session. We provided participants with a handout detailing the websites of some of the leading headache charities where they could find more information on treatments.
Addition of summary and reminders at the end of day 1 An overall summary table of the content covered was added to allow participants to reflect on the material covered and understand the links between the sessions. We also include some reminders to ensure participants continued to complete the headache diary, watched the DVD and practiced the relaxation where possible.
Changes to some of the session and module names This was done to improve clarity.
Mindfulness session This session was broadened to mindfulness and relaxation to give participants the opportunity to understand the differences between the two and have the opportunity to practice these at home.
CHESS intervention training The training for facilitators in the feasibility phase was delivered over two full consecutive days. The training was delivered by two psychologists, a general practitioner, a neurologist and a nurse by background. From the feedback we found many of the facilitators struggled with the amount of information covered and that they would have liked sometime between the two training sessions. Taking into consideration the feedback, we revised the training for the RCT, it is now delivered over three days, with the first two days as consecutive days covering the group educational and self-management components. This is then followed by a third day, a week later, to cover the training for the one to one session and follow-up phone calls.
Further one to one support was provided to each nurse ahead of their first one to one sessions to recap on the logic model and medication advice.
In addition, all facilitators are supported individually as and when required by the intervention design team.