|• Theory based intervention with treatment dose (i.e. number, frequency and duration of sessions) specified in the protocol.|
• Protocol deviations recorded.
• Risks to implementation were mitigated by: 1) piloting the programme in one Trust prior to the RCT; 2) setting a minimum for the number (n = 4) of facilitators per Trust; and, 3) the tracking of trained staff availability and attrition.
|• Written materials and facilitator training were standardised across providers; and, intended delivery style was modelled by expert trainers.|
• Facilitators used role play to test skills and, reflected on their own performance and skill acquisition and made changes (as required).
• Optimum skillset for the role (including one of two having clinical skills) defined for providers.
• Level of education and experience of physical and/or mental health and group work captured.
• Peer support available during delivery.
|• Service user feedback after sessions, semi-structured interview (after foundation course) and facilitator observations informed on the credibility of facilitators, non-specific treatment effects and differences across providers.|
• Training materials, including resource lists, supported standardisation across providers.
• Adherence was monitored via recording attendance, facilitator self-reflection and direct observation of content and delivery; local coordination and monitoring by providers; and, facilitator and service user interviews.
• Contamination (of trial arms) was minimised by standardised study design training and on the ground instructions, regular supervision and on-site and remote monitoring.
|• Service users invited to participate in sessions (e.g. discuss answers to questions with others); and, facilitators used scripted summaries to aid understanding and check comprehension.|
• To ensure ability to use cognitive skills (e.g. goal setting and monitoring progress) and perform behaviour skills (e.g. identify and manage triggers), sessions encouraged identification of (and ways to overcome) obstacles; and, per-session (and overall) feedback was invited. Self-monitoring was encouraged and 1:1 support was provided by facilitators.
|• Interviews invited feedback on the purpose of the intervention and experiences (skills, behaviours, goals); and explored learning and use (or not) of skills by service users and facilitators (self-report).|
• Adherence (frequency and duration) of sessions delivered was monitored.
• Booster and telephone support maintained for 12 months.
|Fidelity goals not monitored (or applicable)|
|• Equivalent dose is not applicable as there was no active control.||• No strategies were employed to minimise “drift” in facilitator skills as no benchmark had been established.|