However, to date there have been no large RCTs of the
classes and NICE has identified a need for such studies
with a health economic component to be completed. We
have, therefore, recently undertaken a pilot RCT using the
same design as the current application. This has allowed us
to test and be confident of our recruitment process, establish
power and test the delivery of the intervention
and research. In a previous pilot in Glasgow and Northern
Ireland (with course delivery by the charities AOD and
AWARE), we successfully screened and randomized 53
participants using the same planned recruitment strategy.
Mean differences at the primary follow-up point (3 months)
have informed our power calculation (see below).
We have therefore successfully tested recruitment, questionnaire
delivery and data collection, randomization and
delivery of the face-to-face classes in the community. This
substantive RCT differs in so far as it has been modified to
include a 6 month rather than 12 week primary endpoint
and is powered to definitively answer the question of
whether the LLTTF course is an effective treatment for
low mood. The 6 month primary follow-up point will allow
a longer-term impact of the intervention to be assessed and
groups can be compared at this time point whilst the
delayed access control (DAC) remain a control group. As
this is a long-term follow-up point, participants may seek
additional support prior to follow-up; data on services
accessed during the study will be collected at 6 months
using the Client Service Receipt Inventory (CSRI).