HEADS: UP (Helping Ease Anxiety and Depression following Stroke) psychological self-management intervention: non-randomised pilot study followed by a randomised cluster pilot trial.
  The aim of this mixed methods research is to conduct feasibility pilot testing of a
tailored adaptation of an existing psychological intervention to help people affected by
stroke self-manage symptoms of anxiety and depression prior to Phase III testing in
future work.
STAGE 1: NON-RANDOMISED PILOT STUDY (MONTHS 1-12; ONE SITE):
1: Assess feasibility and acceptability of delivering HEADS: UP, recruitment and questionnaire data collection processes; identify any additional HEADS: UP adaptions.
STAGE 2: RANDOMISED CLUSTER PILOT TRIAL (MONTHS 13-36; 2 SITES)
We will randomise participant dyads to immediate participation in HEADS: UP or to
waitlist control.
2: Test full-study procedures, including measurement logistics, randomisation, and
check the direction of effect is in the expected direction.
3: Identify potential resource (cost) implications of delivering HEADS: UP and potential
impact on NHS utilisation. This will include devising and testing measurement
tools/approaches for use in a future large-scale trial.
4: Determine whether to proceed to a future Phase III definitive trial.

  • Start Date:

    1 June 2019

  • End Date:

    30 January 2023

  • Activity Type:

    Externally Funded Research

  • Funder:

    Stroke Association

  • Value:

    £5181

Project Team