Clinical trial NCT03956693: Helping Ease Anxiety and Depression Following Stroke
Official title: HEADS: UP (Helping Ease Anxiety and Depression Following Stroke) Psychological Self-management Intervention: Non-randomised Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
CVA (Cerebrovascular Accident)
Anxiety
Depression
Keywords: Stroke
CVA (cardiovascular accident)
Anxiety
Depression
Mindfulness
Mindfulness Based Stress Reduction
Self-management
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: University of Stirling
name: Edinburgh Napier University
name: The Stroke Association, United Kingdom
name: Yunus Centre for Social Business and Health
name: University of Strathclyde
name: University of Manchester
First posted: 2019-05-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: OTHER

Brief summary: The aim of this mixed methods research is to conduct feasibility pilot testing of an existing mindfulness intervention called HEADS: UP. The intervention is designed to help people affected by stroke self-manage symptoms of anxiety and depression.

Detailed description: Mindfulness-based interventions are thought to help people affected by stroke (Lawrence et al., 2013). Helping Ease Anxiety and Depression (HEADS: UP) is an adapted mindfulness-based intervention for people affected by stroke (Lawrence, 2019). This study aligns with the feasibility/piloting stage of the Medical Research Council framework (Craig et al., 2008) and will optimise intervention delivery and study processes, ensuring all elements are working together, ready for testing at a later stage.

The aim of this mixed methods research is to conduct feasibility pilot testing of HEADS: UP to help people affected by stroke self-manage symptoms of anxiety and depression prior to Phase III testing in future work.

This stage is a non-randomised pilot study based in Glasgow, United Kingdom. The purpose of the pilot is to assess feasibility and acceptability of delivering HEADS: UP, and recruitment and questionnaire data collection processes; identify any additional HEADS: UP adaptions.

Eligibility criteria: Inclusion Criteria:

* Have had ≥1 stroke 3-60 months previously (reflects incidence of anxiety/depression)
* Interested in learning skills to help them cope with self-reported anxiety and/or depression
* Able to speak and understand conversational English
* Able to identify a family member/peer who would: like to take part, can speak and understand conversational English; not participating in another trial.

Exclusion Criteria:

* Prior MBSR attendance in the last three years (as this may confound results)
* Current participant in another trial
* Cannot follow a 2-stage command
* ≥28 on Behavioural Assessment of Dysexecutive Syndrome (BADS) scale; assesses the cognitive skills required to engage with group-based interventions (goo.gl/uumeFw)
* Hospital Anxiety and Depression Scale (HADS); screens for anxiety and depression; used extensively in Primary Care research (goo.gl/TtdDDW). A score of 8-10 suggests mood disorder; ≥11 indicates 'probable presence'. A total cut-off score of 11 achieves optimal balance between sensitivity and specificity, and will be used for family/peer participants who have not had a stroke. A lower cut-off score is recommended for stroke survivors i.e. 4 on each sub-scale.

NOTE: A current prescription for anxiolytics or antidepressants is not an exclusion criterion. If screening identifies a potential participant who requires GP referral, that individual may subsequently be prescribed medication; this is a feature of the pilot work. In a future trial, where participants are randomised to two arms and there is equal probability of people being on medication in each arm, it will not be an issue.

Primary outcomes:
measure: Stroke Specific Quality of Life Scale (SS-QOL): change is being assessed
timeFrame: Weeks 0, 9, 21
measure: Stroke Impact Scale (SIS): change is being assessed
timeFrame: Weeks 0, 9, 21
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS): change is being assessed
timeFrame: Weeks 0, 9, 21
measure: Depression Anxiety Stress Scale (DASS): change is being assessed
timeFrame: Weeks 0, 9, 21
measure: Beck Depression Inventory II (BDI-II): change is being assessed
timeFrame: Weeks 0, 9, 21
measure: Beck Anxiety Inventory (BAI): change is being assessed
timeFrame: Weeks 0, 9 21
measure: EQ-5D 5L: change is being assessed
timeFrame: Weeks 0, 9, 21
Other outcomes:
measure: Carer Strain Index (CSI): change is being assessed
timeFrame: Weeks 0, 9, 21
measure: Focus Groups (FG): change is being assessed
timeFrame: Weeks 9, 21
Locations:
city: Glasgow
country: United Kingdom
facility: Glasgow Caledonian University
state: Glasgow (City Of)
Study officials:
affiliation: Glasgow Caledonian University
name: Maggie Lawrence, PhD
role: STUDY_DIRECTOR
References:
citation: Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
citation: Lawrence, M. (2019) Helping Ease Anxiety and Depression After Stroke (HEADS: UP): Research Project Briefing from the Chief Scientific Office. Available at: www.cso.scot.nhs.uk (Accessed: 7 May 2019).
citation: Lawrence M, Booth J, Mercer S, Crawford E. A systematic review of the benefits of mindfulness-based interventions following transient ischemic attack and stroke. Int J Stroke. 2013 Aug;8(6):465-74. doi: 10.1111/ijs.12135.