Clinical trial NCT04985838: Helping Ease Anxiety and Depression Following Stroke Stage 3
Official title: HEADS: UP (Helping Ease Anxiety and Depression Following Stroke) Psychological Self-management Intervention: a Randomised Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cerebrovascular Accident Due to Cerebral Artery Occlusion
Anxiety
Depression
Keywords: Stroke
CVA
Anxiety
Depression
Mindfulness
MBSR
Online
Self-management
Mixed methods
Lead sponsor: Glasgow Caledonian University
Sponsor class: OTHER
Collaborators: name: Edinburgh Napier University
name: University of Manchester
name: University of Stirling
name: University of Strathclyde
name: Leeds Beckett University
name: University of Nottingham
First posted: 2021-08-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A mixed methods randomised controlled pilot trial
Primary purpose: TREATMENT

Brief summary: A mixed methods randomised controlled pilot trial, conducted in miniature of future definitive trial, in which the investigators will test optimised intervention and study processes. The investigators will individually randomise stroke survivor participants in a 1:1 allocation to: HEADS: UP or Control.

Detailed description: AIM To test full-study procedures and determine whether to proceed to a future definitive trial.

Objectives

1. Test full-study procedures, including measurement logistics, randomisation, and check the direction of effect is in the expected direction.
2. Identify potential resource (cost) implications of delivering HEADS: UP and potential impact on NHS utilisation.
3. Determine whether to proceed to a future Phase III definitive trial.

METHODS

SETTING: HEADS: UP will be delivered online, via Zoom or MS Teams according to Trainer preference.

MBSR TRAINERS: Experienced MBSR trainers (n=1-4) will deliver HEADS: UP Online. They will meet the criteria for Mindfulness-Based Teachers and Good Practice Guidelines for Mindfulness-Based Supervisors of MBI Teachers. In addition, all trainers will undertake the HEADS: UP Train the Trainer training (6 hours across 2 sessions) prior to delivering HEADS: UP. The investigators will deliver the training to inform the MBI teachers about the HEADS: UP adaptations and online research processes, with input from an experienced MBSR/HEADS: UP trainer and a member of the Project Advisory group with first-hand experience of stroke. The investigators will encourage fidelity with the HEADS: UP manual and provide a logbook (paper or electronic according to preference) for recording any divergence, along with reasons.

RECRUITMENT METHODS: The investigators will use a UK-focused community-based recruitment strategy comprising social media (e.g. Twitter, Facebook, Instagram) and third sector organisations e.g. Stroke Association, DifferentStrokes, to recruit community-dwelling stroke survivors. When recruiting through third sector organisations the investigators will send gatekeepers project information leaflets (PILs); and consent forms for distribution to relevant (e)mail distribution lists. When recruiting online the investigators will email/post PILs and consent forms in response to expressions of interest. The investigators will document each expression of interest using a first contact form and assign a potential participant ID. Details collected at this stage include contact details for arranging screening, how the potential participant found out about the study for recruitment analysis, and whether they have previously received any information about HEADS: UP. If the potential participant has not previously received information, the investigators will post or email copies of the information and consent forms according to the potential participant's preference.

SAMPLE SIZE: Typically, MBSR is delivered to groups, 15-20 participants. To promote adherence, the investigators will deliver HEADS: UP to dyads (stroke survivor plus 'family/peer'), where possible. As attrition has been estimated in a previous stage testing MBSR at approximately 23%-44% (depending on mode of delivery), the investigators will aim to enrol at least n=90 stroke survivor participants to 6 groups i.e. 15 stroke survivors (who may/may not be partnered by a family member) per group, in 2 'waves' i.e. 2 groups recruited by September 2021 (n= 30 stroke survivor participants); 4 groups recruited by the mid January 2022 (n= 60 stroke survivor participants). Allowing for attrition of 23%-44%, this will leave between 8-12 stroke survivor participants per group (i.e. n=50-69) by the end of the study. This fulfils the recommended minimum number of n=50 participants for feasibility study sample size. Note: if participant numbers are too much for the small research team to manage within the time available, the investigators will stop recruitment after four groups i.e. recruitment n=60, with an estimated n=40 left in the study at the end. This reduced number is still in keeping with NIHR Research Design Service recommendations.

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years
* Have had ≥1 stroke at least 3 months previously
* Able to speak and understand conversational English DESIRABLE BUT NOT ESSENTIAL: Able to identify a family member\* who would: like to take part and can speak and understand conversational English.

  * Family member: we use an inclusive definition of 'family': 'a self-identified group of two or more individuals who consider themselves as 'family' e.g. spouse, parent, friend. When we refer to 'family' in this document our meaning extends beyond 'family', to friends, peers and volunteers/buddies.

Exclusion Criteria:

* Prior MBSR attendance in the last three years (as this may confound results)
* Current participant in another trial of a similar psychological self-management intervention
* Currently receiving treatment for PTSD (post traumatic stress disorder) or psychosis
* Disclosing suicidal ideation
* Cannot follow a 2-stage command e.g. Please spell your surname and then tell me the days of the week; Please count to six and then spell your first name.
* Scores \<3 on the PHQ-4

Primary outcomes:
measure: Beck Depression Inventory II (change being assessed)
timeFrame: Weeks 0, 8, 20, 32 (assessing change)
measure: Beck Anxiety Inventory (change being assessed)
timeFrame: Weeks 0, 8, 20, 32 (assessing change)
measure: Depression Anxiety Stress Scales (change being assessed)
timeFrame: Weeks 0, 8, 20, 32 (assessing change)
Secondary outcomes:
measure: Short Form Stroke Impact Scale (change being assessed)
timeFrame: Weeks 0, 8, 20, 32 (assessing change)
measure: EQ-5D 5L (change being assessed)
timeFrame: Weeks 0, 8, 20, 32 (assessing change)
Other outcomes:
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: PRINCIPAL_INVESTIGATOR
References: