NCT04985838

Helping Ease Anxiety and Depression Following Stroke Stage 3

HEADS: UP (Helping Ease Anxiety and Depression Following Stroke) Psychological Self-management Intervention: a Randomised Controlled Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Glasgow Caledonian University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Cerebrovascular Accident Due to Cerebral Artery Occlusion
• Anxiety
• Depression

Interventions

Type	Name	Description
BEHAVIORAL	HEADS: UP (Helping Ease Anxiety and Depression)	A group-based Mindfulness Based Stress Reduction (MBSR) course adapted for people affected by stroke and delivered online using a video communication platform. An introductory session in the first week is followed by 8 weekly sessions (2.5 hours, incorporating 30-minute comfort breaks). A 6-hour silent retreat is offered in week 7. An optional follow-up session is offered six-eight weeks after completion of the 9-week course. Course materials include a manual (provided after the introductory session), weekly pre/post-session emails with instructions and information about joining the sessions and engaging in personal practice, including links to audio files to complement class-based sessions.

Timeline

• Start date: 2021-06-28
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-08-02
• Last updated: 2023-03-28

Locations

1 site across 1 country: United Kingdom