Helping Ease Anxiety and Depression Following Stroke Stage 3

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Edinburgh Napier University

  collaborator OTHER

• University of Manchester

  collaborator OTHER

• University of Stirling

  collaborator OTHER

• University of Strathclyde

  collaborator OTHER

• Leeds Beckett University

  collaborator OTHER

• University of Nottingham

  collaborator OTHER

• Glasgow Caledonian University

  lead OTHER

Principal Investigators

• Maggie Lawrence, PhD · Glasgow Caledonian University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-28

Primary Completion

2022-09-01

Completion

2022-09-01

Countries

• United Kingdom

Study Locations