Helping Ease Anxiety and Depression Following Stroke Stage 3

NCT04985838 | Completed

• 1 other identifier: HLS/NCH/20/038
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Stroke; CVA; Anxiety; Depression; Mindfulness; MBSR; Online; Self-management; Mixed methods

Outcome Measures

Primary Outcomes (3)

• Beck Depression Inventory II (change being assessed)

  The Beck Depression Inventory II is a 21-item self-report scale to assess the intensity of depression. Each item is a list of four statements arranged in increasing severity about a symptom of depression. Score range between 0-63 with higher score indicating greater severity.

  Weeks 0, 8, 20, 32 (assessing change)

• Beck Anxiety Inventory (change being assessed)

  The Beck Anxiety Inventory is a self-report 21-item scale for measuring anxiety. The questions ask about symptoms of anxiety the subject has had during the past week. Each question is scored between 0 (mild) and 3 (severe) and a total score will vary between 0-63. Higher scores indicate more severe anxiety symptoms.

  Weeks 0, 8, 20, 32 (assessing change)

• Depression Anxiety Stress Scales (change being assessed)

  The Depression Anxiety Stress Scale is a 21-item version of the full 42-item scale, consisting of a set of three self-report scales designed to measure depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items. Participants are asked to use 4-point severity/frequency scales to rate the extent to which they have experienced each state over the past week. Scores for Depression, Anxiety and Stress are calculated by summing the scores for the relevant items and multiplying by two to produce the equivalent DASS-42 score. Higher scores suggesting more severe difficulties.

  Weeks 0, 8, 20, 32 (assessing change)

Secondary Outcomes (2)

• Short Form Stroke Impact Scale (change being assessed)

  Weeks 0, 8, 20, 32 (assessing change)

• EQ-5D 5L (change being assessed)

  Weeks 0, 8, 20, 32 (assessing change)

Study Arms (2)

Online HEADS: UP

EXPERIMENTAL

A group-based Mindfulness Based Stress Reduction (MBSR) course adapted for people affected by stroke and delivered using a video communication platform e.g. Zoom. An informal 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.

Behavioral: HEADS: UP (Helping Ease Anxiety and Depression)

Control

NO INTERVENTION

No intervention provided.

Interventions

HEADS: UP (Helping Ease Anxiety and Depression) BEHAVIORAL

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.

Online HEADS: UP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• Edinburgh Napier University: collaborator
• University of Manchester: collaborator
• University of Stirling: collaborator
• University of Strathclyde: collaborator
• Leeds Beckett University: collaborator
• University of Nottingham: collaborator

Study Sites (1)

Glasgow Caledonian University

Glasgow, Glasgow (City Of), G4 0BA, United Kingdom

Location

MeSH Terms

Conditions

Stroke; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Maggie Lawrence, PhD

  Glasgow Caledonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A mixed methods randomised controlled pilot trial

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 2, 2021
• Study Start: June 28, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after publication of the research report and for a period of five years.
• Access Criteria: By request from Maggie Lawrence maggie.lawrence@gcu.ac.uk

Locations

GB (1)