Helping Ease Anxiety and Depression Following Stroke

NCT03956693 | Completed

• 1 other identifier: SA PPA 18\100011 (stage 1)
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; CVA (Cerebrovascular Accident); Anxiety; Depression

Keywords

Stroke; CVA (cardiovascular accident); Anxiety; Depression; Mindfulness; Mindfulness Based Stress Reduction; Self-management

Outcome Measures

Primary Outcomes (2)

• Stroke Specific Quality of Life Scale (SS-QOL): change is being assessed

  The Stroke Specific Quality of Life Scale (SS-QOL) is an outcome measure intended to assess of health-related quality of life for people affected by stroke. It is a self-report scale containing 49 items in 12 domains. Items are rated on a 5-point Likert scale and the questionnaire is usually completed in 10-15 minutes.

  Weeks 0, 9, 21

• Stroke Impact Scale (SIS): change is being assessed

  The Stroke Impact Scale (SIS) is a self-report, health status measure for people affected by stroke. It was designed to assess strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation. The SIS can be used both in clinical and research settings. It contains 59 items and assesses 8 domains. Each item is rated using a 5-point Likert scale. A final single-item question assesses the individual's perception of recovery from stroke, measured using a visual analogue scale, where 0 = no recovery \& 100 = full recovery. The scale is normally completed in 15-20 minutes.

  Weeks 0, 9, 21

Secondary Outcomes (5)

• Hospital Anxiety and Depression Scale (HADS): change is being assessed

  Weeks 0, 9, 21

• Depression Anxiety Stress Scale (DASS): change is being assessed

  Weeks 0, 9, 21

• Beck Depression Inventory II (BDI-II): change is being assessed

  Weeks 0, 9, 21

• Beck Anxiety Inventory (BAI): change is being assessed

  Weeks 0, 9 21

• EQ-5D 5L: change is being assessed

  Weeks 0, 9, 21

Other Outcomes (2)

• Carer Strain Index (CSI): change is being assessed

  Weeks 0, 9, 21

• Focus Groups (FG): change is being assessed

  Weeks 9, 21

Study Arms (1)

HEADS: UP

EXPERIMENTAL

HEADS: UP is group-based mindfulness intervention based on the original mindfulness based stress reduction course, but adapted for people affected by stroke.

Behavioral: HEADS: UP

Interventions

HEADS: UP BEHAVIORAL

HEADS: UP comprises 9 x 2.5 hour mindfulness teaching sessions and a silent retreat in week 7. Course materials include accessible information packs and resources to complement class-based sessions. The first week of the 9-week course is an introductory class. The purpose of the introductory class is to give participants the opportunity to meet the trainers and to decide if they want to learn more about mindfulness. The introductory session also allows participants to meet other people on the course and to share their (stroke) stories.

HEADS: UP

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• University of Stirling: collaborator
• Edinburgh Napier University: collaborator
• The Stroke Association, United Kingdom: collaborator
• Yunus Centre for Social Business and Health: collaborator
• University of Strathclyde: collaborator
• University of Manchester: collaborator

Study Sites (1)

Glasgow Caledonian University

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

Location

Related Publications (3)

• 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.

  PMID: 18824488 BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 23879751 BACKGROUND

Related Links

• Helping Ease Anxiety and Depression after Stroke (HEADS: UP) - Research Briefing

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 21, 2019
• Study Start: June 1, 2019
• Primary Completion: October 22, 2019
• Study Completion: June 1, 2020
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)