AzTrials
AzTrials

StrokeHEADS:UPNCT03956693

Helping Ease Anxiety and Depression Following Stroke

A study testing HEADS: UP in people with Stroke and CVA (Cerebrovascular Accident), run by Glasgow Caledonian University at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, CVA (Cerebrovascular Accident), Anxiety
What is being tested?
HEADS: UP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited Kingdom
Study dates
1 Jun 2019to 1 Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • NOTE: A current prescription for anxiolytics or antidepressants is not an exclusion criterion. If screening identifies a potential participant who requires GP referral, that individual may subsequently be prescribed medication; this is a feature of the pilot work. In a future trial, where participants are randomised to two arms and there is equal probability of people being on medication in each arm, it will not be an issue.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Glasgow Caledonian University

    Glasgow, Glasgow (City Of), G4 0BA

Other trials in United Kingdom

About this study

Official title: HEADS: UP (Helping Ease Anxiety and Depression Following Stroke) Psychological Self-management Intervention: Non-randomised Pilot Study

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.

Read the detailed description

Mindfulness-based interventions are thought to help people affected by stroke (Lawrence et al., 2013). Helping Ease Anxiety and Depression (HEADS: UP) is an adapted mindfulness-based intervention for people affected by stroke (Lawrence, 2019). This study aligns with the feasibility/piloting stage of the Medical Research Council framework (Craig et al., 2008) and will optimise intervention delivery and study processes, ensuring all elements are working together, ready for testing at a later stage.

The aim of this mixed methods research is to conduct feasibility pilot testing of HEADS: UP to help people affected by stroke self-manage symptoms of anxiety and depression prior to Phase III testing in future work.

This stage is a non-randomised pilot study based in Glasgow, United Kingdom. The purpose of the pilot is to assess feasibility and acceptability of delivering HEADS: UP, and recruitment and questionnaire data collection processes; identify any additional HEADS: UP adaptions.

Being tested
HEADS: UP
Keywords
Stroke, CVA (cardiovascular accident), Anxiety, Depression, Mindfulness, Mindfulness Based Stress Reduction, Self-management
Medical subject headings
Stroke, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HEADS: UPBehavioural

    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.

Study groups in NCT03956693
Study groupRoleWhat they receive
HEADS: UPExperimentalHEADS: UP is group-based mindfulness intervention based on the original mindfulness based stress reduction course, but adapted for people affected by stroke.
Receives: Behavioral: HEADS: UP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Weeks 0, 9, 21

  2. 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.

    Measured: Weeks 0, 9, 21

Secondary outcomes (5)

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

    The Hospital Anxiety and Depression Scale (HADS) is a self-administered measure of depression and anxiety. The HADS is not a diagnostic tool, but can screen for anxiety and depression. The HADS has 14 items in total and asks about mood in the past week. Seven items assess depression and seven items assess anxiety. The HADS can be administered repeatedly without impacting on validity. Each item is rated on a 4-point scale and provide a score 0-21. A higher score indicates higher distress.

    Usually completed in 2-5 minutes

    Measured: Weeks 0, 9, 21

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

    The DASS is a set of three self-report scales designed to measure depression, anxiety and stress. Each of the three DASS scales contains 14 items, divided into subscales of 2-5 items with similar content. The Depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest/involvement, anhedonia, and inertia. The Anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The Stress scale is sensitive to levels of chronic non-specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset/agitated, irritable/over-reactive and impatient. Subjects 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.

    Measured: Weeks 0, 9, 21

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

    The Beck Depression Inventory 11 (BDI-II) is a 21 items 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.

    Normally completed in 5-10 minutes.

    Measured: Weeks 0, 9, 21

  4. Beck Anxiety Inventory (BAI): change is being assessed

    The Beck Anxiety Inventory (BAI) 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.

    Measured: Weeks 0, 9 21

  5. EQ-5D 5L: change is being assessed

    The 5-level EQ-5D version (EQ-5D-5L) comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    Measured: Weeks 0, 9, 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2019
  2. Study start1 Jun 2019
  3. Primary completion22 Oct 2019
  4. Study completion1 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Pilot study
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03956693
Sponsor's protocol ID
SA PPA 18\100011 (stage 1)
Acronym
HEADS:UP
Status last verified
Sep 2020
First submitted
8 May 2019
Last updated
9 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18824488

  • 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).

  • 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.

    PubMed 23879751

Questions about this trial

What is this clinical trial studying?

A study testing HEADS: UP in people with Stroke and CVA (Cerebrovascular Accident), run by Glasgow Caledonian University at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke Specific Quality of Life Scale (SS-QOL): change is being assessed (time frame: Weeks 0, 9, 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03956693, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in