StrokeHEADS:UPNCT04985838
Helping Ease Anxiety and Depression Following Stroke Stage 3
A study testing HEADS: UP (Helping Ease Anxiety and Depression) in people with Stroke and Cerebrovascular Accident Due to Cerebral Artery Occlusion, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Accident Due to Cerebral Artery Occlusion, Anxiety
- What is being tested?
- HEADS: UP (Helping Ease Anxiety and Depression)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2021to 1 Sep 2022
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glasgow Caledonian University
Glasgow, Glasgow (City Of), G4 0BA
About this study
Official title: HEADS: UP (Helping Ease Anxiety and Depression Following Stroke) Psychological Self-management Intervention: a Randomised Controlled Pilot Trial
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.
Read the detailed description
AIM To test full-study procedures and determine whether to proceed to a future definitive trial.
Objectives
- Test full-study procedures, including measurement logistics, randomisation, and check the direction of effect is in the expected direction.
- Identify potential resource (cost) implications of delivering HEADS: UP and potential impact on NHS utilisation.
- 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.
- Being tested
- HEADS: UP (Helping Ease Anxiety and Depression)
- Keywords
- Stroke, CVA, Anxiety, Depression, Mindfulness, MBSR, Online, Self-management, Mixed methods
- 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: UP (Helping Ease Anxiety and Depression)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: HEADS: UP (Helping Ease Anxiety and Depression) |
| Control | No intervention | No intervention provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Weeks 0, 8, 20, 32 (assessing change)
Secondary outcomes (2)
Short Form Stroke Impact Scale (change being assessed)
Short Form Stroke Impact Scale 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 SF-SIS can be used both in clinical and research settings. It contains 8 items across the 8 domains. Each item is rated using a 5-point Likert scale with higher scores indicating lesser impairment.
Measured: Weeks 0, 8, 20, 32 (assessing change)
EQ-5D 5L (change being assessed)
The 5-level EQ-5D version 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, 8, 20, 32 (assessing change)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start28 Jun 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A mixed methods randomised controlled pilot trial
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Edinburgh Napier University, University of Manchester, University of Stirling, University of Strathclyde, Leeds Beckett University, University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Maggie Lawrence, PhD, Principal investigator, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985838
- Sponsor's protocol ID
- HLS/NCH/20/038
- Acronym
- HEADS:UP
- Status last verified
- Mar 2023
- First submitted
- 6 Jul 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous individual participant data will be shared by request with other researchers for ethically approved research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEADS: UP (Helping Ease Anxiety and Depression Following Stroke) Psychological Self-management Intervention: a Randomised Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT04985838
- Acronym / sponsor ID
- HEADS:UP / HLS/NCH/20/038
- Keywords
- Stroke, CVA, Anxiety, Depression, Mindfulness, MBSR, Online, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- Edinburgh Napier University, University of Manchester, University of Stirling, University of Strathclyde, Leeds Beckett University, University of Nottingham
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Test full-study procedures, including measurement logistics, randomisation, and check the direction of effect is in the expected direction.
- Identify potential resource (cost) implications of delivering HEADS: UP and potential impact on NHS utilisation.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A mixed methods randomised controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Online HEADS: UP | Experimental | 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 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. |
| Control | No intervention | –No intervention provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Online HEADS: UP |
Primary outcome
Beck Depression Inventory II (change being assessed)
Time frame: Weeks 0, 8, 20, 32 (assessing change)
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.
Beck Anxiety Inventory (change being assessed)
Time frame: Weeks 0, 8, 20, 32 (assessing change)
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.
Depression Anxiety Stress Scales (change being assessed)
Time frame: Weeks 0, 8, 20, 32 (assessing change)
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.
2 secondary outcomes
Short Form Stroke Impact Scale (change being assessed)
Time frame: Weeks 0, 8, 20, 32 (assessing change)
EQ-5D 5L (change being assessed)
Time frame: Weeks 0, 8, 20, 32 (assessing change)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- HELPING EASE ANXIETY AND DEPRESSION AFTER STROKE (HEADS: UP)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymous individual participant data will be shared by request with other researchers for ethically approved research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maggie Lawrence, PhD principal investigator
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEADS: UP (Helping Ease Anxiety and Depression) in people with Stroke and Cerebrovascular Accident Due to Cerebral Artery Occlusion, 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 28 Mar 2023. 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?
Beck Depression Inventory II (change being assessed) (time frame: Weeks 0, 8, 20, 32 (assessing change)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2023.