Injuries, BrainNCT03231488
The Effect of Mindfulness on Cognition and Emotion Following Acquired Brain Injury
A study testing Mindfulness intervention in people with Injuries, Brain, run by University of East Anglia at 12 sites in United Kingdom.
Trial summary
Can mindfulness help with attention and emotion difficulties after a brain injury? People who have a brain injury often have problems with their attention and emotions. This study will see if a short mindfulness task can help with these problems. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Injuries, Brain
- What is being tested?
- Mindfulness intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- 31 Jul 2017to Jan 2018
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years and over
- Medical evidence of ABI with attention or executive functioning difficulties, such as difficulties with planning, inhibition or attention
- Time since ABI to be 9 months or greater • ABI severity to be moderate to severe, determined by the Mayo classification system (Malec et al., 2007). This is classification system is frequently used to determine ABI severity and is standard practice to record at the acute stage of care when the individual is admitted to hospital. This means there must be evidence of one or more of the following in medical notes: the individual's lowest Glasgow Coma Scale (GCS) score is less than 13, there is a loss of consciousness of at least 30 minutes immediately following ABI and post traumatic amnesia (PTA) is at least 24 hours in length. If there is no evidence of this in the medical notes, then there must be evidence that the individual has clinically significant difficulties resulting from their ABI to have needed a referral to brain injury services.
- There are self-reported or clinician-identified emotional difficulties to adjusting to circumstances post-ABI
Who cannot join
- Significant, severe and enduring presence of mental health difficulties or substance misuse that would prevent valid engagement in experimental tasks
- Perceptual, language, communication, reading or motor difficulties that would prevent valid engagement in experimental tasks
- The presence of developmental or acquired dyslexia affecting the automatic reading of words in the emotional Stroop
- Severe cognitive difficulties that would prevent valid engagement in experimental tasks
- Presence of pre-existing or comorbid disorders that may affect cognitive functioning (other than ABI) that would prevent valid engagement in experimental tasks
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites, 12 recruiting
- Not yet recruiting
Cambridge University Hospitals Nhs Foundation Trust
Cambridge
Katrina Vicentijevic, 07498045055, k.vicentijevic@uea.ac.uk
- Recruiting
Cambridgeshire Community Services Nhs Trust
Cambridge
Katrina Vicentijevic, 07498045055, k.vicentijevic@uea.ac.uk
- Not yet recruiting
Headway Cambridgeshire
Cambridge
Katrina Vicentijevic, 07498045055, k.vicentijevic@uea.ac.uk
- Not yet recruiting
Brain Injury Rehabilitation Trust
Ely
Katrina Vicentijevic, 07498045055, k.vicentijevic@uea.ac.uk
- Recruiting
Headway Essex
Essex
Katrina Vicentijevic, 07498045055, k.vicentijevic@uea.ac.uk
- Recruiting
Headway Norfolk & Waveney
Norfolk
Katrina Vicentijevic, 07498045055, k.vicentijevic@uea.ac.uk
- Recruiting
Norfolk Community Health and Care Nhs Trust
Norfolk
Katrina Vicentijevic, 07498045055, k.vicentijevic@uea.ac.uk
- Recruiting
Northamptonshire Healthcare Nhs Foundation Trust
Northampton
Katrina Vicentijevic, 07498045055, k.vicentijevic@uea.ac.uk
- Not yet recruiting
Partnerships in Care
Northampton
Katrina Vicentijevic, 07498045055, k.vicentijevic@uea.ac.uk
- Not yet recruiting
St Andrews Healthcare
Northampton
Katrina Vicentijevic, 07498045055, k.vicentijevic@uea.ac.uk
- Not yet recruiting
Cambridgeshire and Peterborough Nhs Foundation Trust
Peterborough
Katrina Vicentijevic, 07498045055, k.vicentijevic@uea.ac.uk
- Not yet recruiting
Icanho, Livability
Stowmarket
Katrina Vicentijevic, 07498045055, k.vicentijevic@uea.ac.uk
About this study
Official title: The Effect of Mindfulness on Stimulus Over-selectivity and Selective Attention to Threat Following Acquired Brain Injury
Can mindfulness help with attention and emotion difficulties after a brain injury?
People who have a brain injury often have problems with their attention and emotions. This study will see if a short mindfulness task can help with these problems. So far, there are not many studies looking at this and those that do show mixed results. When being mindful someone is aware of their attention and focuses on the present moment without passing judgement. This study focuses on over-selectivity and selective attention to threat after a brain injury. These are two concepts involved in attention and emotion problems. Over-selectivity is when someone focuses on only one thing around them and misses other key things. Selective attention to threat is when someone's focus is drawn to something around them that is seen as threatening. This has been shown to cause and keep anxious feelings going. This research will see if a short mindfulness task can help those with a brain injury by reducing overselectivity and selective attention to threat on two tasks. Participants will be recruited from NHS and non-NHS brain injury services. The study will take around two hours to complete for each participant. In summary, this study looks to see if a specific mindfulness exercise can be helpful for specific attention and emotion problems. It could be a first step in making treatment better and giving more treatment options for those with a brain injury.
- Conditions
- Injuries, Brain
- Being tested
- Mindfulness intervention, Control intervention (unfocused attention)
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness interventionOther
A 10 minute mindfulness of breath exercise
Control intervention (unfocused attention)Other
A 10 minute unfocused attention intervention - participants are asked to let their mind wander on anything that comes to mind.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness intervention | Experimental | Not described Receives: Other: Mindfulness intervention |
| Control intervention (unfocused attention) | Active comparator | Not described Receives: Other: Control intervention (unfocused attention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emotional Stroop
This will be a computer task that measures selective attention to threat.
In the emotional Stroop, different coloured words are presented to participants and the emotional meaning of the words are manipulated. Participants are instructed to name the colour of the words as quickly as possible, whilst ignoring the meaning of the words. Selective attention to threat will be inferred when word colour-naming takes longer when the meaning of the word is threatening relative to neutral. So, the greater the difference between reaction times to neutral and threatening words, the greater the selective attention to threat.
Measured: Administered pre- and post- 10-minute intervention, so over a period of one hour
Over-selectivity task.
This will be a computer task that measures over-selectivity.
Practice phase - two cards, each with two images appear on the screen. One card is the correct one to select and the other is incorrect. This happens for two sets of two cards (pair 1 and pair 2). Test phase - participants are presented with two single stimuli simultaneously, one from the reinforced compound and one from the verbally punished compound (Figure 4). They are instructed to select one of the pictures on the screen.
Over-selectivity will occur if participants fail to learn about one of the stimuli in the previously reinforced compound and therefore fail to select that stimuli they had not learned about in the practice phase.
So, the higher the score on the over-selectivity task, the greater the difference between the most and least chosen stimuli, which means that the participant is demonstrating greater over-selectivity.
Measured: Administered pre- and post- 10-minute intervention, so over a period of one hour
Secondary outcomes (4)
Hospital Anxiety and Depression Scale (HADS)
A self-report measure consisting of 14 items. The measure gives an overall score, as well as separate scores for severity of anxiety and depression subscales.
Measured: Pre-intervention (baseline measure)
The Five Facet Mindfulness Questionnaire (FFMQ)
This will be used to characterise levels of mindfulness. This is a self-report measure, consisting of 39 items.
Measured: Pre-intervention (baseline measure)
Test of Everyday Attention (TEA)
Subtests will be used to measure baseline measures of attention. Elevator counting is a measure of sustained attention and elevator counting with distraction is a measure of selective attention.
Measured: Pre-intervention (baseline measure)
Weschler Test of Adult Reading (WTAR)
This will be used to measure a baseline measure of pre-morbid functioning. Participants read a list of 50 words with irregular pronunciations to assess previous learning of the words.
Measured: Pre-intervention (baseline measure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start31 Jul 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injuries, BrainStudies 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
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Cambridgeshire Community Services NHS Trust, Cambridgeshire and Peterborough NHS Foundation Trust, NORFOLK COMMUNITY HEALTH AND CARE NHS TRUST, Northamptonshire Healthcare NHS Foundation Trust, Headway Cambridgeshire, Headway Essex, Headway Norfolk and Waveney, Icanho, Livability, Brain Injury Rehabilitation Trust, St Andrew's Healthcare, Partnerships in Care
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231488
- Sponsor's protocol ID
- IRAS project ID: 213205
- Status last verified
- Jun 2017
- First submitted
- 24 Jul 2017
- Last updated
- 11 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness on Stimulus Over-selectivity and Selective Attention to Threat Following Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT03231488
- Acronym / sponsor ID
- IRAS project ID: 213205
- Conditions
- Injuries, Brain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Cambridgeshire Community Services NHS Trust, Cambridgeshire and Peterborough NHS Foundation Trust, NORFOLK COMMUNITY HEALTH AND CARE NHS TRUST, Northamptonshire Healthcare NHS Foundation Trust, Headway Cambridgeshire, Headway Essex, Headway Norfolk and Waveney, Icanho, Livability, Brain Injury Rehabilitation Trust, St Andrew's Healthcare, Partnerships in Care
- Study start
- 31 Jul 2017 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 27 Jul 2017 (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.
Can mindfulness help with attention and emotion difficulties after a brain injury?
People who have a brain injury often have problems with their attention and emotions. This study will see if a short mindfulness task can help with these problems. So far, there are not many studies looking at this and those that do show mixed results. When being mindful someone is aware of their attention and focuses on the present moment without passing judgement. This study focuses on over-selectivity and selective attention to threat after a brain injury. These are two concepts involved in attention and emotion problems. Over-selectivity is when someone focuses on only one thing around them and misses other key things. Selective attention to threat is when someone's focus is drawn to something around them that is seen as threatening. This has been shown to cause and keep anxious feelings going. This research will see if a short mindfulness task can help those with a brain injury by reducing overselectivity and selective attention to threat on two tasks. Participants will be recruited from NHS and non-NHS brain injury services. The study will take around two hours to complete for each participant. In summary, this study looks to see if a specific mindfulness exercise can be helpful for specific attention and emotion problems. It could be a first step in making treatment better and giving more treatment options for those with a brain injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness intervention | Experimental | Other: Mindfulness intervention |
| Control intervention (unfocused attention) | Active comparator | Other: Control intervention (unfocused attention) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years and over
- Medical evidence of ABI with attention or executive functioning difficulties, such as difficulties with planning, inhibition or attention
- Time since ABI to be 9 months or greater • ABI severity to be moderate to severe, determined by the Mayo classification system (Malec et al., 2007). This is classification system is frequently used to determine ABI severity and is standard practice to record at the acute stage of care when the individual is admitted to hospital. This means there must be evidence of one or more of the following in medical notes: the individual's lowest Glasgow Coma Scale (GCS) score is less than 13, there is a loss of consciousness of at least 30 minutes immediately following ABI and post traumatic amnesia (PTA) is at least 24 hours in length. If there is no evidence of this in the medical notes, then there must be evidence that the individual has clinically significant difficulties resulting from their ABI to have needed a referral to brain injury services.
- There are self-reported or clinician-identified emotional difficulties to adjusting to circumstances post-ABI
Key exclusion criteria (5 listed)
- Significant, severe and enduring presence of mental health difficulties or substance misuse that would prevent valid engagement in experimental tasks
- Perceptual, language, communication, reading or motor difficulties that would prevent valid engagement in experimental tasks
- The presence of developmental or acquired dyslexia affecting the automatic reading of words in the emotional Stroop
- Severe cognitive difficulties that would prevent valid engagement in experimental tasks
- Presence of pre-existing or comorbid disorders that may affect cognitive functioning (other than ABI) that would prevent valid engagement in experimental tasks
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 |
|---|---|---|
| Mindfulness interventionA 10 minute mindfulness of breath exercise | Other | Mindfulness intervention |
| Control intervention (unfocused attention)A 10 minute unfocused attention intervention - participants are asked to let their mind wander on anything that comes to mind. | Other | Control intervention (unfocused attention) |
Primary outcome
Emotional Stroop
Time frame: Administered pre- and post- 10-minute intervention, so over a period of one hour
This will be a computer task that measures selective attention to threat. In the emotional Stroop, different coloured words are presented to participants and the emotional meaning of the words are manipulated. Participants are instructed to name the colour of the words as quickly as possible, whilst ignoring the meaning of the words. Selective attention to threat will be inferred when word colour-naming takes longer when the meaning of the word is threatening relative to neutral. So, the greater the difference between reaction times to neutral and threatening words, the greater the selective attention to threat.
Over-selectivity task.
Time frame: Administered pre- and post- 10-minute intervention, so over a period of one hour
This will be a computer task that measures over-selectivity. Practice phase - two cards, each with two images appear on the screen. One card is the correct one to select and the other is incorrect. This happens for two sets of two cards (pair 1 and pair 2). Test phase - participants are presented with two single stimuli simultaneously, one from the reinforced compound and one from the verbally punished compound (Figure 4). They are instructed to select one of the pictures on the screen. Over-selectivity will occur if participants fail to learn about one of the stimuli in the previously reinforced compound and therefore fail to select that stimuli they had not learned about in the practice phase. So, the higher the score on the over-selectivity task, the greater the difference between the most and least chosen stimuli, which means that the participant is demonstrating greater over-selectivity.
4 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: Pre-intervention (baseline measure)
The Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Pre-intervention (baseline measure)
Test of Everyday Attention (TEA)
Time frame: Pre-intervention (baseline measure)
Weschler Test of Adult Reading (WTAR)
Time frame: Pre-intervention (baseline measure)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
Related trials for Injuries, Brain
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness intervention in people with Injuries, Brain, run by University of East Anglia at 12 sites 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 5 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: status not confirmed, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrina Vicentijevic (07498045055, k.vicentijevic@uea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Stroop (time frame: Administered pre- and post- 10-minute intervention, so over a period of one hour). 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?
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 11 Aug 2017.