The Effect of Mindfulness on Cognition and Emotion Following Acquired Brain Injury
NCT ID: NCT03231488
Last Updated: 2017-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
46 participants
INTERVENTIONAL
2017-07-31
2018-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of Neurofeedback to Enhance Attention After Brain Injury
NCT03324178
Animal Assisted Mindfulness Intervention (AAMI) for Patients With Acquired Brain Injury
NCT03729908
Investigating the Physiological, Cognitive, and Psychological Effects of a Cognitive-Based Intervention
NCT02906449
Mindfulness Based Stress Reduction and Post-Stroke Cognition
NCT04302493
Mindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals With a Traumatic Brain Injury
NCT00745940
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mindfulness intervention
Mindfulness intervention
A 10 minute mindfulness of breath exercise
Control intervention (unfocused attention)
Control intervention (unfocused attention)
A 10 minute unfocused attention intervention - participants are asked to let their mind wander on anything that comes to mind.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mindfulness intervention
A 10 minute mindfulness of breath exercise
Control intervention (unfocused attention)
A 10 minute unfocused attention intervention - participants are asked to let their mind wander on anything that comes to mind.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cambridge University Hospitals NHS Foundation Trust
OTHER
Cambridgeshire Community Services NHS Trust
OTHER
Cambridgeshire and Peterborough NHS Foundation Trust
OTHER
NORFOLK COMMUNITY HEALTH AND CARE NHS TRUST
UNKNOWN
NORTHAMPTONSHIRE HEALTHCARE NHS FOUNDATION TRUST
UNKNOWN
Headway Cambridgeshire
UNKNOWN
Headway Essex
UNKNOWN
Headway Norfolk and Waveney
UNKNOWN
Icanho, Livability
UNKNOWN
Brain Injury Rehabilitation Trust
OTHER
St Andrew's Healthcare
OTHER
Partnerships in Care
OTHER
University of East Anglia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cambridge University Hospitals Nhs Foundation Trust
Cambridge, , United Kingdom
Cambridgeshire Community Services Nhs Trust
Cambridge, , United Kingdom
Headway Cambridgeshire
Cambridge, , United Kingdom
Brain Injury Rehabilitation Trust
Ely, , United Kingdom
Headway Essex
Essex, , United Kingdom
Headway Norfolk & Waveney
Norfolk, , United Kingdom
Norfolk Community Health and Care Nhs Trust
Norfolk, , United Kingdom
Northamptonshire Healthcare Nhs Foundation Trust
Northampton, , United Kingdom
Partnerships in Care
Northampton, , United Kingdom
St Andrews Healthcare
Northampton, , United Kingdom
Cambridgeshire and Peterborough Nhs Foundation Trust
Peterborough, , United Kingdom
Icanho, Livability
Stowmarket, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRAS project ID: 213205
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.