Clinical trial NCT03231488: The Effect of Mindfulness on Cognition and Emotion Following Acquired Brain Injury
Official title: The Effect of Mindfulness on Stimulus Over-selectivity and Selective Attention to Threat Following Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Injuries, Brain
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Cambridge University Hospitals NHS Foundation Trust
name: Cambridgeshire Community Services NHS Trust
name: Cambridgeshire and Peterborough NHS Foundation Trust
name: NORFOLK COMMUNITY HEALTH AND CARE NHS TRUST
name: NORTHAMPTONSHIRE HEALTHCARE NHS FOUNDATION TRUST
name: Headway Cambridgeshire
name: Headway Essex
name: Headway Norfolk and Waveney
name: Icanho, Livability
name: Brain Injury Rehabilitation Trust
name: St Andrew's Healthcare
name: Partnerships in Care
First posted: 2017-07-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Emotional Stroop
timeFrame: Administered pre- and post- 10-minute intervention, so over a period of one hour
measure: Over-selectivity task.
timeFrame: Administered pre- and post- 10-minute intervention, so over a period of one hour
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Pre-intervention (baseline measure)
measure: The Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Pre-intervention (baseline measure)
measure: Test of Everyday Attention (TEA)
timeFrame: Pre-intervention (baseline measure)
measure: Weschler Test of Adult Reading (WTAR)
timeFrame: Pre-intervention (baseline measure)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals Nhs Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridgeshire Community Services Nhs Trust
city: Cambridge
country: United Kingdom
facility: Headway Cambridgeshire
city: Ely
country: United Kingdom
facility: Brain Injury Rehabilitation Trust
city: Essex
country: United Kingdom
facility: Headway Essex
city: Norfolk
country: United Kingdom
facility: Headway Norfolk & Waveney
city: Norfolk
country: United Kingdom
facility: Norfolk Community Health and Care Nhs Trust
city: Northampton
country: United Kingdom
facility: Northamptonshire Healthcare Nhs Foundation Trust
city: Northampton
country: United Kingdom
facility: Partnerships in Care
city: Northampton
country: United Kingdom
facility: St Andrews Healthcare
city: Peterborough
country: United Kingdom
facility: Cambridgeshire and Peterborough Nhs Foundation Trust
city: Stowmarket
country: United Kingdom
facility: Icanho, Livability
Study officials:
References: