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The Effect of Mindfulness on Cognition and Emotion Following Acquired Brain Injury

U

University of East Anglia

Status

Unknown

Conditions

Injuries, Brain

Treatments

Other: Mindfulness intervention
Other: Control intervention (unfocused attention)

Study type

Interventional

Funder types

Other

Identifiers

NCT03231488
IRAS project ID: 213205

Details and patient eligibility

About

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.

Enrollment

46 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

46 participants in 2 patient groups

Mindfulness intervention
Experimental group
Treatment:
Other: Mindfulness intervention
Control intervention (unfocused attention)
Active Comparator group
Treatment:
Other: Control intervention (unfocused attention)

Trial contacts and locations

12

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Central trial contact

Katrina Vicentijevic

Data sourced from clinicaltrials.gov

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