The Effect of Mindfulness on Cognition and Emotion Following Acquired Brain Injury
The Effect of Mindfulness on Stimulus Over-selectivity and Selective Attention to Threat Following Acquired Brain Injury
1 other identifier
interventional
46
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
Shorter than P25 for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2017
CompletedFirst Posted
Study publicly available on registry
July 27, 2017
CompletedStudy Start
First participant enrolled
July 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedAugust 11, 2017
June 1, 2017
5 months
July 24, 2017
August 9, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Administered pre- and post- 10-minute intervention, so over a period of one hour
Secondary Outcomes (4)
Hospital Anxiety and Depression Scale (HADS)
Pre-intervention (baseline measure)
The Five Facet Mindfulness Questionnaire (FFMQ)
Pre-intervention (baseline measure)
Test of Everyday Attention (TEA)
Pre-intervention (baseline measure)
Weschler Test of Adult Reading (WTAR)
Pre-intervention (baseline measure)
Study Arms (2)
Mindfulness intervention
EXPERIMENTALControl intervention (unfocused attention)
ACTIVE COMPARATORInterventions
A 10 minute unfocused attention intervention - participants are asked to let their mind wander on anything that comes to mind.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of East Anglialead
- Cambridge University Hospitals NHS Foundation Trustcollaborator
- Cambridgeshire Community Services NHS Trustcollaborator
- Cambridgeshire and Peterborough NHS Foundation Trustcollaborator
- NORFOLK COMMUNITY HEALTH AND CARE NHS TRUSTcollaborator
- Northamptonshire Healthcare NHS Foundation Trustcollaborator
- Headway Cambridgeshirecollaborator
- Headway Essexcollaborator
- Headway Norfolk and Waveneycollaborator
- Icanho, Livabilitycollaborator
- Brain Injury Rehabilitation Trustcollaborator
- St Andrew's Healthcarecollaborator
- Partnerships in Carecollaborator
Study Sites (12)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 24, 2017
First Posted
July 27, 2017
Study Start
July 31, 2017
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
August 11, 2017
Record last verified: 2017-06