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

Primary Purpose

Injuries, Brain

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Mindfulness intervention
Control intervention (unfocused attention)
Sponsored by
University of East Anglia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Injuries, Brain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cambridge University Hospitals Nhs Foundation Trust
  • Cambridgeshire Community Services Nhs TrustRecruiting
  • Headway Cambridgeshire
  • Brain Injury Rehabilitation Trust
  • Headway EssexRecruiting
  • Headway Norfolk & WaveneyRecruiting
  • Norfolk Community Health and Care Nhs TrustRecruiting
  • Northamptonshire Healthcare Nhs Foundation TrustRecruiting
  • Partnerships in Care
  • St Andrews Healthcare
  • Cambridgeshire and Peterborough Nhs Foundation Trust
  • Icanho, Livability

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness intervention

Control intervention (unfocused attention)

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 24, 2017
Last Updated
August 9, 2017
Sponsor
University of East Anglia
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 Andrews Healthcare, Partnerships in Care
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1. Study Identification

Unique Protocol Identification Number
NCT03231488
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of East Anglia
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 Andrews Healthcare, Partnerships in Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injuries, Brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness intervention
Arm Type
Experimental
Arm Title
Control intervention (unfocused attention)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Mindfulness intervention
Intervention Description
A 10 minute mindfulness of breath exercise
Intervention Type
Other
Intervention Name(s)
Control intervention (unfocused attention)
Intervention Description
A 10 minute unfocused attention intervention - participants are asked to let their mind wander on anything that comes to mind.
Primary Outcome Measure Information:
Title
Emotional Stroop
Description
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.
Time Frame
Administered pre- and post- 10-minute intervention, so over a period of one hour
Title
Over-selectivity task.
Description
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.
Time Frame
Administered pre- and post- 10-minute intervention, so over a period of one hour
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
Pre-intervention (baseline measure)
Title
The Five Facet Mindfulness Questionnaire (FFMQ)
Description
This will be used to characterise levels of mindfulness. This is a self-report measure, consisting of 39 items.
Time Frame
Pre-intervention (baseline measure)
Title
Test of Everyday Attention (TEA)
Description
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.
Time Frame
Pre-intervention (baseline measure)
Title
Weschler Test of Adult Reading (WTAR)
Description
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.
Time Frame
Pre-intervention (baseline measure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katrina Vicentijevic
Phone
07498045055
Email
k.vicentijevic@uea.ac.uk
Facility Information:
Facility Name
Cambridge University Hospitals Nhs Foundation Trust
City
Cambridge
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Vicentijevic
Phone
07498045055
Email
k.vicentijevic@uea.ac.uk
Facility Name
Cambridgeshire Community Services Nhs Trust
City
Cambridge
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Vicentijevic
Phone
07498045055
Email
k.vicentijevic@uea.ac.uk
Facility Name
Headway Cambridgeshire
City
Cambridge
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Vicentijevic
Phone
07498045055
Email
k.vicentijevic@uea.ac.uk
Facility Name
Brain Injury Rehabilitation Trust
City
Ely
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Vicentijevic
Phone
07498045055
Email
k.vicentijevic@uea.ac.uk
Facility Name
Headway Essex
City
Essex
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Vicentijevic
Phone
07498045055
Email
k.vicentijevic@uea.ac.uk
Facility Name
Headway Norfolk & Waveney
City
Norfolk
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Vicentijevic
Phone
07498045055
Email
k.vicentijevic@uea.ac.uk
Facility Name
Norfolk Community Health and Care Nhs Trust
City
Norfolk
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Vicentijevic
Phone
07498045055
Email
k.vicentijevic@uea.ac.uk
Facility Name
Northamptonshire Healthcare Nhs Foundation Trust
City
Northampton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Vicentijevic
Phone
07498045055
Email
k.vicentijevic@uea.ac.uk
Facility Name
Partnerships in Care
City
Northampton
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Vicentijevic
Phone
07498045055
Email
k.vicentijevic@uea.ac.uk
Facility Name
St Andrews Healthcare
City
Northampton
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Vicentijevic
Phone
07498045055
Email
k.vicentijevic@uea.ac.uk
Facility Name
Cambridgeshire and Peterborough Nhs Foundation Trust
City
Peterborough
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Vicentijevic
Phone
07498045055
Email
k.vicentijevic@uea.ac.uk
Facility Name
Icanho, Livability
City
Stowmarket
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katrina Vicentijevic
Phone
07498045055
Email
k.vicentijevic@uea.ac.uk

12. IPD Sharing Statement

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

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