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

August 9, 2017 updated by: University of East Anglia

The Effect of Mindfulness on Stimulus Over-selectivity and Selective Attention to Threat Following Acquired Brain Injury

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom
        • Not yet recruiting
        • Cambridge University Hospitals NHS Foundation Trust
        • Contact:
      • Cambridge, United Kingdom
        • Recruiting
        • Cambridgeshire COmmunity Services NHS Trust
        • Contact:
      • Cambridge, United Kingdom
        • Not yet recruiting
        • Headway Cambridgeshire
        • Contact:
      • Ely, United Kingdom
        • Not yet recruiting
        • Brain Injury Rehabilitation Trust
        • Contact:
      • Essex, United Kingdom
      • Norfolk, United Kingdom
        • Recruiting
        • Headway Norfolk & Waveney
        • Contact:
      • Norfolk, United Kingdom
        • Recruiting
        • Norfolk Community Health and Care NHS Trust
        • Contact:
      • Northampton, United Kingdom
        • Recruiting
        • Northamptonshire Healthcare NHS Foundation Trust
        • Contact:
      • Northampton, United Kingdom
        • Not yet recruiting
        • Partnerships in Care
        • Contact:
      • Northampton, United Kingdom
        • Not yet recruiting
        • St Andrews Healthcare
        • Contact:
      • Peterborough, United Kingdom
        • Not yet recruiting
        • Cambridgeshire and Peterborough NHS Foundation Trust
        • Contact:
      • Stowmarket, United Kingdom
        • Not yet recruiting
        • Icanho, Livability
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness intervention
Other: Mindfulness intervention
A 10 minute mindfulness of breath exercise
Active Comparator: Control intervention (unfocused attention)
Other: Control intervention (unfocused attention)
A 10 minute unfocused attention intervention - participants are asked to let their mind wander on anything that comes to mind.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional Stroop
Time Frame: Administered pre- and post- 10-minute intervention, so over a period of one hour

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.
Time Frame: Administered pre- and post- 10-minute intervention, so over a period of one hour

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Pre-intervention (baseline measure)
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.
Pre-intervention (baseline measure)
The Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: Pre-intervention (baseline measure)
This will be used to characterise levels of mindfulness. This is a self-report measure, consisting of 39 items.
Pre-intervention (baseline measure)
Test of Everyday Attention (TEA)
Time Frame: Pre-intervention (baseline measure)
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.
Pre-intervention (baseline measure)
Weschler Test of Adult Reading (WTAR)
Time Frame: Pre-intervention (baseline measure)
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.
Pre-intervention (baseline measure)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of East Anglia

Collaborators

Cambridge University Hospitals NHS Foundation Trust
Cambridgeshire and Peterborough NHS Foundation Trust
Partnerships in Care
Northamptonshire Healthcare NHS Foundation Trust
Cambridgeshire Community Services NHS Trust
NORFOLK COMMUNITY HEALTH AND CARE NHS TRUST
Headway Cambridgeshire
Headway Essex
Headway Norfolk and Waveney
Icanho, Livability
Brain Injury Rehabilitation Trust
St Andrews Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2017

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (Actual)

July 27, 2017

Study Record Updates

Last Update Posted (Actual)

August 11, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS project ID: 213205

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Injuries, Brain

Clinical Trials on Mindfulness intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe