Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000436875
Ethics application status
Approved
Date submitted
16/04/2012
Date registered
18/04/2012
Date last updated
18/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a meditation based stress reduction program during acquired brain injury rehabilitation in an inpatient setting: a pilot study
Scientific title
Feasibility of delivering a meditation based stress reduction program and to determine comparisons between clinical outcomes for individuals undertaking these programs to those engaging in a diversion and relaxation group in an inpatient brain injury rehabilitation unit.
Secondary ID [1] 280334 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 286294 0
Condition category
Condition code
Physical Medicine / Rehabilitation 286533 286533 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those participants allocated to the Intervention Group will attend twice weekly mindfulness meditation based stress reduction (MBSR) sessions run for a small group of 6-8 people for 4 weeks. Each session will last for 60 minutes. A senior Occupational Therapist (OT), who is accreditated in meditation instruction, will provide the intervention. Participants will also be supported to undertake individual meditation practice each day for approximately 15 minutes in between the formal sessions. Their compliance will be monitored by the senior OT. They will be provided with an audiotape of meditation exercises developed by the senior OT. As participants will be admitted and discharged at different times, the make-up of the group is likely to change for individuals.
Intervention code [1] 284717 0
Treatment: Other
Comparator / control treatment
The participants allocated to the Control Group will attend twice weekly “Diversion and Relaxation” groups where they come together in small groups of 6-8 people for 4 weeks and listen to readings of the newspaper, magazines or books and/or listen to audiobooks and are encouraged to relax, be comfortable and enjoy themselves. These sessions which will run for 60 minutes will be run by an experienced rehabilitation assistant. They will also be supported to undertake individual relaxation practice in between the formal sessions each day for approximately 15 minutes and their compliance will be monitored by the smae rehabilitation assistant. As with the mindfulness meditation based stress reduction (MBSR) group, the make-up of the group participants’ will change according to people entering and leaving the group according to their admission and discharge to and from the ward.
Control group
Active

Outcomes
Primary outcome [1] 286965 0
- Goal Attainment Scaling (GAS). This individualised measurement specifies a range of criterion referenced goals using a 5 point ordinal scale: (+2) indicates the most favourable outcome to (-2) which indicates the least favourable outcome. This outcome measure provides a collaborative and individualised approach to goal-setting and treatment and has been found to be useful in measuring goals that fall outside standardised outcome measurement instruments, and is consistent with client and family centred intervention (McLaren and Rodger 2003).
Timepoint [1] 286965 0
Pre and post intervention ie baseline and 4 weeks post intervention
Primary outcome [2] 286966 0
-Generalized Anxiety Disorder Scale 7 items (GAD-7). This scale demonstrated high sensitivity for detecting anxiety as a response to generalised anxiety disorder and panic disorder. Although not tested for validity and reliability in an inpatient brain injury population this outcome measure was selected as it is short with clear questions that are easy to use with clients who have marked impairments of cognition and communication. Also, the 2 item GAD (ie using the first 2 questions of the scale only) has shown high sensitivity and specificity for detecting generalised anxiety disorder in a primary care setting (Kroenke, Spitzer et al. 2007).
Timepoint [2] 286966 0
Pre and post intervention ie baseline and 4 weeks post intervention
Primary outcome [3] 286967 0
-Satisfaction with Life Scale. This scale inquires about participants overall assessment of their lives by comparing their current status and their self-defined expectations of what they would like their lives to be. Good validity, reliability and sensitivity have been demonstrated (Pavot and Diener 1993).
Timepoint [3] 286967 0
Pre and post intervention ie baseline and 4 weeks post intervention
Secondary outcome [1] 297067 0
- Likert scale to measure fatigue. Participants will be asked to rate their levels of fatigue mid morning and mid afternoon and this data will be averaged. This method will be used as it is a simple and quick way of ascribing quantitative value to qualitative data, to make it amenable to statistical analysis for a group of individuals with cognitive and communication difficulties.
Timepoint [1] 297067 0
Baseline and 4 weeks post intervention
Secondary outcome [2] 297068 0
Cognitive performance measures. The battery of three computerised cognitive performance tests are designed to evaluate selective attention, working memory, and psychomotor speed.
-The selective attention task is based on the task described by Posner (Posner 1980) and also Hodgins & Adair (Hodgins and Adair 2010). Hodgins & Adair (2010) reported that meditators demonstrated higher performance than non-meditators.
-Working memory will be assessed using the n-back task where participants are asked to identify if a current letter is the same as that presented 1 or 2 letters previously. McAllister et al. (2004) have reported on working memory deficits after TBI using the n-back task (McAllister, Flashman et al. 2004).
-Psychomotor speed will be assessed using a choice reaction time (CRT) task where participants have to press a corresponding key to the onset of an associated visual stimulus when there is one, two or four potential responses to choose from. Sosnoff et al. (2008) have demonstrated increased CRT latencies after TBI (Sosnoff, Broglio et al. 2008)
Timepoint [2] 297068 0
Baseline and 4 weeks post intervention
Secondary outcome [3] 297070 0
Participants' perspective of their level of mindfulness, anxiety, and satisfaction with life by guided interview.
Timepoint [3] 297070 0
Baseline and 4 weeks post intervention

Eligibility
Key inclusion criteria
Be an inpatient in the Brain Injury Rehabilitation Unit (BIRU) at Hampstead Rehabilitation Centre, Royal Adelaide Hospital
Be expected to be an inpatient for at least 6 weeks to be able to complete the baseline evaluation, intervention and follow-up evaluation.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of active psychosis and/or hallucinations
Behaviours which would be excessively disruptive to the group including excessive lack of inhibition, provocative behaviour and marked perseverative behaviours.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants matched for age, gender, pre-morbid level of global cognitive functioning and post incident Glasgow Coma Scale will be block allocated to either an intervention or control group from the cohort of inpatients undertaking rehabilitation following an acquired brain injury at Hampstead Rehbailitation Centre, Royal Adelaide Hospital. The capacity of the Brain Injury Rehabilitation Unit will not easily allow randomisation or blinding of outcome assessors due to the difficulty of running the two groups simultaneously. Simultaneous group allocation would disallow the recruitment of the required numbers of participants to gain sufficient power to demonstrate change. With block allocation there will be a reduction of rigour due to lack of randomisation. Also it may be difficult to blind an outcome assessor to allocation when groups are being run consecutively rather than simultaneously. An assessor who does not have a clinical role within BIRU will be used in an attempt to keep him/her blinded to allocation. Despite the limitations, this method of recruitment will be essential to ensure appropriate numbers enter the study.

Participants will firstly be block allocated to the mindfulness meditation based stress reduction (MBSR) group. Secondly, matched individuals will be allocated to the “Diversion and Relaxation” group. This group allocation and matching will be undertaken by a psychologist who is not part of the research trial and blinded to the groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation to groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Block randomised
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285111 0
Self funded/Unfunded
Name [1] 285111 0
Country [1] 285111 0
Australia
Primary sponsor type
Government body
Name
South Australian Brain Injury Rehabilitation Services
Address
Central Adelaide Local Health Network
207-255 Hampstead Road
Northfield SA 5085
Country
Australia
Secondary sponsor category [1] 283965 0
None
Name [1] 283965 0
Address [1] 283965 0
Country [1] 283965 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287122 0
Royal Adelaide Hospital
Ethics committee address [1] 287122 0
Level 3 Hanson Institute, RAH, North Terrace, Adelaide SA 5000
Ethics committee country [1] 287122 0
Australia
Date submitted for ethics approval [1] 287122 0
02/11/2011
Approval date [1] 287122 0
02/03/2012
Ethics approval number [1] 287122 0
nil

Summary
Brief summary
This study will investigate whether individuals who are receiving inpatient rehabilitation following an acquired brain injury (ABI) are able to participate safely in a meditation based stress reduction program.

In addition we will try to determine whether participants’ level of “mindfulness”, cognitive performance, level of anxiety, levels of vitality and overall perceived quality of life improves in response to their participation in the program compared to a control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34073 0
Address 34073 0
Country 34073 0
Phone 34073 0
Fax 34073 0
Email 34073 0
Contact person for public queries
Name 17320 0
Dr Maggie Killington
Address 17320 0
SA Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Northfield SA 5085
Country 17320 0
Australia
Phone 17320 0
+61 8 82221958
Fax 17320 0
+61 8 82221966
Email 17320 0
[email protected]
Contact person for scientific queries
Name 8248 0
Dr Maggie Killington
Address 8248 0
SA Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Northfield SA 5085
Country 8248 0
Australia
Phone 8248 0
+61 8 82221958
Fax 8248 0
+61 8 82221966
Email 8248 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.