Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000161820
Ethics application status
Approved
Date submitted
13/01/2012
Date registered
6/02/2012
Date last updated
27/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Direct Benefit of Neuropsychological Assessment with Feedback in Multiple Sclerosis
Scientific title
A randomised control trial of the direct psychological benefit of neuropsychological assessment with feedback in comparison to a wait-list control group in patients with multiple sclerosis and their caregivers
Secondary ID [1] 279726 0
Nil
Universal Trial Number (UTN)
U1111-1127-1585
Trial acronym
BONAMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 285562 0
Psychological health of caregivers 285563 0
Condition category
Condition code
Neurological 285757 285757 0 0
Multiple sclerosis
Mental Health 285758 285758 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Neuropsychological assessment with feedback.

The main components include: a clinical interview, the administration of objective, psychometric tests and observation of behaviour during testing, & interpretaion of the results, followed by collaborative discussion of results and their practical implications with patients and caregivers, and agreeing upon recommedations for management.

The intervention is delivered by qualified and experienced clinical neuropsychologists. It takes approximately 8-10 hours, and is spread over 2-3 face-to-face sessions (typically 2 sessions for the assessment and 1 for the feedback discussion) over a period of 1 - 2 weeks. It is delivered 6-7 weeks after randomisation.

Tests administered for the neuropsychological assessment vary according to clinical need, and are selected from a core battery, as listed below:
* Screening Examination for Cognitive Impairment in MS
* Wechsler Adult Intelligence Test – IV
* Wechsler Memory Scale – IV
* Behavioral Assessment of the Dysexecutive Syndrome
* Delis–Kaplan Executive Function System
* Trail Making Test A & B
* Paced Auditory Serials Additions Test
* Reid Recognition Memory Test
* Rey Auditory Verbal Learning Test
* Rey Complex Figure (Copy and Delayed Recall)
* Austin Maze
* Boston Naming Test
* COWAT Letter Fluency
* Semantic Fluency (Animals)
* Alternate Uses Test
* STROOP
* Wisconsin Card Sorting Test
* Cognitive Estimation Test
* Capacity to Consent to Treatment Instrument
* DEX Questionnaire (Self & Other)
* Spielberger’s State Trait Anxiety Inventory
* Beck Depression Inventory
* Geriatric Depression Scale
* Dissociative Experiences Scale

The feedback session comprises six main components:
* A review of the purpose of the assessment, based on the referral question and including concerns and observations expressed by patients, caregivers, or referrers
* An overview of the assessment process and how the neuropsychologist went about testing the patient’s cognitive and emotional functioning, and interpreting the assessment results
* A description of the patient’s assessed strengths and weaknesses
* An interpretation of the results, including severity of impairment, likely aetiology, role of the patient’s psychological and emotional state, and so forth
* A discussion of the likely practical implications of the patient’s cognitive profile
* Recommended strategies to manage significant cognitive impairment, and for staying well with MS, and the collaborative development of a general plan to implement agreed-upon strategies
The broad content of the strategic management advice is based on the current neuropsychological rehabilitation literature in general, and the MS neuropsychological literature specifically and is constantly updated. The specific content of this advice is adapted to take account of: the nature and severity of the patient’s cognitive impairment; pre-morbid level of intelligence, personality, relevant beliefs; nature of their other impairments and disabilities; personal, vocational and educational history; age, sex and cultural background; nature of the environment in which they are functioning (including the people with whom they interact); the nature of their short-term and long-term life goals. The advice is usually strategic in nature, rather than specific (e.g. recommending that an appointment diary should be used, rather than which specific diary type should be used or how to set it up). Often, patients are referred on to other rehabilitation specialists, such as occupational therapists, clinical psychologists, or social workers, for further therapy or assistance with implementing the agreed-upon strategies. Thus, the recommendations that are provided by treating neuropsychologists contribute to an integrated rehabilitative care plan for individual MS patients.
Intervention code [1] 284023 0
Rehabilitation
Comparator / control treatment
Wait list control.
The intervention is administered 6-7 weeks after randomisation.
Control group
Active

Outcomes
Primary outcome [1] 286281 0
Primary Outcome 1: Improved patient and/or caregiver knowledge of the patient's specific cognitive strengths and weaknesses on the Multiple Sclerosis Neuropsychological Questionnaire and the Domains of Cognitive Impairment Check-list
Timepoint [1] 286281 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Primary outcome [2] 286282 0
Primary Outcome 2: Improved patient use of adaptive psychological strategies for coping with the health problems caused by MS on the Coping with Health and Illness Problems scale.
Timepoint [2] 286282 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Primary outcome [3] 286283 0
Primary Outcome 3: Improved caregiving outcomes for the caregiver on the Bakas Caregiving Outcomes Scale
Timepoint [3] 286283 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [1] 295502 0
Secondary Outcome 1: Reduced patient stress on the Depression Anxiety and Stress Scale-21.
Timepoint [1] 295502 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [2] 295503 0
Secondary Outcome 2: Reduced patient anxiety on the Depression Anxiety and Stress Scale-21.
Timepoint [2] 295503 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [3] 295504 0
Secondary Outcome 3: Reduced patient depression on the Depression Anxiety and Stress Scale-21.
Timepoint [3] 295504 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [4] 295505 0
Secondary Outcome 4: improved patient quality of relationship with the caregiver on the Quality of Relationships Inventory.
Timepoint [4] 295505 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [5] 295506 0
Secondary Outcome 5: Improved patient MS self-efficacy on the Self-Efficacy Scale for MS.
Timepoint [5] 295506 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [6] 295507 0
Secondary Outcome 6: Improved patient use of appropriate memory compensation strategies on the Memory Compensation Questionnaire.
Timepoint [6] 295507 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [7] 295508 0
Secondary Outcome 7: Reduced caregiver stress on the Depression Anxiety and Stress Scale -21.
Timepoint [7] 295508 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [8] 295509 0
Secondary Outcome 8: Reduced caregiver anxiety on the Depression Anxiety and Stress Scale-21.
Timepoint [8] 295509 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [9] 295510 0
Secondary Outcome 9: Reduced caregiver depression on the Depression Anxiety and Stress-21.
Timepoint [9] 295510 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [10] 295511 0
Secondary Outcome 10: Improved caregiver quality of relationship with the patient on the Quality of Relationships Inventory.
Timepoint [10] 295511 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [11] 295512 0
Secondary Outcome 11: Improved caregiver self-efficacy for caregiving on the Family Caregiver Self-Efficacy Scale.
Timepoint [11] 295512 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [12] 295513 0
Secondary Outcome 12: Improved caregiver targeting of the most appropriate care tasks provided to the patient on the Caregiving Tasks in MS Scale.
Timepoint [12] 295513 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [13] 295514 0
Secondary Outcome 13: Improved quality of life for patients on the Life Satisfaction Scale.
Timepoint [13] 295514 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group
Secondary outcome [14] 295515 0
Secondary Outcome 14: Improved quality of life for caregivers on the Life Satisfaction Scale
Timepoint [14] 295515 0
Week 1 for the wait-list control group,
Week 5, 9, 13 for both groups, and
Week 17 for the intervention group

Eligibility
Key inclusion criteria
MS diagnosed by a neurologist
Referral for a non-urgent neuropsychological assessment.
Patients do not have to have a caregiver to participate.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of a developmental intellectual disability
* Severe cognitive impairment, including suspected MS-related dementia
* Significantly impaired hearing despite use of prescribed hearing aids or other equipment
* Impaired command of English due to non-English speaking background or aphasia
* Severe dysarthria or significantly impaired voice volume
* Current severe psychiatric impairment (e.g. severe depression, anxiety, or psychosis)
* Impaired ability to manage the practical requirements of the study, such as an unstable medical or health condition causing delirium or hospitalizations, or a lack of reliable access to a telephone and mailbox due to unstable accommodation and/or support arrangements

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed, random allocation of patients is achieved using a block randomisation process with blocks of variable size. Randomisation is conducted off-site by one of the authors, and allocation is concealed using a computer generated set of random numbers. Group allocation is written onto inserts placed in sequentially–numbered, opaque envelopes which are then opened sequentially as patients are recruited to the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation is concealed using a computer generated set of random numbers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The protocol utilizes a' sham-wait-list' control method which is structured to effectively blind patients and caregivers to their group allocation, but also avoids making the control group participants wait for their neuropsychological assessment appointment. Both groups receive the intervention 6 weeks after randomisation, the only difference between the groups is the timing of the outcome measures; the intervention group receives one set of outcome before the intervention and three afterwards (all 4-weeks apart), and the wait-list control group receives two sets of outcome measures before the intervention and two afterwards (all 4-weeks apart). In this way the control group participants did not have to actually wait for their scheduled neuropsychological assessment, making this a 'sham wait-list' control (that is, the 'waiting' time was a sham, not the neuropsychological assessment intervention that they received).

In order to achieve this, the principle investigator organises the timing of the outcome measures. For each participant, the neuropsychological assessment appointment is set at least 6 weeks after recruitment into the study. Once group allocation has been determined by the randomisation process, the first set of outcome measures is back-dated according to group. For the intervention group the first set of outcome measures occurs 1 week before the neuropsychological assessment (at study week 5), and the next 3 sets occur every 4 weeks after this date. For the control group the first set of outcome measures occurs 5 weeks before the neuropsychological assessment (at study week 1), the next set occurs 4 weeks later (at study week 5), and the next 2 sets occur every 4 weeks after this.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation: Beardmore et al. (Beardmore et al., 1999) examined the effect of feedback from neuropsychological assessment using a knowledge questionnaire developed for that purpose. Data from this study was used to calculate the sample size requirements for this study. Using an a set at .01 (two-tailed) and power of .8, a sample size of 51 participants in each group was required (Bird & Hall, 1986). Attrition from the study was expected to be low and therefore the study aimed to recruit 55 participants per group, 110 in total.

For the RCT phase of the study, the following statistical analyses were used: The data were analysed using the SPSS statistical package version-22 (2013). Repeated- measures Analysis of Variance examined the between-group differences in the primary and secondary variables, after controlling for relevant demographics and disease variables. Group-by-time interaction effects were examined in the analyses. Paired student t-tests examined the within-groups differences, and independent groups t-tests, chi-square tests, and Pearson correlation coefficients were used to test all other comparisons. Cohen’s d was used to calculate effect sizes for the t-tests and chi-square tests, respectively (Fritz, Morris, & Richler, 2012). Parametric statistical analyses were conducted as the assumption of normality is reported to be fairly robust to violations. In the analyses, alpha was set at p=<.01. However, group-by-time interaction effects were examined via effect sizes (i.e. effect sizes were the predominant means of interpreting the data (Perdices, 2017), specifically Eta Partial Squared), but only medium or larger interaction effect sizes (?p2 = 0.06) (Fritz, Morris, & Richler, 2012) were interpreted as being clinically significant.

For the follow-up cross-over phase of the study the following statistical analyses were used: The data were analysed using the SPSS statistical package (version 22, 2013). Independent samples t-tests examined the outcome variables that showed significant improvement at 1-week post-neuropsychological assessment (NPA) feedback; by evaluating the changes the occurred between pre-NPA feedback vs. 5-weeks post-NPA, and 9-weeks post-NPA follow-up. If there was at least a medium effect size (Cohen’s d = .5) between the outcomes between baseline vs. 5- and/or 9-weeks, the effects of the intervention were assumed to have been maintained over time. Adjustments were made (d-unbiased) for smaller sample sizes (n<15) to reduce the over-estimation of the effect sizes (Fritz, Morris, & Richler, 2012).

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The sponsoring organisation (MS Australia-ACT/NSW/VIC) suddenly ceased providing all in-house psychological services, along with cuts and reductions to other services, in June 2013, even though MS Research Australia had provided funding for the project though to May 2014. Without a neuropsychological assessment service to provide to patients and evaluate, recruitment into the trial had to cease. Requests by the principle investigator to be allowed to continue to provide the neuropsychological service part-time to enable the project to be completed as planned were declined.
Date of first participant enrolment
Anticipated
1/10/2009
Actual
1/10/2009
Date of last participant enrolment
Anticipated
Actual
10/05/2013
Date of last data collection
Anticipated
Actual
9/07/2013
Sample size
Target
110
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment postcode(s) [1] 4854 0
2141

Funding & Sponsors
Funding source category [1] 284508 0
Charities/Societies/Foundations
Name [1] 284508 0
MS Australia - ACT/NSW/VIC
Country [1] 284508 0
Australia
Funding source category [2] 284509 0
Charities/Societies/Foundations
Name [2] 284509 0
MS Research Australia
Country [2] 284509 0
Australia
Primary sponsor type
Individual
Name
Wendy Longley
Address
John Walsh Centre for Rehabilitation Research
Northern Clinical School, Faculty of Medicine, Sydney University
Level 12, Kolling Institute,
Royal North Shore Hospital,
Cnr Reserve Road & First Avenue (off Pacific Hwy),
St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 283438 0
University
Name [1] 283438 0
University of Sydney, supervised by Professor Robyn Tate
Address [1] 283438 0
John Walsh Centre for Rehabilitation Research
Northern Clinical School, Faculty of Medicine, Sydney University
Level 12, Kolling Institute,
Royal North Shore Hospital,
Cnr Reserve Road & First Avenue (off Pacific Hwy),
St Leonards, NSW 2065
Country [1] 283438 0
Australia
Secondary sponsor category [2] 283439 0
University
Name [2] 283439 0
Australian National University, supervised by Dr Rhonda Brown
Address [2] 283439 0
Research School of Psychology
The Australian National University,
Canberra,
ACT 0200
Country [2] 283439 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286490 0
Royal Rehabilitation Centre Sydney Ethics Committee
Ethics committee address [1] 286490 0
Ethics committee country [1] 286490 0
Australia
Date submitted for ethics approval [1] 286490 0
Approval date [1] 286490 0
18/06/2008
Ethics approval number [1] 286490 0
08/RRCS/03

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33629 0
Ms Wendy Ann Longley
Address 33629 0
John Walsh Centre for Rehabilitation Research,
(Northern Clinical School, Faculty of Medicine, Sydney University)
Level 12, Kolling Institute, Royal North Shore Hospital,
Cnr Reserve Road & First Avenue (off Pacific Hwy),
St Leonards, NSW 2065
Country 33629 0
Australia
Phone 33629 0
61-2-9926 4962
Fax 33629 0
61-2-9926 4045
Email 33629 0
[email protected]
Contact person for public queries
Name 16876 0
Wendy Ann Longley
Address 16876 0
John Walsh Centre for Rehabilitation Research,
(Northern Clinical School, Faculty of Medicine, Sydney University)
Level 12, Kolling Institute, Royal North Shore Hospital,
Cnr Reserve Road & First Avenue (off Pacific Hwy),
St Leonards, NSW 2065
Country 16876 0
Australia
Phone 16876 0
61-2-9926 4962
Fax 16876 0
61-2-9926 4045
Email 16876 0
[email protected]
Contact person for scientific queries
Name 7804 0
Wendy Ann Longley
Address 7804 0
John Walsh Centre for Rehabilitation Research,
(Northern Clinical School, Faculty of Medicine, Sydney University)
Level 12, Kolling Institute, Royal North Shore Hospital,
Cnr Reserve Road & First Avenue (off Pacific Hwy),
St Leonards, NSW 2065
Country 7804 0
Australia
Phone 7804 0
61-2-9926 4962
Fax 7804 0
61-2-9926 4045
Email 7804 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
SourceTitleYear of PublicationDOI
EmbaseA protocol for measuring the direct psychological benefit of neuropsychological assessment with feedback in multiple sclerosis.2012https://dx.doi.org/10.1017/BrImp.2012.20
N.B. These documents automatically identified may not have been verified by the study sponsor.