Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000031662
Ethics application status
Approved
Date submitted
18/12/2013
Date registered
10/01/2014
Date last updated
4/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of short term support for emergency department attendees who present with moderate and high levels of stress: a pilot study
Scientific title
A randomised controlled trial of a psychosocial brief intervention of motivational interviewing with emergency department attendees with mild and moderate levels of stress
Secondary ID [1] 283804 0
NONE
Universal Trial Number (UTN)
U1111-1151-5232
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate and high levels of non specific psychological distress identified by the Kessler Psychological distress scales (K10) 290780 0
Condition category
Condition code
Mental Health 291145 291145 0 0
Depression
Mental Health 291146 291146 0 0
Anxiety
Public Health 291147 291147 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The detection of health problems before they become severe will enable intervention and support to be provided at an early stage. The Brief Intervention (BI), based on Motivational Interviewing (MI) principles, will be designed to encourage and motivate study participants to seek and obtain further assistance for their psychological needs which may improve health and prevent further deterioration. The MI intervention is designed to be pragmatic in that the MI will be necessarily tailored to each participant’s individual circumstances. Following recruitment, all participants will be provided with 'standard care' (i.e. usual care from their ED admittance). Those participants who have been randomised into the intervention group, the BI will be delivered by telephone interview 48-96 hours after the participant’s ED attendance, with a ‘booster’ MI of three telephone calls during the two week period following the initial BI. The initial MI and the three subsequent MIs are each expected to be 60 minutes in length. (approx 4 hours total for each study participant)

Follow up of all participants will occur at one, three, six and twelve months by telephone contact. Pre and post-intervention measures will be used to assess mental health and well-being, subjective quality of life (SQOL); and intervention based outcomes including motivation and confidence, healthcare-seeking behaviour and appropriate health service utilisation.

Motivational interviewing (MI) is client-centred, directed therapy, which prepares individuals to become more receptive to change by exploring dissonance in the perceived benefits and costs of behaviours. Its central principal is that motivation to change should be elicited from people, not somehow imposed on them. MI is non-confrontational, assumes equity in the client counselor relationship, emphasises the client’s right to define their own problems and to choose how to deal with them. The counselor uses empathetic listening to minimise resistance and increase motivation for change. Motivation is viewed as a state of readiness to change which fluctuates and can be influenced by others. The stages of change model have proved useful for the understanding and conduct of a motivational interviewing session. MI is particularly useful for working with clients who are ambivalent, resistant or reluctant to change. All change is preceded by some degree of ambivalence.

When using an interview technique these components are applied by: exploration of the person’s thoughts about the issue e.g. feeling depressed or stressed; use of reflective listening; showing respect and willingness to understand; giving relevant and accurate health information and providing explanations; helping to clarify personal goals or role in the community; avoiding argument; and helping people to look at their behaviour and how it impacts on others.
Intervention code [1] 288489 0
Early detection / Screening
Comparator / control treatment
The control group will have usual care, i.e. the necessary treatment from their emergency department attendance and no study intervention of motivational interviewing

For all participants, follow up will occur at one, three, six and twelve months by telephone contact. Pre and post-intervention measures will be used to assess mental health and well-being, subjective quality of life (SQOL); and intervention based outcomes including motivation and confidence, healthcare-seeking behaviour and appropriate health service utilisation.
Control group
Active

Outcomes
Primary outcome [1] 291135 0
Reduced psychological distress will be assessed at baseline and results will be compared to the follow up time points at 1, 3, 6, and 12 months. Psychological distress will be measured primarily by the Kessler non-specific psychological distress scales (K10). Other measurements of psychological distress will be measured by the Depression, Anxiety, Stress scales (DASS21).
Timepoint [1] 291135 0
At baseline, 1,3,6 and 12 months
Secondary outcome [1] 306098 0
Reduced use of acute services, such as emergency departments. This will be measured at the follow up time points. Questions will be based on the Australian Bureau of Statistics national health surveys: health related actions from the National Health Survey; and health care utilisation from the National Health and Well Being surveys 2007.
Timepoint [1] 306098 0
At baseline, 1, 3, 6 and 12 months

Eligibility
Key inclusion criteria
Consenting adults, 18 years and over, who are alert and orientated and able to speak English. Those emergency department attendees, who have mild/moderate levels of psychological distress identified by the Kessler Physiological Distress Scales because there is a strong association between very high K10 scores and a current Composite International Diagnostic Interview (CIDI) diagnosis of anxiety and affective disorders, and a lesser but still significant association the K10 and other mental health categories, or the presence of any current mental disorder; and do not require hospital admission, will be eligible
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with 'severe' K10 scores; those unable or unwilling to give consent; people with a cognitive impairment/learning disability; those admitted to hospital as in-patients; those already in mental health programs; those unable or unwilling to be contacted by telephone; or those in police custody.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All adult patients presenting to the ED during specified data collection periods will be screened to participate in the study. Those that meet the screening criteria will be allocated to the relevant study arm (see below), which includes a control group. Based on psychological distress assessment, consenting ED patients will be categorised into 3 initial groups; those with: I) Mild and moderate psychological distress II) Low psychological distress. Subsequently, group I will be randomly allocated to receive either the MI or usual care (usual care does not involve BI or MI). A randomised sample will be selected from group II, and will represent a ‘non-stress’ population control group. Thus, there will be three arms to the study: Group IX. Mild/moderate psychological distress score BI plus usual care Group IO. Mild/moderate psychological distress score Usual care Group IIO.Low psychological distress score Usual care Allocation concealment: Simple randomisation with an experimental to control ratio of 1:1. Sealed opaque envelopes will be used rather than a remote service to simplify procedures in a busy setting. Envelopes will be prepared in advance by an independent team using random number tables which will be generated by an independent random number generator. Participants randomly select an envelope, the contents of which indicate their assigned condition (standard care, or intervention). It is not possible to blind the study participants or those administering the intervention to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Methods used to randomise participants into treatment and control groups will be done using opaque envelopes. Participants randomly select an envelope, the contents of which indicate their assigned condition (standard care, or intervention). Envelopes will be prepared in advance by an independent team using random number tables which will be generated by an independent random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
sample size: There is a limited amount of published data regarding the ideal size for pilot studies and it has been commented that it seems that sample calculations may not be required for this type of study. An audit of the registered trails found that the median sample size per arm for pilot studies was 30 (range from 8 to 114). Based on this evidence we will recruit the median sample of 30 participants per arm, n=90.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/02/2014
Actual
12/02/2015
Date of last participant enrolment
Anticipated
30/06/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1868 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 7652 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 288461 0
Government body
Name [1] 288461 0
Australian Commonwealth Government Department of Education, Science and Training (Australian Post Graduate Award Scholarship)
Country [1] 288461 0
Australia
Funding source category [2] 288462 0
University
Name [2] 288462 0
Australian Catholic University (Australian Post Graduate Award Scholarship)
Country [2] 288462 0
Australia
Primary sponsor type
Hospital
Name
The Prince Charles Hospital
Address
Rode Road
Chermside Queensland 4032
Country
Australia
Secondary sponsor category [1] 287233 0
None
Name [1] 287233 0
Address [1] 287233 0
Country [1] 287233 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290330 0
Human Research Ethics Committee
Ethics committee address [1] 290330 0
Ethics committee country [1] 290330 0
Australia
Date submitted for ethics approval [1] 290330 0
Approval date [1] 290330 0
17/10/2013
Ethics approval number [1] 290330 0
HREC/13/QPCH/244
Ethics committee name [2] 290331 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [2] 290331 0
Ethics committee country [2] 290331 0
Australia
Date submitted for ethics approval [2] 290331 0
Approval date [2] 290331 0
11/11/2013
Ethics approval number [2] 290331 0
2013 294Q

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

Contacts
Principal investigator
Name 45118 0
Ms Petra Lawrence
Address 45118 0
Nursing Research and Practice Development
The Prince Charles Hospital/Australian Catholic University
Rode Road
Chermside Qld 4032
Country 45118 0
Australia
Phone 45118 0
+61 421 946 742
Fax 45118 0
Email 45118 0
[email protected]
Contact person for public queries
Name 45119 0
Petra Lawrence
Address 45119 0
Nursing Research and Practice Development
The Prince Charles Hospital/Australian Catholic University
Rode Road
Chermside Qld 4032
Country 45119 0
Australia
Phone 45119 0
+61 421 946 742
Fax 45119 0
Email 45119 0
[email protected]
Contact person for scientific queries
Name 45120 0
Paul Fulbrook
Address 45120 0
Nursing Research and Practice Development
The Prince Charles Hospital/Australian Catholic University
Rode Road
Chermside Qld 4032
Country 45120 0
Australia
Phone 45120 0
+61 7 3139 4087
Fax 45120 0
Email 45120 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

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