Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000587808
Ethics application status
Approved
Date submitted
31/05/2012
Date registered
31/05/2012
Date last updated
6/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised control trial of ePACT (Electronic Personal Administration of Cognitive Therapy): a flexible treatment for depression and anxiety in adults living with chronic spinal cord injury
Scientific title
Among adults living with chronic spinal cord injury and co-morbid depression and/or anxiety and/or clinical stress, will the administration of the psychological intervention - Electronic Personal Administration of Cognitive Therapy (ePACT) - provide more relief from their symptoms of mental illness compared to business as usual
Secondary ID [1] 280591 0
Nil
Universal Trial Number (UTN)
U1111-1131-3432
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
clinical depression 286588 0
clinical anxiety 286589 0
clinical stress 286590 0
chronic spinal cord injury 286592 0
Condition category
Condition code
Mental Health 286864 286864 0 0
Depression
Mental Health 286865 286865 0 0
Anxiety
Injuries and Accidents 286866 286866 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Electronic Personal Administration of Cognitive Therapy (ePACT) is a 10 week x 10 module (1 module per week) psychological treatment based largely on cognitive behaviour principles with the addition of some positive psychology and mindfulness principles. ePACT is designed to be delivered electronically and supplemented with either or both telephone and email clinician contact should they require some additional support. Each module should take around 45mins to complete. Additional activity/homework tasks designed to personalise the focus of each module will be also be undertaken each week. The delivery of ePACT will be via autorun CD-ROM on computers that are also connected to the internet.
Intervention code [1] 284977 0
Treatment: Other
Intervention code [2] 284978 0
Rehabilitation
Intervention code [3] 284979 0
Behaviour
Comparator / control treatment
ePACT is designed to augment treatment as usual therefore the control will be standard treatment/business as usual. Waitlist control will be eligible to begin ePACT at the post-intervention equivalent time (~10wks) if they are still meet qualifying criteria.
Control group
Active

Outcomes
Primary outcome [1] 287220 0
% whose DASS21 scores drop to below the clinically significant threshold [depression<10; anxiety <8; stress<15]
Timepoint [1] 287220 0
baseline, post-intervention and 24wks post-intervention
Primary outcome [2] 287221 0
% improvement of subjective well-being scores in Personal Wellbeing Index (PWI) whose scores rise to above the homeostatic threshold of 70% scale maximum
Timepoint [2] 287221 0
baseline, post-intervention and 24wks post-intervention
Secondary outcome [1] 297659 0
mean score improvement in Spinal Cord Lesion Emotional Consequences Questionnaire v1 Australia
Timepoint [1] 297659 0
baseline, post-intervention and 24wks post-intervention

Eligibility
Key inclusion criteria
adults (18yrs+); living with chronic spinal cord injury (6mths+ post-injury); DASS21 scores at or above clinical threshold indicating presence of mental illness; proficient in written and spoken English; computer and internet access
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
breach of the key inclusion criteria

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study began with a simple 1:1 randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) in blocks of 10. However, in order to achieve a more balanced final sample, approximately 9mths or 60% into the recruitment period, the randomisation methodology was adapted to be weighted in favour of the allocation group 3:2 in blocks of 10.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study uses a single intervention with delayed start (waitlist control trial) where control group (business as usual) will also receive the intervention with a delayed start of 10-12wks if still eligible
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/06/2012
Actual
21/06/2012
Date of last participant enrolment
Anticipated
Actual
21/09/2013
Date of last data collection
Anticipated
Actual
21/12/2013
Sample size
Target
150
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Recruitment postcode(s) [1] 5345 0
3162

Funding & Sponsors
Funding source category [1] 285347 0
Charities/Societies/Foundations
Name [1] 285347 0
beyondblue Victorian Centre of Excellence
Country [1] 285347 0
Australia
Primary sponsor type
Individual
Name
Dr. Christine Migliorini
Address
Centre for Developmental Psychiatry & Psychology
School of Psychology and Psychiatry
Clayton Campus
Monash University VIC 3800
Country
Australia
Secondary sponsor category [1] 284197 0
None
Name [1] 284197 0
Address [1] 284197 0
Country [1] 284197 0
Other collaborator category [1] 276835 0
Individual
Name [1] 276835 0
Dr. Andrew Sinclair
Address [1] 276835 0
Psychology and Counselling Services
Independence Australia - Community Solutions
208 Wellington St
Collingwood VIC 3066
Country [1] 276835 0
Australia
Other collaborator category [2] 280282 0
Individual
Name [2] 280282 0
Dr. Peter New
Address [2] 280282 0
Spinal Rehabilitation Service,
Caulfield Hospital, Alfred Health, Melbourne, Victoria 3162 and

Epworth-Monash Rehabilitation Medicine Unit,
Southern Medical School, Monash University, Melbourne, Victoria 3800
Country [2] 280282 0
Australia
Other collaborator category [3] 280283 0
Individual
Name [3] 280283 0
Assoc Prof Doug Brown
Address [3] 280283 0
Spinal Research Institute
Austin Health
Melbourne, Victoria 3084
Country [3] 280283 0
Australia
Other collaborator category [4] 280284 0
Individual
Name [4] 280284 0
Prof Bruce Tonge
Address [4] 280284 0
Centre for Developmental Psychiatry & Psychology
Department of Psychiatry
Monash University
Melbourne, Victoria 3800
Country [4] 280284 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287361 0
Alfred Health Ethics Committee
Ethics committee address [1] 287361 0
Office of Ethics and Governance
Ground floor, Linay Pavilion
The Alfred
55 Commercial Rd
Melbourne VIC 3004
Ethics committee country [1] 287361 0
Australia
Date submitted for ethics approval [1] 287361 0
21/03/2012
Approval date [1] 287361 0
09/05/2012
Ethics approval number [1] 287361 0
1/12/0115
Ethics committee name [2] 287362 0
Monash University Ethics Committee
Ethics committee address [2] 287362 0
Human Ethics Office
1st floor, Building 3e
Monash Research Office
Clayton Campus
Monash University VIC 3800
Ethics committee country [2] 287362 0
Australia
Date submitted for ethics approval [2] 287362 0
05/05/2012
Approval date [2] 287362 0
14/05/2012
Ethics approval number [2] 287362 0
CF 12/1328 2012000696
Ethics committee name [3] 287363 0
Austin Health Ethics Committee
Ethics committee address [3] 287363 0
Research Ethics Unit
Austin Hospital
PO Box 5555
Heidelberg VIC 3084
Ethics committee country [3] 287363 0
Australia
Date submitted for ethics approval [3] 287363 0
09/03/2012
Approval date [3] 287363 0
Ethics approval number [3] 287363 0
04608

Summary
Brief summary
Previous research has shown that many people living with spinal cord injury demonstrate great resiliency and lead happy, productive lives. However, there are also many others who experience emotional difficulties such as depression or anxiety. Of particular concern is that the majority of people experiencing those difficulties do not receive any specific treatment or psychological support.
To address this problem, a new flexible psychological treatment has been developed - ePACT. ePACT is delivered electronically and supplemented with personal contact by email and/or phone with a mental health clinician. The recent pilot of ePACT was well received, easily accessible and effective for participants who each found it acceptable and helpful. This current study will expand the distribution of ePACT to provide further evidence supporting the effectiveness of ePACT. This aim of this study is to build on the previous pilot study by investigating the suitability and effectiveness of ePACT on a larger body of people.
Trial website
Trial related presentations / publications
Migliorini, C., Sinclair, A. J., New, P. W., Brown, D. J., & Tonge, B. (2015). Trialling an Online Intervention Treating Mood Disturbance in Persons with SCI. Archives of Physical Medicine and Rehabilitation, 96(10), e62-e63. doi:10.1016/j.apmr.2015.08.211
Migliorini, C., Sinclair, A., Brown, D., Tonge, B., & New, P. (2015). A randomised control trial of an Internet-based cognitive behaviour treatment for mood disorder in adults with chronic spinal cord injury. Spinal Cord, 54, 695. doi:10.1038/sc.2015.221
Migliorini, C., Sinclair, A., Brown, D., Tonge, B., & New, P. (2015). Prevalence of mood disturbance in Australian adults with chronic spinal cord injury. Internal Medicine Journal, 45, 1014-1019. Retrieved from http://dx.doi.org/10.1111/imj.12825 doi:10.1111/imj.12825
Migliorini, C., Sinclair, A., Brown, D., Tonge, B., & New, P. (2016). Screening and treating co-morbid mood disturbance in adults with chronic SCI. Australian & New Zealand Spinal Cord Society Annual Scientific Meeting, Adelaide, South Australia.
Migliorini, C., Sinclair, A., New, P., Brown, D., & Tonge, B. (2014). RCT of an online intervention treating emotional disturbance …. And some lessons that we have learnt. Australian & New Zealand Spinal Cord Society Annual Scientific Meeting, Auckland, New Zealand.
Migliorini, C., Sinclair, A., Brown, D., Tonge, B., & New, P. (2015). Trialling and online intervention treating mood disturbance in persons with SCI. American Congress of Rehabilitation Medicine Conference, Dallas Texas.
Public notes
Due to the impact of the slower-than-expected recruitment rate, and the unbalanced participant withdrawal/drop-out rate (each assigned to the intervention group, none to the waitlist control), recruitment continued past the protocol's expected recruitment curt-off date.
For the same reasons as above and the fixed funding timeframe , the number of participants who were re-assessed at 24weeks post-intervention was reduced.
A full discussion is provided within:
Migliorini, C., Sinclair, A., Brown, D., Tonge, B., & New, P. (2015). A randomised control trial of an Internet-based cognitive behaviour treatment for mood disorder in adults with chronic spinal cord injury. Spinal Cord, 54, 695. doi:10.1038/sc.2015.221

Contacts
Principal investigator
Name 34244 0
Dr Christine Migliorini
Address 34244 0
The Psychosocial Research Centre
Department of Psychiatry
The University of Melbourne
Ground Floor, 130 Bell St
Coburg VIC 3058
Country 34244 0
Australia
Phone 34244 0
+61 3 9355 9830
Fax 34244 0
Email 34244 0
[email protected]
Contact person for public queries
Name 17491 0
Dr Dr Christine Migliorini
Address 17491 0
The Psychosocial Research Centre
Department of Psychiatry
The University of Melbourne
Ground Floor, 130 Bell St
Coburg VIC 3058
Country 17491 0
Australia
Phone 17491 0
+61 3 9355 9830
Fax 17491 0
Email 17491 0
[email protected]
Contact person for scientific queries
Name 8419 0
Dr Dr. Christine Migliorini
Address 8419 0
The Psychosocial Research Centre
Department of Psychiatry
The University of Melbourne
Ground Floor, 130 Bell St
Coburg VIC 3058
Country 8419 0
Australia
Phone 8419 0
+61 3 9355 9830
Fax 8419 0
Email 8419 0
[email protected]

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