Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000984897
Ethics application status
Approved
Date submitted
11/09/2012
Date registered
12/09/2012
Date last updated
12/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Group psychological intervention for adult people with spinal cord injury in the Rehabilitation phase
Scientific title
The effect of group cognitive behavioural therapy on psychological status, pain status and fatigue status in adult people with spinal cord injury in the rehabilitation phase
Secondary ID [1] 281175 0
Nil
Universal Trial Number (UTN)
U1111-1134-5485
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spinal cord injury 287394 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287725 287725 0 0
Other physical medicine / rehabilitation
Mental Health 287739 287739 0 0
Depression
Neurological 287740 287740 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive behaviour therapy (CBT) administered in groups of 4 to 6 people with SCI by two clinical psychologists in each of the two SCI Units. Sessions consist of 2 hours per week for a period of 6 to 8 consecutive weeks, with a maximum of 8 sessions. All participants receiving group CBT also receive standard rehabilitation treatment. If a participant misses a session due to say illness, then they will receive an individual treatment session on the topic missed, equivalent to the group session.
Intervention code [1] 285671 0
Rehabilitation
Intervention code [2] 285685 0
Behaviour
Intervention code [3] 285686 0
Lifestyle
Comparator / control treatment
standard rehabilitation treatment, that is, they continue to receive standard medical, physical and occupational therapies.
Control group
Active

Outcomes
Primary outcome [1] 287966 0
change in mood states measured by HADS, DSM IV criteria, post traumatic adjustment scale,
Timepoint [1] 287966 0
on admission to Rehabilitation, on discharge and 6 months after discharge from rehabilitation
Primary outcome [2] 287967 0
level of pain measured by duration and interference as measured by the International Pain Basic Data Set and by Pain related Self statement Scale (pain catastrophising)
Timepoint [2] 287967 0
on admission to Rehabilitation, on discharge and 6 months after discharge
Primary outcome [3] 287976 0
Quality of Life by Medical Outcomes Study SF-36
Timepoint [3] 287976 0
on admission to Rehabilitation, on discharge and 6 months after discharge
Secondary outcome [1] 299153 0
fatigue change measured by Fatigue severity scale
Coping skills by COPE
Timepoint [1] 299153 0
on discharge and 6 months after discharge

Eligibility
Key inclusion criteria
English speaking, chronic spinal cord injury, patient in rehabilitation unit,
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
severe head injury

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
SCI participants were enrolled into the study based on the year they were in the rehabilitation units at POWH and RRCS
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5738 0
1680
Recruitment postcode(s) [2] 5739 0
2031

Funding & Sponsors
Funding source category [1] 285986 0
Commercial sector/Industry
Name [1] 285986 0
Lifetime Care Support Authority
Country [1] 285986 0
Australia
Primary sponsor type
Individual
Name
Ashley Craig
Address
Professor
Rehabilitation Studies Unit, Northern Clinical School, Sydney Medical School
THE UNIVERSITY OF SYDNEY
PO Box 6, Ryde, NSW, 1680
Country
Australia
Secondary sponsor category [1] 284805 0
Individual
Name [1] 284805 0
James Middleton
Address [1] 284805 0
Director, NSW SCI Service

Associate Professor
Rehabilitation Studies Unit, Northern Clinical School, Sydney Medical School
THE UNIVERSITY OF SYDNEY
PO Box 6, Ryde, NSW 1680
Country [1] 284805 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288031 0
Northern Sydney Central Coast Human Research Ethics Committee
Ethics committee address [1] 288031 0
Research Office Level, Royal North Shore Hospital, Pacific Highway ST LEONARDS NSW 2065
Ethics committee country [1] 288031 0
Australia
Date submitted for ethics approval [1] 288031 0
Approval date [1] 288031 0
03/12/2008
Ethics approval number [1] 288031 0
0812-257M
08/HAWKE/167/168
Ethics committee name [2] 288032 0
South Eastern Sydney Local Health District HREC (Northern Sector
Ethics committee address [2] 288032 0
Research Support Office G71 East Wing, Edmund Blacket Building Prince of Wales Hospital Cnr High and Avoca Streets RANDWICK NSW 2031
Ethics committee country [2] 288032 0
Australia
Date submitted for ethics approval [2] 288032 0
Approval date [2] 288032 0
01/02/2010
Ethics approval number [2] 288032 0
09/G/139; 08/HAWKE/167/168

Summary
Brief summary
SCI results in severe impairment and is managed by a multidisciplinary rehabilitation approach. Unless sensitive and timely psychosocial assessment occurs, serious
complications may not be identified or appropriately managed. This project will investigate the following within the Statewide SCI Units in Sydney:
* develop and pilot a standardised psychosocial assessment schedule that can be used to monitor progress, set goals and detect psychosocial risks in people with SCI;
* assess the efficacy of a multi-layered psychosocial cognitive behavioural therapy self-management rehabilitation package to be run as a service programme during inpatient rehabilitation in the SCI Units in Sydney
Trial website
Trial related presentations / publications
Craig, A., & Nicholson Perry, K. (2008). Guide for health professionals on the psychosocial care for people with spinal cord injury. Sydney: New South Wales State Spinal Cord Injury Service.
Nicholson Perry, K., Craig, A., Middleton, J. (2009). Psychosocial risk factors and outcomes: Measuring risk and progress in an Australian context. Presentation, ISCOS.
Craig, A. (2012). Protection against the adversity of neurological injury: The process of learning to be resilient. Workshop presented in The University of Sydney, 17 July, 2012.
Public notes

Contacts
Principal investigator
Name 34673 0
Address 34673 0
Country 34673 0
Phone 34673 0
Fax 34673 0
Email 34673 0
Contact person for public queries
Name 17920 0
Ashley Craig
Address 17920 0
Rehabilitation Studies Unit, Northern Clinical School,
Sydney Medical School
THE UNIVERSITY OF SYDNEY
PO Box 6, Ryde, NSW 1680
Country 17920 0
Australia
Phone 17920 0
+61 2 9808 9236
Fax 17920 0
+ 61 2 9809 9037
Email 17920 0
[email protected]
Contact person for scientific queries
Name 8848 0
Ashley Craig
Address 8848 0
Rehabilitation Studies Unit, Northern Clinical School,
Sydney Medical School
THE UNIVERSITY OF SYDNEY
PO Box 6, Ryde, NSW 1680
Country 8848 0
Australia
Phone 8848 0
+61 2 9808 9236
Fax 8848 0
+ 61 2 9809 9037
Email 8848 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23804Other    Published papers

Results publications and other study-related documents

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