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Trial registered on ANZCTR
Registration number
ACTRN12614000178640
Ethics application status
Not yet submitted
Date submitted
7/02/2014
Date registered
14/02/2014
Date last updated
14/02/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Posttraumatic Stress Disorder after cardiac surgery: assessing the efficacy of psychoeducation as a pre-Intensive Care Unit intervention.
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Scientific title
Posttraumatic Stress Disorder after cardiac surgery: assessing the efficacy of psychoeducation as a pre-Intensive Care Unit intervention.
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Secondary ID [1]
284045
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
The symptoms of Post Traumatic Stress Disorder in survivors of cardiac intensive care treatment during recovery from surgery.
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Condition category
Condition code
Mental Health
291444
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0
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Depression
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Cardiovascular
291480
291480
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0
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Other cardiovascular diseases
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Surgery
291481
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A self-administered psychoeducational package will be given to the participants in the experimental group 1 week prior to their surgery. The pack is in printed form and will include a relaxation CD. They are expected to take the information pack home with them and practice the exercises and read the information regarding PTSD and their surgery. They are required to complete a self assessment battery once a week to monitor progress (takes a half hour to complete) as well as complete 3 psychological assessments during their meetings with the researcher. The package will contain breathing and relaxation exercises, basic cognitive training skills, and medical information regarding their surgery which they are expected to practice every day for 6 weeks. This will take approximately half an hour. The participants will be asked to keep a daily log indicating adherence to the intervention.
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Intervention code [1]
288738
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Prevention
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Intervention code [2]
288770
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Behaviour
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Comparator / control treatment
A control group will receive standard treatment that includes information regarding their surgery and psychoinformation regarding Post Traumatic Stress Disorder. They will not be required to practice relaxation and cognitive behavioral exercises, but will be asked to monitor their progress using the same weekly self-assessment as the experimental group. The control group will be required to complete 3 psychological tests to assess baseline functioning and any changes during the study. Immediately following the end of the treatment period (10 weeks after surgery) the control group will receive the same self-administered treatment package and full instructions. Both groups and their welfare will be continuously monitored by a registered Clinical Psychologist.
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Control group
Active
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Outcomes
Primary outcome [1]
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Clients will be assessed for baseline PTSD score using the Impact of Events Scale before and following treatment.
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Assessment method [1]
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Timepoint [1]
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Participants will assessed prior to admission for cardiac surgery, ideally 1 - 2 weeks prior, 6 weeks later at the end of the intervention, and again four weeks later during a follow-up meeting.
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Primary outcome [2]
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Subjective Units of Distress self-measure to assess surgery-related distress
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Assessment method [2]
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Timepoint [2]
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Weekly from the point of baseline measure prior to surgery until the end of the intervention (approximately 8 weeks).
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Secondary outcome [1]
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nil
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Assessment method [1]
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Timepoint [1]
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nil
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Eligibility
Key inclusion criteria
Males and females aged between 25 and 65, and awaiting cardiac surgery.
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Minimum age
25
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
No prior incidence of major psychological disorders. Surgery not related to a traumatic incident.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant is awaiting cardiac surgery and has signed consent to participate. Subject will undertake initial screening to evaluate incidence of pre-existing PTSD or similar. They will receive an pack of information related to the study with full instructions on how to self-administer it. The allocation concealment will be performed by a computer program, and the treatment will be allocated according to the number that is assigned to each participant. The control and experimental treatments are issued to the participants in sealed opaque envelopes that is concealed from the researcher and distributor.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will involve the simple randomization generated from a computer program/software
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
2/06/2014
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5809
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Massey University
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Address [1]
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Private Bag 11-222
Palmerston North
Manawatu 4442
New Zealand
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Country [1]
288673
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New Zealand
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Primary sponsor type
University
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Name
Massey University
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Address
Private Bag 11-222
Palmerston North
Manawatu 4442
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Nil
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Address [1]
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Nil
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Country [1]
287381
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Health & Disability Ethics Committee
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Ethics committee address [1]
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Ministry of Health
No 1, The Terrace
PO Box 5013
Wellington 6145
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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13/02/2014
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Approval date [1]
290523
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Ethics approval number [1]
290523
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Summary
Brief summary
This study aims to investigate the efficacy of a psychoeducational treatment for people who survive the ICU, but develop post traumatic reactions to the medical interventions involved. The treatment will be given prior to surgery and outcomes measured. Previous research has suggested that people may benefit from using cognitive self-assessment skills and education regarding their surgery. It is intended that the treatment will alleviate PTSD symptomology.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Fleur Bethell
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Address
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Massey University
26 Norwood Road
Bayswater
Auckland 0622
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Country
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New Zealand
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Phone
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+64 276411886
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Ian de Terte
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Address
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Massey University
PO Box 756
Wellington 6140
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Country
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New Zealand
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Phone
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+64 48015799 x62033
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Fleur Bethell
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Address
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Massey University
26 Norwood Road
Bayswater
Auckland 0622
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Country
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New Zealand
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Phone
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+64 276411886
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Fax
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Email
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[email protected]
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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.
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